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Trial Outcomes & Findings for Phase I Study of LDK378 in Pediatric, Malignancies With a Genetic Alteration in Anaplastic Lymphoma Kinase (ALK) (NCT NCT01742286)

NCT ID: NCT01742286

Last Updated: 2020-06-09

Results Overview

A DLT is defined as an adverse event or abnormal laboratory value assessed as unrelated to disease, disease progression, inter-current illness, or concomitant therapies that occurs within the first 21 days of treatment with LDK378 and meets a specified defined criteria. A participant with multiple occurrences of DLTs under one treatment is counted only once in the Adverse Event category for that treatment. A participant with multiple DLTs within a primary system organ class is counted only once in the total row.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

83 participants

Primary outcome timeframe

up to day 21 after the patient's first dose; cycle = within the first 21 days of patient's first dose

Results posted on

2020-06-09

Participant Flow

Eighty-three patients were treated at different dose levels in both fasted and fed states dose escalation and expansion groups.

At least 15 patients for the fasted dose escalation \& 12 patients for the fed dose escalation were expected to be treated. During the expansion part, approximately 45 patients were planned to be treated on the preferred regimen, approximately 25 patients in group 1 on the preferred regimen, and approximately 20 patients in group 2.

Participant milestones

Participant milestones
Measure
Fasted: Ceritinib 300 mg/m2
Participants in the fasted group who took 300 mg of ceritinib
Fasted: Ceritinib 450 mg/m2
Participants in the fasted group who took 450 mg of ceritinib
Fasted: Ceritinib 510 mg/m2
Participants in the fasted group who took 510 mg of ceritinib
Fasted: Ceritinib 560 mg/m2
Participants in the fasted group who took 560 mg of ceritinib
Fed: Ceritinib 320 mg/m2
Participants in the fed group who took 320 mg of ceritinib
Fed: Ceritinib 400 mg/m2
Participants in the fed group who took 400 mg of ceritinib
Fed: Ceritinib 500 mg/m2
Participants in the fed group who took 500 mg of ceritinib
Escalation Phase
STARTED
5
12
6
2
4
5
6
Escalation Phase
Ended Treatment = Not Completed)
5
12
6
2
4
5
6
Escalation Phase
COMPLETED
0
0
0
0
0
0
0
Escalation Phase
NOT COMPLETED
5
12
6
2
4
5
6
Expansion Phase
STARTED
0
0
7
0
0
0
36
Expansion Phase
End of Treatment = Not Ccompleted
0
0
7
0
0
0
36
Expansion Phase
COMPLETED
0
0
0
0
0
0
0
Expansion Phase
NOT COMPLETED
0
0
7
0
0
0
36

Reasons for withdrawal

Reasons for withdrawal
Measure
Fasted: Ceritinib 300 mg/m2
Participants in the fasted group who took 300 mg of ceritinib
Fasted: Ceritinib 450 mg/m2
Participants in the fasted group who took 450 mg of ceritinib
Fasted: Ceritinib 510 mg/m2
Participants in the fasted group who took 510 mg of ceritinib
Fasted: Ceritinib 560 mg/m2
Participants in the fasted group who took 560 mg of ceritinib
Fed: Ceritinib 320 mg/m2
Participants in the fed group who took 320 mg of ceritinib
Fed: Ceritinib 400 mg/m2
Participants in the fed group who took 400 mg of ceritinib
Fed: Ceritinib 500 mg/m2
Participants in the fed group who took 500 mg of ceritinib
Escalation Phase
Administrative problems
1
1
0
0
0
0
2
Escalation Phase
Adverse Event
0
1
2
0
0
1
0
Escalation Phase
Disease progression
3
7
4
1
4
3
2
Escalation Phase
Death
0
0
0
0
0
1
0
Escalation Phase
Physician Decision
0
3
0
1
0
0
2
Escalation Phase
Subject/guardian decision
1
0
0
0
0
0
0
Expansion Phase
Administrative problems
0
0
0
0
0
0
5
Expansion Phase
Physician Decision
0
0
4
0
0
0
9
Expansion Phase
Adverse Event
0
0
0
0
0
0
6
Expansion Phase
Disease progression
0
0
3
0
0
0
15
Expansion Phase
Withdrawal by Subject
0
0
0
0
0
0
1

Baseline Characteristics

Phase I Study of LDK378 in Pediatric, Malignancies With a Genetic Alteration in Anaplastic Lymphoma Kinase (ALK)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Fasted: Ceritinib 300 mg/m2
n=5 Participants
Participants in the fasted group who took 300 mg of ceritinib
Fasted: Ceritinib 450 mg/m2
n=12 Participants
Participants in the fasted group who took 450 mg of ceritinib
Fasted: Ceritinib 510 mg/m2
n=13 Participants
Participants in the fasted group who took 510 mg of ceritinib
Fasted: Ceritinib 560 mg/m2
n=2 Participants
Participants in the fasted group who took 560 mg of ceritinib
Fed: Ceritinib 320 mg/m2
n=4 Participants
Participants in the fed group who took 320 mg of ceritinib
Fed: Ceritinib 400 mg/m2
n=5 Participants
Participants in the fed group who took 400 mg of ceritinib
Fed: Ceritinib 500 mg/m2
n=42 Participants
Participants in the fed group who took 500 mg of ceritinib
Total
n=83 Participants
Total of all reporting groups
Age, Continuous
11.6 years
STANDARD_DEVIATION 5.27 • n=99 Participants
10.0 years
STANDARD_DEVIATION 4.94 • n=107 Participants
9.2 years
STANDARD_DEVIATION 5.34 • n=206 Participants
9.0 years
STANDARD_DEVIATION 9.90 • n=7 Participants
8.8 years
STANDARD_DEVIATION 4.99 • n=31 Participants
9.2 years
STANDARD_DEVIATION 4.02 • n=30 Participants
7.3 years
STANDARD_DEVIATION 4.73 • n=3 Participants
8.5 years
STANDARD_DEVIATION 4.97 • n=6 Participants
Age, Customized
1 - < 7 yrs
1 Participants
n=99 Participants
4 Participants
n=107 Participants
6 Participants
n=206 Participants
1 Participants
n=7 Participants
2 Participants
n=31 Participants
2 Participants
n=30 Participants
21 Participants
n=3 Participants
37 Participants
n=6 Participants
Age, Customized
7 - < 12 yrs
2 Participants
n=99 Participants
2 Participants
n=107 Participants
1 Participants
n=206 Participants
0 Participants
n=7 Participants
0 Participants
n=31 Participants
1 Participants
n=30 Participants
10 Participants
n=3 Participants
16 Participants
n=6 Participants
Age, Customized
12 - < 18 yrs
2 Participants
n=99 Participants
6 Participants
n=107 Participants
6 Participants
n=206 Participants
1 Participants
n=7 Participants
2 Participants
n=31 Participants
2 Participants
n=30 Participants
11 Participants
n=3 Participants
30 Participants
n=6 Participants
Sex: Female, Male
Female
3 Participants
n=99 Participants
3 Participants
n=107 Participants
5 Participants
n=206 Participants
1 Participants
n=7 Participants
1 Participants
n=31 Participants
3 Participants
n=30 Participants
14 Participants
n=3 Participants
30 Participants
n=6 Participants
Sex: Female, Male
Male
2 Participants
n=99 Participants
9 Participants
n=107 Participants
8 Participants
n=206 Participants
1 Participants
n=7 Participants
3 Participants
n=31 Participants
2 Participants
n=30 Participants
28 Participants
n=3 Participants
53 Participants
n=6 Participants
Race/Ethnicity, Customized
Asian
0 Participants
n=99 Participants
1 Participants
n=107 Participants
1 Participants
n=206 Participants
0 Participants
n=7 Participants
0 Participants
n=31 Participants
0 Participants
n=30 Participants
3 Participants
n=3 Participants
5 Participants
n=6 Participants
Race/Ethnicity, Customized
Black
0 Participants
n=99 Participants
1 Participants
n=107 Participants
0 Participants
n=206 Participants
0 Participants
n=7 Participants
0 Participants
n=31 Participants
0 Participants
n=30 Participants
0 Participants
n=3 Participants
1 Participants
n=6 Participants
Race/Ethnicity, Customized
Caucasian
5 Participants
n=99 Participants
7 Participants
n=107 Participants
11 Participants
n=206 Participants
2 Participants
n=7 Participants
4 Participants
n=31 Participants
3 Participants
n=30 Participants
33 Participants
n=3 Participants
65 Participants
n=6 Participants
Race/Ethnicity, Customized
Other
0 Participants
n=99 Participants
3 Participants
n=107 Participants
1 Participants
n=206 Participants
0 Participants
n=7 Participants
0 Participants
n=31 Participants
2 Participants
n=30 Participants
5 Participants
n=3 Participants
11 Participants
n=6 Participants
Race/Ethnicity, Customized
Native American
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
0 Participants
n=7 Participants
0 Participants
n=31 Participants
0 Participants
n=30 Participants
1 Participants
n=3 Participants
1 Participants
n=6 Participants

PRIMARY outcome

Timeframe: up to day 21 after the patient's first dose; cycle = within the first 21 days of patient's first dose

Population: The dose determining analysis set (DDS) consisted of all patients from the Safety set who either met the minimum exposure criterion and had sufficient safety evaluations or discontinued earlier due to DLT in the escalation phase.

A DLT is defined as an adverse event or abnormal laboratory value assessed as unrelated to disease, disease progression, inter-current illness, or concomitant therapies that occurs within the first 21 days of treatment with LDK378 and meets a specified defined criteria. A participant with multiple occurrences of DLTs under one treatment is counted only once in the Adverse Event category for that treatment. A participant with multiple DLTs within a primary system organ class is counted only once in the total row.

Outcome measures

Outcome measures
Measure
Fasted: Ceritinib 300 mg/m2
n=4 Participants
Participants in the fasted group who took 300 mg of ceritinib
Fasted: Ceritinib 450 mg/m2
n=12 Participants
Participants in the fasted group who took 450 mg of ceritinib
Fasted: Ceritinib 510 mg/m2
n=6 Participants
Participants in the fasted group who took 510 mg of ceritinib
Fasted: Ceritinib 560 mg/m2
n=2 Participants
Participants in the fasted group who took 560 mg of ceritinib
Fed: Ceritinib 320 mg/m2
n=4 Participants
Participants in the fed group who took 320 mg of ceritinib
Fed: Ceritinib 400 mg/m2
n=4 Participants
Participants in the fed group who took 400 mg of ceritinib
Fed: Ceritinib 500 mg/m2
n=5 Participants
Participants in the fed group who took 500 mg of ceritinib
Incidence Rate of Dose Limiting Toxicities (DLTs) Occurring During First Cycle of Treatment
Investigations: Alanine aminotransferase incr.
0 Participants
0 Participants
0 Participants
1 Participants
0 Participants
1 Participants
0 Participants
Incidence Rate of Dose Limiting Toxicities (DLTs) Occurring During First Cycle of Treatment
Gastrointestinal disorders: abdominal pain
0 Participants
0 Participants
0 Participants
1 Participants
0 Participants
0 Participants
0 Participants
Incidence Rate of Dose Limiting Toxicities (DLTs) Occurring During First Cycle of Treatment
Gastrointestinal disorders: Influenza
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
1 Participants
Incidence Rate of Dose Limiting Toxicities (DLTs) Occurring During First Cycle of Treatment
Total DLTs
0 Participants
0 Participants
0 Participants
2 Participants
0 Participants
1 Participants
1 Participants

SECONDARY outcome

Timeframe: 30 months

Population: Full Analysis Set (FAS)/Maximum Tolerated Dose MTD)/Recommended dose for expansion (RDE): Results are presented only for patients who received at least 1 dose of ceritinib in either of the 2 MTD/RDE groups and were based on combining data from across the dose-escalation \& dose-expansion phases, \& summarized according to primary diagnosis of tumor.

