Trial Outcomes & Findings for A Study to Evaluate the Efficacy and Safety of Pemigatinib (INCB054828) in Subjects With Urothelial Carcinoma - (FIGHT-201) (NCT NCT02872714)
NCT ID: NCT02872714
Last Updated: 2025-08-14
Results Overview
ORR was defined as the percentage of participants with a best overall response of complete response (CR) or partial response (PR) at any post-Baseline visit prior to first progressive disease (PD), per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 (v1.1). CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to \<10 millimeters (mm). PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. Response was based on review of scans by an independent centralized radiological review committee. Response was confirmed.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
263 participants
Primary outcome timeframe
up to 1138 days
Results posted on
2025-08-14
Participant Flow
The study was conducted at a total of 73 study centers in 11 countries (United States, France, Italy, Spain, Israel, Belgium, United Kingdom, Germany, Japan, Denmark, and the Netherlands).
Participant milestones
| Measure |
Cohort A-ID: FGFR3 Mutations or Fusions
Participants with fibroblast growth factor (FGF) receptor 3 (FGFR3) mutations or fusions self-administered oral pemigatinib at a starting dose of 13.5 milligrams (mg) once daily (QD) on an intermittent dose (ID) (2-weeks-on/1-week-off therapy) schedule in 21-day cycles. Participants who did not reach the target serum phosphate level of \> 5.5 mg/deciliter (dL) could have increased the daily dose to 18 mg, provided they had no ongoing Grade 2 or higher treatment-related treatment-emergent adverse events (TEAEs), and they had been compliant with taking the study drug.
|
Cohort B-ID: All Other FGF/FGFR Alterations
Participants with all other FGF/FGFR alterations self-administered oral pemigatinib at a starting dose of 13.5 mg QD on an ID (2-weeks-on/1-week-off therapy) schedule in 21-day cycles. Participants who did not reach the target serum phosphate level of \> 5.5 mg/dL could have increased the daily dose to 18 mg, provided they had no ongoing Grade 2 or higher treatment-related TEAEs, and they had been compliant with taking the study drug.
|
Other-ID
Participants with no FGF/FGFR alterations or with an undetermined FGF/FGFR status self-administered oral pemigatinib at a starting dose of 13.5 mg QD on an ID (2-weeks-on/1-week-off therapy) schedule in 21-day cycles. Participants who did not reach the target serum phosphate level of \> 5.5 mg/dL could have increased the daily dose to 18 mg, provided they had no ongoing Grade 2 or higher treatment-related TEAEs, and they had been compliant with taking the study drug.
|
Cohort A-CD: FGFR3 Mutations or Fusions
Participants with FGFR3 mutations or fusions self-administered oral pemigatinib at a starting dose of 13.5 mg QD on a continuous dose (CD) (no planned dose hold) schedule in 21-day cycles. Participants who did not reach the target serum phosphate level of \> 5.5 mg/dL could have increased the daily dose to 18 mg, provided they had no ongoing Grade 2 or higher treatment-related TEAEs, and they had been compliant with taking the study drug.
|
Other-CD
Participants with no FGF/FGFR alterations or with an undetermined FGF/FGFR status self-administered oral pemigatinib at a starting dose of 13.5 mg QD on a continuous dose (CD) (no planned dose hold) schedule in 21-day cycles. Participants who did not reach the target serum phosphate level of \> 5.5 mg/dL could have increased the daily dose to 18 mg, provided they had no ongoing Grade 2 or higher treatment-related TEAEs, and they had been compliant with taking the study drug.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
103
|
44
|
9
|
101
|
3
|
|
Overall Study
COMPLETED
|
10
|
2
|
1
|
13
|
1
|
|
Overall Study
NOT COMPLETED
|
93
|
42
|
8
|
88
|
2
|
Reasons for withdrawal
| Measure |
Cohort A-ID: FGFR3 Mutations or Fusions
Participants with fibroblast growth factor (FGF) receptor 3 (FGFR3) mutations or fusions self-administered oral pemigatinib at a starting dose of 13.5 milligrams (mg) once daily (QD) on an intermittent dose (ID) (2-weeks-on/1-week-off therapy) schedule in 21-day cycles. Participants who did not reach the target serum phosphate level of \> 5.5 mg/deciliter (dL) could have increased the daily dose to 18 mg, provided they had no ongoing Grade 2 or higher treatment-related treatment-emergent adverse events (TEAEs), and they had been compliant with taking the study drug.
