Trial Outcomes & Findings for Study of MEK162 for Children With Low-Grade Gliomas (NCT NCT02285439)
NCT ID: NCT02285439
Last Updated: 2025-10-07
Results Overview
For each stratum, the percentage of patients achieving at least a minor response (defined as greater than or equal to 25% decrease in maximal two dimensional measurements compared to baseline) during the first 12 cycles (nominally 48 weeks) of treatment will be reported.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
105 participants
Primary outcome timeframe
48 weeks
Results posted on
2025-10-07
Participant Flow
Participant milestones
| Measure |
Phase I Dose Level 1
Starting dose of 16 mg/m2/dose BID (twice a day) for patients with recurrent, refractory, or progressive non-hematologic malignancies (CNS or solid tumors) associated with activation of the RAS/RAF/ERK pathway, including any low grade glioma (LGG), any tumor in a patient with NF1, or any tumor with a documented activating BRAF, NRAS, or KRAS mutation, will be eligible. LGG is defined as any WHO grade I or II (or equivalent) astrocytic, oligodendroglial, and/or glioneuronal tumor.
|
Phase I Dose Level 2
Starting dose of 20 mg/m2/dose BID (twice a day) for patients with recurrent, refractory, or progressive non-hematologic malignancies (CNS or solid tumors) associated with activation of the RAS/RAF/ERK pathway, including any low grade glioma (LGG), any tumor in a patient with NF1, or any tumor with a documented activating BRAF, NRAS, or KRAS mutation, will be eligible. LGG is defined as any WHO grade I or II (or equivalent) astrocytic, oligodendroglial, and/or glioneuronal tumor.
|
Phase I Dose Level 3
Starting dose of 24 mg/m2/dose BID (twice a day) for patients with recurrent, refractory, or progressive non-hematologic malignancies (CNS or solid tumors) associated with activation of the RAS/RAF/ERK pathway, including any low grade glioma (LGG), any tumor in a patient with NF1, or any tumor with a documented activating BRAF, NRAS, or KRAS mutation, will be eligible. LGG is defined as any WHO grade I or II (or equivalent) astrocytic, oligodendroglial, and/or glioneuronal tumor.
|
Phase I Dose Level 4
Starting dose of 28 mg/m2/dose BID (twice a day) for patients with recurrent, refractory, or progressive non-hematologic malignancies (CNS or solid tumors) associated with activation of the RAS/RAF/ERK pathway, including any low grade glioma (LGG), any tumor in a patient with NF1, or any tumor with a documented activating BRAF, NRAS, or KRAS mutation, will be eligible. LGG is defined as any WHO grade I or II (or equivalent) astrocytic, oligodendroglial, and/or glioneuronal tumor.
|
Phase I Dose Level 5
Starting dose of 32 mg/m2/dose BID (twice a day) for patients with recurrent, refractory, or progressive non-hematologic malignancies (CNS or solid tumors) associated with activation of the RAS/RAF/ERK pathway, including any low grade glioma (LGG), any tumor in a patient with NF1, or any tumor with a documented activating BRAF, NRAS, or KRAS mutation, will be eligible. LGG is defined as any WHO grade I or II (or equivalent) astrocytic, oligodendroglial, and/or glioneuronal tumor.
|
Phase II Stratum 1
Starting dose of 32 mg/m2/dose BID (twice a day) for patients with a recurrent or progressive low grade glioma (LGG) with a BRAF truncated fusion that is measurable in at least two dimensions on imaging
|
Phase II Stratum 2
Starting dose of 32 mg/m2/dose BID (twice a day) for NF1 patients with a recurrent or progressive low grade glioma (LGG) that is measurable in at least two dimensions on imaging
|
Phase II Stratum 3
Starting dose of 32 mg/m2/dose BID (twice a day) for patients with a recurrent or progressive tumor thought to involve the Ras/Raf/ERK pathway but not included in Stratum 1 or 2. This includes any low grade glioma (LGG) not included in Stratum 1 or 2 (any LGG without a BRAF truncated fusion in a patient without NF1), any tumor other than LGG in a patient with NF1, and any other tumor with a documented activating BRAF, NRAS, or KRAS mutation.
|
Phase II Stratum 4 - Surgical Arm, Target Validation
Starting dose of 32 mg/m2/dose BID (twice a day) continuous administration for 7-21 days followed by biopsy or resection. Then restarting BID administration after surgery. For patients who meet criteria for stratum 1, 2, or 3 for whom tumor biopsy and/or resection is clinically indicated. Re-institute MEK162 BID after recovery from tumor resection.
