Trial Outcomes & Findings for A Phase II Study to Evaluate the Efficacy and Safety of Oral Ceritinib in Patients With ALK-positive NSCLC Metastatic to the Brain and/or to Leptomeninges (NCT NCT02336451)
NCT ID: NCT02336451
Last Updated: 2020-04-21
Results Overview
Overall response rate (ORR) is defined as the percentage of participants with a best overall confirmed response of complete response (CR) or partial response (PR) in the whole body as assessed per RECIST 1.1 by the investigator. CR: Disappearance of all non-nodal target and non-target lesions. In addition, all lymph nodes assigned a target or a non-target lesions must be non-pathological in size (\< 10 mm short axis), and no new lesion is identified. PR: When all target lesions have disappeared or there is a decrease by at least 30% in the sum of diameter of all target lesions (taking as reference the baseline sum of diameters) is observed \& non-target lesions are not in progression or in complete response.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
156 participants
Primary outcome timeframe
43 months
Results posted on
2020-04-21
Participant Flow
A total of 156 patients were enrolled and treated with ceritinib. The FAS (N=156) included all patients who received at least one dose of ceritinib with 42, 40, 12, 44 and 18 patients in arms 1 to 5 respectively. The Safety set was identical to full analysis set in this study.
Approximately 160 patients were planned to be enrolled.
Participant milestones
| Measure |
Arm 1 (PrALKi=Y, PrBRad=Y)
Participants with metastases in the brain without evidence of leptomeningeal carcinomatosis (LC), previously treated with radiation to the brain and with prior exposure to an Anaplastic lymphoma kinase inhibitor (ALK-I). Previous treatment with ALK-I other than crizotinib was not allowed in this arm as of protocol amendment 3 and had to present with active brain lesion defined as a lesion free of any local treatment (like stereotactic radiosurgery or whole brain radiation).
|
Arm 2 (PrALKi=Y, PrBRad=N)
Participants with metastases in the brain without evidence of LC, previously untreated with radiation to the brain but with prior exposure to an ALK-I. Previous treatment with ALK-I other than crizotinib was not allowed in this arm 2 as of protocol amendment 3 and had to present with active brain lesion defined as a lesion free of any local treatment (like stereotactic radiosurgery or whole brain radiation).
|
Arm 3 (PrALKi=N, PrBRad=Y)
Participants with metastases in the brain without evidence of LC, previously treated with radiation to the brain but with no prior exposure to an ALK-I. Participants in this arm had to present with active brain lesion defined as a lesion free of any local treatment (like stereotactic radiosurgery or whole brain radiation).
|
Arm 4 (PrALKi=N, PrBRad=N)
Participants with metastases in the brain without evidence of LC, previously untreated with radiation to the brain and with no prior exposure to an ALK-I. Participants in this arm had to present with active brain lesion defined as a lesion free of any local treatment (like stereotactic radiosurgery or whole brain radiation).
|
Arm 5 (LepDis)
Participants had LC with or without evidence of active lesion at the baseline Gadolinium-enhanced brain magnetic resonance imaging (MRI). Previous treatment with ALK-I other than crizotinib was not allowed in this arm as of protocol amendment 3.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
42
|
40
|
12
|
44
|
18
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
42
|
40
|
12
|
44
|
18
|
Reasons for withdrawal
| Measure |
Arm 1 (PrALKi=Y, PrBRad=Y)
Participants with metastases in the brain without evidence of leptomeningeal carcinomatosis (LC), previously treated with radiation to the brain and with prior exposure to an Anaplastic lymphoma kinase inhibitor (ALK-I). Previous treatment with ALK-I other than crizotinib was not allowed in this arm as of protocol amendment 3 and had to present with active brain lesion defined as a lesion free of any local treatment (like stereotactic radiosurgery or whole brain radiation).
|
Arm 2 (PrALKi=Y, PrBRad=N)
Participants with metastases in the brain without evidence of LC, previously untreated with radiation to the brain but with prior exposure to an ALK-I. Previous treatment with ALK-I other than crizotinib was not allowed in this arm 2 as of protocol amendment 3 and had to present with active brain lesion defined as a lesion free of any local treatment (like stereotactic radiosurgery or whole brain radiation).
|
Arm 3 (PrALKi=N, PrBRad=Y)
Participants with metastases in the brain without evidence of LC, previously treated with radiation to the brain but with no prior exposure to an ALK-I. Participants in this arm had to present with active brain lesion defined as a lesion free of any local treatment (like stereotactic radiosurgery or whole brain radiation).
|
Arm 4 (PrALKi=N, PrBRad=N)
Participants with metastases in the brain without evidence of LC, previously untreated with radiation to the brain and with no prior exposure to an ALK-I. Participants in this arm had to present with active brain lesion defined as a lesion free of any local treatment (like stereotactic radiosurgery or whole brain radiation).
|
Arm 5 (LepDis)
Participants had LC with or without evidence of active lesion at the baseline Gadolinium-enhanced brain magnetic resonance imaging (MRI). Previous treatment with ALK-I other than crizotinib was not allowed in this arm as of protocol amendment 3.
|
|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
2
|
0
|
6
|
4
|
|
Overall Study
Death
|
6
|
2
|
3
|
6
|
6
|
|
Overall Study
Physician Decision
|
9
|
6
|
7
|
16
|
3
|
|
Overall Study
Progressive disease
|
23
|
26
|
2
|
14
|
4
|
|
Overall Study
Protocol Violation
|
1
|
0
|
0
|
0
|
0
|
|
Overall Study
Patient/guardian decision
|
2
|
4
|
0
|
2
|
1
|
Baseline Characteristics
The Full Analysis Set (FAS) comprised of all patients who received at least one dose of ceritinib.
Baseline characteristics by cohort
| Measure |
Arm 1 (PrALKi=Y, PrBRad=Y)
n=42 Participants
Participants with metastases in the brain without evidence of leptomeningeal carcinomatosis (LC), previously treated with radiation to the brain and with prior exposure to an Anaplastic lymphoma kinase inhibitor (ALK-I). Previous treatment with ALK-I other than crizotinib was not allowed in this arm as of protocol amendment 3 and had to present with active brain lesion defined as a lesion free of any local treatment (like stereotactic radiosurgery or whole brain radiation).
|
Arm 2 (PrALKi=Y, PrBRad=N)
n=40 Participants
Participants with metastases in the brain without evidence of LC, previously untreated with radiation to the brain but with prior exposure to an ALK-I. Previous treatment with ALK-I other than crizotinib was not allowed in this arm 2 as of protocol amendment 3 and had to present with active brain lesion defined as a lesion free of any local treatment (like stereotactic radiosurgery or whole brain radiation).
|
Arm 3 (PrALKi=N, PrBRad=Y)
n=12 Participants
Participants with metastases in the brain without evidence of LC, previously treated with radiation to the brain but with no prior exposure to an ALK-I. Participants in this arm had to present with active brain lesion defined as a lesion free of any local treatment (like stereotactic radiosurgery or whole brain radiation).
|
Arm 4 (PrALKi=N, PrBRad=N)
n=44 Participants
Participants with metastases in the brain without evidence of LC, previously untreated with radiation to the brain and with no prior exposure to an ALK-I. Participants in this arm had to present with active brain lesion defined as a lesion free of any local treatment (like stereotactic radiosurgery or whole brain radiation).
|
Arm 5 (LepDis)
n=18 Participants
Participants had LC with or without evidence of active lesion at the baseline Gadolinium-enhanced brain magnetic resonance imaging (MRI). Previous treatment with ALK-I other than crizotinib was not allowed in this arm as of protocol amendment 3.
|
Total
n=156 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
48.6 years
STANDARD_DEVIATION 11.37 • n=99 Participants • The Full Analysis Set (FAS) comprised of all patients who received at least one dose of ceritinib.
|
54.5 years
STANDARD_DEVIATION 12.32 • n=107 Participants • The Full Analysis Set (FAS) comprised of all patients who received at least one dose of ceritinib.
|
50.0 years
STANDARD_DEVIATION 9.67 • n=206 Participants • The Full Analysis Set (FAS) comprised of all patients who received at least one dose of ceritinib.
|
51.8 years
STANDARD_DEVIATION 11.21 • n=7 Participants • The Full Analysis Set (FAS) comprised of all patients who received at least one dose of ceritinib.
|
49.9 years
STANDARD_DEVIATION 11.38 • n=31 Participants • The Full Analysis Set (FAS) comprised of all patients who received at least one dose of ceritinib.
|
51.3 years
STANDARD_DEVIATION 11.53 • n=30 Participants • The Full Analysis Set (FAS) comprised of all patients who received at least one dose of ceritinib.
|
|
Sex: Female, Male
Female
|
21 Participants
n=99 Participants • The Full Analysis Set (FAS) comprised of all patients who received at least one dose of ceritinib.
|
19 Participants
n=107 Participants • The Full Analysis Set (FAS) comprised of all patients who received at least one dose of ceritinib.
|
6 Participants
n=206 Participants • The Full Analysis Set (FAS) comprised of all patients who received at least one dose of ceritinib.
|
27 Participants
n=7 Participants • The Full Analysis Set (FAS) comprised of all patients who received at least one dose of ceritinib.
|
9 Participants
n=31 Participants • The Full Analysis Set (FAS) comprised of all patients who received at least one dose of ceritinib.
|
82 Participants
n=30 Participants • The Full Analysis Set (FAS) comprised of all patients who received at least one dose of ceritinib.
|
|
Sex: Female, Male
Male
|
21 Participants
n=99 Participants • The Full Analysis Set (FAS) comprised of all patients who received at least one dose of ceritinib.
|
21 Participants
n=107 Participants • The Full Analysis Set (FAS) comprised of all patients who received at least one dose of ceritinib.
|
6 Participants
n=206 Participants • The Full Analysis Set (FAS) comprised of all patients who received at least one dose of ceritinib.
|
17 Participants
n=7 Participants • The Full Analysis Set (FAS) comprised of all patients who received at least one dose of ceritinib.
|
9 Participants
n=31 Participants • The Full Analysis Set (FAS) comprised of all patients who received at least one dose of ceritinib.
|
74 Participants
n=30 Participants • The Full Analysis Set (FAS) comprised of all patients who received at least one dose of ceritinib.
|
|
Race/Ethnicity, Customized
Asian
|
18 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
8 Participants
n=7 Participants
|
3 Participants
n=31 Participants
|
47 Participants
n=30 Participants
|
|
Race/Ethnicity, Customized
Black
|
0 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
|
|
Race/Ethnicity, Customized
Caucasian
|
24 Participants
n=99 Participants
|
27 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
32 Participants
n=7 Participants
|
15 Participants
n=31 Participants
|
102 Participants
n=30 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
5 Participants
n=30 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
0 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
|
PRIMARY outcome
Timeframe: 43 monthsPopulation: The Full Analysis Set (FAS) comprised of all patients who received at least one dose of ceritinib.
Overall response rate (ORR) is defined as the percentage of participants with a best overall confirmed response of complete response (CR) or partial response (PR) in the whole body as assessed per RECIST 1.1 by the investigator. CR: Disappearance of all non-nodal target and non-target lesions. In addition, all lymph nodes assigned a target or a non-target lesions must be non-pathological in size (\< 10 mm short axis), and no new lesion is identified. PR: When all target lesions have disappeared or there is a decrease by at least 30% in the sum of diameter of all target lesions (taking as reference the baseline sum of diameters) is observed \& non-target lesions are not in progression or in complete response.
Outcome measures
| Measure |
Arm 1 (PrALKi=Y, PrBRad=Y)
n=42 Participants
Participants with metastases in the brain without evidence of leptomeningeal carcinomatosis (LC), previously treated with radiation to the brain and with prior exposure to an Anaplastic lymphoma kinase inhibitor (ALK-I). Previous treatment with ALK-I other than crizotinib was not allowed in this arm as of protocol amendment 3 and had to present with active brain lesion defined as a lesion free of any local treatment (like stereotactic radiosurgery or whole brain radiation).
|
Arm 2 (PrALKi=Y, PrBRad=N)
n=40 Participants
Participants with metastases in the brain without evidence of LC, previously untreated with radiation to the brain but with prior exposure to an ALK-I. Previous treatment with ALK-I other than crizotinib was not allowed in this arm 2 as of protocol amendment 3 and had to present with active brain lesion defined as a lesion free of any local treatment (like stereotactic radiosurgery or whole brain radiation).
|
Arm 3 (PrALKi=N, PrBRad=Y)
n=12 Participants
Participants with metastases in the brain without evidence of LC, previously treated with radiation to the brain but with no prior exposure to an ALK-I. Participants in this arm had to present with active brain lesion defined as a lesion free of any local treatment (like stereotactic radiosurgery or whole brain radiation).
|
Arm 4 (PrALKi=N, PrBRad=N)
n=44 Participants
Participants with metastases in the brain without evidence of LC, previously untreated with radiation to the brain and with no prior exposure to an ALK-I. Participants in this arm had to present with active brain lesion defined as a lesion free of any local treatment (like stereotactic radiosurgery or whole brain radiation).
|
Arm 5 (LepDis)
n=18 Participants
Participants had LC with or without evidence of active lesion at the baseline Gadolinium-enhanced brain magnetic resonance imaging (MRI). Previous treatment with ALK-I other than crizotinib was not allowed in this arm as of protocol amendment 3.
|
|---|---|---|---|---|---|
|
Overall Response Rate (ORR) Per Investigator Assessment
|
35.7 Percentage of participants
Interval 21.6 to 52.0
|
30.0 Percentage of participants
Interval 16.6 to 46.5
|
50.0 Percentage of participants
Interval 21.1 to 78.9
|
59.1 Percentage of participants
Interval 43.2 to 73.7
|
16.7 Percentage of participants
Interval 3.6 to 41.4
|
SECONDARY outcome
Timeframe: 43 monthsPopulation: The Full Analysis Set (FAS) comprised of all patients who received at least one dose of ceritinib.
DCR: percentage of parts. with best overall response of CR, PR or stable disease (SD) in the whole body, as assessed per RECIST 1.1 by investigator. CR: Disappearance of all non-nodal target and non-target lesions. In addition, all lymph nodes assigned a target or a non-target lesions must be non-pathological in size (\< 10 mm short axis), \& no new lesion is identified. PR: When all target lesions have disappeared or there is a decrease by at least 30% in the sum of diameter of all target lesions (taking as reference the baseline sum of diameters) is observed and non-target lesions are not in progression or in complete response. SD: Neither sufficient shrinkage in the target lesion to qualify for PR or CR nor an increase in lesions which would qualify for PD \& non-target lesions are not in unequivocal progression.
Outcome measures
| Measure |
Arm 1 (PrALKi=Y, PrBRad=Y)
n=42 Participants
Participants with metastases in the brain without evidence of leptomeningeal carcinomatosis (LC), previously treated with radiation to the brain and with prior exposure to an Anaplastic lymphoma kinase inhibitor (ALK-I). Previous treatment with ALK-I other than crizotinib was not allowed in this arm as of protocol amendment 3 and had to present with active brain lesion defined as a lesion free of any local treatment (like stereotactic radiosurgery or whole brain radiation).
|
Arm 2 (PrALKi=Y, PrBRad=N)
n=40 Participants
Participants with metastases in the brain without evidence of LC, previously untreated with radiation to the brain but with prior exposure to an ALK-I. Previous treatment with ALK-I other than crizotinib was not allowed in this arm 2 as of protocol amendment 3 and had to present with active brain lesion defined as a lesion free of any local treatment (like stereotactic radiosurgery or whole brain radiation).
|
Arm 3 (PrALKi=N, PrBRad=Y)
n=12 Participants
Participants with metastases in the brain without evidence of LC, previously treated with radiation to the brain but with no prior exposure to an ALK-I. Participants in this arm had to present with active brain lesion defined as a lesion free of any local treatment (like stereotactic radiosurgery or whole brain radiation).
|
Arm 4 (PrALKi=N, PrBRad=N)
n=44 Participants
Participants with metastases in the brain without evidence of LC, previously untreated with radiation to the brain and with no prior exposure to an ALK-I. Participants in this arm had to present with active brain lesion defined as a lesion free of any local treatment (like stereotactic radiosurgery or whole brain radiation).
|
Arm 5 (LepDis)
n=18 Participants
Participants had LC with or without evidence of active lesion at the baseline Gadolinium-enhanced brain magnetic resonance imaging (MRI). Previous treatment with ALK-I other than crizotinib was not allowed in this arm as of protocol amendment 3.
|
|---|---|---|---|---|---|
|
Disease Control Rate (DCR) Per Investigator Assessment
|
66.7 Percentage of participants
Interval 50.5 to 80.4
|
82.5 Percentage of participants
Interval 67.2 to 92.7
|
66.7 Percentage of participants
Interval 34.9 to 90.1
|
70.5 Percentage of participants
Interval 54.8 to 83.2
|
66.7 Percentage of participants
Interval 41.0 to 86.7
|
SECONDARY outcome
Timeframe: 43 monthsPopulation: A subset of FAS (comprised of all patients who received at least one dose of ceritinib) where participants had measurable brain metastases at baseline.