|
Cohort B-ID: All Other FGF/FGFR Alterations
Participants with all other FGF/FGFR alterations self-administered oral pemigatinib at a starting dose of 13.5 mg QD on an ID (2-weeks-on/1-week-off therapy) schedule in 21-day cycles. Participants who did not reach the target serum phosphate level of \> 5.5 mg/dL could have increased the daily dose to 18 mg, provided they had no ongoing Grade 2 or higher treatment-related TEAEs, and they had been compliant with taking the study drug.
|
Other-ID
Participants with no FGF/FGFR alterations or with an undetermined FGF/FGFR status self-administered oral pemigatinib at a starting dose of 13.5 mg QD on an ID (2-weeks-on/1-week-off therapy) schedule in 21-day cycles. Participants who did not reach the target serum phosphate level of \> 5.5 mg/dL could have increased the daily dose to 18 mg, provided they had no ongoing Grade 2 or higher treatment-related TEAEs, and they had been compliant with taking the study drug.
|
Cohort A-CD: FGFR3 Mutations or Fusions
Participants with FGFR3 mutations or fusions self-administered oral pemigatinib at a starting dose of 13.5 mg QD on a continuous dose (CD) (no planned dose hold) schedule in 21-day cycles. Participants who did not reach the target serum phosphate level of \> 5.5 mg/dL could have increased the daily dose to 18 mg, provided they had no ongoing Grade 2 or higher treatment-related TEAEs, and they had been compliant with taking the study drug.
|
Other-CD
Participants with no FGF/FGFR alterations or with an undetermined FGF/FGFR status self-administered oral pemigatinib at a starting dose of 13.5 mg QD on a continuous dose (CD) (no planned dose hold) schedule in 21-day cycles. Participants who did not reach the target serum phosphate level of \> 5.5 mg/dL could have increased the daily dose to 18 mg, provided they had no ongoing Grade 2 or higher treatment-related TEAEs, and they had been compliant with taking the study drug.
|
|---|---|---|---|---|---|
|
Overall Study
Progressive Disease
|
1
|
2
|
0
|
0
|
0
|
|
Overall Study
Death
|
87
|
36
|
8
|
81
|
2
|
|
Overall Study
Lost to Follow-up
|
2
|
1
|
0
|
3
|
0
|
|
Overall Study
Physician Decision
|
0
|
0
|
0
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
3
|
0
|
2
|
0
|
|
Overall Study
Captured as Other
|
2
|
0
|
0
|
1
|
0
|
Baseline Characteristics
A Study to Evaluate the Efficacy and Safety of Pemigatinib (INCB054828) in Subjects With Urothelial Carcinoma - (FIGHT-201)
Baseline characteristics by cohort
| Measure |
Cohort A-ID: FGFR3 Mutations or Fusions
n=103 Participants
Participants with fibroblast growth factor (FGF) receptor 3 (FGFR3) mutations or fusions self-administered oral pemigatinib at a starting dose of 13.5 milligrams (mg) once daily (QD) on an intermittent dose (ID) (2-weeks-on/1-week-off therapy) schedule in 21-day cycles. Participants who did not reach the target serum phosphate level of \> 5.5 mg/deciliter (dL) could have increased the daily dose to 18 mg, provided they had no ongoing Grade 2 or higher treatment-related treatment-emergent adverse events (TEAEs), and they had been compliant with taking the study drug.
|
Cohort B-ID: All Other FGF/FGFR Alterations
n=44 Participants
Participants with all other FGF/FGFR alterations self-administered oral pemigatinib at a starting dose of 13.5 mg QD on an ID (2-weeks-on/1-week-off therapy) schedule in 21-day cycles. Participants who did not reach the target serum phosphate level of \> 5.5 mg/dL could have increased the daily dose to 18 mg, provided they had no ongoing Grade 2 or higher treatment-related TEAEs, and they had been compliant with taking the study drug.