|
|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
4
|
3
|
3
|
3
|
6
|
27
|
22
|
30
|
7
|
|
Overall Study
Dose Limiting Toxicity Evaluable
|
3
|
3
|
3
|
3
|
6
|
26
|
20
|
28
|
7
|
|
Overall Study
COMPLETED
|
3
|
2
|
3
|
0
|
3
|
9
|
17
|
23
|
5
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
0
|
3
|
3
|
18
|
5
|
7
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of MEK162 for Children With Low-Grade Gliomas
Baseline characteristics by cohort
| Measure |
Phase I Dose Level 1
n=4 Participants
Starting dose of 16 mg/m2/dose BID for patients with recurrent, refractory, or progressive non-hematologic malignancies (CNS or solid tumors) associated with activation of the RAS/RAF/ERK pathway, including any LGG, any tumor in a patient with NF1, or any tumor with a documented activating BRAF, NRAS, or KRAS mutation, will be eligible. LGG is defined as any WHO grade I or II (or equivalent) astrocytic, oligodendroglial, and/or glioneuronal tumor.
|
Phase I Dose Level 2
n=3 Participants
Starting dose of 20 mg/m2/dose BID for patients with recurrent, refractory, or progressive non-hematologic malignancies (CNS or solid tumors) associated with activation of the RAS/RAF/ERK pathway, including any LGG, any tumor in a patient with NF1, or any tumor with a documented activating BRAF, NRAS, or KRAS mutation, will be eligible. LGG is defined as any WHO grade I or II (or equivalent) astrocytic, oligodendroglial, and/or glioneuronal tumor.
|
Phase I Dose Level 3
n=3 Participants
Starting dose of 24 mg/m2/dose BID for patients with recurrent, refractory, or progressive non-hematologic malignancies (CNS or solid tumors) associated with activation of the RAS/RAF/ERK pathway, including any LGG, any tumor in a patient with NF1, or any tumor with a documented activating BRAF, NRAS, or KRAS mutation, will be eligible. LGG is defined as any WHO grade I or II (or equivalent) astrocytic, oligodendroglial, and/or glioneuronal tumor.
|
Phase I Dose Level 4
n=3 Participants
Starting dose of 28 mg/m2/dose BID for patients with recurrent, refractory, or progressive non-hematologic malignancies (CNS or solid tumors) associated with activation of the RAS/RAF/ERK pathway, including any LGG, any tumor in a patient with NF1, or any tumor with a documented activating BRAF, NRAS, or KRAS mutation, will be eligible. LGG is defined as any WHO grade I or II (or equivalent) astrocytic, oligodendroglial, and/or glioneuronal tumor.
|
Phase I Dose Level 5
n=6 Participants
Starting dose of 32 mg/m2/dose BID for patients with recurrent, refractory, or progressive non-hematologic malignancies (CNS or solid tumors) associated with activation of the RAS/RAF/ERK pathway, including any LGG, any tumor in a patient with NF1, or any tumor with a documented activating BRAF, NRAS, or KRAS mutation, will be eligible. LGG is defined as any WHO grade I or II (or equivalent) astrocytic, oligodendroglial, and/or glioneuronal tumor.
|
Phase II Stratum 1
n=27 Participants
Starting dose of 32 mg/m2/dose BID for patients with a recurrent or progressive LGG with a BRAF truncated fusion that is measurable in at least two dimensions on imaging
|
Phase II Stratum 2
n=22 Participants
Starting dose of 32 mg/m2/dose BID for NF1 patients with a recurrent or progressive LGG that is measurable in at least two dimensions on imaging
|
Phase II Stratum 3
n=30 Participants
Starting dose of 32 mg/m2/dose BID for patients with a recurrent or progressive tumor thought to involve the Ras/Raf/ERK pathway but not included in stratum 1 or 2 that is measurable in at least two dimensions on imaging. This includes any LGG not included in strata 1 or 2 (i.e., any LGG without a BRAF truncated fusion in a patient without NF1), any tumor other than LGG in a patient with NF1, and any other tumor with a documented activating BRAF, NRAS, or KRAS mutation.
|
Phase II Stratum 4 (Surgical Arm, Target Validation
n=7 Participants
Starting dose of 32 mg/m2/dose BID for patients who meet criteria for stratum 1, 2, or 3 for whom tumor biopsy and/or resection is clinically indicated.