OIRR was calculated based on response assessments in the brain for patients having measurable brain metastases at baseline. OIRR was defined as the percentage of participants with a best overall confirmed response of CR or PR in the brain as assessed per modified RECIST 1.1. This was applied to the brain only. CR: Disappearance of all non-nodal target \& non-target lesions. All lymph nodes assigned a target or a non-target lesions must be non-pathological in size (\< 10 mm short axis), \& no new lesion is identified. PR: When all target lesions have disappeared or decreased by at least 30% in the sum of diameter of all target lesions (taking as reference the baseline sum of diameters) \& non-target lesions are not in progression or in complete response.
Outcome measures
| Measure |
Arm 1 (PrALKi=Y, PrBRad=Y)
n=28 Participants
Participants with metastases in the brain without evidence of leptomeningeal carcinomatosis (LC), previously treated with radiation to the brain and with prior exposure to an Anaplastic lymphoma kinase inhibitor (ALK-I). Previous treatment with ALK-I other than crizotinib was not allowed in this arm as of protocol amendment 3 and had to present with active brain lesion defined as a lesion free of any local treatment (like stereotactic radiosurgery or whole brain radiation).
|
Arm 2 (PrALKi=Y, PrBRad=N)
n=29 Participants
Participants with metastases in the brain without evidence of LC, previously untreated with radiation to the brain but with prior exposure to an ALK-I. Previous treatment with ALK-I other than crizotinib was not allowed in this arm 2 as of protocol amendment 3 and had to present with active brain lesion defined as a lesion free of any local treatment (like stereotactic radiosurgery or whole brain radiation).
|
Arm 3 (PrALKi=N, PrBRad=Y)
n=7 Participants
Participants with metastases in the brain without evidence of LC, previously treated with radiation to the brain but with no prior exposure to an ALK-I. Participants in this arm had to present with active brain lesion defined as a lesion free of any local treatment (like stereotactic radiosurgery or whole brain radiation).
|
Arm 4 (PrALKi=N, PrBRad=N)
n=33 Participants
Participants with metastases in the brain without evidence of LC, previously untreated with radiation to the brain and with no prior exposure to an ALK-I. Participants in this arm had to present with active brain lesion defined as a lesion free of any local treatment (like stereotactic radiosurgery or whole brain radiation).
|
Arm 5 (LepDis)
n=8 Participants
Participants had LC with or without evidence of active lesion at the baseline Gadolinium-enhanced brain magnetic resonance imaging (MRI). Previous treatment with ALK-I other than crizotinib was not allowed in this arm as of protocol amendment 3.
|
|---|---|---|---|---|---|
|
Overall Intracranial Response Rate (OIRR) Per Modified RECIST 1.1 Per Investigator Assessment
|
39.3 Percentage of participants
Interval 21.5 to 59.4
|
27.6 Percentage of participants
Interval 12.7 to 47.2
|
28.6 Percentage of participants
Interval 3.7 to 71.0
|
51.5 Percentage of participants
Interval 33.5 to 69.2
|
12.5 Percentage of participants
Interval 0.3 to 52.7
|
SECONDARY outcome
Timeframe: 43 monthsPopulation: A subset of FAS (comprised of all patients who received at least one dose of ceritinib) where participants had measurable brain metastases at baseline.
OIRR was calculated based on response assessments in the brain for patients having measurable brain metastases at baseline. OIRR was defined as the percentage of participants with a best overall confirmed response of CR or PR in the brain as assessed per modified RECIST 1.1. This was applied to the brain only. CR: Disappearance of all non-nodal target \& non-target lesions. All lymph nodes assigned a target or a non-target lesions must be non-pathological in size (\< 10 mm short axis), \& no new lesion is identified. PR: When all target lesions have disappeared or decreased by at least 30% in the sum of diameter of all target lesions (taking as reference the baseline sum of diameters) \& non-target lesions are not in progression or in complete response.
Outcome measures
| Measure |
Arm 1 (PrALKi=Y, PrBRad=Y)
n=30 Participants
Participants with metastases in the brain without evidence of leptomeningeal carcinomatosis (LC), previously treated with radiation to the brain and with prior exposure to an Anaplastic lymphoma kinase inhibitor (ALK-I). Previous treatment with ALK-I other than crizotinib was not allowed in this arm as of protocol amendment 3 and had to present with active brain lesion defined as a lesion free of any local treatment (like stereotactic radiosurgery or whole brain radiation).
|
Arm 2 (PrALKi=Y, PrBRad=N)
n=29 Participants
Participants with metastases in the brain without evidence of LC, previously untreated with radiation to the brain but with prior exposure to an ALK-I. Previous treatment with ALK-I other than crizotinib was not allowed in this arm 2 as of protocol amendment 3 and had to present with active brain lesion defined as a lesion free of any local treatment (like stereotactic radiosurgery or whole brain radiation).
|
Arm 3 (PrALKi=N, PrBRad=Y)
n=6 Participants
Participants with metastases in the brain without evidence of LC, previously treated with radiation to the brain but with no prior exposure to an ALK-I. Participants in this arm had to present with active brain lesion defined as a lesion free of any local treatment (like stereotactic radiosurgery or whole brain radiation).
|
Arm 4 (PrALKi=N, PrBRad=N)
n=34 Participants
Participants with metastases in the brain without evidence of LC, previously untreated with radiation to the brain and with no prior exposure to an ALK-I. Participants in this arm had to present with active brain lesion defined as a lesion free of any local treatment (like stereotactic radiosurgery or whole brain radiation).
|
Arm 5 (LepDis)
n=10 Participants
Participants had LC with or without evidence of active lesion at the baseline Gadolinium-enhanced brain magnetic resonance imaging (MRI). Previous treatment with ALK-I other than crizotinib was not allowed in this arm as of protocol amendment 3.
|
|---|---|---|---|---|---|
|
Overall Intracranial Response Rate (OIRR) Per Modified RECIST 1.1 Per Blinded Independent Review Committee (BIRC) Assessment
|
33.3 Percentage of participants
Interval 17.3 to 52.8
|
24.1 Percentage of participants
Interval 10.3 to 43.5
|
33.3 Percentage of participants
Interval 4.3 to 77.7
|
58.8 Percentage of participants
Interval 40.7 to 75.4
|
20.0 Percentage of participants
Interval 2.5 to 55.6
|
SECONDARY outcome
Timeframe: Week 8 and Week 16Population: The Full Analysis Set (FAS) comprised of all patients who received at least one dose of ceritinib.
IDCR overall: percentage of participants with a best overall response of CR, PR, SD or non-CR/non-PD in the brain, as assessed per modified RECIST 1.1 by the Investigator. This was applied to the brain only. CR: Disappearance of all non-nodal target \& non-target lesions. All lymph nodes assigned a target or a non-target lesions must be non-pathological in size (\< 10 mm short axis), \& no new lesion is identified. PR: When all target lesions have disappeared or there is a decrease by at least 30% in the sum of diameter of all target lesions (taking as reference the baseline sum of diameters) is observed \& non-target lesions are not in progression or in complete response. SD: Neither sufficient shrinkage in the target lesion to qualify for PR or CR nor an increase in lesions which would qualify for PD \& non-target lesions are not in unequivocal progression.
Outcome measures
| Measure |
Arm 1 (PrALKi=Y, PrBRad=Y)
n=42 Participants
Participants with metastases in the brain without evidence of leptomeningeal carcinomatosis (LC), previously treated with radiation to the brain and with prior exposure to an Anaplastic lymphoma kinase inhibitor (ALK-I). Previous treatment with ALK-I other than crizotinib was not allowed in this arm as of protocol amendment 3 and had to present with active brain lesion defined as a lesion free of any local treatment (like stereotactic radiosurgery or whole brain radiation).
|
Arm 2 (PrALKi=Y, PrBRad=N)
n=40 Participants
Participants with metastases in the brain without evidence of LC, previously untreated with radiation to the brain but with prior exposure to an ALK-I. Previous treatment with ALK-I other than crizotinib was not allowed in this arm 2 as of protocol amendment 3 and had to present with active brain lesion defined as a lesion free of any local treatment (like stereotactic radiosurgery or whole brain radiation).
|
Arm 3 (PrALKi=N, PrBRad=Y)
n=12 Participants
Participants with metastases in the brain without evidence of LC, previously treated with radiation to the brain but with no prior exposure to an ALK-I. Participants in this arm had to present with active brain lesion defined as a lesion free of any local treatment (like stereotactic radiosurgery or whole brain radiation).
|
Arm 4 (PrALKi=N, PrBRad=N)
n=44 Participants
Participants with metastases in the brain without evidence of LC, previously untreated with radiation to the brain and with no prior exposure to an ALK-I. Participants in this arm had to present with active brain lesion defined as a lesion free of any local treatment (like stereotactic radiosurgery or whole brain radiation).
|
Arm 5 (LepDis)
n=18 Participants
Participants had LC with or without evidence of active lesion at the baseline Gadolinium-enhanced brain magnetic resonance imaging (MRI). Previous treatment with ALK-I other than crizotinib was not allowed in this arm as of protocol amendment 3.
|
|---|---|---|---|---|---|
|
Intracranial Disease Control Rate (IDCR) Per Modified RECIST 1.1 Per Investigator Assessment at Weeks 8 & 16
IDCR at Week 8
|
71.4 Percentage of participants
Interval 55.4 to 84.3
|
75.0 Percentage of participants
Interval 58.8 to 87.3
|
58.3 Percentage of participants
Interval 27.7 to 84.8
|
68.2 Percentage of participants
Interval 52.4 to 81.4
|
66.7 Percentage of participants
Interval 41.0 to 86.7
|
|
Intracranial Disease Control Rate (IDCR) Per Modified RECIST 1.1 Per Investigator Assessment at Weeks 8 & 16
IDCR at Week 16
|
59.5 Percentage of participants
Interval 43.3 to 74.4
|
62.5 Percentage of participants
Interval 45.8 to 77.3
|
58.3 Percentage of participants
Interval 27.7 to 84.8
|
65.9 Percentage of participants
Interval 50.1 to 79.5
|
50.0 Percentage of participants
Interval 26.0 to 74.0
|
SECONDARY outcome
Timeframe: 43 monthsPopulation: The Full Analysis Set (FAS) comprised of all patients who received at least one dose of ceritinib.
IDCR overall: percentage of participants with a best overall response of CR, PR, SD or non-CR/non-PD in the brain, as assessed per modified RECIST 1.1 by the Investigator. This was applied to the brain only. CR: Disappearance of all non-nodal target \& non-target lesions. All lymph nodes assigned a target or a non-target lesions must be non-pathological in size (\< 10 mm short axis), \& no new lesion is identified. PR: When all target lesions have disappeared or there is a decrease by at least 30% in the sum of diameter of all target lesions (taking as reference the baseline sum of diameters) is observed \& non-target lesions are not in progression or in complete response. SD: Neither sufficient shrinkage in the target lesion to qualify for PR or CR nor an increase in lesions which would qualify for PD \& non-target lesions are not in unequivocal progression.
Outcome measures
| Measure |
Arm 1 (PrALKi=Y, PrBRad=Y)
n=42 Participants
Participants with metastases in the brain without evidence of leptomeningeal carcinomatosis (LC), previously treated with radiation to the brain and with prior exposure to an Anaplastic lymphoma kinase inhibitor (ALK-I). Previous treatment with ALK-I other than crizotinib was not allowed in this arm as of protocol amendment 3 and had to present with active brain lesion defined as a lesion free of any local treatment (like stereotactic radiosurgery or whole brain radiation).
|
Arm 2 (PrALKi=Y, PrBRad=N)
n=40 Participants
Participants with metastases in the brain without evidence of LC, previously untreated with radiation to the brain but with prior exposure to an ALK-I. Previous treatment with ALK-I other than crizotinib was not allowed in this arm 2 as of protocol amendment 3 and had to present with active brain lesion defined as a lesion free of any local treatment (like stereotactic radiosurgery or whole brain radiation).
|
Arm 3 (PrALKi=N, PrBRad=Y)
n=12 Participants
Participants with metastases in the brain without evidence of LC, previously treated with radiation to the brain but with no prior exposure to an ALK-I. Participants in this arm had to present with active brain lesion defined as a lesion free of any local treatment (like stereotactic radiosurgery or whole brain radiation).
|
Arm 4 (PrALKi=N, PrBRad=N)
n=44 Participants
Participants with metastases in the brain without evidence of LC, previously untreated with radiation to the brain and with no prior exposure to an ALK-I. Participants in this arm had to present with active brain lesion defined as a lesion free of any local treatment (like stereotactic radiosurgery or whole brain radiation).
|
Arm 5 (LepDis)
n=18 Participants
Participants had LC with or without evidence of active lesion at the baseline Gadolinium-enhanced brain magnetic resonance imaging (MRI). Previous treatment with ALK-I other than crizotinib was not allowed in this arm as of protocol amendment 3.
|
|---|---|---|---|---|---|
|
Intracranial Disease Control Rate (IDCR) Per Modified RECIST 1.1 Per Investigator Assessment - Overall
|
71.4 Percentage of participants
Interval 55.4 to 84.3
|
85.0 Percentage of participants
Interval 70.2 to 94.3
|
75.0 Percentage of participants
Interval 42.8 to 94.5
|
75.0 Percentage of participants
Interval 59.7 to 86.8
|
66.7 Percentage of participants
Interval 41.0 to 86.7
|
SECONDARY outcome
Timeframe: Week 8 and Week 16Population: The Full Analysis Set (FAS) comprised of all patients who received at least one dose of ceritinib.
IDCR overall: percentage of participants with a best overall response of CR, PR, SD or non-CR/non-PD in the brain, as assessed per modified RECIST 1.1 by Investigator. This was applied to the brain only. CR: Disappearance of all non-nodal target \& non-target lesions. All lymph nodes assigned a target or a non-target lesions must be non-pathological in size (\< 10 mm short axis), \& no new lesion is identified. PR: When all target lesions have disappeared or there is a decrease by at least 30% in the sum of diameter of all target lesions (taking as reference the baseline sum of diameters) is observed \& non-target lesions are not in progression or in complete response. SD: Neither sufficient shrinkage in the target lesion to qualify for PR or CR nor an increase in lesions which would qualify for PD \& non-target lesions are not in unequivocal progression.
Outcome measures
| Measure |
Arm 1 (PrALKi=Y, PrBRad=Y)
n=42 Participants
Participants with metastases in the brain without evidence of leptomeningeal carcinomatosis (LC), previously treated with radiation to the brain and with prior exposure to an Anaplastic lymphoma kinase inhibitor (ALK-I). Previous treatment with ALK-I other than crizotinib was not allowed in this arm as of protocol amendment 3 and had to present with active brain lesion defined as a lesion free of any local treatment (like stereotactic radiosurgery or whole brain radiation).
|
Arm 2 (PrALKi=Y, PrBRad=N)
n=40 Participants
Participants with metastases in the brain without evidence of LC, previously untreated with radiation to the brain but with prior exposure to an ALK-I. Previous treatment with ALK-I other than crizotinib was not allowed in this arm 2 as of protocol amendment 3 and had to present with active brain lesion defined as a lesion free of any local treatment (like stereotactic radiosurgery or whole brain radiation).
|
Arm 3 (PrALKi=N, PrBRad=Y)
n=12 Participants
Participants with metastases in the brain without evidence of LC, previously treated with radiation to the brain but with no prior exposure to an ALK-I. Participants in this arm had to present with active brain lesion defined as a lesion free of any local treatment (like stereotactic radiosurgery or whole brain radiation).
|
Arm 4 (PrALKi=N, PrBRad=N)
n=44 Participants
Participants with metastases in the brain without evidence of LC, previously untreated with radiation to the brain and with no prior exposure to an ALK-I. Participants in this arm had to present with active brain lesion defined as a lesion free of any local treatment (like stereotactic radiosurgery or whole brain radiation).
|
Arm 5 (LepDis)
n=18 Participants
Participants had LC with or without evidence of active lesion at the baseline Gadolinium-enhanced brain magnetic resonance imaging (MRI). Previous treatment with ALK-I other than crizotinib was not allowed in this arm as of protocol amendment 3.
|
|---|---|---|---|---|---|
|
Intracranial Disease Control Rate (IDCR) Per Modified RECIST 1.1 Per BIRC Assessment at Weeks 8 & 16
IDCR at 8 weeks
|
76.2 Percentage of participants
Interval 60.5 to 87.9
|
80.0 Percentage of participants
Interval 64.4 to 90.9
|
58.3 Percentage of participants
Interval 27.7 to 84.8
|
68.2 Percentage of participants
Interval 52.4 to 81.4
|
66.7 Percentage of participants
Interval 41.0 to 86.7
|
|
Intracranial Disease Control Rate (IDCR) Per Modified RECIST 1.1 Per BIRC Assessment at Weeks 8 & 16
IDCR at 16 weeks
|
69.0 Percentage of participants
Interval 52.9 to 82.4
|
62.5 Percentage of participants
Interval 45.8 to 77.3
|
58.3 Percentage of participants
Interval 27.7 to 84.8
|
68.2 Percentage of participants
Interval 52.4 to 81.4
|
38.9 Percentage of participants
Interval 17.3 to 64.3
|
SECONDARY outcome
Timeframe: 43 monthsPopulation: The Full Analysis Set (FAS) comprised of all patients who received at least one dose of ceritinib.