ORR is the percentage of participants with a best overall response of complete response (CR) or partial response (PR). ORR was assessed per Investigator as per RECIST 1.1 in participants with neuroblastoma and other solid tumors, and by International Working Group (IWG) criteria in patients with lymphoma. Per RECIST 1.1 (for neuroblastoma \& other solid tumors): CR: disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \< 10 mm. PR: at least a 30% decrease in the sum of diameter of all target lesion, taking as reference the baseline sum diameters. Per IWG criteria (for patients with lymphoma): CR: normalization of all index nodal lesions or complete disappearance of all index extranodal lesions. PR: at least 50% decrease from baseline in the sum of diameters of all index lesions.

Outcome measures

Outcome measures
Measure
Fasted: Ceritinib 300 mg/m2
n=30 Participants
Participants in the fasted group who took 300 mg of ceritinib
Fasted: Ceritinib 450 mg/m2
n=10 Participants
Participants in the fasted group who took 450 mg of ceritinib
Fasted: Ceritinib 510 mg/m2
n=8 Participants
Participants in the fasted group who took 510 mg of ceritinib
Fasted: Ceritinib 560 mg/m2
n=7 Participants
Participants in the fasted group who took 560 mg of ceritinib
Fed: Ceritinib 320 mg/m2
Participants in the fed group who took 320 mg of ceritinib
Fed: Ceritinib 400 mg/m2
Participants in the fed group who took 400 mg of ceritinib
Fed: Ceritinib 500 mg/m2
Participants in the fed group who took 500 mg of ceritinib
Summary of Best Overall Response by Overall Response Rate (ORR) Per Investigator Assessment
20.0 percentage of participants
Interval 7.7 to 38.6
70.0 percentage of participants
Interval 34.8 to 93.3
75.0 percentage of participants
Interval 34.9 to 96.8
14.3 percentage of participants
Interval 0.4 to 57.9
—
—
—

SECONDARY outcome

Timeframe: 30 months

Population: Full Analysis Set/MTD/RDE patients with confirmed CR or PR): Efficacy results are presented only for patients with confirmed CR or PR who received at least 1 dose of ceritinib in either of the 2 MTD/RDE groups \& were based on combining data from across the dose-escalation \& dose-expansion phases, \& summarized according to primary tumor diagnosis.

DOR is defined as the time from first documented response (PR or CR) to the date of first documented disease progression (PD) or death due to any cause. DOR was assessed per Investigator as per RECIST 1.1 in participants with neuroblastoma and other solid tumors, and by International Working Group (IWG) criteria in patients with lymphoma. Per RECIST 1.1 (for neuroblastoma \& other solid tumors): CR: disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \< 10 mm. PR: at least a 30% decrease in the sum of diameter of all target lesion, taking as reference the baseline sum diameters. Per IWG criteria (for patients with lymphoma): CR: normalization of all index nodal lesions or complete disappearance of all index extranodal lesions. PR: at least 50% decrease from baseline in the sum of diameters of all index lesions.

Outcome measures

Outcome measures
Measure
Fasted: Ceritinib 300 mg/m2
n=6 Participants
Participants in the fasted group who took 300 mg of ceritinib
Fasted: Ceritinib 450 mg/m2
n=7 Participants
Participants in the fasted group who took 450 mg of ceritinib
Fasted: Ceritinib 510 mg/m2
n=6 Participants
Participants in the fasted group who took 510 mg of ceritinib
Fasted: Ceritinib 560 mg/m2
n=1 Participants
Participants in the fasted group who took 560 mg of ceritinib
Fed: Ceritinib 320 mg/m2
Participants in the fed group who took 320 mg of ceritinib
Fed: Ceritinib 400 mg/m2
Participants in the fed group who took 400 mg of ceritinib
Fed: Ceritinib 500 mg/m2
Participants in the fed group who took 500 mg of ceritinib
Duration of Response (DoR) Per Investigator Assessment
15.0 months
Interval 5.8 to 22.2
NA months
Interval 3.5 to
N/A: Median not reached for subjects with ALCL, IMT \& Other tumor types as most of the subjects did not have a DOR event (progression or death).
NA months
Interval 2.8 to
N/A: Median not reached for subjects with ALCL, IMT \& Other tumor types as most of the subjects did not have a DOR event (progression or death).
NA months
N/A: Median not reached for subjects with ALCL, IMT \& Other tumor types as most of the subjects did not have a DOR event (progression or death).
—
—
—

SECONDARY outcome

Timeframe: 30 months

Population: Full Analysis Set (FAS)/MTD/RDE: Efficacy results are presented only for patients who received at least 1 dose of ceritinib in either of the two MTD/RDE groups and were based on combining data from across the dose-escalation \& dose-expansion phases, \& summarized according to primary diagnosis of tumor.

PFS is the time from date of randomization/start of treatment to the date of event defined as the first documented progression or death due to any cause. PFS was assessed per Investigator as per RECIST 1.1 in participants with neuroblastoma and other solid tumors, and by International Working Group (IWG) criteria in patients with lymphoma. Per RECIST 1.1 (for neuroblastoma \& other solid tumors): CR: disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \< 10 mm. PR: at least a 30% decrease in the sum of diameter of all target lesion, taking as reference the baseline sum diameters. Per IWG criteria (for patients with lymphoma): CR: normalization of all index nodal lesions or complete disappearance of all index extranodal lesions. PR: at least 50% decrease from baseline in the sum of diameters of all index lesions.

Outcome measures

Outcome measures
Measure
Fasted: Ceritinib 300 mg/m2
n=30 Participants
Participants in the fasted group who took 300 mg of ceritinib
Fasted: Ceritinib 450 mg/m2
n=10 Participants
Participants in the fasted group who took 450 mg of ceritinib
Fasted: Ceritinib 510 mg/m2
n=8 Participants
Participants in the fasted group who took 510 mg of ceritinib
Fasted: Ceritinib 560 mg/m2
n=7 Participants
Participants in the fasted group who took 560 mg of ceritinib
Fed: Ceritinib 320 mg/m2
Participants in the fed group who took 320 mg of ceritinib
Fed: Ceritinib 400 mg/m2
Participants in the fed group who took 400 mg of ceritinib
Fed: Ceritinib 500 mg/m2
Participants in the fed group who took 500 mg of ceritinib
Progression Free Survival (PFS) Based on Investigator Assessment
2.4 months
Interval 1.2 to 6.8
NA months
Interval 1.2 to
N/A: The median was not reached for subjects with IMT and ALCL
NA months
Interval 4.1 to
N/A: The median was not reached for subjects with IMT and ALCL
1.9 months
Interval 1.2 to
N/A: The median was not reached for subjects with IMT and ALCL
—
—
—

SECONDARY outcome

Timeframe: 0hr pre-dose, 2hrs post-dose, 4hrs post-dose, 6hrs post-dose & 24hrs post-dose in Cycle1 Day1 & Cycle 2 day 1; 0hr pre-dose in Cycle 1 Day 15, Cycle 2 Day1, Cycle 2 Day 2, Cycle 3 day 1 & Cycle 4 Day 1

Population: The PK analysis set (PAS) consisted of all patients who received at least one dose of ceritinib and had at least one evaluable PK sample.

Characterize single and multiple-dose PK of LDK378 in pediatric patients. Only PK plasma concentrations with non-missing sampling date and time, and for which the last dose date and time prior to the PK sample draw are non-missing, were included in the PK analysis.

Outcome measures

Outcome measures
Measure
Fasted: Ceritinib 300 mg/m2
n=5 Participants
Participants in the fasted group who took 300 mg of ceritinib
Fasted: Ceritinib 450 mg/m2
n=12 Participants
Participants in the fasted group who took 450 mg of ceritinib
Fasted: Ceritinib 510 mg/m2
n=6 Participants
Participants in the fasted group who took 510 mg of ceritinib
Fasted: Ceritinib 560 mg/m2
n=2 Participants
Participants in the fasted group who took 560 mg of ceritinib
Fed: Ceritinib 320 mg/m2
n=4 Participants
Participants in the fed group who took 320 mg of ceritinib
Fed: Ceritinib 400 mg/m2
n=5 Participants
Participants in the fed group who took 400 mg of ceritinib
Fed: Ceritinib 500 mg/m2
n=5 Participants
Participants in the fed group who took 500 mg of ceritinib
Plasma Concentration Time Profiles by Treatment Group in Escalation Phase
Cycle1 Day1 (C1D1) 0 hr pre-dose
0.0 ng/mL
Geometric Coefficient of Variation 0.0
0.0 ng/mL
Geometric Coefficient of Variation 0.0
0.0 ng/mL
Geometric Coefficient of Variation 0.0
0.0 ng/mL
Geometric Coefficient of Variation 0.0
0.0 ng/mL
Geometric Coefficient of Variation 0.0
0.0 ng/mL
Geometric Coefficient of Variation 0.0
0.0 ng/mL
Geometric Coefficient of Variation 0.0
Plasma Concentration Time Profiles by Treatment Group in Escalation Phase
C1D1 2 hrs post-dose
104 ng/mL
Geometric Coefficient of Variation 97.9
99.0 ng/mL
Geometric Coefficient of Variation 94.7
112 ng/mL
Geometric Coefficient of Variation 90.6
126 ng/mL
Geometric Coefficient of Variation 0.6
52.4 ng/mL
Geometric Coefficient of Variation 138.1
197 ng/mL
Geometric Coefficient of Variation 58.3
72.5 ng/mL
Geometric Coefficient of Variation 82.3
Plasma Concentration Time Profiles by Treatment Group in Escalation Phase
C1D1 4 hrs post-dose
216 ng/mL
Geometric Coefficient of Variation 39.6
233 ng/mL
Geometric Coefficient of Variation 69.0
250 ng/mL
Geometric Coefficient of Variation 93.5
350 ng/mL
Geometric Coefficient of Variation 54.7
166 ng/mL
Geometric Coefficient of Variation 92.8
311 ng/mL
Geometric Coefficient of Variation 28.1
153 ng/mL
Geometric Coefficient of Variation 34.1
Plasma Concentration Time Profiles by Treatment Group in Escalation Phase
C1D1 6 hrs post-dose
227 ng/mL
Geometric Coefficient of Variation 33.8
245 ng/mL
Geometric Coefficient of Variation 78.1
245 ng/mL
Geometric Coefficient of Variation 97.2
423 ng/mL
Geometric Coefficient of Variation 74.2
275 ng/mL
Geometric Coefficient of Variation 35.3
318 ng/mL
Geometric Coefficient of Variation 36.7
168 ng/mL
Geometric Coefficient of Variation 68.9
Plasma Concentration Time Profiles by Treatment Group in Escalation Phase
C1D1 24 hrs post-dose
130 ng/mL
Geometric Coefficient of Variation 66.3
141 ng/mL
Geometric Coefficient of Variation 89.9
86.4 ng/mL
Geometric Coefficient of Variation 117.2
268 ng/mL
Geometric Coefficient of Variation 73.6
98.5 ng/mL
Geometric Coefficient of Variation 63.7
126 ng/mL
Geometric Coefficient of Variation 107.7
161 ng/mL
Geometric Coefficient of Variation 111.3
Plasma Concentration Time Profiles by Treatment Group in Escalation Phase
C1D2 0 hr pre-dose
130 ng/mL
Geometric Coefficient of Variation 66.3
141 ng/mL
Geometric Coefficient of Variation 89.9
86.4 ng/mL
Geometric Coefficient of Variation 117.2
268 ng/mL
Geometric Coefficient of Variation 73.6
98.5 ng/mL
Geometric Coefficient of Variation 63.7
126 ng/mL
Geometric Coefficient of Variation 107.7
161 ng/mL
Geometric Coefficient of Variation 111.3
Plasma Concentration Time Profiles by Treatment Group in Escalation Phase
C1D15 0 hr pre-dose
193 ng/mL
Geometric Coefficient of Variation 99.6
618 ng/mL
Geometric Coefficient of Variation 64.6
537 ng/mL
Geometric Coefficient of Variation 49.9
942 ng/mL
Geometric Coefficient of Variation 5.1
262 ng/mL
Geometric Coefficient of Variation 118.4
379 ng/mL
Geometric Coefficient of Variation 119.2
461 ng/mL
Geometric Coefficient of Variation 76.3
Plasma Concentration Time Profiles by Treatment Group in Escalation Phase
C2D1 0 hr pre-dose
169 ng/mL
Geometric Coefficient of Variation 299.5
661 ng/mL
Geometric Coefficient of Variation 53.5
672 ng/mL
Geometric Coefficient of Variation 45.4
695 ng/mL
Geometric Coefficient of Variation 152.7
218 ng/mL
Geometric Coefficient of Variation 103.7
429 ng/mL
Geometric Coefficient of Variation 73.8
655 ng/mL
Geometric Coefficient of Variation 12.4
Plasma Concentration Time Profiles by Treatment Group in Escalation Phase
C2D1 2 hrs post-dose
287 ng/mL
Geometric Coefficient of Variation 85.4
687 ng/mL
Geometric Coefficient of Variation 61.6
801 ng/mL
Geometric Coefficient of Variation 45.9
662 ng/mL
Geometric Coefficient of Variation 99.6
196 ng/mL
Geometric Coefficient of Variation 112.4
475 ng/mL
Geometric Coefficient of Variation 96.6
718 ng/mL
Geometric Coefficient of Variation 21.1
Plasma Concentration Time Profiles by Treatment Group in Escalation Phase
C2D1 4 hrs post-dose
386 ng/mL
Geometric Coefficient of Variation 47.6
810 ng/mL
Geometric Coefficient of Variation 51.9
1000 ng/mL
Geometric Coefficient of Variation 30.4
1230 ng/mL
Geometric Coefficient of Variation 30.1
262 ng/mL
Geometric Coefficient of Variation 133.9
631 ng/mL
Geometric Coefficient of Variation 86.6
744 ng/mL
Geometric Coefficient of Variation 13.2
Plasma Concentration Time Profiles by Treatment Group in Escalation Phase
C2D1 6 hrs post-dose
426 ng/mL
Geometric Coefficient of Variation 38.4
852 ng/mL
Geometric Coefficient of Variation 47.8
898 ng/mL
Geometric Coefficient of Variation 37.6
1260 ng/mL
Geometric Coefficient of Variation 16.4
300 ng/mL
Geometric Coefficient of Variation 130.3
648 ng/mL
Geometric Coefficient of Variation 105.5
786 ng/mL
Geometric Coefficient of Variation 7.7
Plasma Concentration Time Profiles by Treatment Group in Escalation Phase
C2D1 24 hrs post-dose
247 ng/mL
Geometric Coefficient of Variation 46.9
651 ng/mL
Geometric Coefficient of Variation 53.7
714 ng/mL
Geometric Coefficient of Variation 40.8
847 ng/mL
Geometric Coefficient of Variation 72.2
194 ng/mL
Geometric Coefficient of Variation 106.5
411 ng/mL
Geometric Coefficient of Variation 147.3
448 ng/mL
Geometric Coefficient of Variation 43.9
Plasma Concentration Time Profiles by Treatment Group in Escalation Phase
C2D2 0 hr pre-dose
247 ng/mL
Geometric Coefficient of Variation 46.9
651 ng/mL
Geometric Coefficient of Variation 53.7
714 ng/mL
Geometric Coefficient of Variation 40.8
847 ng/mL
Geometric Coefficient of Variation 72.2
194 ng/mL
Geometric Coefficient of Variation 106.5
411 ng/mL
Geometric Coefficient of Variation 147.3
448 ng/mL
Geometric Coefficient of Variation 43.9
Plasma Concentration Time Profiles by Treatment Group in Escalation Phase
C3D1 0 hr pre-dose
399 ng/mL
Geometric Coefficient of Variation 94.4
810 ng/mL
Geometric Coefficient of Variation 34.3
415 ng/mL
Geometric Coefficient of Variation 117.7
1320 ng/mL
Geometric Coefficient of Variation 0.0
167 ng/mL
Geometric Coefficient of Variation 218.3
328 ng/mL
Geometric Coefficient of Variation 0.0
433 ng/mL
Geometric Coefficient of Variation 128.5
Plasma Concentration Time Profiles by Treatment Group in Escalation Phase
C4D1 0 hr pre-dose
503 ng/mL
Geometric Coefficient of Variation 35.1
960 ng/mL
Geometric Coefficient of Variation 36.2
321 ng/mL
Geometric Coefficient of Variation 874.8
857 ng/mL
Geometric Coefficient of Variation 0.0
403 ng/mL
Geometric Coefficient of Variation 0.0
1320 ng/mL
Geometric Coefficient of Variation 0.0
658 ng/mL
Geometric Coefficient of Variation 27.0