|
Total
n=105 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
4 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=31 Participants
|
27 Participants
n=30 Participants
|
22 Participants
n=3 Participants
|
30 Participants
n=6 Participants
|
7 Participants
n=114 Participants
|
105 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
0 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
0 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=31 Participants
|
14 Participants
n=30 Participants
|
12 Participants
n=3 Participants
|
13 Participants
n=6 Participants
|
4 Participants
n=114 Participants
|
55 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=31 Participants
|
13 Participants
n=30 Participants
|
10 Participants
n=3 Participants
|
17 Participants
n=6 Participants
|
3 Participants
n=114 Participants
|
50 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
2 Participants
n=30 Participants
|
2 Participants
n=3 Participants
|
7 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
14 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=31 Participants
|
24 Participants
n=30 Participants
|
19 Participants
n=3 Participants
|
22 Participants
n=6 Participants
|
6 Participants
n=114 Participants
|
85 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
1 Participants
n=30 Participants
|
1 Participants
n=3 Participants
|
1 Participants
n=6 Participants
|
1 Participants
n=114 Participants
|
6 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
1 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
1 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
0 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
1 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
1 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
3 Participants
n=30 Participants
|
1 Participants
n=3 Participants
|
3 Participants
n=6 Participants
|
2 Participants
n=114 Participants
|
11 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=31 Participants
|
21 Participants
n=30 Participants
|
19 Participants
n=3 Participants
|
20 Participants
n=6 Participants
|
3 Participants
n=114 Participants
|
76 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
0 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
3 Participants
n=30 Participants
|
2 Participants
n=3 Participants
|
5 Participants
n=6 Participants
|
2 Participants
n=114 Participants
|
16 Participants
|
PRIMARY outcome
Timeframe: 48 weeksPopulation: Phase II Stratum 2 population n=22; Analysis population n=21. One patient enrolled to this stratum did not initiate treatment and was excluded from analysis.
For each stratum, the percentage of patients achieving at least a minor response (defined as greater than or equal to 25% decrease in maximal two dimensional measurements compared to baseline) during the first 12 cycles (nominally 48 weeks) of treatment will be reported.
Outcome measures
| Measure |
Phase II Stratum 1
n=27 Participants
Starting dose of 32 mg/m2/dose BID for patients with a recurrent or progressive LGG with a BRAF truncated fusion that is measurable in at least two dimensions on imaging
|
Phase II Stratum 2
n=21 Participants
Starting dose of 32 mg/m2/dose BID (twice a day) for NF1 patients with a recurrent or progressive low grade glioma (LGG) that is measurable in at least two dimensions on imaging
|
|---|---|---|
|
Best Overall Response Rate (Strata 1 and 2)
|
15 Participants
|
12 Participants
|
PRIMARY outcome
Timeframe: 48 weeksPopulation: Phase II Stratum 2 population n=22; Analysis population n=21. One patient enrolled to this stratum did not initiate treatment and was excluded from analysis.
Progression free and overall survival will be reported as Kaplan-Meier estimate who are alive without disease progression, alive with disease progression, deceased without disease progression, and deceased with disease progression 12 cycles (48 weeks) after treatment initiation.
Outcome measures
| Measure |
Phase II Stratum 1
n=27 Participants
Starting dose of 32 mg/m2/dose BID for patients with a recurrent or progressive LGG with a BRAF truncated fusion that is measurable in at least two dimensions on imaging
|
Phase II Stratum 2
n=21 Participants
Starting dose of 32 mg/m2/dose BID (twice a day) for NF1 patients with a recurrent or progressive low grade glioma (LGG) that is measurable in at least two dimensions on imaging
|
|---|---|---|
|
12 Cycle Progression-free and Overall Survival (Strata 1 and 2)
Overall Survival at 12 cycles
|
95.8 percentage of participants
Interval 73.9 to 99.4
|
100 percentage of participants
All patients are surviving
|
|
12 Cycle Progression-free and Overall Survival (Strata 1 and 2)
Progression Free Survival at 12 cycles
|
59.1 percentage of participants
Interval 37.1 to 75.7
|
90.0 percentage of participants
Interval 65.6 to 97.4
|
Adverse Events
Phase I Dose Level 1
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Phase I Dose Level 2
Serious events: 2 serious events
Other events: 2 other events
Deaths: 0 deaths
Phase I Dose Level 3
Serious events: 2 serious events
Other events: 2 other events
Deaths: 0 deaths
Phase I Dose Level 4
Serious events: 3 serious events
Other events: 1 other events
Deaths: 0 deaths
Phase I Dose Level 5
Serious events: 4 serious events
Other events: 6 other events
Deaths: 0 deaths
Phase II Stratum 1
Serious events: 12 serious events
Other events: 19 other events
Deaths: 0 deaths
Phase II Stratum 2
Serious events: 6 serious events
Other events: 13 other events
Deaths: 0 deaths
Phase II Stratum 3
Serious events: 12 serious events
Other events: 20 other events
Deaths: 0 deaths
Phase II Stratum 4 (Surgical Arm, Target Validation)
Serious events: 5 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Phase I Dose Level 1
n=4 participants at risk
Starting dose of 16 mg/m2/dose BID for patients with recurrent, refractory, or progressive non-hematologic malignancies (CNS or solid tumors) associated with activation of the RAS/RAF/ERK pathway, including any LGG, any tumor in a patient with NF1, or any tumor with a documented activating BRAF, NRAS, or KRAS mutation, will be eligible. LGG is defined as any WHO grade I or II (or equivalent) astrocytic, oligodendroglial, and/or glioneuronal tumor.