IDCR overall: percentage of participants with a best overall response of CR, PR, SD or non-CR/non-PD in the brain, as assessed per modified RECIST 1.1 by Investigator. This was applied to the brain only. CR: Disappearance of all non-nodal target \& non-target lesions. All lymph nodes assigned a target or a non-target lesions must be non-pathological in size (\< 10 mm short axis), \& no new lesion is identified. PR: When all target lesions have disappeared or there is a decrease by at least 30% in the sum of diameter of all target lesions (taking as reference the baseline sum of diameters) is observed \& non-target lesions are not in progression or in complete response. SD: Neither sufficient shrinkage in the target lesion to qualify for PR or CR nor an increase in lesions which would qualify for PD \& non-target lesions are not in unequivocal progression.
Outcome measures
| Measure |
Arm 1 (PrALKi=Y, PrBRad=Y)
n=42 Participants
Participants with metastases in the brain without evidence of leptomeningeal carcinomatosis (LC), previously treated with radiation to the brain and with prior exposure to an Anaplastic lymphoma kinase inhibitor (ALK-I). Previous treatment with ALK-I other than crizotinib was not allowed in this arm as of protocol amendment 3 and had to present with active brain lesion defined as a lesion free of any local treatment (like stereotactic radiosurgery or whole brain radiation).
|
Arm 2 (PrALKi=Y, PrBRad=N)
n=40 Participants
Participants with metastases in the brain without evidence of LC, previously untreated with radiation to the brain but with prior exposure to an ALK-I. Previous treatment with ALK-I other than crizotinib was not allowed in this arm 2 as of protocol amendment 3 and had to present with active brain lesion defined as a lesion free of any local treatment (like stereotactic radiosurgery or whole brain radiation).
|
Arm 3 (PrALKi=N, PrBRad=Y)
n=12 Participants
Participants with metastases in the brain without evidence of LC, previously treated with radiation to the brain but with no prior exposure to an ALK-I. Participants in this arm had to present with active brain lesion defined as a lesion free of any local treatment (like stereotactic radiosurgery or whole brain radiation).
|
Arm 4 (PrALKi=N, PrBRad=N)
n=44 Participants
Participants with metastases in the brain without evidence of LC, previously untreated with radiation to the brain and with no prior exposure to an ALK-I. Participants in this arm had to present with active brain lesion defined as a lesion free of any local treatment (like stereotactic radiosurgery or whole brain radiation).
|
Arm 5 (LepDis)
n=18 Participants
Participants had LC with or without evidence of active lesion at the baseline Gadolinium-enhanced brain magnetic resonance imaging (MRI). Previous treatment with ALK-I other than crizotinib was not allowed in this arm as of protocol amendment 3.
|
|---|---|---|---|---|---|
|
Intracranial Disease Control Rate (IDCR) Per Modified RECIST 1.1 Per BIRC Assessment - Overall
|
73.8 Percentage of participants
Interval 58.0 to 86.1
|
85.0 Percentage of participants
Interval 70.2 to 94.3
|
66.7 Percentage of participants
Interval 34.9 to 90.1
|
75.0 Percentage of participants
Interval 59.7 to 86.8
|
66.7 Percentage of participants
Interval 41.0 to 86.7
|
SECONDARY outcome
Timeframe: 43 monthsPopulation: A subset of FAS (comprised of all patients who received at least one dose of ceritinib) where participants had measurable brain metastases at baseline and confirmed CR or PR.
TTIR was defined as the time from the date of the first dose of ceritinib to the date of the first documented response (CR or PR) in the brain as assessed per modified RECIST 1.1 criteria for patients with measurable brain metastases at baseline. This was applied to the brain only. CR: Disappearance of all non-nodal target and non-target lesions. In addition, all lymph nodes assigned a target or a non-target lesions must be non-pathological in size (\< 10 mm short axis), and no new lesion is identified. PR: When all target lesions have disappeared or there is a decrease by at least 30% in the sum of diameter of all target lesions (taking as reference the baseline sum of diameters) is observed \& non-target lesions are not in progression or in complete response.
Outcome measures
| Measure |
Arm 1 (PrALKi=Y, PrBRad=Y)
n=11 Participants
Participants with metastases in the brain without evidence of leptomeningeal carcinomatosis (LC), previously treated with radiation to the brain and with prior exposure to an Anaplastic lymphoma kinase inhibitor (ALK-I). Previous treatment with ALK-I other than crizotinib was not allowed in this arm as of protocol amendment 3 and had to present with active brain lesion defined as a lesion free of any local treatment (like stereotactic radiosurgery or whole brain radiation).
|
Arm 2 (PrALKi=Y, PrBRad=N)
n=8 Participants
Participants with metastases in the brain without evidence of LC, previously untreated with radiation to the brain but with prior exposure to an ALK-I. Previous treatment with ALK-I other than crizotinib was not allowed in this arm 2 as of protocol amendment 3 and had to present with active brain lesion defined as a lesion free of any local treatment (like stereotactic radiosurgery or whole brain radiation).
|
Arm 3 (PrALKi=N, PrBRad=Y)
n=2 Participants
Participants with metastases in the brain without evidence of LC, previously treated with radiation to the brain but with no prior exposure to an ALK-I. Participants in this arm had to present with active brain lesion defined as a lesion free of any local treatment (like stereotactic radiosurgery or whole brain radiation).
|
Arm 4 (PrALKi=N, PrBRad=N)
n=17 Participants
Participants with metastases in the brain without evidence of LC, previously untreated with radiation to the brain and with no prior exposure to an ALK-I. Participants in this arm had to present with active brain lesion defined as a lesion free of any local treatment (like stereotactic radiosurgery or whole brain radiation).
|
Arm 5 (LepDis)
n=1 Participants
Participants had LC with or without evidence of active lesion at the baseline Gadolinium-enhanced brain magnetic resonance imaging (MRI). Previous treatment with ALK-I other than crizotinib was not allowed in this arm as of protocol amendment 3.
|
|---|---|---|---|---|---|
|
Time to Intracranial Tumor Response (TTIR) Per Modified RECIST 1.1 Per Investigator Assessment
|
1.87 months
Interval 1.7 to 7.5
|
1.84 months
Interval 1.6 to 9.1
|
3.56 months
Interval 1.8 to 5.3
|
1.77 months
Interval 1.3 to 7.4
|
1.80 months
Interval 1.8 to 1.8
|
SECONDARY outcome
Timeframe: 43 monthsPopulation: A subset of FAS (comprised of all patients who received at least one dose of ceritinib) where participants had measurable brain metastases at baseline and confirmed CR or PR.
TTIR was defined as the time from the date of the first dose of ceritinib to the date of the first documented response (CR or PR) in the brain as assessed per modified RECIST 1.1 criteria for patients with measurable brain metastases at baseline. This was applied to the brain only. CR: Disappearance of all non-nodal target and non-target lesions. In addition, all lymph nodes assigned a target or a non-target lesions must be non-pathological in size (\< 10 mm short axis), and no new lesion is identified. PR: When all target lesions have disappeared or there is a decrease by at least 30% in the sum of diameter of all target lesions (taking as reference the baseline sum of diameters) is observed \& non-target lesions are not in progression or in complete response.
Outcome measures
| Measure |
Arm 1 (PrALKi=Y, PrBRad=Y)
n=10 Participants
Participants with metastases in the brain without evidence of leptomeningeal carcinomatosis (LC), previously treated with radiation to the brain and with prior exposure to an Anaplastic lymphoma kinase inhibitor (ALK-I). Previous treatment with ALK-I other than crizotinib was not allowed in this arm as of protocol amendment 3 and had to present with active brain lesion defined as a lesion free of any local treatment (like stereotactic radiosurgery or whole brain radiation).
|
Arm 2 (PrALKi=Y, PrBRad=N)
n=7 Participants
Participants with metastases in the brain without evidence of LC, previously untreated with radiation to the brain but with prior exposure to an ALK-I. Previous treatment with ALK-I other than crizotinib was not allowed in this arm 2 as of protocol amendment 3 and had to present with active brain lesion defined as a lesion free of any local treatment (like stereotactic radiosurgery or whole brain radiation).
|
Arm 3 (PrALKi=N, PrBRad=Y)
n=2 Participants
Participants with metastases in the brain without evidence of LC, previously treated with radiation to the brain but with no prior exposure to an ALK-I. Participants in this arm had to present with active brain lesion defined as a lesion free of any local treatment (like stereotactic radiosurgery or whole brain radiation).
|
Arm 4 (PrALKi=N, PrBRad=N)
n=20 Participants
Participants with metastases in the brain without evidence of LC, previously untreated with radiation to the brain and with no prior exposure to an ALK-I. Participants in this arm had to present with active brain lesion defined as a lesion free of any local treatment (like stereotactic radiosurgery or whole brain radiation).
|
Arm 5 (LepDis)
n=2 Participants
Participants had LC with or without evidence of active lesion at the baseline Gadolinium-enhanced brain magnetic resonance imaging (MRI). Previous treatment with ALK-I other than crizotinib was not allowed in this arm as of protocol amendment 3.
|
|---|---|---|---|---|---|
|
Time to Intracranial Tumor Response (TTIR) Per Modified RECIST 1.1 Per BIRC Assessment
|
1.91 months
Interval 1.7 to 5.6
|
1.68 months
Interval 1.6 to 7.2
|
6.31 months
Interval 3.5 to 9.1
|
1.81 months
Interval 1.3 to 9.2
|
1.22 months
Interval 0.7 to 1.8
|
SECONDARY outcome
Timeframe: 43 monthsPopulation: A subset of FAS (comprised of all patients who received at least one dose of ceritinib) where participants had measurable brain metastases at baseline and confirmed CR or PR.
Defined as the time from the first documented response (PR or CR) in the brain to the date of the first documented disease progression in the brain or death due to any cause, amongst participants with measurable brain metastases at baseline and a confirmed response (PR or CR) in the brain as per modified RECIST 1.1. This was applied to the brain only. CR: Disappearance of all non-nodal target and non-target lesions. In addition, all lymph nodes assigned a target or a non-target lesions must be non-pathological in size (\< 10 mm short axis), and no new lesion is identified. PR: When all target lesions have disappeared or there is a decrease by at least 30% in the sum of diameter of all target lesions (taking as reference the baseline sum of diameters) is observed \& non-target lesions are not in progression or in complete response.
Outcome measures
| Measure |
Arm 1 (PrALKi=Y, PrBRad=Y)
n=11 Participants
Participants with metastases in the brain without evidence of leptomeningeal carcinomatosis (LC), previously treated with radiation to the brain and with prior exposure to an Anaplastic lymphoma kinase inhibitor (ALK-I). Previous treatment with ALK-I other than crizotinib was not allowed in this arm as of protocol amendment 3 and had to present with active brain lesion defined as a lesion free of any local treatment (like stereotactic radiosurgery or whole brain radiation).
|
Arm 2 (PrALKi=Y, PrBRad=N)
n=8 Participants
Participants with metastases in the brain without evidence of LC, previously untreated with radiation to the brain but with prior exposure to an ALK-I. Previous treatment with ALK-I other than crizotinib was not allowed in this arm 2 as of protocol amendment 3 and had to present with active brain lesion defined as a lesion free of any local treatment (like stereotactic radiosurgery or whole brain radiation).
|
Arm 3 (PrALKi=N, PrBRad=Y)
n=2 Participants
Participants with metastases in the brain without evidence of LC, previously treated with radiation to the brain but with no prior exposure to an ALK-I. Participants in this arm had to present with active brain lesion defined as a lesion free of any local treatment (like stereotactic radiosurgery or whole brain radiation).
|
Arm 4 (PrALKi=N, PrBRad=N)
n=17 Participants
Participants with metastases in the brain without evidence of LC, previously untreated with radiation to the brain and with no prior exposure to an ALK-I. Participants in this arm had to present with active brain lesion defined as a lesion free of any local treatment (like stereotactic radiosurgery or whole brain radiation).
|
Arm 5 (LepDis)
n=1 Participants
Participants had LC with or without evidence of active lesion at the baseline Gadolinium-enhanced brain magnetic resonance imaging (MRI). Previous treatment with ALK-I other than crizotinib was not allowed in this arm as of protocol amendment 3.
|
|---|---|---|---|---|---|
|
Duration of Intracranial Response (DOIR) by Modified RECIST 1.1 Per Investigator Assessment
|
9.2 months
Interval 3.7 to
NA: Not estimable due to small number of responders
|
10.1 months
Interval 3.8 to 17.3
|
NA months
NA: Not estimable due to no responders
|
7.5 months
Interval 5.6 to 11.2
|
5.5 months
NA:there was only 1 responder in arm 5, for which the 95% CI was not estimable using Kaplan-Meier method
|
SECONDARY outcome
Timeframe: 43 monthsPopulation: A subset of FAS (comprised of all patients who received at least one dose of ceritinib) where participants had measurable brain metastases at baseline and confirmed CR or PR.
Defined as the time from the first documented response (PR or CR) in the brain to the date of the first documented disease progression in the brain or death due to any cause, amongst participants with measurable brain metastases at baseline and a confirmed response (PR or CR) in the brain as per modified RECIST 1.1. CR: Disappearance of all non-nodal target and non-target lesions. In addition, all lymph nodes assigned a target or a non-target lesions must be non-pathological in size (\< 10 mm short axis), and no new lesion is identified. PR: When all target lesions have disappeared or there is a decrease by at least 30% in the sum of diameter of all target lesions (taking as reference the baseline sum of diameters) is observed \& non-target lesions are not in progression or in complete response.
Outcome measures
| Measure |
Arm 1 (PrALKi=Y, PrBRad=Y)
n=10 Participants
Participants with metastases in the brain without evidence of leptomeningeal carcinomatosis (LC), previously treated with radiation to the brain and with prior exposure to an Anaplastic lymphoma kinase inhibitor (ALK-I). Previous treatment with ALK-I other than crizotinib was not allowed in this arm as of protocol amendment 3 and had to present with active brain lesion defined as a lesion free of any local treatment (like stereotactic radiosurgery or whole brain radiation).
|
Arm 2 (PrALKi=Y, PrBRad=N)
n=7 Participants
Participants with metastases in the brain without evidence of LC, previously untreated with radiation to the brain but with prior exposure to an ALK-I. Previous treatment with ALK-I other than crizotinib was not allowed in this arm 2 as of protocol amendment 3 and had to present with active brain lesion defined as a lesion free of any local treatment (like stereotactic radiosurgery or whole brain radiation).
|
Arm 3 (PrALKi=N, PrBRad=Y)
n=2 Participants
Participants with metastases in the brain without evidence of LC, previously treated with radiation to the brain but with no prior exposure to an ALK-I. Participants in this arm had to present with active brain lesion defined as a lesion free of any local treatment (like stereotactic radiosurgery or whole brain radiation).
|
Arm 4 (PrALKi=N, PrBRad=N)
n=20 Participants
Participants with metastases in the brain without evidence of LC, previously untreated with radiation to the brain and with no prior exposure to an ALK-I. Participants in this arm had to present with active brain lesion defined as a lesion free of any local treatment (like stereotactic radiosurgery or whole brain radiation).
|
Arm 5 (LepDis)
n=2 Participants
Participants had LC with or without evidence of active lesion at the baseline Gadolinium-enhanced brain magnetic resonance imaging (MRI). Previous treatment with ALK-I other than crizotinib was not allowed in this arm as of protocol amendment 3.
|
|---|---|---|---|---|---|
|
Duration of Intracranial Response (DOIR) by Modified RECIST 1.1 Per BIRC Assessment
|
11.0 months
Interval 3.8 to
NA: Not estimable due to small number of responders
|
4.6 months
Interval 3.5 to 20.3
|
NA months
Interval 18.4 to
NA: Not estimable due to small number of responders
|
9.2 months
Interval 5.7 to 11.3
|
3.4 months
Interval 2.0 to 4.7
|
SECONDARY outcome
Timeframe: 43 monthsPopulation: The Full Analysis Set (FAS) comprised of all patients who received at least one dose of ceritinib.
OERR was defined as the percentage of participants with a best overall confirmed response of CR or PR outside of the brain, as assessed per RECIST 1.1. CR: Disappearance of all non-nodal target and non-target lesions. In addition, all lymph nodes assigned a target or a non-target lesions must be non-pathological in size (\< 10 mm short axis), and no new lesion is identified. PR: When all target lesions have disappeared or there is a decrease by at least 30% in the sum of diameter of all target lesions (taking as reference the baseline sum of diameters) is observed \& non-target lesions are not in progression or in complete response.