SECONDARY outcome

Timeframe: 0hr pre-dose Cycle 1 Day 1, cycle 1 Day 15; 0hr pre-dose, 2hrs post-dose, 4hrs post-dose, 6hrs post-dose & 24hrs post-dose in Cycle2 Day1; 0hr pre-dose in Cycle2 Day2, Cycle 3 Day 1 & Cycle 4 Day 1

Population: The PK analysis set (PAS) consisted of all patients who received at least one dose of ceritinib and had at least one evaluable PK sample.

Characterize single and multiple-dose PK of LDK378 in pediatric patients. Only PK plasma concentrations with non-missing sampling date and time, and for which the last dose date and time prior to the PK sample draw are non-missing, were included in the PK analysis.

Outcome measures

Outcome measures
Measure
Fasted: Ceritinib 300 mg/m2
Participants in the fasted group who took 300 mg of ceritinib
Fasted: Ceritinib 450 mg/m2
Participants in the fasted group who took 450 mg of ceritinib
Fasted: Ceritinib 510 mg/m2
n=7 Participants
Participants in the fasted group who took 510 mg of ceritinib
Fasted: Ceritinib 560 mg/m2
Participants in the fasted group who took 560 mg of ceritinib
Fed: Ceritinib 320 mg/m2
Participants in the fed group who took 320 mg of ceritinib
Fed: Ceritinib 400 mg/m2
Participants in the fed group who took 400 mg of ceritinib
Fed: Ceritinib 500 mg/m2
n=16 Participants
Participants in the fed group who took 500 mg of ceritinib
Plasma Concentration Time Profiles by Treatment Group in Expansion Phase
C1D1 0 hr pre-dose
—
—
0.0 ng/mL
Geometric Coefficient of Variation 0.0
—
—
—
0.0 ng/mL
Geometric Coefficient of Variation 0.0
Plasma Concentration Time Profiles by Treatment Group in Expansion Phase
C1D15 0 hr post-dose
—
—
1190 ng/mL
Geometric Coefficient of Variation 0.0
—
—
—
—
Plasma Concentration Time Profiles by Treatment Group in Expansion Phase
C2D1 0 hr pre-dose
—
—
529 ng/mL
Geometric Coefficient of Variation 365.4
—
—
—
627 ng/mL
Geometric Coefficient of Variation 93.6
Plasma Concentration Time Profiles by Treatment Group in Expansion Phase
C2D1 2 hrs post-dose
—
—
798 ng/mL
Geometric Coefficient of Variation 69.0
—
—
—
729 ng/mL
Geometric Coefficient of Variation 72.3
Plasma Concentration Time Profiles by Treatment Group in Expansion Phase
C2D1 4 hrs post-dose
—
—
863 ng/mL
Geometric Coefficient of Variation 65.2
—
—
—
828 ng/mL
Geometric Coefficient of Variation 47.9
Plasma Concentration Time Profiles by Treatment Group in Expansion Phase
C2D1 6 hrs post-dose
—
—
939 ng/mL
Geometric Coefficient of Variation 71.4
—
—
—
870 ng/mL
Geometric Coefficient of Variation 52.6
Plasma Concentration Time Profiles by Treatment Group in Expansion Phase
C2D1 24 hrs post-dose
—
—
615 ng/mL
Geometric Coefficient of Variation 119.9
—
—
—
596 ng/mL
Geometric Coefficient of Variation 75.5
Plasma Concentration Time Profiles by Treatment Group in Expansion Phase
C2D2 0 hr pre-dose
—
—
615 ng/mL
Geometric Coefficient of Variation 119.9
—
—
—
596 ng/mL
Geometric Coefficient of Variation 75.5
Plasma Concentration Time Profiles by Treatment Group in Expansion Phase
C3D1 0 hr pre-dose
—
—
836 ng/mL
Geometric Coefficient of Variation 60.4
—
—
—
573 ng/mL
Geometric Coefficient of Variation 134.2
Plasma Concentration Time Profiles by Treatment Group in Expansion Phase
C4D1 0 hr pre-dose
—
—
834 ng/mL
Geometric Coefficient of Variation 78.8
—
—
—
622 ng/mL
Geometric Coefficient of Variation 96.5

SECONDARY outcome

Timeframe: 0hr pre-dose, 2, 4, 6 & 24hrs post-dose

Population: The PK analysis set (PAS) consisted of all patients who received at least one dose of ceritinib and had at least one evaluable PK sample.

Characterize single and multiple-dose PK of LDK378 in pediatric patients. AUC: Area under the plasma (serum, or blood) concentration versus time curve AUClast: Area under the concentration-time curve from time zero to the last measureable concentration time AUC0-24h: Area under the plasma concentration-time curve t=0-24 h

Outcome measures

Outcome measures
Measure
Fasted: Ceritinib 300 mg/m2
n=5 Participants
Participants in the fasted group who took 300 mg of ceritinib
Fasted: Ceritinib 450 mg/m2
n=10 Participants
Participants in the fasted group who took 450 mg of ceritinib
Fasted: Ceritinib 510 mg/m2
n=3 Participants
Participants in the fasted group who took 510 mg of ceritinib
Fasted: Ceritinib 560 mg/m2
n=1 Participants
Participants in the fasted group who took 560 mg of ceritinib
Fed: Ceritinib 320 mg/m2
n=3 Participants
Participants in the fed group who took 320 mg of ceritinib
Fed: Ceritinib 400 mg/m2
n=4 Participants
Participants in the fed group who took 400 mg of ceritinib
Fed: Ceritinib 500 mg/m2
n=3 Participants
Participants in the fed group who took 500 mg of ceritinib
Pharmacokinetics (PK) Parameters: AUC0 - 24h & AUClast in Cycle 1 Day 1 - Dose Escalation Phase (Single Dose)
AUC0-24h
3920 hr*ng/mL
Geometric Coefficient of Variation 39.9
5220 hr*ng/mL
Geometric Coefficient of Variation 58.0
8750 hr*ng/mL
Geometric Coefficient of Variation 11.1
—
5720 hr*ng/mL
Geometric Coefficient of Variation 0.0
7272 hr*ng/mL
Geometric Coefficient of Variation 0.0
4730 hr*ng/mL
Geometric Coefficient of Variation 59.4
Pharmacokinetics (PK) Parameters: AUC0 - 24h & AUClast in Cycle 1 Day 1 - Dose Escalation Phase (Single Dose)
AUClast
4260 hr*ng/mL
Geometric Coefficient of Variation 39.3
4350 hr*ng/mL
Geometric Coefficient of Variation 91.8
7670 hr*ng/mL
Geometric Coefficient of Variation 24.5
4860 hr*ng/mL
Geometric Coefficient of Variation 0.0
3730 hr*ng/mL
Geometric Coefficient of Variation 48.6
5760 hr*ng/mL
Geometric Coefficient of Variation 49.1
4940 hr*ng/mL
Geometric Coefficient of Variation 32.6

SECONDARY outcome

Timeframe: 0hr pre-dose, 2, 4, 6 & 24hrs post-dose

Population: The PK analysis set (PAS) consisted of all patients who received at least one dose of ceritinib and had at least one evaluable PK sample.