|
Phase I Dose Level 2
n=3 participants at risk
Children with recurrent tumors signaling through the Ras/Raf pathway will be treated in 3 strata to define the activity of MEK162. S1: Children with LGG characterized by a BRAF truncated fusion (KIAA1549 and similar translocations). S2: Children with NF1 and LGG. S 3: Children with tumors involving the Ras/Raf pathway not included in strata 1 or 2.
MEK162: • MEK162 is currently supplied as film-coated tablets in dose strength of 15 mg. The film-coated tablets consist of MEK162 drug substance, lactose monohydrate, microcrystalline cellulose, colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, and a commercial film coating. The original tablets are yellow to dark yellow capsule-shaped
|
Phase I Dose Level 3
n=3 participants at risk
Starting dose of 24 mg/m2/dose BID for patients with recurrent, refractory, or progressive non-hematologic malignancies (CNS or solid tumors) associated with activation of the RAS/RAF/ERK pathway, including any LGG, any tumor in a patient with NF1, or any tumor with a documented activating BRAF, NRAS, or KRAS mutation, will be eligible. LGG is defined as any WHO grade I or II (or equivalent) astrocytic, oligodendroglial, and/or glioneuronal tumor.
|
Phase I Dose Level 4
n=3 participants at risk
Starting dose of 28 mg/m2/dose BID for patients with recurrent, refractory, or progressive non-hematologic malignancies (CNS or solid tumors) associated with activation of the RAS/RAF/ERK pathway, including any LGG, any tumor in a patient with NF1, or any tumor with a documented activating BRAF, NRAS, or KRAS mutation, will be eligible. LGG is defined as any WHO grade I or II (or equivalent) astrocytic, oligodendroglial, and/or glioneuronal tumor.
|
Phase I Dose Level 5
n=6 participants at risk
Starting dose of 32 mg/m2/dose BID for patients with recurrent, refractory, or progressive non-hematologic malignancies (CNS or solid tumors) associated with activation of the RAS/RAF/ERK pathway, including any LGG, any tumor in a patient with NF1, or any tumor with a documented activating BRAF, NRAS, or KRAS mutation, will be eligible. LGG is defined as any WHO grade I or II (or equivalent) astrocytic, oligodendroglial, and/or glioneuronal tumor.
|
Phase II Stratum 1
n=27 participants at risk
Starting dose of 32 mg/m2/dose BID for patients with a recurrent or progressive LGG with a BRAF truncated fusion that is measurable in at least two dimensions on imaging
|
Phase II Stratum 2
n=22 participants at risk
Starting dose of 32 mg/m2/dose BID for NF1 patients with a recurrent or progressive LGG that is measurable in at least two dimensions on imaging
|
Phase II Stratum 3
n=30 participants at risk
Starting dose of 32 mg/m2/dose BID for patients with a recurrent or progressive tumor thought to involve the Ras/Raf/ERK pathway but not included in stratum 1 or 2 that is measurable in at least two dimensions on imaging. This includes any LGG not included in strata 1 or 2 (i.e., any LGG without a BRAF truncated fusion in a patient without NF1), any tumor other than LGG in a patient with NF1, and any other tumor with a documented activating BRAF, NRAS, or KRAS mutation.
|
Phase II Stratum 4 (Surgical Arm, Target Validation)
n=7 participants at risk
Starting dose of 32 mg/m2/dose BID for patients who meet criteria for stratum 1, 2, or 3 for whom tumor biopsy and/or resection is clinically indicated.