Outcome measures
| Measure |
Arm 1 (PrALKi=Y, PrBRad=Y)
n=42 Participants
Participants with metastases in the brain without evidence of leptomeningeal carcinomatosis (LC), previously treated with radiation to the brain and with prior exposure to an Anaplastic lymphoma kinase inhibitor (ALK-I). Previous treatment with ALK-I other than crizotinib was not allowed in this arm as of protocol amendment 3 and had to present with active brain lesion defined as a lesion free of any local treatment (like stereotactic radiosurgery or whole brain radiation).
|
Arm 2 (PrALKi=Y, PrBRad=N)
n=40 Participants
Participants with metastases in the brain without evidence of LC, previously untreated with radiation to the brain but with prior exposure to an ALK-I. Previous treatment with ALK-I other than crizotinib was not allowed in this arm 2 as of protocol amendment 3 and had to present with active brain lesion defined as a lesion free of any local treatment (like stereotactic radiosurgery or whole brain radiation).
|
Arm 3 (PrALKi=N, PrBRad=Y)
n=12 Participants
Participants with metastases in the brain without evidence of LC, previously treated with radiation to the brain but with no prior exposure to an ALK-I. Participants in this arm had to present with active brain lesion defined as a lesion free of any local treatment (like stereotactic radiosurgery or whole brain radiation).
|
Arm 4 (PrALKi=N, PrBRad=N)
n=44 Participants
Participants with metastases in the brain without evidence of LC, previously untreated with radiation to the brain and with no prior exposure to an ALK-I. Participants in this arm had to present with active brain lesion defined as a lesion free of any local treatment (like stereotactic radiosurgery or whole brain radiation).
|
Arm 5 (LepDis)
n=18 Participants
Participants had LC with or without evidence of active lesion at the baseline Gadolinium-enhanced brain magnetic resonance imaging (MRI). Previous treatment with ALK-I other than crizotinib was not allowed in this arm as of protocol amendment 3.
|
|---|---|---|---|---|---|
|
Overall Extracranial Response Rate (OERR) Per RECIST 1.1 Per Investigator & BIRC Assessment
OERR per Investigator assessment
|
31.0 Percentage of participants
Interval 17.6 to 47.1
|
42.5 Percentage of participants
Interval 27.0 to 59.1
|
41.7 Percentage of participants
Interval 15.2 to 72.3
|
61.4 Percentage of participants
Interval 45.5 to 75.6
|
22.2 Percentage of participants
Interval 6.4 to 47.6
|
|
Overall Extracranial Response Rate (OERR) Per RECIST 1.1 Per Investigator & BIRC Assessment
OERR per BIRC assessment
|
26.2 Percentage of participants
Interval 13.9 to 42.0
|
25.0 Percentage of participants
Interval 12.7 to 41.2
|
50.0 Percentage of participants
Interval 21.1 to 78.9
|
61.4 Percentage of participants
Interval 45.5 to 75.6
|
16.7 Percentage of participants
Interval 3.6 to 41.4
|
SECONDARY outcome
Timeframe: 43 monthsPopulation: The Full Analysis Set (FAS) comprised of all patients who received at least one dose of ceritinib.
EDCR overall was defined as the percentage of participants with a best overall response of CR, PR or SD outside of the brain as assessed per RECIST 1.1. CR: Disappearance of all non-nodal target and non-target lesions. In addition, all lymph nodes assigned a target or a non-target lesions must be non-pathological in size (\< 10 mm short axis), \& no new lesion is identified. PR: When all target lesions have disappeared or there is a decrease by at least 30% in the sum of diameter of all target lesions (taking as reference the baseline sum of diameters) is observed and non-target lesions are not in progression or in complete response. SD: Neither sufficient shrinkage in the target lesion to qualify for PR or CR nor an increase in lesions which would qualify for PD \& non-target lesions are not in unequivocal progression.
Outcome measures
| Measure |
Arm 1 (PrALKi=Y, PrBRad=Y)
n=42 Participants
Participants with metastases in the brain without evidence of leptomeningeal carcinomatosis (LC), previously treated with radiation to the brain and with prior exposure to an Anaplastic lymphoma kinase inhibitor (ALK-I). Previous treatment with ALK-I other than crizotinib was not allowed in this arm as of protocol amendment 3 and had to present with active brain lesion defined as a lesion free of any local treatment (like stereotactic radiosurgery or whole brain radiation).
|
Arm 2 (PrALKi=Y, PrBRad=N)
n=40 Participants
Participants with metastases in the brain without evidence of LC, previously untreated with radiation to the brain but with prior exposure to an ALK-I. Previous treatment with ALK-I other than crizotinib was not allowed in this arm 2 as of protocol amendment 3 and had to present with active brain lesion defined as a lesion free of any local treatment (like stereotactic radiosurgery or whole brain radiation).
|
Arm 3 (PrALKi=N, PrBRad=Y)
n=12 Participants
Participants with metastases in the brain without evidence of LC, previously treated with radiation to the brain but with no prior exposure to an ALK-I. Participants in this arm had to present with active brain lesion defined as a lesion free of any local treatment (like stereotactic radiosurgery or whole brain radiation).
|
Arm 4 (PrALKi=N, PrBRad=N)
n=44 Participants
Participants with metastases in the brain without evidence of LC, previously untreated with radiation to the brain and with no prior exposure to an ALK-I. Participants in this arm had to present with active brain lesion defined as a lesion free of any local treatment (like stereotactic radiosurgery or whole brain radiation).
|
Arm 5 (LepDis)
n=18 Participants
Participants had LC with or without evidence of active lesion at the baseline Gadolinium-enhanced brain magnetic resonance imaging (MRI). Previous treatment with ALK-I other than crizotinib was not allowed in this arm as of protocol amendment 3.
|
|---|---|---|---|---|---|
|
Extracranial Disease Control Rate (EDCR) Per RECIST 1.1 Per Investigator & BIRC Assessment - Overall
EDCR per BIRC assessment
|
64.3 Percentage of participants
Interval 48.0 to 78.4
|
80.0 Percentage of participants
Interval 64.4 to 90.9
|
66.7 Percentage of participants
Interval 34.9 to 90.1
|
68.2 Percentage of participants
Interval 52.4 to 81.4
|
72.2 Percentage of participants
Interval 46.5 to 90.3
|
|
Extracranial Disease Control Rate (EDCR) Per RECIST 1.1 Per Investigator & BIRC Assessment - Overall
EDCR per Investigator assessment
|
69.0 Percentage of participants
Interval 52.9 to 82.4
|
92.5 Percentage of participants
Interval 79.6 to 98.4
|
66.7 Percentage of participants
Interval 34.9 to 90.1
|
72.7 Percentage of participants
Interval 57.2 to 85.0
|
72.2 Percentage of participants
Interval 46.5 to 90.3
|
SECONDARY outcome
Timeframe: Week 8 and Week 16Population: The Full Analysis Set (FAS) comprised of all patients who received at least one dose of ceritinib.
EDCR at weeks 8 \& 16: defined as percentage of parts. with CR, PR or SD outside of the brain at Wk 8 \& 16 extracranial tumor evaluations respectively, per RECIST 1.1. CR: Disappearance of all non-nodal target and non-target lesions. In addition, all lymph nodes assigned a target or a non-target lesions must be non-pathological in size (\< 10 mm short axis), \& no new lesion is identified. PR: When all target lesions have disappeared or there is a decrease by at least 30% in the sum of diameter of all target lesions (taking as reference the baseline sum of diameters) is observed and non-target lesions are not in progression or in complete response. SD: Neither sufficient shrinkage in the target lesion to qualify for PR or CR nor an increase in lesions which would qualify for PD \& non-target lesions are not in unequivocal progression.
Outcome measures
| Measure |
Arm 1 (PrALKi=Y, PrBRad=Y)
n=42 Participants
Participants with metastases in the brain without evidence of leptomeningeal carcinomatosis (LC), previously treated with radiation to the brain and with prior exposure to an Anaplastic lymphoma kinase inhibitor (ALK-I). Previous treatment with ALK-I other than crizotinib was not allowed in this arm as of protocol amendment 3 and had to present with active brain lesion defined as a lesion free of any local treatment (like stereotactic radiosurgery or whole brain radiation).
|
Arm 2 (PrALKi=Y, PrBRad=N)
n=40 Participants
Participants with metastases in the brain without evidence of LC, previously untreated with radiation to the brain but with prior exposure to an ALK-I. Previous treatment with ALK-I other than crizotinib was not allowed in this arm 2 as of protocol amendment 3 and had to present with active brain lesion defined as a lesion free of any local treatment (like stereotactic radiosurgery or whole brain radiation).
|
Arm 3 (PrALKi=N, PrBRad=Y)
n=12 Participants
Participants with metastases in the brain without evidence of LC, previously treated with radiation to the brain but with no prior exposure to an ALK-I. Participants in this arm had to present with active brain lesion defined as a lesion free of any local treatment (like stereotactic radiosurgery or whole brain radiation).
|
Arm 4 (PrALKi=N, PrBRad=N)
n=44 Participants
Participants with metastases in the brain without evidence of LC, previously untreated with radiation to the brain and with no prior exposure to an ALK-I. Participants in this arm had to present with active brain lesion defined as a lesion free of any local treatment (like stereotactic radiosurgery or whole brain radiation).
|
Arm 5 (LepDis)
n=18 Participants
Participants had LC with or without evidence of active lesion at the baseline Gadolinium-enhanced brain magnetic resonance imaging (MRI). Previous treatment with ALK-I other than crizotinib was not allowed in this arm as of protocol amendment 3.
|
|---|---|---|---|---|---|
|
Extracranial Disease Control Rate (EDCR) Per RECIST 1.1 Per Investigator & BIRC Assessment at Weeks 8 & 16
EDCR per Investigator @ Week 8
|
69.0 Percentage of participants
Interval 52.9 to 82.4
|
82.5 Percentage of participants
Interval 67.2 to 92.7
|
58.3 Percentage of participants
Interval 27.7 to 84.8
|
63.6 Percentage of participants
Interval 47.8 to 77.6
|
72.2 Percentage of participants
Interval 46.5 to 90.3
|
|
Extracranial Disease Control Rate (EDCR) Per RECIST 1.1 Per Investigator & BIRC Assessment at Weeks 8 & 16
EDCR per Investigator @ Week 16
|
57.1 Percentage of participants
Interval 41.0 to 72.3
|
82.5 Percentage of participants
Interval 67.2 to 92.7
|
66.7 Percentage of participants
Interval 34.9 to 90.1
|
65.9 Percentage of participants
Interval 50.1 to 79.5
|
50.0 Percentage of participants
Interval 26.0 to 74.0
|
|
Extracranial Disease Control Rate (EDCR) Per RECIST 1.1 Per Investigator & BIRC Assessment at Weeks 8 & 16
EDCR per BIRC @ Week 8
|
66.7 Percentage of participants
Interval 50.5 to 80.4
|
72.5 Percentage of participants
Interval 56.1 to 85.4
|
58.3 Percentage of participants
Interval 27.7 to 84.8
|
61.4 Percentage of participants
Interval 45.5 to 75.6
|
72.2 Percentage of participants
Interval 46.5 to 90.3
|
|
Extracranial Disease Control Rate (EDCR) Per RECIST 1.1 Per Investigator & BIRC Assessment at Weeks 8 & 16
EDCR per BIRC @ Week 16
|
54.8 Percentage of participants
Interval 38.7 to 70.2
|
70.0 Percentage of participants
Interval 53.5 to 83.4
|
66.7 Percentage of participants
Interval 34.9 to 90.1
|
68.2 Percentage of participants
Interval 52.4 to 81.4
|
44.4 Percentage of participants
Interval 21.5 to 69.2
|
SECONDARY outcome
Timeframe: 43 monthsPopulation: A subset of FAS (comprised of all patients who received at least one dose of ceritinib) where participants had confirmed CR or PR.
TTER was defined as the time from the date of the first dose of ceritinib to the date of the first documented response (CR or PR) outside of the brain as assessed per RECIST 1.1 criteria. CR: Disappearance of all non-nodal target and non-target lesions. In addition, all lymph nodes assigned a target or a non-target lesions must be non-pathological in size (\< 10 mm short axis), and no new lesion is identified. PR: When all target lesions have disappeared or there is a decrease by at least 30% in the sum of diameter of all target lesions (taking as reference the baseline sum of diameters) is observed \& non-target lesions are not in progression or in complete response.
Outcome measures
| Measure |
Arm 1 (PrALKi=Y, PrBRad=Y)
n=13 Participants
Participants with metastases in the brain without evidence of leptomeningeal carcinomatosis (LC), previously treated with radiation to the brain and with prior exposure to an Anaplastic lymphoma kinase inhibitor (ALK-I). Previous treatment with ALK-I other than crizotinib was not allowed in this arm as of protocol amendment 3 and had to present with active brain lesion defined as a lesion free of any local treatment (like stereotactic radiosurgery or whole brain radiation).
|
Arm 2 (PrALKi=Y, PrBRad=N)
n=17 Participants
Participants with metastases in the brain without evidence of LC, previously untreated with radiation to the brain but with prior exposure to an ALK-I. Previous treatment with ALK-I other than crizotinib was not allowed in this arm 2 as of protocol amendment 3 and had to present with active brain lesion defined as a lesion free of any local treatment (like stereotactic radiosurgery or whole brain radiation).
|
Arm 3 (PrALKi=N, PrBRad=Y)
n=5 Participants
Participants with metastases in the brain without evidence of LC, previously treated with radiation to the brain but with no prior exposure to an ALK-I. Participants in this arm had to present with active brain lesion defined as a lesion free of any local treatment (like stereotactic radiosurgery or whole brain radiation).
|
Arm 4 (PrALKi=N, PrBRad=N)
n=27 Participants
Participants with metastases in the brain without evidence of LC, previously untreated with radiation to the brain and with no prior exposure to an ALK-I. Participants in this arm had to present with active brain lesion defined as a lesion free of any local treatment (like stereotactic radiosurgery or whole brain radiation).
|
Arm 5 (LepDis)
n=4 Participants
Participants had LC with or without evidence of active lesion at the baseline Gadolinium-enhanced brain magnetic resonance imaging (MRI). Previous treatment with ALK-I other than crizotinib was not allowed in this arm as of protocol amendment 3.
|
|---|---|---|---|---|---|
|
Time to Extracranial Tumor Response (TTER) Per RECIST 1.1 Per Investigator Assessment
|
1.87 months
Interval 1.7 to 18.2
|
1.87 months
Interval 1.6 to 9.3
|
1.81 months
Interval 1.2 to 12.7
|
1.77 months
Interval 1.3 to 5.7
|
2.73 months
Interval 1.8 to 3.6
|
SECONDARY outcome
Timeframe: 43 monthsPopulation: A subset of FAS (comprised of all patients who received at least one dose of ceritinib) where participants had confirmed CR or PR.
TTER was defined as the time from the date of the first dose of ceritinib to the date of the first documented response (CR or PR) outside of the brain as assessed per RECIST 1.1 criteria. CR: Disappearance of all non-nodal target and non-target lesions. In addition, all lymph nodes assigned a target or a non-target lesions must be non-pathological in size (\< 10 mm short axis), and no new lesion is identified. PR: When all target lesions have disappeared or there is a decrease by at least 30% in the sum of diameter of all target lesions (taking as reference the baseline sum of diameters) is observed \& non-target lesions are not in progression or in complete response.
Outcome measures
| Measure |
Arm 1 (PrALKi=Y, PrBRad=Y)
n=10 Participants
Participants with metastases in the brain without evidence of leptomeningeal carcinomatosis (LC), previously treated with radiation to the brain and with prior exposure to an Anaplastic lymphoma kinase inhibitor (ALK-I). Previous treatment with ALK-I other than crizotinib was not allowed in this arm as of protocol amendment 3 and had to present with active brain lesion defined as a lesion free of any local treatment (like stereotactic radiosurgery or whole brain radiation).
|
Arm 2 (PrALKi=Y, PrBRad=N)
n=6 Participants
Participants with metastases in the brain without evidence of LC, previously untreated with radiation to the brain but with prior exposure to an ALK-I. Previous treatment with ALK-I other than crizotinib was not allowed in this arm 2 as of protocol amendment 3 and had to present with active brain lesion defined as a lesion free of any local treatment (like stereotactic radiosurgery or whole brain radiation).
|
Arm 3 (PrALKi=N, PrBRad=Y)
n=4 Participants
Participants with metastases in the brain without evidence of LC, previously treated with radiation to the brain but with no prior exposure to an ALK-I. Participants in this arm had to present with active brain lesion defined as a lesion free of any local treatment (like stereotactic radiosurgery or whole brain radiation).
|
Arm 4 (PrALKi=N, PrBRad=N)
n=27 Participants
Participants with metastases in the brain without evidence of LC, previously untreated with radiation to the brain and with no prior exposure to an ALK-I. Participants in this arm had to present with active brain lesion defined as a lesion free of any local treatment (like stereotactic radiosurgery or whole brain radiation).
|
Arm 5 (LepDis)
n=4 Participants
Participants had LC with or without evidence of active lesion at the baseline Gadolinium-enhanced brain magnetic resonance imaging (MRI). Previous treatment with ALK-I other than crizotinib was not allowed in this arm as of protocol amendment 3.
|
|---|---|---|---|---|---|
|
Time to Extracranial Tumor Response (TTER) Per RECIST 1.1 Per BIRC Assessment
|
1.81 months
Interval 1.7 to 12.9
|
1.86 months
Interval 1.6 to 22.9
|
2.66 months
Interval 1.7 to 5.5
|
1.77 months
Interval 1.3 to 22.0
|
1.81 months
Interval 1.8 to 1.9
|
SECONDARY outcome
Timeframe: 43 monthsPopulation: A subset of FAS (comprised of all patients who received at least one dose of ceritinib) where participants had confirmed CR or PR.