Characterize single and multiple-dose PK of LDK378 in pediatric patients. AUC: Area under the plasma (serum, or blood) concentration versus time curve AUClast: Area under the concentration-time curve from time zero to the last measureable concentration time; AUC0-24h: Area under the plasma concentration-time curve t=0-24 h

Outcome measures

Outcome measures
Measure
Fasted: Ceritinib 300 mg/m2
n=5 Participants
Participants in the fasted group who took 300 mg of ceritinib
Fasted: Ceritinib 450 mg/m2
n=12 Participants
Participants in the fasted group who took 450 mg of ceritinib
Fasted: Ceritinib 510 mg/m2
n=5 Participants
Participants in the fasted group who took 510 mg of ceritinib
Fasted: Ceritinib 560 mg/m2
n=2 Participants
Participants in the fasted group who took 560 mg of ceritinib
Fed: Ceritinib 320 mg/m2
n=3 Participants
Participants in the fed group who took 320 mg of ceritinib
Fed: Ceritinib 400 mg/m2
n=4 Participants
Participants in the fed group who took 400 mg of ceritinib
Fed: Ceritinib 500 mg/m2
n=2 Participants
Participants in the fed group who took 500 mg of ceritinib
Pharmacokinetics (PK) Parameters: AUC0 - 24h & AUClast in Cycle 2 Day 1 - Dose Escalation Phase (Single Dose)
AUC0-24h
8160 hr*ng/mL
Geometric Coefficient of Variation 44.0
16900 hr*ng/mL
Geometric Coefficient of Variation 59.1
21000 hr*ng/mL
Geometric Coefficient of Variation 20.8
25300 hr*ng/mL
Geometric Coefficient of Variation 39.2
2100 hr*ng/mL
Geometric Coefficient of Variation 0.0
30500 hr*ng/mL
Geometric Coefficient of Variation 0.0
16500 hr*ng/mL
Geometric Coefficient of Variation 0.0
Pharmacokinetics (PK) Parameters: AUC0 - 24h & AUClast in Cycle 2 Day 1 - Dose Escalation Phase (Single Dose)
AUClast
8210 hr*ng/mL
Geometric Coefficient of Variation 44.3
18000 hr*ng/mL
Geometric Coefficient of Variation 50.0
17200 hr*ng/mL
Geometric Coefficient of Variation 51.2
25600 hr*ng/mL
Geometric Coefficient of Variation 39.0
5840 hr*ng/mL
Geometric Coefficient of Variation 118.4
125000 hr*ng/mL
Geometric Coefficient of Variation 113.2
16700 hr*ng/mL
Geometric Coefficient of Variation 1.8

SECONDARY outcome

Timeframe: 0hr pre-dose, 2, 4, 6 & 24hrs post-dose

Population: The PK analysis set (PAS), MTD/RDE consisted of all patients who received at least one dose of ceritinib and had at least one evaluable PK sample.

Characterize single and multiple-dose PK of LDK378 in pediatric patients. In this phase ceritinib was expanded at 500mg/m2 fed and 510mg/m2 fasted administered orally once daily and was assessed only at steady state, Cycle 2 Day 1. AUC: Area under the plasma (serum, or blood) concentration versus time curve AUClast: Area under the plasma (serum, or blood) concentration versus time curverea under the concentration-time curve from time zero to the last measureable concentration time AUC0-24h: Area under the plasma concentration-time curve t=0-24 h

Outcome measures

Outcome measures
Measure
Fasted: Ceritinib 300 mg/m2
n=4 Participants
Participants in the fasted group who took 300 mg of ceritinib
Fasted: Ceritinib 450 mg/m2
n=14 Participants
Participants in the fasted group who took 450 mg of ceritinib
Fasted: Ceritinib 510 mg/m2
Participants in the fasted group who took 510 mg of ceritinib
Fasted: Ceritinib 560 mg/m2
Participants in the fasted group who took 560 mg of ceritinib
Fed: Ceritinib 320 mg/m2
Participants in the fed group who took 320 mg of ceritinib
Fed: Ceritinib 400 mg/m2
Participants in the fed group who took 400 mg of ceritinib
Fed: Ceritinib 500 mg/m2
Participants in the fed group who took 500 mg of ceritinib
Pharmacokinetics (PK) Parameters: AUC0 - 24h & AUClast in Cycle 2 Day 1 - Dose Expansion Phase (Multiple Dose)
AUC0-24h
—
15900 hr*ng/mL
Geometric Coefficient of Variation 93.8
—
—
—
—
—
Pharmacokinetics (PK) Parameters: AUC0 - 24h & AUClast in Cycle 2 Day 1 - Dose Expansion Phase (Multiple Dose)
AUClast
24100 hr*ng/mL
Geometric Coefficient of Variation 38.9
16100 hr*ng/mL
Geometric Coefficient of Variation 61.2
—
—
—
—
—

SECONDARY outcome

Timeframe: 0hr pre-dose, 2, 4, 6 & 24hrs post-dose

Population: The PK analysis set (PAS) consisted of all patients who received at least one dose of ceritinib and had at least one evaluable PK sample.

Characterize single and multiple-dose PK of LDK378 in pediatric patients. Cmax: Maximum (peak) concentration of drug

Outcome measures

Outcome measures
Measure
Fasted: Ceritinib 300 mg/m2
n=5 Participants
Participants in the fasted group who took 300 mg of ceritinib
Fasted: Ceritinib 450 mg/m2
n=10 Participants
Participants in the fasted group who took 450 mg of ceritinib
Fasted: Ceritinib 510 mg/m2
n=3 Participants
Participants in the fasted group who took 510 mg of ceritinib
Fasted: Ceritinib 560 mg/m2
n=1 Participants
Participants in the fasted group who took 560 mg of ceritinib
Fed: Ceritinib 320 mg/m2
n=3 Participants
Participants in the fed group who took 320 mg of ceritinib
Fed: Ceritinib 400 mg/m2
n=4 Participants
Participants in the fed group who took 400 mg of ceritinib
Fed: Ceritinib 500 mg/m2
n=3 Participants
Participants in the fed group who took 500 mg of ceritinib
PK Parameter: Cmax in Cycle 1 Day 1 - Dose Escalation Phase (Single Dose)
258 ng/mL
Geometric Coefficient of Variation 39.0
270 ng/mL
Geometric Coefficient of Variation 82.1
537 ng/mL
Geometric Coefficient of Variation 22.2
265 ng/mL
Geometric Coefficient of Variation 0.0
251 ng/mL
Geometric Coefficient of Variation 37.0
341 ng/mL
Geometric Coefficient of Variation 34.2
204 ng/mL
Geometric Coefficient of Variation 54.6

SECONDARY outcome

Timeframe: 0hr pre-dose, 2, 4, 6 & 24hrs post-dose

Population: The PK analysis set (PAS) consisted of all patients who received at least one dose of ceritinib and had at least one evaluable PK sample.

Characterize single and multiple-dose PK of LDK378 in pediatric patients. Cmax: Maximum (peak) concentration of drug.

Outcome measures

Outcome measures
Measure
Fasted: Ceritinib 300 mg/m2
n=5 Participants
Participants in the fasted group who took 300 mg of ceritinib
Fasted: Ceritinib 450 mg/m2
n=12 Participants
Participants in the fasted group who took 450 mg of ceritinib
Fasted: Ceritinib 510 mg/m2
n=5 Participants
Participants in the fasted group who took 510 mg of ceritinib
Fasted: Ceritinib 560 mg/m2
n=2 Participants
Participants in the fasted group who took 560 mg of ceritinib
Fed: Ceritinib 320 mg/m2
n=3 Participants
Participants in the fed group who took 320 mg of ceritinib
Fed: Ceritinib 400 mg/m2
n=4 Participants
Participants in the fed group who took 400 mg of ceritinib
Fed: Ceritinib 500 mg/m2
n=2 Participants
Participants in the fed group who took 500 mg of ceritinib
PK Parameter: Cmax in Cycle 2 Day 1 - Dose Escalation Phase (Single Dose)
427 ng/mL
Geometric Coefficient of Variation 38.5
870 ng/mL
Geometric Coefficient of Variation 48.7
1020 ng/mL
Geometric Coefficient of Variation 32.1
1300 ng/mL
Geometric Coefficient of Variation 21.4
300 ng/mL
Geometric Coefficient of Variation 130.3
674 ng/mL
Geometric Coefficient of Variation 93.8
804 ng/mL
Geometric Coefficient of Variation 10.4

SECONDARY outcome

Timeframe: 0hr pre-dose, 2, 4, 6 & 24hrs post-dose

Population: The PK analysis set (PAS), MTD/RDE consisted of all patients who received at least one dose of ceritinib and had at least one evaluable PK sample.

Characterize single and multiple-dose PK of LDK378 in pediatric patients. In this phase ceritinib was expanded at 500mg/m2 fed and 510mg/m2 fasted administered orally once daily and was assessed only at steady state, Cycle 2 Day 1. Cmax: Maximum (peak) concentration of drug

Outcome measures

Outcome measures
Measure
Fasted: Ceritinib 300 mg/m2
n=4 Participants
Participants in the fasted group who took 300 mg of ceritinib
Fasted: Ceritinib 450 mg/m2
n=14 Participants
Participants in the fasted group who took 450 mg of ceritinib
Fasted: Ceritinib 510 mg/m2
Participants in the fasted group who took 510 mg of ceritinib
Fasted: Ceritinib 560 mg/m2
Participants in the fasted group who took 560 mg of ceritinib
Fed: Ceritinib 320 mg/m2
Participants in the fed group who took 320 mg of ceritinib
Fed: Ceritinib 400 mg/m2
Participants in the fed group who took 400 mg of ceritinib
Fed: Ceritinib 500 mg/m2
Participants in the fed group who took 500 mg of ceritinib
PK Parameter: Cmax in Cycle 2 Day 1 - Dose Expansion Phase (Multiple Dose)
1220 ng/mL
Geometric Coefficient of Variation 40.2
890 ng/mL
Geometric Coefficient of Variation 50.9
—
—
—
—
—

SECONDARY outcome

Timeframe: 0hr pre-dose, 2, 4, 6 & 24hrs post-dose

Population: The PK analysis set (PAS) consisted of all patients who received at least one dose of ceritinib and had at least one evaluable PK sample.

Characterize single and multiple-dose PK of LDK378 in pediatric patients. Tmax: The time to reach maximum plasma concentration

Outcome measures

Outcome measures
Measure
Fasted: Ceritinib 300 mg/m2
n=5 Participants
Participants in the fasted group who took 300 mg of ceritinib
Fasted: Ceritinib 450 mg/m2
n=10 Participants
Participants in the fasted group who took 450 mg of ceritinib
Fasted: Ceritinib 510 mg/m2
n=3 Participants
Participants in the fasted group who took 510 mg of ceritinib
Fasted: Ceritinib 560 mg/m2
n=1 Participants
Participants in the fasted group who took 560 mg of ceritinib
Fed: Ceritinib 320 mg/m2
n=3 Participants
Participants in the fed group who took 320 mg of ceritinib
Fed: Ceritinib 400 mg/m2
n=4 Participants
Participants in the fed group who took 400 mg of ceritinib
Fed: Ceritinib 500 mg/m2
n=3 Participants
Participants in the fed group who took 500 mg of ceritinib
PK Parameter: Tmax in Cycle 1 Day 1 - Dose Escalation Phase (Single Dose)
4.20 hour (hr)
Interval 1.9 to 24.0
4.25 hour (hr)
Interval 0.0 to 6.1
4.30 hour (hr)
Interval 4.1 to 6.0
6.10 hour (hr)
Interval 6.1 to 6.1
6.10 hour (hr)
Interval 5.7 to 6.3
6.00 hour (hr)
Interval 4.3 to 6.2
5.80 hour (hr)
Interval 4.1 to 6.1

SECONDARY outcome

Timeframe: 0hr pre-dose, 2, 4, 6 & 24hrs post-dose

Population: The PK analysis set (PAS) consisted of all patients who received at least one dose of ceritinib and had at least one evaluable PK sample.