|
|---|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/4 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/6 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
3.7%
1/27 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/21 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/30 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/7 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/4 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/6 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/27 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
4.8%
1/21 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/30 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
14.3%
1/7 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/4 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/6 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/27 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
4.8%
1/21 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/30 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/7 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/4 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/6 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
3.7%
1/27 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/21 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/30 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/7 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/4 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/6 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
3.7%
1/27 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/21 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/30 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/7 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/4 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
33.3%
1/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/6 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/27 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/21 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/30 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/7 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/4 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/6 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/27 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
4.8%
1/21 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/30 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/7 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/4 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/6 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/27 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
4.8%
1/21 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/30 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/7 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify
|
0.00%
0/4 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/6 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
7.4%
2/27 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/21 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
3.3%
1/30 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/7 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
|
Gastrointestinal disorders
Mucositis oral
|
0.00%
0/4 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/6 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
3.7%
1/27 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/21 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/30 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/7 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/4 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
66.7%
2/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/6 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
14.8%
4/27 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/21 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
3.3%
1/30 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/7 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
|
General disorders
Edema face
|
0.00%
0/4 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
33.3%
1/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/6 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/27 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/21 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/30 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/7 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
|
General disorders
Edema limbs
|
0.00%
0/4 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/6 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
3.7%
1/27 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/21 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/30 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/7 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
|
General disorders
Fatigue
|
0.00%
0/4 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/6 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
3.7%
1/27 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/21 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/30 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/7 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
|
General disorders
Fever
|
0.00%
0/4 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/6 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
7.4%
2/27 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
4.8%
1/21 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/30 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
28.6%
2/7 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
|
General disorders
Flu like symptoms
|
0.00%
0/4 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/6 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
7.4%
2/27 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/21 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/30 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/7 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
|
General disorders
Gait disturbance
|
0.00%
0/4 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/6 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
7.4%
2/27 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/21 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/30 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/7 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
|
General disorders
Hypothermia
|
0.00%
0/4 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/6 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
3.7%
1/27 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/21 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
3.3%
1/30 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/7 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
|
General disorders
Pain
|
0.00%
0/4 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/6 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
3.7%
1/27 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/21 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
6.7%
2/30 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/7 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
|
Infections and infestations
Bone infection
|
0.00%
0/4 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
33.3%
1/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/6 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/27 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/21 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/30 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/7 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
|
Infections and infestations
Bronchial infection
|
0.00%
0/4 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/6 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/27 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
4.8%
1/21 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
3.3%
1/30 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/7 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
|
Infections and infestations
Catheter related infection
|
0.00%
0/4 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/6 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/27 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/21 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/30 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
14.3%
1/7 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
|
Infections and infestations
Infections and infestations - Other, specify
|
0.00%
0/4 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
33.3%
1/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/6 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/27 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
4.8%
1/21 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/30 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
14.3%
1/7 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
|
Infections and infestations
Infective myositis
|
0.00%
0/4 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
33.3%
1/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/6 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/27 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/21 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/30 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/7 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
|
Infections and infestations
Lung infection
|
0.00%
0/4 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/6 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
11.1%
3/27 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/21 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/30 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/7 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
|
Infections and infestations
Sepsis
|
0.00%
0/4 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/6 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/27 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
4.8%
1/21 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/30 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/7 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/4 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/6 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/27 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
4.8%
1/21 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/30 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/7 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
|
Infections and infestations
Skin infection
|
0.00%
0/4 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/6 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
7.4%
2/27 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
9.5%
2/21 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/30 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/7 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
|
Infections and infestations
Upper respiratory infection
|
0.00%
0/4 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/6 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
3.7%
1/27 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
4.8%
1/21 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
3.3%
1/30 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/7 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/4 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/6 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/27 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/21 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
3.3%
1/30 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/7 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/4 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
16.7%
1/6 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
3.7%
1/27 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/21 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/30 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/7 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
|
Investigations
CPK increased
|
0.00%
0/4 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/6 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
7.4%
2/27 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/21 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/30 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/7 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/4 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/6 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/27 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
4.8%
1/21 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/30 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/7 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/4 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/6 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/27 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
9.5%
2/21 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/30 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/7 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
|
Metabolism and nutrition disorders
Hypernatremia
|
0.00%
0/4 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/6 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
3.7%
1/27 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/21 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/30 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
14.3%
1/7 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
0.00%
0/4 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
33.3%