DOER was defined as the time from the first documented response (PR or CR) outside of the brain to the date of the first documented disease progression outside of the brain or death due to any cause, amongst patients with a confirmed response (PR or CR) outside of the brain per RECIST 1.1. CR: Disappearance of all non-nodal target and non-target lesions. In addition, all lymph nodes assigned a target or a non-target lesions must be non-pathological in size (\< 10 mm short axis), and no new lesion is identified. PR: When all target lesions have disappeared or there is a decrease by at least 30% in the sum of diameter of all target lesions (taking as reference the baseline sum of diameters) is observed \& non-target lesions are not in progression or in complete response.
Outcome measures
| Measure |
Arm 1 (PrALKi=Y, PrBRad=Y)
n=13 Participants
Participants with metastases in the brain without evidence of leptomeningeal carcinomatosis (LC), previously treated with radiation to the brain and with prior exposure to an Anaplastic lymphoma kinase inhibitor (ALK-I). Previous treatment with ALK-I other than crizotinib was not allowed in this arm as of protocol amendment 3 and had to present with active brain lesion defined as a lesion free of any local treatment (like stereotactic radiosurgery or whole brain radiation).
|
Arm 2 (PrALKi=Y, PrBRad=N)
n=17 Participants
Participants with metastases in the brain without evidence of LC, previously untreated with radiation to the brain but with prior exposure to an ALK-I. Previous treatment with ALK-I other than crizotinib was not allowed in this arm 2 as of protocol amendment 3 and had to present with active brain lesion defined as a lesion free of any local treatment (like stereotactic radiosurgery or whole brain radiation).
|
Arm 3 (PrALKi=N, PrBRad=Y)
n=5 Participants
Participants with metastases in the brain without evidence of LC, previously treated with radiation to the brain but with no prior exposure to an ALK-I. Participants in this arm had to present with active brain lesion defined as a lesion free of any local treatment (like stereotactic radiosurgery or whole brain radiation).
|
Arm 4 (PrALKi=N, PrBRad=N)
n=27 Participants
Participants with metastases in the brain without evidence of LC, previously untreated with radiation to the brain and with no prior exposure to an ALK-I. Participants in this arm had to present with active brain lesion defined as a lesion free of any local treatment (like stereotactic radiosurgery or whole brain radiation).
|
Arm 5 (LepDis)
n=4 Participants
Participants had LC with or without evidence of active lesion at the baseline Gadolinium-enhanced brain magnetic resonance imaging (MRI). Previous treatment with ALK-I other than crizotinib was not allowed in this arm as of protocol amendment 3.
|
|---|---|---|---|---|---|
|
Duration of Extracranial Response (DOER) Per RECIST 1.1 Per Investigator Assessment
|
18.4 months
Interval 5.6 to
NA = Not estimable due to small number of responders
|
19.3 months
Interval 5.7 to
NA = Not estimable due to small number of responders
|
NA months
NA = Not estimable due to no responders
|
NA months
Interval 24.4 to
NA = Not estimable due to small number of responders
|
4.6 months
Interval 1.9 to
NA = Not estimable due to small sample size
|
SECONDARY outcome
Timeframe: 43 monthsPopulation: A subset of FAS (comprised of all patients who received at least one dose of ceritinib) where participants had confirmed CR or PR.
DOER was defined as the time from the first documented response (PR or CR) outside of the brain to the date of the first documented disease progression outside of the brain or death due to any cause, amongst patients with a confirmed response (PR or CR) outside of the brain per RECIST 1.1. CR: Disappearance of all non-nodal target and non-target lesions. In addition, all lymph nodes assigned a target or a non-target lesions must be non-pathological in size (\< 10 mm short axis), and no new lesion is identified. PR: When all target lesions have disappeared or there is a decrease by at least 30% in the sum of diameter of all target lesions (taking as reference the baseline sum of diameters) is observed \& non-target lesions are not in progression or in complete response.
Outcome measures
| Measure |
Arm 1 (PrALKi=Y, PrBRad=Y)
n=11 Participants
Participants with metastases in the brain without evidence of leptomeningeal carcinomatosis (LC), previously treated with radiation to the brain and with prior exposure to an Anaplastic lymphoma kinase inhibitor (ALK-I). Previous treatment with ALK-I other than crizotinib was not allowed in this arm as of protocol amendment 3 and had to present with active brain lesion defined as a lesion free of any local treatment (like stereotactic radiosurgery or whole brain radiation).
|
Arm 2 (PrALKi=Y, PrBRad=N)
n=10 Participants
Participants with metastases in the brain without evidence of LC, previously untreated with radiation to the brain but with prior exposure to an ALK-I. Previous treatment with ALK-I other than crizotinib was not allowed in this arm 2 as of protocol amendment 3 and had to present with active brain lesion defined as a lesion free of any local treatment (like stereotactic radiosurgery or whole brain radiation).
|
Arm 3 (PrALKi=N, PrBRad=Y)
n=6 Participants
Participants with metastases in the brain without evidence of LC, previously treated with radiation to the brain but with no prior exposure to an ALK-I. Participants in this arm had to present with active brain lesion defined as a lesion free of any local treatment (like stereotactic radiosurgery or whole brain radiation).
|
Arm 4 (PrALKi=N, PrBRad=N)
n=27 Participants
Participants with metastases in the brain without evidence of LC, previously untreated with radiation to the brain and with no prior exposure to an ALK-I. Participants in this arm had to present with active brain lesion defined as a lesion free of any local treatment (like stereotactic radiosurgery or whole brain radiation).
|
Arm 5 (LepDis)
n=3 Participants
Participants had LC with or without evidence of active lesion at the baseline Gadolinium-enhanced brain magnetic resonance imaging (MRI). Previous treatment with ALK-I other than crizotinib was not allowed in this arm as of protocol amendment 3.
|
|---|---|---|---|---|---|
|
Duration of Extracranial Response (DOER) Per RECIST 1.1 Per BIRC Assessment
|
NA months
Interval 5.5 to
NA = Not estimable due to small number of responders
|
6.0 months
Interval 3.7 to 27.7
|
NA months
Interval 16.5 to
NA = Not estimable due to small sample size
|
NA months
Interval 11.5 to
NA = Not estimable due to small number of responders
|
5.5 months
Interval 3.8 to
NA = Not estimable due to small sample size
|
SECONDARY outcome
Timeframe: 43 monthsPopulation: The Full Analysis Set (FAS) comprised of all patients who received at least one dose of ceritinib.
Overall response rate ORR is defined as the percentage of participants with a best overall confirmed response of complete response (CR) or partial response (PR) in the whole body as assessed per RECIST 1.1 by BIRC. CR: Disappearance of all non-nodal target and non-target lesions. In addition, all lymph nodes assigned a target or a non-target lesions must be non-pathological in size (\< 10 mm short axis), and no new lesion is identified. PR: When all target lesions have disappeared or there is a decrease by at least 30% in the sum of diameter of all target lesions (taking as reference the baseline sum of diameters) is observed \& non-target lesions are not in progression or in complete response.
Outcome measures
| Measure |
Arm 1 (PrALKi=Y, PrBRad=Y)
n=42 Participants
Participants with metastases in the brain without evidence of leptomeningeal carcinomatosis (LC), previously treated with radiation to the brain and with prior exposure to an Anaplastic lymphoma kinase inhibitor (ALK-I). Previous treatment with ALK-I other than crizotinib was not allowed in this arm as of protocol amendment 3 and had to present with active brain lesion defined as a lesion free of any local treatment (like stereotactic radiosurgery or whole brain radiation).
|
Arm 2 (PrALKi=Y, PrBRad=N)
n=40 Participants
Participants with metastases in the brain without evidence of LC, previously untreated with radiation to the brain but with prior exposure to an ALK-I. Previous treatment with ALK-I other than crizotinib was not allowed in this arm 2 as of protocol amendment 3 and had to present with active brain lesion defined as a lesion free of any local treatment (like stereotactic radiosurgery or whole brain radiation).
|
Arm 3 (PrALKi=N, PrBRad=Y)
n=12 Participants
Participants with metastases in the brain without evidence of LC, previously treated with radiation to the brain but with no prior exposure to an ALK-I. Participants in this arm had to present with active brain lesion defined as a lesion free of any local treatment (like stereotactic radiosurgery or whole brain radiation).
|
Arm 4 (PrALKi=N, PrBRad=N)
n=44 Participants
Participants with metastases in the brain without evidence of LC, previously untreated with radiation to the brain and with no prior exposure to an ALK-I. Participants in this arm had to present with active brain lesion defined as a lesion free of any local treatment (like stereotactic radiosurgery or whole brain radiation).
|
Arm 5 (LepDis)
n=18 Participants
Participants had LC with or without evidence of active lesion at the baseline Gadolinium-enhanced brain magnetic resonance imaging (MRI). Previous treatment with ALK-I other than crizotinib was not allowed in this arm as of protocol amendment 3.
|
|---|---|---|---|---|---|
|
Overall Response Rate (ORR) (Whole Body) Per RECIST 1.1 Per BIRC Assessment
|
23.8 Percentage of participants
Interval 12.1 to 39.5
|
15.0 Percentage of participants
Interval 5.7 to 29.8
|
33.3 Percentage of participants
Interval 9.9 to 65.1
|
61.4 Percentage of participants
Interval 45.5 to 75.6
|
11.1 Percentage of participants
Interval 1.4 to 34.7
|
SECONDARY outcome
Timeframe: 43 monthsPopulation: The Full Analysis Set (FAS) comprised of all patients who received at least one dose of ceritinib.
DCR: defined as percentage of participants with a best overall response of CR, PR or stable disease (SD) in the whole body, per RECIST 1.1 by BIRC. CR: Disappearance of all non-nodal target and non-target lesions. In addition, all lymph nodes assigned a target or a non-target lesions must be non-pathological in size (\< 10 mm short axis), \& no new lesion is identified. PR: When all target lesions have disappeared or there is a decrease by at least 30% in the sum of diameter of all target lesions (taking as reference the baseline sum of diameters) is observed and non-target lesions are not in progression or in complete response. SD: Neither sufficient shrinkage in the target lesion to qualify for PR or CR nor an increase in lesions which would qualify for PD \& non-target lesions are not in unequivocal progression.
Outcome measures
| Measure |
Arm 1 (PrALKi=Y, PrBRad=Y)
n=42 Participants
Participants with metastases in the brain without evidence of leptomeningeal carcinomatosis (LC), previously treated with radiation to the brain and with prior exposure to an Anaplastic lymphoma kinase inhibitor (ALK-I). Previous treatment with ALK-I other than crizotinib was not allowed in this arm as of protocol amendment 3 and had to present with active brain lesion defined as a lesion free of any local treatment (like stereotactic radiosurgery or whole brain radiation).
|
Arm 2 (PrALKi=Y, PrBRad=N)
n=40 Participants
Participants with metastases in the brain without evidence of LC, previously untreated with radiation to the brain but with prior exposure to an ALK-I. Previous treatment with ALK-I other than crizotinib was not allowed in this arm 2 as of protocol amendment 3 and had to present with active brain lesion defined as a lesion free of any local treatment (like stereotactic radiosurgery or whole brain radiation).
|
Arm 3 (PrALKi=N, PrBRad=Y)
n=12 Participants
Participants with metastases in the brain without evidence of LC, previously treated with radiation to the brain but with no prior exposure to an ALK-I. Participants in this arm had to present with active brain lesion defined as a lesion free of any local treatment (like stereotactic radiosurgery or whole brain radiation).
|
Arm 4 (PrALKi=N, PrBRad=N)
n=44 Participants
Participants with metastases in the brain without evidence of LC, previously untreated with radiation to the brain and with no prior exposure to an ALK-I. Participants in this arm had to present with active brain lesion defined as a lesion free of any local treatment (like stereotactic radiosurgery or whole brain radiation).
|
Arm 5 (LepDis)
n=18 Participants
Participants had LC with or without evidence of active lesion at the baseline Gadolinium-enhanced brain magnetic resonance imaging (MRI). Previous treatment with ALK-I other than crizotinib was not allowed in this arm as of protocol amendment 3.
|
|---|---|---|---|---|---|
|
Disease Control Rate (DCR) (Whole Body) Per RECIST 1.1 Per BIRC Assessment
|
61.9 Percentage of participants
Interval 45.6 to 76.4
|
80.0 Percentage of participants
Interval 64.4 to 90.9
|
66.7 Percentage of participants
Interval 34.9 to 90.1
|
68.2 Percentage of participants
Interval 52.4 to 81.4
|
72.2 Percentage of participants
Interval 46.5 to 90.3
|
SECONDARY outcome
Timeframe: 43 monthsPopulation: A subset of FAS (comprised of all patients who received at least one dose of ceritinib) where participants had confirmed CR or PR.
TTR was defined as the time from the date of the first dose of ceritinib to the date of the first documented response (CR or PR) in the whole body as assessed per RECIST 1.1 criteria per Investigator. CR: Disappearance of all non-nodal target and non-target lesions. In addition, all lymph nodes assigned a target or a non-target lesions must be non-pathological in size (\< 10 mm short axis), and no new lesion is identified. PR: When all target lesions have disappeared or there is a decrease by at least 30% in the sum of diameter of all target lesions (taking as reference the baseline sum of diameters) is observed \& non-target lesions are not in progression or in complete response.
Outcome measures
| Measure |
Arm 1 (PrALKi=Y, PrBRad=Y)
n=15 Participants
Participants with metastases in the brain without evidence of leptomeningeal carcinomatosis (LC), previously treated with radiation to the brain and with prior exposure to an Anaplastic lymphoma kinase inhibitor (ALK-I). Previous treatment with ALK-I other than crizotinib was not allowed in this arm as of protocol amendment 3 and had to present with active brain lesion defined as a lesion free of any local treatment (like stereotactic radiosurgery or whole brain radiation).
|
Arm 2 (PrALKi=Y, PrBRad=N)
n=12 Participants
Participants with metastases in the brain without evidence of LC, previously untreated with radiation to the brain but with prior exposure to an ALK-I. Previous treatment with ALK-I other than crizotinib was not allowed in this arm 2 as of protocol amendment 3 and had to present with active brain lesion defined as a lesion free of any local treatment (like stereotactic radiosurgery or whole brain radiation).
|
Arm 3 (PrALKi=N, PrBRad=Y)
n=6 Participants
Participants with metastases in the brain without evidence of LC, previously treated with radiation to the brain but with no prior exposure to an ALK-I. Participants in this arm had to present with active brain lesion defined as a lesion free of any local treatment (like stereotactic radiosurgery or whole brain radiation).
|
Arm 4 (PrALKi=N, PrBRad=N)
n=26 Participants
Participants with metastases in the brain without evidence of LC, previously untreated with radiation to the brain and with no prior exposure to an ALK-I. Participants in this arm had to present with active brain lesion defined as a lesion free of any local treatment (like stereotactic radiosurgery or whole brain radiation).
|
Arm 5 (LepDis)
n=3 Participants
Participants had LC with or without evidence of active lesion at the baseline Gadolinium-enhanced brain magnetic resonance imaging (MRI). Previous treatment with ALK-I other than crizotinib was not allowed in this arm as of protocol amendment 3.
|
|---|---|---|---|---|---|
|
Time to Tumor Response (TTR) (Whole Body) Per RECIST 1.1 Per Investigator Assessment
|
1.87 months
Interval 1.7 to 9.3
|
2.00 months
Interval 1.7 to 9.3
|
1.82 months
Interval 1.2 to 30.1
|
1.81 months
Interval 1.3 to 3.7
|
1.91 months
Interval 1.8 to 3.6
|
SECONDARY outcome
Timeframe: 43 monthsPopulation: A subset of FAS (comprised of all patients who received at least one dose of ceritinib) where participants had confirmed CR or PR.
TTR was defined as the time from the date of the first dose of ceritinib to the date of the first documented response (CR or PR) in the whole body as assessed by RECIST 1.1 criteria per BIRC assessment. CR: Disappearance of all non-nodal target and non-target lesions. In addition, all lymph nodes assigned a target or a non-target lesions must be non-pathological in size (\< 10 mm short axis), and no new lesion is identified. PR: When all target lesions have disappeared or there is a decrease by at least 30% in the sum of diameter of all target lesions (taking as reference the baseline sum of diameters) is observed \& non-target lesions are not in progression or in complete response.