|
Other-ID
n=9 Participants
Participants with no FGF/FGFR alterations or with an undetermined FGF/FGFR status self-administered oral pemigatinib at a starting dose of 13.5 mg QD on an ID (2-weeks-on/1-week-off therapy) schedule in 21-day cycles. Participants who did not reach the target serum phosphate level of \> 5.5 mg/dL could have increased the daily dose to 18 mg, provided they had no ongoing Grade 2 or higher treatment-related TEAEs, and they had been compliant with taking the study drug.
|
Cohort A-CD: FGFR3 Mutations or Fusions
n=101 Participants
Participants with FGFR3 mutations or fusions self-administered oral pemigatinib at a starting dose of 13.5 mg QD on a continuous dose (CD) (no planned dose hold) schedule in 21-day cycles. Participants who did not reach the target serum phosphate level of \> 5.5 mg/dL could have increased the daily dose to 18 mg, provided they had no ongoing Grade 2 or higher treatment-related TEAEs, and they had been compliant with taking the study drug.
|
Other-CD
n=3 Participants
Participants with no FGF/FGFR alterations or with an undetermined FGF/FGFR status self-administered oral pemigatinib at a starting dose of 13.5 mg QD on a continuous dose (CD) (no planned dose hold) schedule in 21-day cycles. Participants who did not reach the target serum phosphate level of \> 5.5 mg/dL could have increased the daily dose to 18 mg, provided they had no ongoing Grade 2 or higher treatment-related TEAEs, and they had been compliant with taking the study drug.
|
Total
n=260 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
67.6 years
STANDARD_DEVIATION 9.09 • n=5 Participants
|
65.1 years
STANDARD_DEVIATION 10.83 • n=7 Participants
|
69.3 years
STANDARD_DEVIATION 7.98 • n=5 Participants
|
68.5 years
STANDARD_DEVIATION 9.39 • n=4 Participants
|
60.3 years
STANDARD_DEVIATION 9.02 • n=21 Participants
|
67.5 years
STANDARD_DEVIATION 9.53 • n=10 Participants
|
|
Sex: Female, Male
Female
|
29 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
23 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
68 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
74 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
78 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
192 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
White
|
64 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
63 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
164 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
Black or African-American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
Asian
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
17 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
Turkish
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
Persian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
Unknown or Not Reported
|
30 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
22 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
66 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
Missing
|
5 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
7 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
3 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
64 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
66 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
171 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
Not Reported
|
23 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
22 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
59 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
5 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
9 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
Captured as Other
|
5 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
11 Participants
n=10 Participants
|
PRIMARY outcome
Timeframe: up to 1138 daysPopulation: Efficacy Evaluable Population: all participants enrolled in the study who had a known FGF/FGFR alteration confirmed by the sponsor's central laboratory and who had received at least 1 dose of study drug. The confidence interval was calculated based on the exact method for binomial distribution.
ORR was defined as the percentage of participants with a best overall response of complete response (CR) or partial response (PR) at any post-Baseline visit prior to first progressive disease (PD), per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 (v1.1). CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to \<10 millimeters (mm). PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. Response was based on review of scans by an independent centralized radiological review committee. Response was confirmed.
Outcome measures
| Measure |
Other-CD
Participants with no FGF/FGFR alterations or with an undetermined FGF/FGFR status self-administered oral pemigatinib at a starting dose of 13.5 mg QD on a continuous dose (CD) (no planned dose hold) schedule in 21-day cycles. Participants who did not reach the target serum phosphate level of \> 5.5 mg/dL could have increased the daily dose to 18 mg, provided they had no ongoing Grade 2 or higher treatment-related TEAEs, and they had been compliant with taking the study drug.