1/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/6 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/27 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/21 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/30 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/7 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/4 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/6 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/27 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/21 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/30 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
14.3%
1/7 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/4 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
33.3%
1/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
33.3%
1/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
16.7%
1/6 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
3.7%
1/27 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
4.8%
1/21 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/30 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/7 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/4 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
33.3%
1/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/6 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/27 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/21 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/30 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/7 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
0.00%
0/4 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/6 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/27 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/21 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
10.0%
3/30 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/7 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
0.00%
0/4 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/6 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/27 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
4.8%
1/21 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/30 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/7 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/4 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/6 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
3.7%
1/27 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/21 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/30 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/7 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
|
Nervous system disorders
Depressed level of consciousness
|
0.00%
0/4 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
33.3%
1/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/6 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/27 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/21 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/30 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
14.3%
1/7 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/4 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/6 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/27 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/21 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
3.3%
1/30 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/7 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
|
Nervous system disorders
Headache
|
0.00%
0/4 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/6 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
3.7%
1/27 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/21 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
6.7%
2/30 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/7 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
|
Nervous system disorders
Hydrocephalus
|
0.00%
0/4 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
16.7%
1/6 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
7.4%
2/27 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/21 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
6.7%
2/30 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/7 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
|
Nervous system disorders
Intracranial hemorrhage
|
0.00%
0/4 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/6 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/27 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/21 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/30 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
14.3%
1/7 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
|
Nervous system disorders
Seizure
|
0.00%
0/4 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
33.3%
1/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/6 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/27 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/21 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
3.3%
1/30 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/7 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/4 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
16.7%
1/6 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/27 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/21 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/30 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/7 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
|
Psychiatric disorders
Suicide attempt
|
0.00%
0/4 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
16.7%
1/6 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/27 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/21 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/30 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/7 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/4 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
33.3%
1/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/6 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/27 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/21 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/30 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/7 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.00%
0/4 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/6 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
3.7%
1/27 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/21 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/30 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/7 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/4 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/6 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
3.7%
1/27 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/21 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/30 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/7 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/4 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/6 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
3.7%
1/27 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/21 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/30 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/7 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/4 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
16.7%
1/6 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
3.7%
1/27 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/21 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/30 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/7 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/4 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
33.3%
1/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
16.7%
1/6 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/27 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
4.8%
1/21 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/30 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/7 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/4 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/6 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/27 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/21 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
3.3%
1/30 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/7 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, specify
|
0.00%
0/4 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
16.7%
1/6 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/27 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
4.8%
1/21 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/30 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/7 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
|
Skin and subcutaneous tissue disorders
Photosensitivity
|
0.00%
0/4 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/6 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/27 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/21 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/30 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
14.3%
1/7 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
0.00%
0/4 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/6 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/27 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/21 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
3.3%
1/30 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/7 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify
|
0.00%
0/4 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/6 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
3.7%
1/27 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/21 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/30 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/7 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
|
Surgical and medical procedures
Surgical and medical procedures - Other, specify
|
0.00%
0/4 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
16.7%
1/6 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/27 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/21 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/30 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/7 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
|
Vascular disorders
Hypertension
|
0.00%
0/4 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/6 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
3.7%
1/27 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/21 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/30 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/7 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
|
Vascular disorders
Hypotension
|
0.00%
0/4 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/6 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/27 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/21 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
3.3%
1/30 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
14.3%
1/7 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
|
Vascular disorders
Thromboembolic event
|
0.00%
0/4 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/6 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/27 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/21 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
3.3%
1/30 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/7 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
Other adverse events
| Measure |
Phase I Dose Level 1
n=4 participants at risk
Starting dose of 16 mg/m2/dose BID for patients with recurrent, refractory, or progressive non-hematologic malignancies (CNS or solid tumors) associated with activation of the RAS/RAF/ERK pathway, including any LGG, any tumor in a patient with NF1, or any tumor with a documented activating BRAF, NRAS, or KRAS mutation, will be eligible. LGG is defined as any WHO grade I or II (or equivalent) astrocytic, oligodendroglial, and/or glioneuronal tumor.
|
Phase I Dose Level 2
n=3 participants at risk
Children with recurrent tumors signaling through the Ras/Raf pathway will be treated in 3 strata to define the activity of MEK162. S1: Children with LGG characterized by a BRAF truncated fusion (KIAA1549 and similar translocations). S2: Children with NF1 and LGG. S 3: Children with tumors involving the Ras/Raf pathway not included in strata 1 or 2.
MEK162: • MEK162 is currently supplied as film-coated tablets in dose strength of 15 mg. The film-coated tablets consist of MEK162 drug substance, lactose monohydrate, microcrystalline cellulose, colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, and a commercial film coating. The original tablets are yellow to dark yellow capsule-shaped
|
Phase I Dose Level 3
n=3 participants at risk
Starting dose of 24 mg/m2/dose BID for patients with recurrent, refractory, or progressive non-hematologic malignancies (CNS or solid tumors) associated with activation of the RAS/RAF/ERK pathway, including any LGG, any tumor in a patient with NF1, or any tumor with a documented activating BRAF, NRAS, or KRAS mutation, will be eligible. LGG is defined as any WHO grade I or II (or equivalent) astrocytic, oligodendroglial, and/or glioneuronal tumor.
|
Phase I Dose Level 4
n=3 participants at risk
Starting dose of 28 mg/m2/dose BID for patients with recurrent, refractory, or progressive non-hematologic malignancies (CNS or solid tumors) associated with activation of the RAS/RAF/ERK pathway, including any LGG, any tumor in a patient with NF1, or any tumor with a documented activating BRAF, NRAS, or KRAS mutation, will be eligible. LGG is defined as any WHO grade I or II (or equivalent) astrocytic, oligodendroglial, and/or glioneuronal tumor.