Outcome measures
| Measure |
Arm 1 (PrALKi=Y, PrBRad=Y)
n=10 Participants
Participants with metastases in the brain without evidence of leptomeningeal carcinomatosis (LC), previously treated with radiation to the brain and with prior exposure to an Anaplastic lymphoma kinase inhibitor (ALK-I). Previous treatment with ALK-I other than crizotinib was not allowed in this arm as of protocol amendment 3 and had to present with active brain lesion defined as a lesion free of any local treatment (like stereotactic radiosurgery or whole brain radiation).
|
Arm 2 (PrALKi=Y, PrBRad=N)
n=6 Participants
Participants with metastases in the brain without evidence of LC, previously untreated with radiation to the brain but with prior exposure to an ALK-I. Previous treatment with ALK-I other than crizotinib was not allowed in this arm 2 as of protocol amendment 3 and had to present with active brain lesion defined as a lesion free of any local treatment (like stereotactic radiosurgery or whole brain radiation).
|
Arm 3 (PrALKi=N, PrBRad=Y)
n=4 Participants
Participants with metastases in the brain without evidence of LC, previously treated with radiation to the brain but with no prior exposure to an ALK-I. Participants in this arm had to present with active brain lesion defined as a lesion free of any local treatment (like stereotactic radiosurgery or whole brain radiation).
|
Arm 4 (PrALKi=N, PrBRad=N)
n=27 Participants
Participants with metastases in the brain without evidence of LC, previously untreated with radiation to the brain and with no prior exposure to an ALK-I. Participants in this arm had to present with active brain lesion defined as a lesion free of any local treatment (like stereotactic radiosurgery or whole brain radiation).
|
Arm 5 (LepDis)
n=2 Participants
Participants had LC with or without evidence of active lesion at the baseline Gadolinium-enhanced brain magnetic resonance imaging (MRI). Previous treatment with ALK-I other than crizotinib was not allowed in this arm as of protocol amendment 3.
|
|---|---|---|---|---|---|
|
Time to Tumor Response (TTR) (Whole Body) Per RECIST 1.1 Per BIRC Assessment
|
2.00 months
Interval 1.7 to 12.9
|
1.76 months
Interval 1.6 to 1.9
|
1.82 months
Interval 1.7 to 26.5
|
1.81 months
Interval 1.3 to 22.0
|
1.86 months
Interval 1.8 to 1.9
|
SECONDARY outcome
Timeframe: 43 monthsPopulation: A subset of FAS (comprised of all patients who received at least one dose of ceritinib) where participants had confirmed CR or PR.
DOR was defined as the time from the first documented response (PR or CR) to the date of the first documented disease progression or death due to any cause, amongst patients with a confirmed response (PR or CR) in the whole body per RECIST 1.1 per Investigator. CR: Disappearance of all non-nodal target and non-target lesions. In addition, all lymph nodes assigned a target or a non-target lesions must be non-pathological in size (\< 10 mm short axis), and no new lesion is identified. PR: When all target lesions have disappeared or there is a decrease by at least 30% in the sum of diameter of all target lesions (taking as reference the baseline sum of diameters) is observed \& non-target lesions are not in progression or in complete response.
Outcome measures
| Measure |
Arm 1 (PrALKi=Y, PrBRad=Y)
n=15 Participants
Participants with metastases in the brain without evidence of leptomeningeal carcinomatosis (LC), previously treated with radiation to the brain and with prior exposure to an Anaplastic lymphoma kinase inhibitor (ALK-I). Previous treatment with ALK-I other than crizotinib was not allowed in this arm as of protocol amendment 3 and had to present with active brain lesion defined as a lesion free of any local treatment (like stereotactic radiosurgery or whole brain radiation).
|
Arm 2 (PrALKi=Y, PrBRad=N)
n=12 Participants
Participants with metastases in the brain without evidence of LC, previously untreated with radiation to the brain but with prior exposure to an ALK-I. Previous treatment with ALK-I other than crizotinib was not allowed in this arm 2 as of protocol amendment 3 and had to present with active brain lesion defined as a lesion free of any local treatment (like stereotactic radiosurgery or whole brain radiation).
|
Arm 3 (PrALKi=N, PrBRad=Y)
n=6 Participants
Participants with metastases in the brain without evidence of LC, previously treated with radiation to the brain but with no prior exposure to an ALK-I. Participants in this arm had to present with active brain lesion defined as a lesion free of any local treatment (like stereotactic radiosurgery or whole brain radiation).
|
Arm 4 (PrALKi=N, PrBRad=N)
n=26 Participants
Participants with metastases in the brain without evidence of LC, previously untreated with radiation to the brain and with no prior exposure to an ALK-I. Participants in this arm had to present with active brain lesion defined as a lesion free of any local treatment (like stereotactic radiosurgery or whole brain radiation).
|
Arm 5 (LepDis)
n=3 Participants
Participants had LC with or without evidence of active lesion at the baseline Gadolinium-enhanced brain magnetic resonance imaging (MRI). Previous treatment with ALK-I other than crizotinib was not allowed in this arm as of protocol amendment 3.
|
|---|---|---|---|---|---|
|
Duration of Response (DOR) (Whole Body) Per RECIST 1.1 Per Investigator Assessment
|
10.8 months
Interval 4.1 to
NA =Not estimable due to small sample size
|
12.8 months
Interval 3.7 to 17.3
|
NA months
Interval 11.7 to
NA = Not estimable due to small number of responders/sample size
|
9.2 months
Interval 7.3 to 23.9
|
5.5 months
Interval 3.7 to 9.9
|
SECONDARY outcome
Timeframe: 43 monthsPopulation: A subset of FAS (comprised of all patients who received at least one dose of ceritinib) where participants had confirmed CR or PR.
DOR was defined as the time from the first documented response (PR or CR) to the date of the first documented disease progression or death due to any cause, amongst patients with a confirmed response (PR or CR) in the whole body per RECIST 1.1 per BIRC. CR: Disappearance of all non-nodal target and non-target lesions. In addition, all lymph nodes assigned a target or a non-target lesions must be non-pathological in size (\< 10 mm short axis), and no new lesion is identified. PR: When all target lesions have disappeared or there is a decrease by at least 30% in the sum of diameter of all target lesions (taking as reference the baseline sum of diameters) is observed \& non-target lesions are not in progression or in complete response.
Outcome measures
| Measure |
Arm 1 (PrALKi=Y, PrBRad=Y)
n=10 Participants
Participants with metastases in the brain without evidence of leptomeningeal carcinomatosis (LC), previously treated with radiation to the brain and with prior exposure to an Anaplastic lymphoma kinase inhibitor (ALK-I). Previous treatment with ALK-I other than crizotinib was not allowed in this arm as of protocol amendment 3 and had to present with active brain lesion defined as a lesion free of any local treatment (like stereotactic radiosurgery or whole brain radiation).
|
Arm 2 (PrALKi=Y, PrBRad=N)
n=6 Participants
Participants with metastases in the brain without evidence of LC, previously untreated with radiation to the brain but with prior exposure to an ALK-I. Previous treatment with ALK-I other than crizotinib was not allowed in this arm 2 as of protocol amendment 3 and had to present with active brain lesion defined as a lesion free of any local treatment (like stereotactic radiosurgery or whole brain radiation).
|
Arm 3 (PrALKi=N, PrBRad=Y)
n=4 Participants
Participants with metastases in the brain without evidence of LC, previously treated with radiation to the brain but with no prior exposure to an ALK-I. Participants in this arm had to present with active brain lesion defined as a lesion free of any local treatment (like stereotactic radiosurgery or whole brain radiation).
|
Arm 4 (PrALKi=N, PrBRad=N)
n=27 Participants
Participants with metastases in the brain without evidence of LC, previously untreated with radiation to the brain and with no prior exposure to an ALK-I. Participants in this arm had to present with active brain lesion defined as a lesion free of any local treatment (like stereotactic radiosurgery or whole brain radiation).
|
Arm 5 (LepDis)
n=2 Participants
Participants had LC with or without evidence of active lesion at the baseline Gadolinium-enhanced brain magnetic resonance imaging (MRI). Previous treatment with ALK-I other than crizotinib was not allowed in this arm as of protocol amendment 3.
|
|---|---|---|---|---|---|
|
Duration of Response (DOR) (Whole Body) Per RECIST 1.1 Per BIRC Assessment
|
11.0 months
Interval 2.0 to
NA = Not estimable due to small sample size
|
10.6 months
Interval 3.7 to 20.3
|
NA months
Interval 16.5 to
NA = Not estimable due to small sample size
|
9.2 months
Interval 5.7 to 14.3
|
5.7 months
Interval 5.5 to 6.0
|
SECONDARY outcome
Timeframe: 43 monthsPopulation: The Full Analysis Set (FAS) comprised of all patients who received at least one dose of ceritinib
PFS was defined as the time from the date of the first dose of ceritinib to the date of the first radiologically documented disease progression in the whole body per RECIST 1.1 or death due to any cause. A patient who had not progressed or died at the date of the analysis was censored at the time of the last adequate tumor evaluation on or before the cut-off date.
Outcome measures
| Measure |
Arm 1 (PrALKi=Y, PrBRad=Y)
n=42 Participants
Participants with metastases in the brain without evidence of leptomeningeal carcinomatosis (LC), previously treated with radiation to the brain and with prior exposure to an Anaplastic lymphoma kinase inhibitor (ALK-I). Previous treatment with ALK-I other than crizotinib was not allowed in this arm as of protocol amendment 3 and had to present with active brain lesion defined as a lesion free of any local treatment (like stereotactic radiosurgery or whole brain radiation).
|
Arm 2 (PrALKi=Y, PrBRad=N)
n=40 Participants
Participants with metastases in the brain without evidence of LC, previously untreated with radiation to the brain but with prior exposure to an ALK-I. Previous treatment with ALK-I other than crizotinib was not allowed in this arm 2 as of protocol amendment 3 and had to present with active brain lesion defined as a lesion free of any local treatment (like stereotactic radiosurgery or whole brain radiation).
|
Arm 3 (PrALKi=N, PrBRad=Y)
n=12 Participants
Participants with metastases in the brain without evidence of LC, previously treated with radiation to the brain but with no prior exposure to an ALK-I. Participants in this arm had to present with active brain lesion defined as a lesion free of any local treatment (like stereotactic radiosurgery or whole brain radiation).
|
Arm 4 (PrALKi=N, PrBRad=N)
n=44 Participants
Participants with metastases in the brain without evidence of LC, previously untreated with radiation to the brain and with no prior exposure to an ALK-I. Participants in this arm had to present with active brain lesion defined as a lesion free of any local treatment (like stereotactic radiosurgery or whole brain radiation).
|
Arm 5 (LepDis)
n=18 Participants
Participants had LC with or without evidence of active lesion at the baseline Gadolinium-enhanced brain magnetic resonance imaging (MRI). Previous treatment with ALK-I other than crizotinib was not allowed in this arm as of protocol amendment 3.
|
|---|---|---|---|---|---|
|
Progression Free Survival (PFS) (Whole Body) Per RECIST 1.1 Per Investigator & BIRC Assessment
PFS per Investigator assessment
|
7.2 months
Interval 3.3 to 10.9
|
5.6 months
Interval 3.6 to 9.2
|
NA months
Interval 1.0 to
NA = Not estimable due to small sample size
|
7.9 months
Interval 5.5 to 9.4
|
5.2 months
Interval 1.6 to 7.2
|
|
Progression Free Survival (PFS) (Whole Body) Per RECIST 1.1 Per Investigator & BIRC Assessment
PFS per BIRC assessment
|
5.0 months
Interval 3.3 to 9.1
|
5.5 months
Interval 3.6 to 7.3
|
15.5 months
Interval 1.0 to
NA = Not estimable due to small sample size
|
7.7 months
Interval 5.5 to 9.7
|
3.6 months
Interval 1.6 to 5.4
|
SECONDARY outcome
Timeframe: 24 weeksPopulation: The Full Analysis Set (FAS) comprised of all patients who received at least one dose of ceritinib
OS was defined as time from the date of first dose of ceritinib to the date of death due to any cause. The OS time for patients who were alive at the end of the study or were lost to follow-up was censored at the date of last contact.
Outcome measures
| Measure |
Arm 1 (PrALKi=Y, PrBRad=Y)
n=42 Participants
Participants with metastases in the brain without evidence of leptomeningeal carcinomatosis (LC), previously treated with radiation to the brain and with prior exposure to an Anaplastic lymphoma kinase inhibitor (ALK-I). Previous treatment with ALK-I other than crizotinib was not allowed in this arm as of protocol amendment 3 and had to present with active brain lesion defined as a lesion free of any local treatment (like stereotactic radiosurgery or whole brain radiation).
|
Arm 2 (PrALKi=Y, PrBRad=N)
n=40 Participants
Participants with metastases in the brain without evidence of LC, previously untreated with radiation to the brain but with prior exposure to an ALK-I. Previous treatment with ALK-I other than crizotinib was not allowed in this arm 2 as of protocol amendment 3 and had to present with active brain lesion defined as a lesion free of any local treatment (like stereotactic radiosurgery or whole brain radiation).
|
Arm 3 (PrALKi=N, PrBRad=Y)
n=12 Participants
Participants with metastases in the brain without evidence of LC, previously treated with radiation to the brain but with no prior exposure to an ALK-I. Participants in this arm had to present with active brain lesion defined as a lesion free of any local treatment (like stereotactic radiosurgery or whole brain radiation).
|
Arm 4 (PrALKi=N, PrBRad=N)
n=44 Participants
Participants with metastases in the brain without evidence of LC, previously untreated with radiation to the brain and with no prior exposure to an ALK-I. Participants in this arm had to present with active brain lesion defined as a lesion free of any local treatment (like stereotactic radiosurgery or whole brain radiation).
|
Arm 5 (LepDis)
n=18 Participants
Participants had LC with or without evidence of active lesion at the baseline Gadolinium-enhanced brain magnetic resonance imaging (MRI). Previous treatment with ALK-I other than crizotinib was not allowed in this arm as of protocol amendment 3.
|
|---|---|---|---|---|---|
|
Overall Survival (OS)
|
24.0 months
Interval 12.6 to
NA = Not estimable due to small number of responders
|
NA months
Interval 16.2 to
NA = Not estimable due to small number of responders
|
NA months
Interval 1.0 to
NA = Not estimable due to small sample size
|
NA months
Interval 26.5 to
NA = Not estimable due to small number of responders
|
7.2 months
Interval 1.6 to 16.9
|
SECONDARY outcome
Timeframe: Cmax: Cycle 2 Day 1 (C2D1); Cmin: C1D1, C1D8, C1D15, C2D1, C3D1, C4D1, C5D1, C6D1 - all 0hr (pre dose)Population: The Pharmacokinetic Analysis Set (PAS) comprised of all the patients who received at least one (full or partial) dose of ceritinib and provided at least one evaluable PK blood sample.
Cmax is the maximum (peak) concentration of drug in plasma. Cmin is the minimum (trough) concentration of drug in plasma. Sparse blood samples for ceritinib PK evaluation in plasma were collected on C1D1 up to C6D1 from all patients who received at least one dose of investigational study treatment.