Characterize single and multiple-dose PK of LDK378 in pediatric patients. Tmax: The time to reach maximum plasma concentration

Outcome measures

Outcome measures
Measure
Fasted: Ceritinib 300 mg/m2
n=5 Participants
Participants in the fasted group who took 300 mg of ceritinib
Fasted: Ceritinib 450 mg/m2
n=12 Participants
Participants in the fasted group who took 450 mg of ceritinib
Fasted: Ceritinib 510 mg/m2
n=5 Participants
Participants in the fasted group who took 510 mg of ceritinib
Fasted: Ceritinib 560 mg/m2
n=2 Participants
Participants in the fasted group who took 560 mg of ceritinib
Fed: Ceritinib 320 mg/m2
n=3 Participants
Participants in the fed group who took 320 mg of ceritinib
Fed: Ceritinib 400 mg/m2
n=4 Participants
Participants in the fed group who took 400 mg of ceritinib
Fed: Ceritinib 500 mg/m2
n=2 Participants
Participants in the fed group who took 500 mg of ceritinib
PK Parameter: Tmax in Cycle 2 Day 1 - Dose Escalation Phase (Single Dose)
6.00 hour (hr)
Interval 4.1 to 6.7
5.10 hour (hr)
Interval 2.0 to 6.6
4.00 hour (hr)
Interval 2.1 to 6.0
3.95 hour (hr)
Interval 0.0 to 6.7
5.90 hour (hr)
Interval 5.8 to 6.1
6.00 hour (hr)
Interval 4.0 to 6.1
2.20 hour (hr)
Interval 2.0 to 2.4

SECONDARY outcome

Timeframe: 0hr pre-dose, 2, 4, 6 & 24hrs post-dose

Population: The PK analysis set (PAS), MTD/RDE consisted of all patients who received at least one dose of ceritinib and had at least one evaluable PK sample.

Characterize single and multiple-dose PK of LDK378 in pediatric patients. In this phase ceritinib was expanded at 500mg/m2 fed and 510mg/m2 fasted administered orally once daily and was assessed only at steady state, Cycle 2 Day 1. Characterize single and multiple-dose PK of LDK378 in pediatric patients. Tmax: The time to reach maximum plasma concentration

Outcome measures

Outcome measures
Measure
Fasted: Ceritinib 300 mg/m2
n=4 Participants
Participants in the fasted group who took 300 mg of ceritinib
Fasted: Ceritinib 450 mg/m2
n=14 Participants
Participants in the fasted group who took 450 mg of ceritinib
Fasted: Ceritinib 510 mg/m2
Participants in the fasted group who took 510 mg of ceritinib
Fasted: Ceritinib 560 mg/m2
Participants in the fasted group who took 560 mg of ceritinib
Fed: Ceritinib 320 mg/m2
Participants in the fed group who took 320 mg of ceritinib
Fed: Ceritinib 400 mg/m2
Participants in the fed group who took 400 mg of ceritinib
Fed: Ceritinib 500 mg/m2
Participants in the fed group who took 500 mg of ceritinib
PK Parameter: Tmax in Cycle 2 Day 1 - Dose Expansion Phase (Multiple Dose)
6.20 hour (hr)
Interval 3.8 to 23.8
5.90 hour (hr)
Interval 1.9 to 23.6
—
—
—
—
—

SECONDARY outcome

Timeframe: 0hr pre-dose, 2, 4, 6 & 24hrs post-dose

Population: The PK analysis set (PAS) consisted of all patients who received at least one dose of ceritinib and had at least one evaluable PK sample.

Characterize single and multiple-dose PK of LDK378 in pediatric patients. Racc: Accumulation ratio

Outcome measures

Outcome measures
Measure
Fasted: Ceritinib 300 mg/m2
n=5 Participants
Participants in the fasted group who took 300 mg of ceritinib
Fasted: Ceritinib 450 mg/m2
n=12 Participants
Participants in the fasted group who took 450 mg of ceritinib
Fasted: Ceritinib 510 mg/m2
n=5 Participants
Participants in the fasted group who took 510 mg of ceritinib
Fasted: Ceritinib 560 mg/m2
n=2 Participants
Participants in the fasted group who took 560 mg of ceritinib
Fed: Ceritinib 320 mg/m2
n=3 Participants
Participants in the fed group who took 320 mg of ceritinib
Fed: Ceritinib 400 mg/m2
n=4 Participants
Participants in the fed group who took 400 mg of ceritinib
Fed: Ceritinib 500 mg/m2
n=2 Participants
Participants in the fed group who took 500 mg of ceritinib
PK Parameter: Racc in Dose Escalation Phase Cycle 2 Day 1
1.93 ratio
Geometric Coefficient of Variation 64.2
5.50 ratio
Geometric Coefficient of Variation 30.3
2.56 ratio
Geometric Coefficient of Variation 0.0
6.86 ratio
Geometric Coefficient of Variation 0.0
0.533 ratio
Geometric Coefficient of Variation 0.0
3.41 ratio
Geometric Coefficient of Variation 0.0
3.62 ratio
Geometric Coefficient of Variation 0.0

Adverse Events

Fasted Ceritinib 300mg/m2

Serious events: 1 serious events
Other events: 5 other events
Deaths: 1 deaths

Fasted Ceritinib 450mg/m2

Serious events: 4 serious events
Other events: 12 other events
Deaths: 1 deaths

Fasted Ceritinib 510mg/m2

Serious events: 8 serious events
Other events: 13 other events
Deaths: 2 deaths

Fasted Ceritinib 560mg/m2

Serious events: 2 serious events
Other events: 2 other events
Deaths: 0 deaths

Fed Ceritinib 320mg/m2

Serious events: 3 serious events
Other events: 4 other events
Deaths: 2 deaths

Fed Ceritinib 400mg/m2

Serious events: 1 serious events
Other events: 5 other events
Deaths: 1 deaths

Fed Ceritinib 500mg/m2

Serious events: 21 serious events
Other events: 42 other events
Deaths: 5 deaths

Fasted+Fed All Patients

Serious events: 40 serious events
Other events: 83 other events
Deaths: 12 deaths

Serious adverse events

Serious adverse events
Measure
Fasted Ceritinib 300mg/m2
n=5 participants at risk
Participants in the fasted group who took 300 mg of ceritinib
Fasted Ceritinib 450mg/m2
n=12 participants at risk
Participants in the fasted group who took 450 mg of ceritinib
Fasted Ceritinib 510mg/m2
n=13 participants at risk
Participants in the fasted group who took 510 mg of ceritinib
Fasted Ceritinib 560mg/m2
n=2 participants at risk
Participants in the fasted group who took 560 mg of ceritinib
Fed Ceritinib 320mg/m2
n=4 participants at risk
Participants in the fed group who took 320 mg of ceritinib
Fed Ceritinib 400mg/m2
n=5 participants at risk
Participants in the fed group who took 400 mg of ceritinib
Fed Ceritinib 500mg/m2
n=42 participants at risk
Participants in the fed group who took 500 mg of ceritinib
Fasted+Fed All Patients
n=83 participants at risk
All participants in the Fasted and Fed groups
Metabolism and nutrition disorders
Hypoglycaemia
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/12 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/13 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/2 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/4 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
2.4%
1/42 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
1.2%
1/83 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
Musculoskeletal and connective tissue disorders
Bone pain
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
8.3%
1/12 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/13 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/2 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/4 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/42 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
1.2%
1/83 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour haemorrhage
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/12 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/13 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/2 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/4 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
2.4%
1/42 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
1.2%
1/83 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
Nervous system disorders
Hemiplegia
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/12 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/13 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/2 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/4 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
2.4%
1/42 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
1.2%
1/83 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
Nervous system disorders
Seizure
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/12 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/13 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/2 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/4 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
4.8%
2/42 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
2.4%
2/83 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
Psychiatric disorders
Suicide attempt
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/12 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/13 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/2 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/4 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
4.8%
2/42 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
2.4%
2/83 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
Renal and urinary disorders
Acute kidney injury
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
8.3%
1/12 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
7.7%
1/13 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/2 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/4 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/42 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
2.4%
2/83 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
Respiratory, thoracic and mediastinal disorders
Bronchopleural fistula
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/12 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/13 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/2 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
25.0%
1/4 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/42 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
1.2%
1/83 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
Blood and lymphatic system disorders
Anaemia
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/12 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/13 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/2 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
25.0%
1/4 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
2.4%
1/42 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
2.4%
2/83 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
Blood and lymphatic system disorders
Febrile bone marrow aplasia
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/12 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/13 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
50.0%
1/2 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/4 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/42 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
1.2%
1/83 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
Blood and lymphatic system disorders
Febrile neutropenia
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
8.3%
1/12 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
7.7%
1/13 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/2 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/4 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/42 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
2.4%
2/83 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
Blood and lymphatic system disorders
Thrombocytopenia
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/12 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/13 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/2 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/4 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
2.4%
1/42 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
1.2%
1/83 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
Cardiac disorders
Cardiac failure
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/12 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/13 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/2 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/4 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
2.4%
1/42 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
1.2%
1/83 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
Cardiac disorders
Pericarditis
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
8.3%
1/12 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/13 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/2 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/4 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/42 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
1.2%
1/83 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
Gastrointestinal disorders
Abdominal distension
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/12 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/13 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/2 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/4 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
2.4%
1/42 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
1.2%
1/83 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
Gastrointestinal disorders
Abdominal pain
20.0%
1/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/12 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
7.7%
1/13 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
50.0%
1/2 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
25.0%
1/4 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
2.4%
1/42 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
6.0%
5/83 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
Gastrointestinal disorders
Ascites
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/12 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
7.7%
1/13 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/2 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/4 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/42 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
1.2%
1/83 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
Gastrointestinal disorders
Dental caries
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/12 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/13 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/2 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/4 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
2.4%
1/42 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
1.2%
1/83 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
Gastrointestinal disorders
Gastric haemorrhage
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/12 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/13 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/2 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/4 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
2.4%
1/42 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
1.2%
1/83 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
Gastrointestinal disorders
Small intestinal haemorrhage
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/12 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/13 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/2 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/4 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
2.4%
1/42 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
1.2%
1/83 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
Gastrointestinal disorders
Subileus
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/12 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/13 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/2 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/4 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
2.4%
1/42 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
1.2%
1/83 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
Gastrointestinal disorders
Vomiting
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/12 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/13 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/2 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/4 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
2.4%
1/42 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
1.2%
1/83 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
General disorders
Chest pain
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
8.3%
1/12 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/13 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/2 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/4 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
20.0%
1/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/42 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
2.4%
2/83 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
General disorders
General physical health deterioration
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/12 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
7.7%
1/13 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/2 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/4 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/42 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
1.2%
1/83 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
General disorders
Multiple organ dysfunction syndrome
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/12 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
7.7%
1/13 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/2 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/4 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/42 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
1.2%
1/83 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
General disorders
Pyrexia
20.0%
1/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
8.3%
1/12 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
7.7%
1/13 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/2 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/4 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
7.1%
3/42 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
7.2%
6/83 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
Hepatobiliary disorders
Acute hepatic failure
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
8.3%
1/12 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/13 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/2 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/4 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/42 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
1.2%
1/83 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
Hepatobiliary disorders
Hepatotoxicity
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/12 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
7.7%
1/13 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/2 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/4 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/42 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
1.2%
1/83 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
Infections and infestations
Appendicitis
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/12 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/13 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/2 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
25.0%
1/4 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/42 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
1.2%
1/83 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
Infections and infestations
Device related infection
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/12 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/13 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/2 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/4 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
9.5%
4/42 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
4.8%
4/83 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
Infections and infestations
Ear infection
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/12 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/13 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/2 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/4 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
2.4%
1/42 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
1.2%
1/83 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
Infections and infestations
Encephalitis
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/12 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
7.7%
1/13 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/2 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/4 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/42 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
1.2%
1/83 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
Infections and infestations
Enterovirus infection
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/12 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/13 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/2 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/4 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
2.4%
1/42 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
1.2%
1/83 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
Infections and infestations
Gastroenteritis
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/12 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/13 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/2 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/4 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
4.8%
2/42 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
2.4%
2/83 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
Infections and infestations
Infection
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/12 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/13 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/2 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/4 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
2.4%
1/42 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
1.2%
1/83 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
Infections and infestations
Influenza
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/12 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/13 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/2 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/4 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
7.1%
3/42 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
3.6%
3/83 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
Infections and infestations
Metapneumovirus infection
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/12 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/13 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/2 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/4 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
2.4%
1/42 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
1.2%
1/83 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
Infections and infestations
Pneumonia
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
8.3%
1/12 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/13 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/2 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/4 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/42 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
1.2%
1/83 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
Infections and infestations
Pneumonia viral
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/12 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/13 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/2 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/4 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
2.4%
1/42 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
1.2%
1/83 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
Infections and infestations
Pyelonephritis
20.0%
1/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/12 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/13 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/2 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/4 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/42 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
1.2%
1/83 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
Infections and infestations
Sepsis
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/12 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/13 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/2 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/4 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
7.1%
3/42 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
3.6%
3/83 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
Infections and infestations
Septic shock
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/12 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/13 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/2 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/4 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
2.4%
1/42 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
1.2%
1/83 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
Infections and infestations
Staphylococcal infection
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/12 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/13 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/2 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/4 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
2.4%
1/42 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
1.2%
1/83 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
Infections and infestations
Tonsillitis
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/12 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/13 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/2 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/4 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
2.4%
1/42 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
1.2%
1/83 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
Infections and infestations
Wound infection
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/12 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/13 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
50.0%
1/2 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/4 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/42 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
1.2%
1/83 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
Investigations
Alanine aminotransferase increased
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
8.3%
1/12 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
7.7%
1/13 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/2 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/4 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
4.8%
2/42 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
4.8%
4/83 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
Investigations
Amylase increased
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/12 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
7.7%
1/13 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/2 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/4 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/42 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
1.2%
1/83 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
Investigations
Aspartate aminotransferase increased
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
8.3%
1/12 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
15.4%
2/13 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/2 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/4 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
2.4%
1/42 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
4.8%
4/83 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
Investigations
Blood lactate dehydrogenase increased
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/12 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
7.7%
1/13 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/2 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/4 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/42 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
1.2%
1/83 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
Investigations
C-reactive protein increased
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/12 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/13 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/2 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/4 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
2.4%
1/42 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
1.2%
1/83 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
Investigations
Lipase increased
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/12 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
15.4%
2/13 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/2 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/4 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/42 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
2.4%
2/83 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
Metabolism and nutrition disorders
Dehydration
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/12 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/13 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/2 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/4 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
2.4%
1/42 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
1.2%
1/83 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
Respiratory, thoracic and mediastinal disorders
Pneumothorax
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/12 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/13 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/2 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
25.0%
1/4 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/42 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
1.2%
1/83 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
Respiratory, thoracic and mediastinal disorders
Respiratory failure
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/12 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/13 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/2 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/4 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
2.4%
1/42 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
1.2%
1/83 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
Vascular disorders
Hypotension
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/12 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
7.7%
1/13 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/2 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/4 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/42 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
1.2%
1/83 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment

Other adverse events

Other adverse events
Measure
Fasted Ceritinib 300mg/m2
n=5 participants at risk
Participants in the fasted group who took 300 mg of ceritinib
Fasted Ceritinib 450mg/m2
n=12 participants at risk
Participants in the fasted group who took 450 mg of ceritinib
Fasted Ceritinib 510mg/m2
n=13 participants at risk
Participants in the fasted group who took 510 mg of ceritinib
Fasted Ceritinib 560mg/m2
n=2 participants at risk
Participants in the fasted group who took 560 mg of ceritinib
Fed Ceritinib 320mg/m2
n=4 participants at risk
Participants in the fed group who took 320 mg of ceritinib
Fed Ceritinib 400mg/m2
n=5 participants at risk
Participants in the fed group who took 400 mg of ceritinib
Fed Ceritinib 500mg/m2
n=42 participants at risk
Participants in the fed group who took 500 mg of ceritinib
Fasted+Fed All Patients
n=83 participants at risk
All participants in the Fasted and Fed groups
Metabolism and nutrition disorders
Hypermagnesaemia
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/12 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
7.7%
1/13 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/2 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/4 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/42 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
1.2%
1/83 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
Infections and infestations
Human herpesvirus 6 infection
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
8.3%
1/12 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/13 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/2 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/4 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/42 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
1.2%
1/83 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
Cardiac disorders
Pericardial effusion
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
8.3%
1/12 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/13 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/2 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/4 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
2.4%
1/42 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
2.4%
2/83 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
Cardiac disorders
Tachycardia
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
8.3%
1/12 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
7.7%
1/13 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/2 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/4 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
4.8%
2/42 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
4.8%
4/83 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
Ear and labyrinth disorders
Ear pain
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
8.3%
1/12 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/13 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/2 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/4 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
7.1%
3/42 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
4.8%
4/83 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
Psychiatric disorders
Mental disorder
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/12 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
7.7%
1/13 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/2 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/4 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/42 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
1.2%
1/83 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
Gastrointestinal disorders
Constipation
60.0%
3/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
16.7%
2/12 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
15.4%
2/13 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
50.0%
1/2 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
25.0%
1/4 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
20.0%
1/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
9.5%
4/42 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
16.9%
14/83 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
Investigations
Blood urea increased
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/12 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/13 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/2 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/4 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
7.1%
3/42 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
3.6%
3/83 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
Blood and lymphatic system disorders
Anaemia
20.0%
1/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
25.0%
3/12 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
23.1%
3/13 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
50.0%
1/2 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
75.0%
3/4 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
26.2%
11/42 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
26.5%
22/83 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
Blood and lymphatic system disorders
Bone marrow disorder
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/12 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
7.7%
1/13 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/2 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/4 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/42 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
1.2%
1/83 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
Blood and lymphatic system disorders
Leukocytosis
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/12 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
7.7%
1/13 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/2 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
25.0%
1/4 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/42 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
2.4%
2/83 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
Blood and lymphatic system disorders
Leukopenia
20.0%
1/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/12 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
15.4%
2/13 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/2 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/4 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
11.9%
5/42 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
9.6%
8/83 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
Blood and lymphatic system disorders
Lymphadenopathy
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
8.3%
1/12 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/13 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/2 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/4 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/42 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
1.2%
1/83 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
Blood and lymphatic system disorders
Neutropenia
20.0%
1/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
8.3%
1/12 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
23.1%
3/13 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/2 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/4 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
11.9%
5/42 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
12.0%
10/83 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
Blood and lymphatic system disorders
Thrombocytopenia
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
16.7%
2/12 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
15.4%
2/13 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
100.0%
2/2 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
50.0%
2/4 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
26.2%
11/42 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
22.9%
19/83 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
Cardiac disorders
Left ventricular dysfunction
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
8.3%
1/12 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/13 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/2 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/4 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/42 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
1.2%
1/83 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
Cardiac disorders
Palpitations
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
8.3%
1/12 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/13 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/2 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/4 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
2.4%
1/42 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
2.4%
2/83 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
Ear and labyrinth disorders
External ear inflammation
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
8.3%
1/12 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/13 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/2 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/4 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/42 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
1.2%
1/83 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
Ear and labyrinth disorders
Hypoacusis
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
8.3%
1/12 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/13 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/2 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/4 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/42 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
1.2%
1/83 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
Endocrine disorders
Delayed puberty
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/12 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/13 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/2 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
25.0%
1/4 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/42 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
1.2%
1/83 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
Endocrine disorders
Hypothyroidism
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/12 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
15.4%
2/13 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/2 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/4 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/42 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
2.4%
2/83 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
Eye disorders
Eye pain
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
8.3%
1/12 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/13 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/2 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/4 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/42 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
1.2%
1/83 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
Eye disorders
Eye swelling
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/12 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
7.7%
1/13 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/2 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/4 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/42 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
1.2%
1/83 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
Eye disorders
Ocular discomfort
20.0%
1/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/12 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/13 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/2 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/4 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/42 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
1.2%
1/83 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
Eye disorders
Vision blurred
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
8.3%
1/12 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/13 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/2 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/4 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/42 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
1.2%
1/83 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
Gastrointestinal disorders
Abdominal discomfort
20.0%
1/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
8.3%
1/12 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/13 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/2 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/4 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/42 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
2.4%
2/83 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
Gastrointestinal disorders
Abdominal pain
60.0%
3/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
50.0%
6/12 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
46.2%
6/13 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
100.0%
2/2 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
50.0%
2/4 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
20.0%
1/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
52.4%
22/42 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
50.6%
42/83 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
Infections and infestations
Gastroenteritis
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/12 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/13 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/2 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/4 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
9.5%
4/42 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
4.8%
4/83 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
Gastrointestinal disorders
Abdominal pain upper
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
16.7%
2/12 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/13 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/2 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
25.0%
1/4 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
20.0%
1/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
7.1%
3/42 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
8.4%
7/83 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
Gastrointestinal disorders
Anal fissure
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/12 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
7.7%
1/13 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/2 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/4 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/42 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
1.2%
1/83 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
Gastrointestinal disorders
Anal incontinence
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/12 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
7.7%
1/13 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/2 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/4 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/42 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
1.2%
1/83 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
Gastrointestinal disorders
Anal inflammation
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
8.3%
1/12 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/13 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/2 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/4 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/42 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
1.2%
1/83 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
Gastrointestinal disorders
Diarrhoea
80.0%
4/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
100.0%
12/12 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
76.9%
10/13 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
100.0%
2/2 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
50.0%
2/4 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
60.0%
3/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
76.2%
32/42 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
78.3%
65/83 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
Gastrointestinal disorders
Dyspepsia
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
8.3%
1/12 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
7.7%
1/13 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/2 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/4 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
9.5%
4/42 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
7.2%
6/83 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
Gastrointestinal disorders
Flatulence
20.0%
1/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/12 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
7.7%
1/13 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/2 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/4 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
20.0%
1/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
2.4%
1/42 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
4.8%
4/83 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
Gastrointestinal disorders
Gastrointestinal disorder
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
8.3%
1/12 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/13 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/2 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/4 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/42 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
1.2%
1/83 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
Gastrointestinal disorders
Gingival pain
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
8.3%
1/12 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/13 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/2 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/4 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/42 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
1.2%
1/83 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
Gastrointestinal disorders
Haematemesis
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/12 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
7.7%
1/13 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/2 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/4 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/42 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
1.2%
1/83 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
Gastrointestinal disorders
Haematochezia
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
8.3%
1/12 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/13 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/2 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/4 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/42 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
1.2%
1/83 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
Gastrointestinal disorders
Nausea
40.0%
2/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
66.7%
8/12 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
76.9%
10/13 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
50.0%
1/2 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
50.0%
2/4 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
60.0%
3/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
50.0%
21/42 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
56.6%
47/83 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
Gastrointestinal disorders
Odynophagia
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/12 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/13 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/2 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/4 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
7.1%
3/42 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
3.6%
3/83 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
Gastrointestinal disorders
Proctalgia
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/12 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
7.7%
1/13 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/2 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/4 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/42 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
1.2%
1/83 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
Infections and infestations
Genital candidiasis
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
8.3%
1/12 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/13 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/2 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/4 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/42 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
1.2%
1/83 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
Gastrointestinal disorders
Rectal haemorrhage
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
8.3%
1/12 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/13 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/2 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/4 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/42 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
1.2%
1/83 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
Gastrointestinal disorders
Stomatitis
20.0%
1/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
8.3%
1/12 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/13 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
50.0%
1/2 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/4 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
7.1%
3/42 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
7.2%
6/83 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
Gastrointestinal disorders
Vomiting
80.0%
4/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
83.3%
10/12 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
100.0%
13/13 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
100.0%
2/2 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
100.0%
4/4 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
60.0%
3/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
85.7%
36/42 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
86.7%
72/83 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
General disorders
Asthenia
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
8.3%
1/12 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/13 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/2 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/4 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
21.4%
9/42 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
12.0%
10/83 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
General disorders
Catheter site pain
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
16.7%
2/12 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
7.7%
1/13 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/2 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/4 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/42 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
3.6%
3/83 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
General disorders
Chest pain
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
16.7%
2/12 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
7.7%
1/13 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/2 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
25.0%
1/4 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
20.0%
1/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
14.3%
6/42 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
13.3%
11/83 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
General disorders
Fatigue
60.0%
3/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
33.3%
4/12 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
23.1%
3/13 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
100.0%
2/2 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
25.0%
1/4 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
21.4%
9/42 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
26.5%
22/83 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
General disorders
Gait disturbance
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
8.3%
1/12 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/13 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/2 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/4 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/42 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
1.2%
1/83 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
General disorders
General physical health deterioration
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/12 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
7.7%
1/13 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/2 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
25.0%
1/4 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/42 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
2.4%
2/83 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
General disorders
Influenza like illness
20.0%
1/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/12 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/13 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/2 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/4 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
2.4%
1/42 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
2.4%
2/83 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
General disorders
Malaise
20.0%
1/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/12 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/13 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/2 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/4 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
2.4%
1/42 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
2.4%
2/83 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
General disorders
Oedema peripheral
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/12 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/13 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/2 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
50.0%
2/4 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
4.8%
2/42 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
4.8%
4/83 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
General disorders
Pyrexia
60.0%
3/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
33.3%
4/12 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
46.2%
6/13 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
50.0%
1/2 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/4 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
20.0%
1/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
47.6%
20/42 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
42.2%
35/83 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
General disorders
Secretion discharge
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/12 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/13 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/2 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/4 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
7.1%
3/42 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
3.6%
3/83 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
General disorders
Ulcer
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
8.3%
1/12 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/13 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/2 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/4 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/42 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
1.2%
1/83 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
Hepatobiliary disorders
Hepatomegaly
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/12 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/13 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/2 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
25.0%
1/4 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/42 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
1.2%
1/83 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
Hepatobiliary disorders
Hyperbilirubinaemia
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
8.3%
1/12 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/13 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/2 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/4 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
2.4%
1/42 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
2.4%
2/83 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
Infections and infestations
Bacterial vulvovaginitis
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/12 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/13 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
50.0%
1/2 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/4 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/42 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
1.2%
1/83 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
Infections and infestations
Bronchitis
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/12 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
7.7%
1/13 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/2 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/4 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
4.8%
2/42 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
3.6%
3/83 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
Infections and infestations
Conjunctivitis
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
8.3%
1/12 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
7.7%
1/13 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/2 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/4 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