|
Phase I Dose Level 5
n=6 participants at risk
Starting dose of 32 mg/m2/dose BID for patients with recurrent, refractory, or progressive non-hematologic malignancies (CNS or solid tumors) associated with activation of the RAS/RAF/ERK pathway, including any LGG, any tumor in a patient with NF1, or any tumor with a documented activating BRAF, NRAS, or KRAS mutation, will be eligible. LGG is defined as any WHO grade I or II (or equivalent) astrocytic, oligodendroglial, and/or glioneuronal tumor.
|
Phase II Stratum 1
n=27 participants at risk
Starting dose of 32 mg/m2/dose BID for patients with a recurrent or progressive LGG with a BRAF truncated fusion that is measurable in at least two dimensions on imaging
|
Phase II Stratum 2
n=22 participants at risk
Starting dose of 32 mg/m2/dose BID for NF1 patients with a recurrent or progressive LGG that is measurable in at least two dimensions on imaging
|
Phase II Stratum 3
n=30 participants at risk
Starting dose of 32 mg/m2/dose BID for patients with a recurrent or progressive tumor thought to involve the Ras/Raf/ERK pathway but not included in stratum 1 or 2 that is measurable in at least two dimensions on imaging. This includes any LGG not included in strata 1 or 2 (i.e., any LGG without a BRAF truncated fusion in a patient without NF1), any tumor other than LGG in a patient with NF1, and any other tumor with a documented activating BRAF, NRAS, or KRAS mutation.
|
Phase II Stratum 4 (Surgical Arm, Target Validation)
n=7 participants at risk
Starting dose of 32 mg/m2/dose BID for patients who meet criteria for stratum 1, 2, or 3 for whom tumor biopsy and/or resection is clinically indicated.
|
|---|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/4 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
33.3%
1/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
16.7%
1/6 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/27 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
9.5%
2/21 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/30 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/7 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/4 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
33.3%
1/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
33.3%
1/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/6 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/27 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
4.8%
1/21 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/30 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/7 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/4 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/6 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/27 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/21 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
3.3%
1/30 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/7 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
|
Cardiac disorders
Left ventricular systolic dysfunction
|
0.00%
0/4 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/6 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/27 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
4.8%
1/21 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
3.3%
1/30 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/7 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/4 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
16.7%
1/6 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
3.7%
1/27 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/21 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/30 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/7 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
|
Eye disorders
Optic nerve disorder
|
0.00%
0/4 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/6 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
3.7%
1/27 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/21 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
3.3%
1/30 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/7 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/4 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
16.7%
1/6 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
3.7%
1/27 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/21 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/30 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/7 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/4 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/6 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
3.7%
1/27 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/21 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/30 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/7 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/4 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
33.3%
1/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/6 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/27 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
9.5%
2/21 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/30 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/7 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
|
General disorders
Edema limbs
|
0.00%
0/4 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/6 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
7.4%
2/27 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/21 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/30 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/7 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, specify
|
0.00%
0/4 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
16.7%
1/6 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/27 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/21 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/30 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/7 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
|
General disorders
Edema trunk
|
0.00%
0/4 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/6 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
3.7%
1/27 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/21 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/30 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/7 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
|
General disorders
Fatigue
|
0.00%
0/4 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
16.7%
1/6 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/27 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/21 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
3.3%
1/30 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/7 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
|
General disorders
Fever
|
0.00%
0/4 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
16.7%
1/6 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/27 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/21 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/30 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/7 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
|
General disorders
Flu like symptoms
|
0.00%
0/4 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/6 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
3.7%
1/27 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/21 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/30 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/7 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
|
General disorders
Irritability
|
0.00%
0/4 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/6 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/27 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/21 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/30 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
14.3%
1/7 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
|
Infections and infestations
Papulopustular rash
|
0.00%
0/4 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/6 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/27 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
4.8%
1/21 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/30 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/7 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
|
Infections and infestations
Paronychia
|
0.00%
0/4 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/6 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
3.7%
1/27 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/21 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
6.7%
2/30 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/7 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
|
Infections and infestations
Peritoneal infection
|
0.00%
0/4 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
16.7%
1/6 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/27 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/21 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/30 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/7 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/4 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
16.7%
1/6 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/27 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/21 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/30 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/7 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
|
Infections and infestations
Rash pustular
|
0.00%
0/4 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/6 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/27 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/21 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/30 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
14.3%
1/7 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/4 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
16.7%
1/6 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/27 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/21 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/30 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/7 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
|
Injury, poisoning and procedural complications
Pharyngeal anastomotic leak
|
0.00%
0/4 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
16.7%
1/6 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/27 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/21 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/30 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/7 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
0.00%
0/4 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/6 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
3.7%
1/27 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/21 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/30 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/7 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
|
Investigations
Activated partial thromboplastin time prolonged
|
0.00%
0/4 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
16.7%
1/6 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/27 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/21 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/30 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/7 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/4 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/6 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
3.7%
1/27 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/21 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
3.3%
1/30 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/7 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/4 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/6 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
3.7%
1/27 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
4.8%
1/21 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
3.3%
1/30 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/7 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
|
Investigations
CPK increased
|
25.0%
1/4 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
33.3%
1/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
33.3%
2/6 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
11.1%
3/27 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
23.8%
5/21 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
23.3%
7/30 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