|
Cohort A-ID: FGFR3 Mutations or Fusions
Participants with fibroblast growth factor (FGF) receptor 3 (FGFR3) mutations or fusions self-administered oral pemigatinib at a starting dose of 13.5 milligrams (mg) once daily (QD) on an intermittent dose (ID) (2-weeks-on/1-week-off therapy) schedule in 21-day cycles. Participants who did not reach the target serum phosphate level of \> 5.5 mg/deciliter (dL) could have increased the daily dose to 18 mg, provided they had no ongoing Grade 2 or higher treatment-related treatment-emergent adverse events (TEAEs), and they had been compliant with taking the study drug.
|
Cohort B-ID: All Other FGF/FGFR Alterations
Participants with all other FGF/FGFR alterations self-administered oral pemigatinib at a starting dose of 13.5 mg QD on an ID (2-weeks-on/1-week-off therapy) schedule in 21-day cycles. Participants who did not reach the target serum phosphate level of \> 5.5 mg/dL could have increased the daily dose to 18 mg, provided they had no ongoing Grade 2 or higher treatment-related TEAEs, and they had been compliant with taking the study drug.
|
Other-ID
Participants with no FGF/FGFR alterations or with an undetermined FGF/FGFR status self-administered oral pemigatinib at a starting dose of 13.5 mg QD on an ID (2-weeks-on/1-week-off therapy) schedule in 21-day cycles. Participants who did not reach the target serum phosphate level of \> 5.5 mg/dL could have increased the daily dose to 18 mg, provided they had no ongoing Grade 2 or higher treatment-related TEAEs, and they had been compliant with taking the study drug.
|
Cohort A-CD: FGFR3 Mutations or Fusions
n=101 Participants
Participants with FGFR3 mutations or fusions self-administered oral pemigatinib at a starting dose of 13.5 mg QD on a continuous dose (CD) (no planned dose hold) schedule in 21-day cycles. Participants who did not reach the target serum phosphate level of \> 5.5 mg/dL could have increased the daily dose to 18 mg, provided they had no ongoing Grade 2 or higher treatment-related TEAEs, and they had been compliant with taking the study drug.
|
Cohort A-ID + Cohort B-ID
Participants with FGFR3 mutations or fusions (Cohort A) or with all other FGF/FGFR alterations (Cohort B) self-administered oral pemigatinib at a starting dose of 13.5 mg QD on an ID (2-weeks-on/1-week-off therapy) schedule in 21-day cycles. Participants who did not reach the target serum phosphate level of \> 5.5 mg/dL could have increased the daily dose to 18 mg, provided they had no ongoing Grade 2 or higher treatment-related TEAEs, and they had been compliant with taking the study drug.
|
Cohort A-ID + Cohort A-CD
Participants with FGFR3 mutations or fusions self-administered oral pemigatinib at a starting dose of 13.5 mg QD on an ID (2-weeks-on/1-week-off therapy) schedule (Cohort A-ID) or on a CD (no planned dose hold) schedule (Cohort A-CD) in 21-day cycles. Participants who did not reach the target serum phosphate level of \> 5.5 mg/dL could have increased the daily dose to 18 mg, provided they had no ongoing Grade 2 or higher treatment-related TEAEs, and they had been compliant with taking the study drug.
|
Cohort A-ID + Cohort B-ID + Cohort A-CD
Participants with FGFR3 mutations or fusions (Cohort A) or with all other FGF/FGFR alterations (Cohort B) self-administered oral pemigatinib at a starting dose of 13.5 mg QD on an ID (2-weeks-on/1-week-off therapy) schedule (Cohort A-ID and Cohort B-ID) in 21-day cycles or on a CD (no planned dose hold) schedule (Cohort A-CD). Participants who did not reach the target serum phosphate level of \> 5.5 mg/dL could have increased the daily dose to 18 mg, provided they had no ongoing Grade 2 or higher treatment-related TEAEs, and they had been compliant with taking the study drug.
|
|---|---|---|---|---|---|---|---|---|
|
Objective Response Rate (ORR) in Participants With FGFR3 Mutations or Fusions on a CD Regimen
|
—
|
—
|
—
|
—
|
17.8 percentage of participants
Interval 10.92 to 26.7
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: up to 817 daysPopulation: Efficacy Evaluable Population. The confidence interval was calculated based on the exact method for binomial distribution.