7.1%
3/42 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
6.0%
5/83 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
Infections and infestations
Device related infection
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/12 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/13 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/2 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/4 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
7.1%
3/42 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
3.6%
3/83 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
Infections and infestations
Ear infection
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
8.3%
1/12 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/13 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/2 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/4 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
4.8%
2/42 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
3.6%
3/83 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
Infections and infestations
Influenza
20.0%
1/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
8.3%
1/12 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/13 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/2 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/4 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
4.8%
2/42 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
4.8%
4/83 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
Infections and infestations
Molluscum contagiosum
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/12 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
7.7%
1/13 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/2 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/4 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/42 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
1.2%
1/83 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
Infections and infestations
Mycoplasma infection
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/12 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
7.7%
1/13 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/2 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/4 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/42 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
1.2%
1/83 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
Metabolism and nutrition disorders
Hyperkalaemia
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/12 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
7.7%
1/13 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/2 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/4 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
2.4%
1/42 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
2.4%
2/83 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
Infections and infestations
Nasopharyngitis
40.0%
2/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
8.3%
1/12 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
15.4%
2/13 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/2 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
25.0%
1/4 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
9.5%
4/42 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
12.0%
10/83 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
Infections and infestations
Oral herpes
20.0%
1/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/12 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/13 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/2 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/4 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/42 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
1.2%
1/83 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
Infections and infestations
Pharyngitis
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/12 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
7.7%
1/13 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/2 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/4 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
2.4%
1/42 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
2.4%
2/83 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
Infections and infestations
Pneumonia
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/12 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/13 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/2 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/4 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
7.1%
3/42 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
3.6%
3/83 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
Infections and infestations
Rhinitis
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
16.7%
2/12 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
7.7%
1/13 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/2 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/4 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
19.0%
8/42 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
13.3%
11/83 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
Infections and infestations
Sinusitis
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
8.3%
1/12 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/13 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/2 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/4 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/42 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
1.2%
1/83 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
Infections and infestations
Upper respiratory tract infection
20.0%
1/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
16.7%
2/12 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
23.1%
3/13 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
50.0%
1/2 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/4 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
19.0%
8/42 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
18.1%
15/83 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
Infections and infestations
Urinary tract infection
20.0%
1/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
8.3%
1/12 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/13 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/2 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/4 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
20.0%
1/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/42 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
3.6%
3/83 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
Infections and infestations
Varicella
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/12 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
7.7%
1/13 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/2 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/4 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
2.4%
1/42 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
2.4%
2/83 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
Infections and infestations
Viral infection
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/12 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/13 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/2 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
25.0%
1/4 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
2.4%
1/42 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
2.4%
2/83 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
Infections and infestations
Wound infection
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
8.3%
1/12 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/13 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
50.0%
1/2 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/4 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/42 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
2.4%
2/83 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
Injury, poisoning and procedural complications
Contusion
20.0%
1/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/12 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/13 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/2 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/4 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/42 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
1.2%
1/83 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
Injury, poisoning and procedural complications
Fall
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/12 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
7.7%
1/13 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/2 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/4 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
2.4%
1/42 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
2.4%
2/83 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
Injury, poisoning and procedural complications
Hand fracture
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/12 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
7.7%
1/13 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/2 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/4 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/42 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
1.2%
1/83 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
Injury, poisoning and procedural complications
Muscle injury
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/12 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
7.7%
1/13 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/2 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/4 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/42 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
1.2%
1/83 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
Investigations
Alanine aminotransferase increased
20.0%
1/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
66.7%
8/12 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
61.5%
8/13 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
100.0%
2/2 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
75.0%
3/4 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
40.0%
2/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
71.4%
30/42 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
65.1%
54/83 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
Investigations
Amylase increased
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
8.3%
1/12 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
7.7%
1/13 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/2 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/4 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
20.0%
1/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
7.1%
3/42 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
7.2%
6/83 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
Investigations
Aspartate aminotransferase increased
20.0%
1/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
50.0%
6/12 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
53.8%
7/13 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
100.0%
2/2 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
75.0%
3/4 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
20.0%
1/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
66.7%
28/42 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
57.8%
48/83 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
Investigations
Blood albumin decreased
20.0%
1/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/12 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/13 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/2 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/4 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/42 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
1.2%
1/83 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
Investigations
Blood alkaline phosphatase increased
20.0%
1/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
33.3%
4/12 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/13 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/2 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
25.0%
1/4 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
9.5%
4/42 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
12.0%
10/83 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
Investigations
Blood bicarbonate decreased
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/12 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
7.7%
1/13 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/2 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/4 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
2.4%
1/42 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
2.4%
2/83 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
Investigations
Blood bilirubin increased
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
16.7%
2/12 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/13 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/2 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
25.0%
1/4 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
11.9%
5/42 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
9.6%
8/83 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
Investigations
Blood creatine increased
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/12 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/13 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/2 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/4 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
7.1%
3/42 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
3.6%
3/83 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
Investigations
Blood creatine phosphokinase MB increased
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/12 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
7.7%
1/13 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/2 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/4 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/42 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
1.2%
1/83 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
Investigations
Blood creatine phosphokinase increased
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/12 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
7.7%
1/13 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/2 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/4 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/42 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
1.2%
1/83 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
Investigations
Blood creatinine increased
40.0%
2/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
33.3%
4/12 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
7.7%
1/13 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/2 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/4 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
26.2%
11/42 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
21.7%
18/83 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
Investigations
Blood glucose increased
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/12 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/13 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/2 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/4 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
20.0%
1/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/42 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
1.2%
1/83 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
Investigations
Blood lactate dehydrogenase increased
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
16.7%
2/12 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
23.1%
3/13 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/2 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/4 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
20.0%
1/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
11.9%
5/42 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
13.3%
11/83 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
Investigations
Blood magnesium increased
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/12 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/13 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/2 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/4 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
7.1%
3/42 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
3.6%
3/83 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
Investigations
Blood pressure increased
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
8.3%
1/12 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/13 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/2 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/4 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/42 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
1.2%
1/83 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
Investigations
Blood uric acid increased
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
8.3%
1/12 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/13 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/2 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/4 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
7.1%
3/42 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
4.8%
4/83 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
Investigations
C-reactive protein increased
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/12 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/13 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/2 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
25.0%
1/4 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
20.0%
1/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
9.5%
4/42 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
7.2%
6/83 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
Investigations
Electrocardiogram QT prolonged
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
16.7%
2/12 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/13 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/2 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/4 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
2.4%
1/42 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
3.6%
3/83 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
Investigations
Gamma-glutamyltransferase increased
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
25.0%
3/12 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
23.1%
3/13 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
50.0%
1/2 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
50.0%
2/4 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
60.0%
3/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
33.3%
14/42 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
31.3%
26/83 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
Investigations
Haemoglobin decreased
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
8.3%
1/12 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/13 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/2 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/4 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
4.8%
2/42 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
3.6%
3/83 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
Investigations
Lipase increased
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/12 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
15.4%
2/13 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/2 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/4 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
20.0%
1/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
14.3%
6/42 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
10.8%
9/83 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
Investigations
Lymphocyte count decreased
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
8.3%
1/12 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
7.7%
1/13 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/2 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/4 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
4.8%
2/42 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
4.8%
4/83 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
Investigations
Neutrophil count decreased
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
8.3%
1/12 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
7.7%
1/13 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/2 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
25.0%
1/4 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
4.8%
2/42 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
6.0%
5/83 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
Investigations
Platelet count decreased
20.0%
1/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/12 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
7.7%
1/13 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/2 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/4 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
2.4%
1/42 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
3.6%
3/83 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
Investigations
Prothrombin time prolonged
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/12 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
7.7%
1/13 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/2 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/4 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/42 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
1.2%
1/83 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
Investigations
Prothrombin time shortened
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/12 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
7.7%
1/13 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/2 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/4 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/42 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
1.2%
1/83 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
Investigations
Troponin increased
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
8.3%
1/12 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
7.7%
1/13 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/2 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/4 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/42 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
2.4%
2/83 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
Investigations
Tumour marker increased
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/12 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
7.7%
1/13 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/2 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/4 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/42 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
1.2%
1/83 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
Investigations
Weight decreased
20.0%
1/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
16.7%
2/12 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
23.1%
3/13 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
50.0%
1/2 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/4 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
14.3%
6/42 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
15.7%
13/83 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
Investigations
White blood cell count decreased
20.0%
1/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
8.3%
1/12 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/13 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
50.0%
1/2 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/4 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
2.4%
1/42 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
4.8%
4/83 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
Investigations
White blood cell count increased
20.0%
1/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/12 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/13 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/2 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/4 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/42 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
1.2%
1/83 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
Metabolism and nutrition disorders
Decreased appetite
60.0%
3/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
33.3%
4/12 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/13 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
100.0%
2/2 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
25.0%
1/4 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
38.1%
16/42 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
31.3%
26/83 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
Metabolism and nutrition disorders
Dehydration
20.0%
1/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/12 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/13 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/2 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/4 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/42 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
1.2%
1/83 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
Metabolism and nutrition disorders
Electrolyte imbalance
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/12 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
7.7%
1/13 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/2 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/4 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/42 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
1.2%
1/83 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
Metabolism and nutrition disorders
Fluid retention
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/12 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/13 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
50.0%
1/2 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/4 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/42 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
1.2%
1/83 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
Metabolism and nutrition disorders
Hypoalbuminaemia
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/12 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/13 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/2 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
25.0%
1/4 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
9.5%
4/42 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
6.0%
5/83 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
Metabolism and nutrition disorders
Hypocalcaemia
20.0%
1/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
8.3%
1/12 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
7.7%
1/13 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/2 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/4 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
2.4%
1/42 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
4.8%
4/83 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
Metabolism and nutrition disorders
Hypokalaemia
60.0%
3/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
8.3%
1/12 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/13 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/2 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/4 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
20.0%
1/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
16.7%
7/42 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
14.5%
12/83 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
Metabolism and nutrition disorders
Hypomagnesaemia
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
8.3%
1/12 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/13 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
50.0%
1/2 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/4 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
7.1%
3/42 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
6.0%
5/83 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
Metabolism and nutrition disorders
Hyponatraemia
40.0%
2/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
8.3%
1/12 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
7.7%
1/13 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/2 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/4 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
7.1%
3/42 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
8.4%
7/83 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
Metabolism and nutrition disorders
Hypophosphataemia
40.0%
2/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
16.7%
2/12 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
7.7%
1/13 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/2 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
25.0%
1/4 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
4.8%
2/42 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
9.6%
8/83 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
Metabolism and nutrition disorders
Obesity
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
8.3%
1/12 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/13 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/2 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/4 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/42 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
1.2%
1/83 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
Musculoskeletal and connective tissue disorders
Arthralgia
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