Outcome measures
| Measure |
Arm 1 (PrALKi=Y, PrBRad=Y)
n=145 Participants
Participants with metastases in the brain without evidence of leptomeningeal carcinomatosis (LC), previously treated with radiation to the brain and with prior exposure to an Anaplastic lymphoma kinase inhibitor (ALK-I). Previous treatment with ALK-I other than crizotinib was not allowed in this arm as of protocol amendment 3 and had to present with active brain lesion defined as a lesion free of any local treatment (like stereotactic radiosurgery or whole brain radiation).
|
Arm 2 (PrALKi=Y, PrBRad=N)
Participants with metastases in the brain without evidence of LC, previously untreated with radiation to the brain but with prior exposure to an ALK-I. Previous treatment with ALK-I other than crizotinib was not allowed in this arm 2 as of protocol amendment 3 and had to present with active brain lesion defined as a lesion free of any local treatment (like stereotactic radiosurgery or whole brain radiation).
|
Arm 3 (PrALKi=N, PrBRad=Y)
Participants with metastases in the brain without evidence of LC, previously treated with radiation to the brain but with no prior exposure to an ALK-I. Participants in this arm had to present with active brain lesion defined as a lesion free of any local treatment (like stereotactic radiosurgery or whole brain radiation).
|
Arm 4 (PrALKi=N, PrBRad=N)
Participants with metastases in the brain without evidence of LC, previously untreated with radiation to the brain and with no prior exposure to an ALK-I. Participants in this arm had to present with active brain lesion defined as a lesion free of any local treatment (like stereotactic radiosurgery or whole brain radiation).
|
Arm 5 (LepDis)
Participants had LC with or without evidence of active lesion at the baseline Gadolinium-enhanced brain magnetic resonance imaging (MRI). Previous treatment with ALK-I other than crizotinib was not allowed in this arm as of protocol amendment 3.
|
|---|---|---|---|---|---|
|
Pharmacokinetics (PK) of Ceritinib in Study Population: Cmax & Cmin (Trough)
Cmin C1D1: 0hr. (pre dose)
|
0 ng/mL
Geometric Coefficient of Variation 0.0
|
—
|
—
|
—
|
—
|
|
Pharmacokinetics (PK) of Ceritinib in Study Population: Cmax & Cmin (Trough)
Cmin C1D8: 0hr. (pre dose)
|
658 ng/mL
Geometric Coefficient of Variation 59.2
|
—
|
—
|
—
|
—
|
|
Pharmacokinetics (PK) of Ceritinib in Study Population: Cmax & Cmin (Trough)
Cmin C1D15: 0hr. (pre dose)
|
846 ng/mL
Geometric Coefficient of Variation 52.9
|
—
|
—
|
—
|
—
|
|
Pharmacokinetics (PK) of Ceritinib in Study Population: Cmax & Cmin (Trough)
Cmin C2D1: 0hr. (pre dose)
|
1000 ng/mL
Geometric Coefficient of Variation 50.0
|
—
|
—
|
—
|
—
|
|
Pharmacokinetics (PK) of Ceritinib in Study Population: Cmax & Cmin (Trough)
Cmax C2D1: 4 - 10 hrs. (post dose)
|
1100 ng/mL
Geometric Coefficient of Variation 47.8
|
—
|
—
|
—
|
—
|
|
Pharmacokinetics (PK) of Ceritinib in Study Population: Cmax & Cmin (Trough)
Cmin C3D1: 0hr. (pre dose)
|
982 ng/mL
Geometric Coefficient of Variation 59.1
|
—
|
—
|
—
|
—
|
|
Pharmacokinetics (PK) of Ceritinib in Study Population: Cmax & Cmin (Trough)
Cmin C4D1: 0hr. (pre dose)
|
978 ng/mL
Geometric Coefficient of Variation 75.4
|
—
|
—
|
—
|
—
|
|
Pharmacokinetics (PK) of Ceritinib in Study Population: Cmax & Cmin (Trough)
Cmin C5D1: 0hr. (pre dose)
|
885 ng/mL
Geometric Coefficient of Variation 75.5
|
—
|
—
|
—
|
—
|
|
Pharmacokinetics (PK) of Ceritinib in Study Population: Cmax & Cmin (Trough)
Cmin C6D1: 0hr. (pre dose)
|
785 ng/mL
Geometric Coefficient of Variation 120.4
|
—
|
—
|
—
|
—
|
Adverse Events
Arm 1 (PrALKi=Y, PrBRad=Y)
Serious events: 28 serious events
Other events: 42 other events
Deaths: 8 deaths
Arm 2 (PrALKi=Y, PrBRad=N)
Serious events: 17 serious events
Other events: 40 other events
Deaths: 5 deaths
Arm 3 (PrALKi=N, PrBRad=Y)
Serious events: 4 serious events
Other events: 11 other events
Deaths: 3 deaths
Arm 4 (PrALKi=N, PrBRad=N)
Serious events: 15 serious events
Other events: 43 other events
Deaths: 6 deaths
Arm 5 (LepDis)
Serious events: 11 serious events
Other events: 18 other events
Deaths: 9 deaths
All Participants
Serious events: 75 serious events
Other events: 154 other events
Deaths: 31 deaths
Serious adverse events
| Measure |
Arm 1 (PrALKi=Y, PrBRad=Y)
n=42 participants at risk
Participants with metastases in the brain without evidence of leptomeningeal carcinomatosis (LC), previously treated with radiation to the brain and with prior exposure to an Anaplastic lymphoma kinase inhibitor (ALK-I). Previous treatment with ALK-I other than crizotinib was not allowed in this arm as of protocol amendment 3 and had to present with active brain lesion defined as a lesion free of any local treatment (like stereotactic radiosurgery or whole brain radiation).
|
Arm 2 (PrALKi=Y, PrBRad=N)
n=40 participants at risk
Participants with metastases in the brain without evidence of LC, previously untreated with radiation to the brain but with prior exposure to an ALK-I. Previous treatment with ALK-I other than crizotinib was not allowed in this arm 2 as of protocol amendment 3 and had to present with active brain lesion defined as a lesion free of any local treatment (like stereotactic radiosurgery or whole brain radiation).
|
Arm 3 (PrALKi=N, PrBRad=Y)
n=12 participants at risk
Participants with metastases in the brain without evidence of LC, previously treated with radiation to the brain but with no prior exposure to an ALK-I. Participants in this arm had to present with active brain lesion defined as a lesion free of any local treatment (like stereotactic radiosurgery or whole brain radiation).
|
Arm 4 (PrALKi=N, PrBRad=N)
n=44 participants at risk
Participants with metastases in the brain without evidence of LC, previously untreated with radiation to the brain and with no prior exposure to an ALK-I. Participants in this arm had to present with active brain lesion defined as a lesion free of any local treatment (like stereotactic radiosurgery or whole brain radiation
|
Arm 5 (LepDis)
n=18 participants at risk
Participants had LC with or without evidence of active lesion at the baseline Gadolinium-enhanced brain magnetic resonance imaging (MRI). Previous treatment with ALK-I other than crizotinib was not allowed in this arm as of protocol amendment 3.
|
All Participants
n=156 participants at risk
All participants who participated in the study and received at least one (full or partial) dose of ceritinib and provided at least one evaluable PK blood sample
|
|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/42 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
2.3%
1/44 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.64%
1/156 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Cardiac disorders
Atrial fibrillation
|
2.4%
1/42 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/44 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.64%
1/156 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Cardiac disorders
Left ventricular dysfunction
|
0.00%
0/42 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
2.5%
1/40 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/44 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.64%
1/156 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Cardiac disorders
Pericardial effusion
|
4.8%
2/42 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
2.3%
1/44 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
1.9%
3/156 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Cardiac disorders
Pericarditis
|
4.8%
2/42 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.0%
2/40 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/44 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
2.6%
4/156 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Cardiac disorders
Tachycardia
|
4.8%
2/42 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/44 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
1.3%
2/156 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Eye disorders
Keratitis
|
0.00%
0/42 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
2.5%
1/40 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/44 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.64%
1/156 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/42 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
2.3%
1/44 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.64%
1/156 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/42 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/44 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.6%
1/18 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.64%
1/156 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Gastrointestinal disorders
Oesophagopleural fistula
|
2.4%
1/42 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/44 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.64%
1/156 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Gastrointestinal disorders
Salivary hypersecretion
|
2.4%
1/42 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/44 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.64%
1/156 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/42 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
2.3%
1/44 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.64%
1/156 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Gastrointestinal disorders
Subileus
|
0.00%
0/42 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
2.5%
1/40 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/44 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.64%
1/156 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
2.4%
1/42 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/44 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.64%
1/156 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/42 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/44 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.6%
1/18 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.64%
1/156 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
General disorders
Adverse drug reaction
|
0.00%
0/42 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
2.3%
1/44 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.64%
1/156 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
General disorders
Disease progression
|
0.00%
0/42 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
2.5%
1/40 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/44 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.6%
1/18 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
1.3%
2/156 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
General disorders
General physical health deterioration
|
0.00%
0/42 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/44 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.6%
1/18 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.64%
1/156 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
General disorders
Hyperthermia
|
0.00%
0/42 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/44 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.6%
1/18 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.64%
1/156 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/42 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
2.5%
1/40 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
2.3%
1/44 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
1.3%
2/156 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
General disorders
Pyrexia
|
2.4%
1/42 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
2.5%
1/40 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/44 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.6%
1/18 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
1.9%
3/156 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
General disorders
Sudden death
|
2.4%
1/42 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
2.3%
1/44 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
1.3%
2/156 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Hepatobiliary disorders
Hepatitis
|
0.00%
0/42 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
2.3%
1/44 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.64%
1/156 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Infections and infestations
Colonic abscess
|
0.00%
0/42 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
2.3%
1/44 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.64%
1/156 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Infections and infestations
Herpes zoster
|
2.4%
1/42 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/44 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.64%
1/156 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/42 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
2.5%
1/40 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/44 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.64%
1/156 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Infections and infestations
Lung infection
|
0.00%
0/42 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/44 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.6%
1/18 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.64%
1/156 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Infections and infestations
Lung infection pseudomonal
|
2.4%
1/42 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/44 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.64%
1/156 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Infections and infestations
Nocardia sepsis
|
0.00%
0/42 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
2.3%
1/44 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.64%
1/156 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Infections and infestations
Pneumonia
|
9.5%
4/42 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
10.0%
4/40 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
8.3%
1/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
2.3%
1/44 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
11.1%
2/18 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
7.7%
12/156 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/42 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
2.5%
1/40 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/44 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.64%
1/156 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Infections and infestations
Septic shock
|
2.4%
1/42 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/44 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.64%
1/156 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Infections and infestations
Staphylococcal bacteraemia
|
2.4%
1/42 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/44 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.64%
1/156 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Infections and infestations
Staphylococcal infection
|
0.00%
0/42 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
8.3%
1/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/44 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.64%
1/156 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/42 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/44 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.6%
1/18 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.64%
1/156 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Injury, poisoning and procedural complications
Post procedural complication
|
0.00%
0/42 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
2.3%
1/44 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.64%
1/156 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/42 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
8.3%
1/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/44 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.64%
1/156 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Investigations
General physical condition abnormal
|
0.00%
0/42 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/44 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.6%
1/18 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.64%
1/156 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/42 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
2.3%
1/44 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.64%
1/156 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Investigations
Inflammatory marker increased
|
0.00%
0/42 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
2.5%
1/40 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/44 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.64%
1/156 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Investigations
Platelet count decreased
|
2.4%
1/42 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/44 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.64%
1/156 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/42 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
2.3%
1/44 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.64%
1/156 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
4.8%
2/42 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
8.3%
1/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
6.8%
3/44 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.6%
1/18 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.5%
7/156 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/42 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
8.3%
1/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
2.3%
1/44 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
1.3%
2/156 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/42 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/44 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.6%
1/18 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.64%
1/156 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
0.00%
0/42 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/44 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.6%
1/18 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.64%
1/156 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Nervous system disorders
Aphasia
|
0.00%
0/42 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
2.3%
1/44 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.6%
1/18 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
1.3%
2/156 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Nervous system disorders
Ataxia
|
0.00%
0/42 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/44 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.6%
1/18 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.64%
1/156 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.00%
0/42 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/44 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.6%
1/18 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.64%
1/156 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/42 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/44 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.6%
1/18 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.64%
1/156 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Nervous system disorders
Dysarthria
|
0.00%
0/42 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
2.5%
1/40 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/44 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.6%
1/18 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
1.3%
2/156 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Nervous system disorders
Dysmetria
|
0.00%
0/42 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
2.3%
1/44 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.64%
1/156 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Nervous system disorders
Epilepsy
|
2.4%
1/42 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
2.5%
1/40 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/44 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.6%
1/18 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
1.9%
3/156 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Nervous system disorders
Extrapyramidal disorder
|
0.00%
0/42 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
2.3%
1/44 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.64%
1/156 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Nervous system disorders
Haemorrhage intracranial
|
2.4%
1/42 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/44 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.64%
1/156 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Nervous system disorders
Headache
|
0.00%
0/42 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/44 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.6%
1/18 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.64%
1/156 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Nervous system disorders
Hemiparesis
|
2.4%
1/42 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/44 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.64%
1/156 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Nervous system disorders
Loss of consciousness
|
2.4%
1/42 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/44 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.64%
1/156 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/42 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
2.5%
1/40 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/44 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.64%
1/156 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Nervous system disorders
Partial seizures
|
2.4%
1/42 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/44 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.64%
1/156 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Nervous system disorders
Seizure
|
7.1%
3/42 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.5%
2/44 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.6%
1/18 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
3.8%
6/156 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Nervous system disorders
Spinal cord compression
|
2.4%
1/42 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/44 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.64%
1/156 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Psychiatric disorders
Bradyphrenia
|
0.00%
0/42 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/44 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.6%
1/18 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.64%
1/156 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/42 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
2.3%
1/44 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.6%
1/18 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
1.3%
2/156 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Psychiatric disorders
Delirium
|
0.00%
0/42 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
2.3%
1/44 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.64%
1/156 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/42 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
8.3%
1/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/44 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.64%
1/156 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Renal and urinary disorders
Nephrolithiasis
|
2.4%
1/42 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/44 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.64%
1/156 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
2.4%
1/42 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/44 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.64%
1/156 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
2.4%
1/42 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
2.5%
1/40 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
2.3%
1/44 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
1.9%
3/156 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
2.4%
1/42 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/44 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.64%
1/156 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
0.00%
0/42 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
2.3%
1/44 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.64%
1/156 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/42 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
2.5%
1/40 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
2.3%
1/44 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
1.3%
2/156 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.00%
0/42 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
8.3%
1/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/44 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.64%
1/156 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
2.4%
1/42 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/44 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.64%
1/156 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
2.4%
1/42 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
8.3%
1/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/44 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
1.3%
2/156 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
4.8%
2/42 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/44 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
1.3%
2/156 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Skin and subcutaneous tissue disorders
Vascular purpura
|
2.4%
1/42 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/44 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.64%
1/156 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Vascular disorders
Aortic aneurysm rupture
|
0.00%
0/42 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
2.3%
1/44 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.64%
1/156 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Vascular disorders
Embolism
|
0.00%
0/42 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
2.5%
1/40 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/44 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.64%
1/156 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Vascular disorders
Peripheral ischaemia
|
0.00%
0/42 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
2.3%
1/44 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.64%
1/156 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Vascular disorders
Thrombosis
|
0.00%
0/42 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
2.3%
1/44 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.64%
1/156 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
Other adverse events
| Measure |
Arm 1 (PrALKi=Y, PrBRad=Y)
n=42 participants at risk
Participants with metastases in the brain without evidence of leptomeningeal carcinomatosis (LC), previously treated with radiation to the brain and with prior exposure to an Anaplastic lymphoma kinase inhibitor (ALK-I). Previous treatment with ALK-I other than crizotinib was not allowed in this arm as of protocol amendment 3 and had to present with active brain lesion defined as a lesion free of any local treatment (like stereotactic radiosurgery or whole brain radiation).
|
Arm 2 (PrALKi=Y, PrBRad=N)
n=40 participants at risk
Participants with metastases in the brain without evidence of LC, previously untreated with radiation to the brain but with prior exposure to an ALK-I. Previous treatment with ALK-I other than crizotinib was not allowed in this arm 2 as of protocol amendment 3 and had to present with active brain lesion defined as a lesion free of any local treatment (like stereotactic radiosurgery or whole brain radiation).
|
Arm 3 (PrALKi=N, PrBRad=Y)
n=12 participants at risk
Participants with metastases in the brain without evidence of LC, previously treated with radiation to the brain but with no prior exposure to an ALK-I. Participants in this arm had to present with active brain lesion defined as a lesion free of any local treatment (like stereotactic radiosurgery or whole brain radiation).
|
Arm 4 (PrALKi=N, PrBRad=N)
n=44 participants at risk
Participants with metastases in the brain without evidence of LC, previously untreated with radiation to the brain and with no prior exposure to an ALK-I. Participants in this arm had to present with active brain lesion defined as a lesion free of any local treatment (like stereotactic radiosurgery or whole brain radiation
|
Arm 5 (LepDis)
n=18 participants at risk
Participants had LC with or without evidence of active lesion at the baseline Gadolinium-enhanced brain magnetic resonance imaging (MRI). Previous treatment with ALK-I other than crizotinib was not allowed in this arm as of protocol amendment 3.