28.6%
2/7 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
|
Investigations
Creatinine increased
|
0.00%
0/4 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/6 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/27 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/21 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
3.3%
1/30 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/7 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
|
Investigations
Ejection fraction decreased
|
0.00%
0/4 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/6 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
3.7%
1/27 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
4.8%
1/21 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
3.3%
1/30 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/7 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
|
Investigations
Investigations - Other, specify
|
0.00%
0/4 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
33.3%
1/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/6 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/27 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/21 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/30 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/7 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/4 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
16.7%
1/6 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/27 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/21 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/30 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/7 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/4 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
33.3%
1/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
16.7%
1/6 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
3.7%
1/27 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/21 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
3.3%
1/30 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/7 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
|
Investigations
Weight gain
|
0.00%
0/4 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/6 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
11.1%
3/27 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
4.8%
1/21 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
16.7%
5/30 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
28.6%
2/7 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/4 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/6 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
3.7%
1/27 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/21 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/30 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/7 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/4 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/6 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
7.4%
2/27 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/21 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/30 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/7 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
|
Metabolism and nutrition disorders
Hypernatremia
|
0.00%
0/4 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/6 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/27 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/21 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/30 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
14.3%
1/7 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
0.00%
0/4 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/6 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/27 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
4.8%
1/21 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/30 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/7 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
0.00%
0/4 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/6 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/27 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/21 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/30 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
14.3%
1/7 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/4 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
33.3%
2/6 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
3.7%
1/27 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/21 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/30 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/7 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/4 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
33.3%
1/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
33.3%
1/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/6 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/27 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
4.8%
1/21 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/30 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/7 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
0.00%
0/4 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/6 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
3.7%
1/27 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/21 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
3.3%
1/30 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/7 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
0.00%
0/4 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/6 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
7.4%
2/27 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/21 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
6.7%
2/30 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/7 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
|
Musculoskeletal and connective tissue disorders
Joint range of motion decreased
|
0.00%
0/4 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/6 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/27 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
4.8%
1/21 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/30 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/7 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
0.00%
0/4 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/6 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/27 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
4.8%
1/21 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/30 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/7 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness upper limb
|
0.00%
0/4 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
16.7%
1/6 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
3.7%
1/27 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
4.8%
1/21 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/30 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/7 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/4 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/6 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/27 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/21 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
3.3%
1/30 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/7 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
|
Nervous system disorders
Headache
|
0.00%
0/4 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/6 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/27 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/21 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/30 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
14.3%
1/7 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
|
Nervous system disorders
Hydrocephalus
|
0.00%
0/4 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
33.3%
1/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
16.7%
1/6 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/27 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/21 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
3.3%
1/30 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/7 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
|
Nervous system disorders
Seizure
|
0.00%
0/4 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
16.7%
1/6 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/27 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/21 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/30 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/7 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
|
Nervous system disorders
Syncope
|
0.00%
0/4 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/6 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/27 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
4.8%
1/21 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/30 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
14.3%
1/7 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
|
Renal and urinary disorders
Hematuria
|
0.00%
0/4 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
16.7%
1/6 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/27 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
4.8%
1/21 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/30 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/7 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/4 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
16.7%
1/6 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/27 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/21 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/30 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/7 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/4 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
16.7%
1/6 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/27 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/21 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/30 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/7 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
0.00%
0/4 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
33.3%
1/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/6 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
3.7%
1/27 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
14.3%
3/21 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
13.3%
4/30 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
14.3%
1/7 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/4 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
33.3%
1/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
16.7%
1/6 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
11.1%
3/27 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
14.3%
3/21 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
10.0%
3/30 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/7 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify
|
0.00%
0/4 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/6 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/27 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/21 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
3.3%
1/30 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/7 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
|
Surgical and medical procedures
Surgical and medical procedures - Other, specify
|
0.00%
0/4 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
16.7%
1/6 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/27 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/21 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/30 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/7 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
|
Vascular disorders
Hypertension
|
0.00%
0/4 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/3 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/6 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
0.00%
0/27 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
9.5%
2/21 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
10.0%
3/30 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
14.3%
1/7 • From time of first dose of investigational product through 30 days after last dose (maximum 96 weeks treatment duration)
For non-serious adverse events, maximum AE grades 3 or 4 were reported regardless of attribution. Only one instance of each AE name is reported per subject.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place