8.3%
1/12 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
7.7%
1/13 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/2 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
25.0%
1/4 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
2.4%
1/42 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
4.8%
4/83 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
Musculoskeletal and connective tissue disorders
Back pain
20.0%
1/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
8.3%
1/12 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/13 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/2 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/4 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
9.5%
4/42 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
7.2%
6/83 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
Musculoskeletal and connective tissue disorders
Bone pain
20.0%
1/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
16.7%
2/12 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/13 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/2 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
25.0%
1/4 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
4.8%
2/42 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
7.2%
6/83 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
Musculoskeletal and connective tissue disorders
Groin pain
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
8.3%
1/12 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
7.7%
1/13 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/2 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/4 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
2.4%
1/42 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
3.6%
3/83 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
Musculoskeletal and connective tissue disorders
Joint range of motion decreased
20.0%
1/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/12 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/13 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/2 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/4 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/42 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
1.2%
1/83 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
Musculoskeletal and connective tissue disorders
Muscle spasms
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/12 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/13 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
50.0%
1/2 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/4 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
2.4%
1/42 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
2.4%
2/83 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/12 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
7.7%
1/13 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/2 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/4 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/42 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
1.2%
1/83 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
Musculoskeletal and connective tissue disorders
Muscular weakness
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/12 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/13 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/2 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
25.0%
1/4 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/42 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
1.2%
1/83 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
8.3%
1/12 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/13 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/2 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/4 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
4.8%
2/42 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
3.6%
3/83 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
16.7%
2/12 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
7.7%
1/13 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/2 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/4 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
4.8%
2/42 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
6.0%
5/83 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
Musculoskeletal and connective tissue disorders
Neck pain
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
8.3%
1/12 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/13 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/2 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/4 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
4.8%
2/42 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
3.6%
3/83 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
Musculoskeletal and connective tissue disorders
Pain in extremity
20.0%
1/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
41.7%
5/12 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/13 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/2 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
25.0%
1/4 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
20.0%
1/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
11.9%
5/42 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
15.7%
13/83 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
Musculoskeletal and connective tissue disorders
Torticollis
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
8.3%
1/12 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/13 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/2 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/4 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/42 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
1.2%
1/83 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin papilloma
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/12 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
7.7%
1/13 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/2 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/4 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/42 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
1.2%
1/83 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
Nervous system disorders
Dizziness
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
16.7%
2/12 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
7.7%
1/13 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/2 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/4 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
4.8%
2/42 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
6.0%
5/83 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
Nervous system disorders
Dysaesthesia
20.0%
1/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/12 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/13 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/2 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/4 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
2.4%
1/42 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
2.4%
2/83 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
Nervous system disorders
Dysgeusia
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
8.3%
1/12 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/13 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/2 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/4 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/42 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
1.2%
1/83 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
Nervous system disorders
Headache
60.0%
3/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
33.3%
4/12 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
7.7%
1/13 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/2 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
50.0%
2/4 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
20.0%
1/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
19.0%
8/42 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
22.9%
19/83 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
Nervous system disorders
Hypertonia
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/12 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
7.7%
1/13 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/2 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/4 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/42 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
1.2%
1/83 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
Nervous system disorders
Lethargy
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/12 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
7.7%
1/13 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/2 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/4 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/42 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
1.2%
1/83 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
Nervous system disorders
Migraine
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/12 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/13 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/2 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
25.0%
1/4 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/42 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
1.2%
1/83 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
Nervous system disorders
Neuralgia
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
8.3%
1/12 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/13 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/2 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/4 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/42 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
1.2%
1/83 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
Nervous system disorders
Somnolence
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/12 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
7.7%
1/13 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/2 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/4 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/42 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
1.2%
1/83 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
Nervous system disorders
Syncope
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
8.3%
1/12 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/13 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/2 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/4 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/42 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
1.2%
1/83 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
Nervous system disorders
Tremor
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
8.3%
1/12 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/13 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
50.0%
1/2 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/4 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
2.4%
1/42 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
3.6%
3/83 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
Psychiatric disorders
Anxiety
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/12 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
7.7%
1/13 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
50.0%
1/2 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/4 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
2.4%
1/42 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
3.6%
3/83 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
Psychiatric disorders
Irritability
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/12 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
7.7%
1/13 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/2 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/4 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/42 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
1.2%
1/83 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
Psychiatric disorders
Restlessness
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/12 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
7.7%
1/13 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/2 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/4 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/42 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
1.2%
1/83 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
8.3%
1/12 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/13 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/2 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/4 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
7.1%
3/42 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
4.8%
4/83 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
Psychiatric disorders
Sleep disorder
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/12 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
7.7%
1/13 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/2 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/4 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/42 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
1.2%
1/83 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
Renal and urinary disorders
Dysuria
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
8.3%
1/12 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/13 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/2 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/4 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/42 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
1.2%
1/83 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
Renal and urinary disorders
Micturition urgency
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
8.3%
1/12 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/13 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/2 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/4 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/42 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
1.2%
1/83 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
Renal and urinary disorders
Pollakiuria
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
8.3%
1/12 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/13 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/2 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/4 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/42 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
1.2%
1/83 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
Reproductive system and breast disorders
Dysmenorrhoea
20.0%
1/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/12 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/13 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/2 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/4 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/42 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
1.2%
1/83 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
Respiratory, thoracic and mediastinal disorders
Atelectasis
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/12 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/13 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/2 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
25.0%
1/4 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/42 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
1.2%
1/83 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
Respiratory, thoracic and mediastinal disorders
Cough
20.0%
1/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
8.3%
1/12 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
15.4%
2/13 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
50.0%
1/2 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/4 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
19.0%
8/42 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
15.7%
13/83 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
Respiratory, thoracic and mediastinal disorders
Dyspnoea
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
8.3%
1/12 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/13 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/2 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/4 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
20.0%
1/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
9.5%
4/42 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
7.2%
6/83 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/12 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/13 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/2 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
25.0%
1/4 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/42 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
1.2%
1/83 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
Respiratory, thoracic and mediastinal disorders
Emphysema
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/12 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/13 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/2 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
25.0%
1/4 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/42 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
1.2%
1/83 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
Respiratory, thoracic and mediastinal disorders
Epistaxis
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
8.3%
1/12 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
7.7%
1/13 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/2 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/4 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
4.8%
2/42 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
4.8%
4/83 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
Respiratory, thoracic and mediastinal disorders
Nasal congestion
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
8.3%
1/12 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/13 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
50.0%
1/2 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/4 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
2.4%
1/42 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
3.6%
3/83 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
8.3%
1/12 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
7.7%
1/13 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/2 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/4 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
7.1%
3/42 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
6.0%
5/83 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
Respiratory, thoracic and mediastinal disorders
Pleural effusion
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/12 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
7.7%
1/13 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/2 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/4 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
4.8%
2/42 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
3.6%
3/83 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/12 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/13 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
50.0%
1/2 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/4 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
2.4%
1/42 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
2.4%
2/83 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/12 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/13 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
50.0%
1/2 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/4 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/42 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
1.2%
1/83 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
Skin and subcutaneous tissue disorders
Acne
20.0%
1/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/12 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/13 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
50.0%
1/2 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/4 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
4.8%
2/42 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
4.8%
4/83 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
Skin and subcutaneous tissue disorders
Alopecia
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
8.3%
1/12 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
7.7%
1/13 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/2 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/4 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
2.4%
1/42 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
3.6%
3/83 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
Skin and subcutaneous tissue disorders
Eczema
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/12 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/13 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/2 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/4 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
7.1%
3/42 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
3.6%
3/83 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
Skin and subcutaneous tissue disorders
Erythema
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/12 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/13 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/2 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/4 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
9.5%
4/42 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
4.8%
4/83 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
Skin and subcutaneous tissue disorders
Night sweats
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/12 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/13 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/2 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/4 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
7.1%
3/42 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
3.6%
3/83 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
Skin and subcutaneous tissue disorders
Pain of skin
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/12 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/13 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/2 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
25.0%
1/4 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/42 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
1.2%
1/83 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
Skin and subcutaneous tissue disorders
Pruritus
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
16.7%
2/12 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
15.4%
2/13 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
50.0%
1/2 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/4 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
20.0%
1/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
2.4%
1/42 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
8.4%
7/83 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
Skin and subcutaneous tissue disorders
Rash
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
16.7%
2/12 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/13 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/2 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/4 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
14.3%
6/42 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
9.6%
8/83 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
Skin and subcutaneous tissue disorders
Rash erythematous
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
8.3%
1/12 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/13 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/2 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/4 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/42 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
1.2%
1/83 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
Skin and subcutaneous tissue disorders
Rash maculo-papular
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
25.0%
3/12 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
7.7%
1/13 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/2 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/4 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
2.4%
1/42 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
6.0%
5/83 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
Skin and subcutaneous tissue disorders
Skin exfoliation
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
16.7%
2/12 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/13 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/2 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/4 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/42 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
2.4%
2/83 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/12 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
7.7%
1/13 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/2 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/4 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/42 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
1.2%
1/83 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
Skin and subcutaneous tissue disorders
Skin irritation
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/12 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/13 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
50.0%
1/2 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/4 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/42 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
1.2%
1/83 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
Skin and subcutaneous tissue disorders
Skin lesion
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
8.3%
1/12 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/13 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/2 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/4 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/42 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
1.2%
1/83 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
Skin and subcutaneous tissue disorders
Swelling face
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/12 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/13 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/2 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
25.0%
1/4 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/42 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
1.2%
1/83 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
Skin and subcutaneous tissue disorders
Urticaria
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
8.3%
1/12 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/13 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/2 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
25.0%
1/4 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/42 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
2.4%
2/83 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
Vascular disorders
Embolism
20.0%
1/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/12 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/13 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/2 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/4 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/42 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
1.2%
1/83 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
Vascular disorders
Haematoma
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
8.3%
1/12 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
7.7%
1/13 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/2 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/4 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/42 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
2.4%
2/83 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
Vascular disorders
Hypertension
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/12 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/13 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
50.0%
1/2 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/4 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
2.4%
1/42 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
2.4%
2/83 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
Vascular disorders
Hypotension
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/12 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
7.7%
1/13 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/2 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/4 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/42 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
1.2%
1/83 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
Vascular disorders
Pallor
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/12 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/13 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/2 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/4 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
0.00%
0/5 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
7.1%
3/42 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment
3.6%
3/83 • Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of 63.7 months.
AE is any sign or symptom that occurs during the study treatment plus the 30 days post treatment

Additional Information

Study Director

Study Director

Phone: 862-778-8300

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 pooled data (i.e.,data from all sites) in clinical trial or disclosure of trial results in their entirety.
  • Publication restrictions are in place

Restriction type: OTHER