|
All Participants
n=156 participants at risk
All participants who participated in the study and received at least one (full or partial) dose of ceritinib and provided at least one evaluable PK blood sample
|
|---|---|---|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/42 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.0%
2/40 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
8.3%
1/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/44 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
1.9%
3/156 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Blood and lymphatic system disorders
Anaemia
|
19.0%
8/42 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
15.0%
6/40 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
11.4%
5/44 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
3/18 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
14.1%
22/156 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Blood and lymphatic system disorders
Neutropenia
|
2.4%
1/42 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
2.5%
1/40 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
8.3%
1/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.5%
2/44 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
11.1%
2/18 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.5%
7/156 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/42 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/44 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.6%
1/18 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.64%
1/156 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/42 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
2.5%
1/40 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/44 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.6%
1/18 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
1.3%
2/156 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Cardiac disorders
Palpitations
|
2.4%
1/42 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
7.5%
3/40 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/44 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
2.6%
4/156 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Cardiac disorders
Sinus bradycardia
|
7.1%
3/42 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
2.5%
1/40 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/44 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
2.6%
4/156 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Ear and labyrinth disorders
Vertigo
|
9.5%
4/42 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
8.3%
1/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.5%
2/44 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.5%
7/156 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Endocrine disorders
Cushingoid
|
0.00%
0/42 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/44 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.6%
1/18 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.64%
1/156 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Eye disorders
Vitreous detachment
|
0.00%
0/42 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
8.3%
1/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/44 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.64%
1/156 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
11.9%
5/42 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
10.0%
4/40 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
8.3%
1/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
2.3%
1/44 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
7.1%
11/156 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Gastrointestinal disorders
Abdominal pain
|
16.7%
7/42 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
30.0%
12/40 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
33.3%
4/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
13.6%
6/44 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
22.2%
4/18 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
21.2%
33/156 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
14.3%
6/42 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
15.0%
6/40 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
8.3%
1/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
22.7%
10/44 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
11.1%
2/18 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.0%
25/156 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Gastrointestinal disorders
Bowel movement irregularity
|
0.00%
0/42 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/44 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.6%
1/18 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.64%
1/156 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Gastrointestinal disorders
Constipation
|
23.8%
10/42 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
22.5%
9/40 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
2/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
15.9%
7/44 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
22.2%
4/18 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
20.5%
32/156 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Gastrointestinal disorders
Diarrhoea
|
64.3%
27/42 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
85.0%
34/40 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
66.7%
8/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
72.7%
32/44 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
33.3%
6/18 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
68.6%
107/156 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Gastrointestinal disorders
Dyspepsia
|
16.7%
7/42 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
15.0%
6/40 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
8.3%
1/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.5%
2/44 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
10.3%
16/156 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Gastrointestinal disorders
Dysphagia
|
7.1%
3/42 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
2.5%
1/40 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
8.3%
1/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/44 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
3.2%
5/156 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Gastrointestinal disorders
Epigastric discomfort
|
4.8%
2/42 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/44 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.6%
1/18 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
1.9%
3/156 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Gastrointestinal disorders
Faecaloma
|
0.00%
0/42 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/44 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.6%
1/18 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.64%
1/156 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/42 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/44 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.6%
1/18 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.64%
1/156 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Gastrointestinal disorders
Mouth ulceration
|
7.1%
3/42 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
8.3%
1/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
2.3%
1/44 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
3.2%
5/156 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Gastrointestinal disorders
Nausea
|
54.8%
23/42 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
72.5%
29/40 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
66.7%
8/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
43.2%
19/44 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
44.4%
8/18 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
55.8%
87/156 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Gastrointestinal disorders
Stomatitis
|
7.1%
3/42 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.0%
2/40 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
2.3%
1/44 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
3.8%
6/156 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Gastrointestinal disorders
Vomiting
|
52.4%
22/42 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
60.0%
24/40 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
33.3%
4/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
29.5%
13/44 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
50.0%
9/18 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
46.2%
72/156 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
General disorders
Asthenia
|
26.2%
11/42 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
22.5%
9/40 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
33.3%
4/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
20.5%
9/44 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
27.8%
5/18 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
24.4%
38/156 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
General disorders
Fatigue
|
31.0%
13/42 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
35.0%
14/40 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
25.0%
3/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
20.5%
9/44 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
3/18 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
26.9%
42/156 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
General disorders
Feeling cold
|
0.00%
0/42 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/44 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.6%
1/18 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.64%
1/156 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
General disorders
Gait disturbance
|
9.5%
4/42 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
2.3%
1/44 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.6%
1/18 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
3.8%
6/156 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
General disorders
General physical health deterioration
|
0.00%
0/42 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
2.5%
1/40 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
8.3%
1/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
2.3%
1/44 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
1.9%
3/156 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
General disorders
Hyperthermia
|
2.4%
1/42 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
8.3%
1/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/44 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
1.3%
2/156 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
General disorders
Influenza like illness
|
4.8%
2/42 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
6.8%
3/44 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
3.2%
5/156 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
General disorders
Malaise
|
0.00%
0/42 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
7.5%
3/40 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
8.3%
1/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/44 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.6%
1/18 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
3.2%
5/156 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
General disorders
Non-cardiac chest pain
|
21.4%
9/42 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
17.5%
7/40 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
8.3%
1/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
6.8%
3/44 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
12.8%
20/156 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
General disorders
Oedema peripheral
|
19.0%
8/42 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
15.0%
6/40 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
8.3%
1/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.5%
2/44 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
11.1%
2/18 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
12.2%
19/156 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
General disorders
Pain
|
2.4%
1/42 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
2.3%
1/44 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
11.1%
2/18 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
2.6%
4/156 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
General disorders
Pyrexia
|
14.3%
6/42 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
35.0%
14/40 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
6.8%
3/44 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.6%
1/18 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
15.4%
24/156 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Infections and infestations
Influenza
|
2.4%
1/42 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.0%
2/40 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
8.3%
1/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.5%
2/44 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
3.8%
6/156 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Infections and infestations
Mucosal infection
|
4.8%
2/42 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
2.5%
1/40 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/44 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.6%
1/18 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
2.6%
4/156 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/42 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.0%
2/40 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
8.3%
1/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
6.8%
3/44 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
3.8%
6/156 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Infections and infestations
Oral candidiasis
|
4.8%
2/42 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
7.5%
3/40 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
2.3%
1/44 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.6%
1/18 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.5%
7/156 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Infections and infestations
Pneumonia
|
2.4%
1/42 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
2.5%
1/40 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
8.3%
1/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/44 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
11.1%
2/18 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
3.2%
5/156 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/42 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
2.5%
1/40 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/44 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.6%
1/18 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
1.3%
2/156 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Infections and infestations
Tuberculosis
|
0.00%
0/42 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
8.3%
1/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/44 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.64%
1/156 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Infections and infestations
Upper respiratory tract infection
|
7.1%
3/42 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.0%
2/40 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
2/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
9.1%
4/44 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
7.1%
11/156 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Infections and infestations
Urinary tract infection
|
7.1%
3/42 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
10.0%
4/40 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.5%
2/44 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
11.1%
2/18 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
7.1%
11/156 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Infections and infestations
Vulvovaginal candidiasis
|
0.00%
0/42 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/44 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.6%
1/18 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.64%
1/156 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Injury, poisoning and procedural complications
Procedural dizziness
|
0.00%
0/42 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
8.3%
1/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/44 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.64%
1/156 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Injury, poisoning and procedural complications
Subcutaneous haematoma
|
0.00%
0/42 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
8.3%
1/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/44 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.64%
1/156 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Investigations
Alanine aminotransferase increased
|
42.9%
18/42 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
60.0%
24/40 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
25.0%
3/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
52.3%
23/44 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
33.3%
6/18 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
47.4%
74/156 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Investigations
Amylase increased
|
4.8%
2/42 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.0%
2/40 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
8.3%
1/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
6.8%
3/44 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.6%
1/18 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.8%
9/156 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Investigations
Aspartate aminotransferase increased
|
42.9%
18/42 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
47.5%
19/40 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
2/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
29.5%
13/44 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
22.2%
4/18 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
35.9%
56/156 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Investigations
Bilirubin conjugated increased
|
0.00%
0/42 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/44 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.6%
1/18 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.64%
1/156 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Investigations
Blood alkaline phosphatase increased
|
7.1%
3/42 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
20.0%
8/40 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
8.3%
1/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
13.6%
6/44 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
11.1%
2/18 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
12.8%
20/156 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/42 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/44 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.6%
1/18 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.64%
1/156 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Investigations
Blood creatinine increased
|
9.5%
4/42 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
10.0%
4/40 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
2/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
22.7%
10/44 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
11.1%
2/18 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
14.1%
22/156 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.00%
0/42 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/44 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.6%
1/18 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.64%
1/156 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Investigations
Blood phosphorus decreased
|
0.00%
0/42 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/44 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.6%
1/18 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.64%
1/156 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Investigations
Cardiac murmur
|
0.00%
0/42 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/44 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.6%
1/18 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.64%
1/156 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Investigations
Electrocardiogram QT prolonged
|
14.3%
6/42 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
2.5%
1/40 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/44 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.6%
1/18 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.1%
8/156 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Investigations
Gamma-glutamyltransferase increased
|
19.0%
8/42 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
32.5%
13/40 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
2/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
20.5%
9/44 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
3/18 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
22.4%
35/156 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Investigations
Lipase increased
|
7.1%
3/42 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
18.2%
8/44 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
11.1%
2/18 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
8.3%
13/156 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/42 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
8.3%
1/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
2.3%
1/44 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
1.3%
2/156 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Investigations
Weight decreased
|
14.3%
6/42 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
20.0%
8/40 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
33.3%
4/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.5%
2/44 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
3/18 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
14.7%
23/156 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Investigations
Weight increased
|
0.00%
0/42 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.0%
2/40 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
2.3%
1/44 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.6%
1/18 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
2.6%
4/156 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
50.0%
21/42 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
35.0%
14/40 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
25.0%
3/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
13.6%
6/44 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
33.3%
6/18 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
32.1%
50/156 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/42 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
8.3%
1/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/44 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.64%
1/156 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
9.5%
4/42 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.0%
2/40 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
8.3%
1/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
11.4%
5/44 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
22.2%
4/18 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
10.3%
16/156 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
4.8%
2/42 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.0%
2/40 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
8.3%
1/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.5%
2/44 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.6%
1/18 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.1%
8/156 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
2.4%
1/42 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.5%
2/44 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.6%
1/18 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
2.6%
4/156 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
19.0%
8/42 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
2.5%
1/40 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
2.3%
1/44 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
22.2%
4/18 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
9.0%
14/156 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/42 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
2.5%
1/40 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
8.3%
1/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/44 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.6%
1/18 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
1.9%
3/156 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Metabolism and nutrition disorders
Hypophagia
|
2.4%
1/42 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
8.3%
1/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/44 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.6%
1/18 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
1.9%
3/156 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
9.5%
4/42 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
2.5%
1/40 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
2.3%
1/44 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.6%
1/18 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.5%
7/156 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
11.9%
5/42 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
12.5%
5/40 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
2/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
6.8%
3/44 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
9.6%
15/156 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
21.4%
9/42 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
20.0%
8/40 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
8.3%
1/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
2.3%
1/44 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
12.2%
19/156 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Musculoskeletal and connective tissue disorders
Coccydynia
|
0.00%
0/42 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
2.5%
1/40 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/44 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.6%
1/18 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
1.3%
2/156 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/42 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
2.5%
1/40 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/44 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.6%
1/18 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
1.3%
2/156 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/42 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/44 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.6%
1/18 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.64%
1/156 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Musculoskeletal and connective tissue disorders
Muscle hypertrophy
|
0.00%
0/42 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/44 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.6%
1/18 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.64%
1/156 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
7.1%
3/42 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
12.5%
5/40 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
9.1%
4/44 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
7.7%
12/156 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
9.5%
4/42 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
7.5%
3/40 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/44 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
3/18 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
6.4%
10/156 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
7.1%
3/42 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
2.5%
1/40 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.5%
2/44 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.6%
1/18 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.5%
7/156 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal discomfort
|
0.00%
0/42 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
8.3%
1/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/44 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.64%
1/156 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
14.3%
6/42 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
2.5%
1/40 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
8.3%
1/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.5%
2/44 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.6%
1/18 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
7.1%
11/156 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/42 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.0%
2/40 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
8.3%
1/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.5%
2/44 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
3.2%
5/156 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Musculoskeletal and connective tissue disorders
Myopathy
|
0.00%
0/42 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/44 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.6%
1/18 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.64%
1/156 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/42 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
2.5%
1/40 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
8.3%
1/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
2.3%
1/44 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
1.9%
3/156 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
4.8%
2/42 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.0%
2/40 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
8.3%
1/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
2.3%
1/44 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.6%
1/18 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.5%
7/156 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Nervous system disorders
Amnesia
|
0.00%
0/42 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/44 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
11.1%
2/18 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
1.3%
2/156 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Nervous system disorders
Aphasia
|
0.00%
0/42 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
2.3%
1/44 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.6%
1/18 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
1.3%
2/156 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Nervous system disorders
Balance disorder
|
0.00%
0/42 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
8.3%
1/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
2.3%
1/44 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
1.3%
2/156 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Nervous system disorders
Dizziness
|
14.3%
6/42 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
20.0%
8/40 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
8.3%
1/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
9.1%
4/44 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
3/18 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
14.1%
22/156 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Nervous system disorders
Dysarthria
|
2.4%
1/42 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
7.5%
3/40 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
8.3%
1/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
2.3%
1/44 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
3/18 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.8%
9/156 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/42 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
11.4%
5/44 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.6%
1/18 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
3.8%
6/156 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Nervous system disorders
Headache
|
28.6%
12/42 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
32.5%
13/40 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
25.0%
3/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
22.7%
10/44 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
22.2%
4/18 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
26.9%
42/156 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Nervous system disorders
Memory impairment
|
9.5%
4/42 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
2.5%
1/40 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
2.3%
1/44 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.6%
1/18 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.5%
7/156 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Nervous system disorders
Paraesthesia
|
9.5%
4/42 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
2.5%
1/40 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
6.8%
3/44 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.6%
1/18 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.8%
9/156 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Nervous system disorders
Partial seizures
|
0.00%
0/42 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/44 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.6%
1/18 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.64%
1/156 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Nervous system disorders
Seizure
|
4.8%
2/42 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
10.0%
4/40 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.5%
2/44 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
3/18 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
7.1%
11/156 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Nervous system disorders
Somnolence
|
2.4%
1/42 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
2.5%
1/40 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
2.3%
1/44 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
11.1%
2/18 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
3.2%
5/156 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Nervous system disorders
Tremor
|
2.4%
1/42 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
7.5%
3/40 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
2.3%
1/44 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
3.2%
5/156 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Psychiatric disorders
Aggression
|
0.00%
0/42 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/44 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.6%
1/18 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.64%
1/156 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Psychiatric disorders
Agitation
|
7.1%
3/42 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/44 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.6%
1/18 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
2.6%
4/156 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Psychiatric disorders
Anxiety
|
2.4%
1/42 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
2.5%
1/40 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
8.3%
1/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
2.3%
1/44 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
2.6%
4/156 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Psychiatric disorders
Bradyphrenia
|
0.00%
0/42 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/44 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.6%
1/18 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.64%
1/156 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Psychiatric disorders
Depression
|
7.1%
3/42 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/44 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
1.9%
3/156 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Psychiatric disorders
Disorientation
|
0.00%
0/42 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/44 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.6%
1/18 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.64%
1/156 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Psychiatric disorders
Hallucination, auditory
|
0.00%
0/42 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/44 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.6%
1/18 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.64%
1/156 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Psychiatric disorders
Hallucinations, mixed
|
0.00%
0/42 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/44 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.6%
1/18 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.64%
1/156 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Psychiatric disorders
Insomnia
|
7.1%
3/42 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
10.0%
4/40 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
8.3%
1/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
9.1%
4/44 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.6%
1/18 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
8.3%
13/156 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/42 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/44 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.6%
1/18 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.64%
1/156 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/42 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/44 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.6%
1/18 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.64%
1/156 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Renal and urinary disorders
Urinary incontinence
|
2.4%
1/42 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/44 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.6%
1/18 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
1.3%
2/156 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.00%
0/42 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/44 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.6%
1/18 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.64%
1/156 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
23.8%
10/42 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
20.0%
8/40 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
8.3%
1/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
13.6%
6/44 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
22.2%
4/18 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
18.6%
29/156 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
9.5%
4/42 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
20.0%
8/40 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
2/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
11.4%
5/44 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
11.1%
2/18 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
13.5%
21/156 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
2.4%
1/42 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
2.5%
1/40 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
8.3%
1/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
2.3%
1/44 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
2.6%
4/156 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
7.1%
3/42 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
6.8%
3/44 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
3.8%
6/156 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
2.4%
1/42 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
8.3%
1/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
2.3%
1/44 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.6%
1/18 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
2.6%
4/156 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
2.4%
1/42 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
7.5%
3/40 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
2.3%
1/44 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
3.2%
5/156 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
7.1%
3/42 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
2.5%
1/40 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
8.3%
1/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
9.1%
4/44 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.6%
1/18 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
6.4%
10/156 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
4.8%
2/42 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
9.1%
4/44 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
3.8%
6/156 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
2.4%
1/42 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/44 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.6%
1/18 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
1.3%
2/156 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
2.4%
1/42 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/44 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.6%
1/18 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
1.3%
2/156 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
7.1%
3/42 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
7.5%
3/40 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
16.7%
2/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
2.3%
1/44 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.8%
9/156 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Skin and subcutaneous tissue disorders
Rash
|
9.5%
4/42 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
15.0%
6/40 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
33.3%
4/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
15.9%
7/44 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.6%
1/18 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
14.1%
22/156 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
7.1%
3/42 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.5%
2/44 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
3.2%
5/156 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Skin and subcutaneous tissue disorders
Skin fissures
|
0.00%
0/42 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
8.3%
1/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/44 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/18 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.64%
1/156 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Skin and subcutaneous tissue disorders
Skin striae
|
0.00%
0/42 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/40 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/44 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.6%
1/18 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.64%
1/156 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Vascular disorders
Hypertension
|
2.4%
1/42 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
7.5%
3/40 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
8.3%
1/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
2.3%
1/44 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.6%
1/18 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
4.5%
7/156 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
|
Vascular disorders
Hypotension
|
0.00%
0/42 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
2.5%
1/40 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/12 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
0.00%
0/44 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
5.6%
1/18 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
1.3%
2/156 • Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approx. 168 weeks.
Adverse Event (AE): Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial or disclosure of trial results in their entirety.
- Publication restrictions are in place
Restriction type: OTHER