ORR was defined as the percentage of participants with a best overall response of CR or PR at any post-Baseline visit prior to first PD, per RECIST v1.1. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to \<10 millimeters (mm). PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. Response was based on review of scans by an independent centralized radiological review committee. Response was confirmed.
Outcome measures
| Measure |
Other-CD
Participants with no FGF/FGFR alterations or with an undetermined FGF/FGFR status self-administered oral pemigatinib at a starting dose of 13.5 mg QD on a continuous dose (CD) (no planned dose hold) schedule in 21-day cycles. Participants who did not reach the target serum phosphate level of \> 5.5 mg/dL could have increased the daily dose to 18 mg, provided they had no ongoing Grade 2 or higher treatment-related TEAEs, and they had been compliant with taking the study drug.
|
Cohort A-ID: FGFR3 Mutations or Fusions
n=103 Participants
Participants with fibroblast growth factor (FGF) receptor 3 (FGFR3) mutations or fusions self-administered oral pemigatinib at a starting dose of 13.5 milligrams (mg) once daily (QD) on an intermittent dose (ID) (2-weeks-on/1-week-off therapy) schedule in 21-day cycles. Participants who did not reach the target serum phosphate level of \> 5.5 mg/deciliter (dL) could have increased the daily dose to 18 mg, provided they had no ongoing Grade 2 or higher treatment-related treatment-emergent adverse events (TEAEs), and they had been compliant with taking the study drug.
|
Cohort B-ID: All Other FGF/FGFR Alterations
Participants with all other FGF/FGFR alterations self-administered oral pemigatinib at a starting dose of 13.5 mg QD on an ID (2-weeks-on/1-week-off therapy) schedule in 21-day cycles. Participants who did not reach the target serum phosphate level of \> 5.5 mg/dL could have increased the daily dose to 18 mg, provided they had no ongoing Grade 2 or higher treatment-related TEAEs, and they had been compliant with taking the study drug.
|
Other-ID
Participants with no FGF/FGFR alterations or with an undetermined FGF/FGFR status self-administered oral pemigatinib at a starting dose of 13.5 mg QD on an ID (2-weeks-on/1-week-off therapy) schedule in 21-day cycles. Participants who did not reach the target serum phosphate level of \> 5.5 mg/dL could have increased the daily dose to 18 mg, provided they had no ongoing Grade 2 or higher treatment-related TEAEs, and they had been compliant with taking the study drug.
|
Cohort A-CD: FGFR3 Mutations or Fusions
Participants with FGFR3 mutations or fusions self-administered oral pemigatinib at a starting dose of 13.5 mg QD on a continuous dose (CD) (no planned dose hold) schedule in 21-day cycles. Participants who did not reach the target serum phosphate level of \> 5.5 mg/dL could have increased the daily dose to 18 mg, provided they had no ongoing Grade 2 or higher treatment-related TEAEs, and they had been compliant with taking the study drug.
|
Cohort A-ID + Cohort B-ID
Participants with FGFR3 mutations or fusions (Cohort A) or with all other FGF/FGFR alterations (Cohort B) self-administered oral pemigatinib at a starting dose of 13.5 mg QD on an ID (2-weeks-on/1-week-off therapy) schedule in 21-day cycles. Participants who did not reach the target serum phosphate level of \> 5.5 mg/dL could have increased the daily dose to 18 mg, provided they had no ongoing Grade 2 or higher treatment-related TEAEs, and they had been compliant with taking the study drug.
|
Cohort A-ID + Cohort A-CD
Participants with FGFR3 mutations or fusions self-administered oral pemigatinib at a starting dose of 13.5 mg QD on an ID (2-weeks-on/1-week-off therapy) schedule (Cohort A-ID) or on a CD (no planned dose hold) schedule (Cohort A-CD) in 21-day cycles. Participants who did not reach the target serum phosphate level of \> 5.5 mg/dL could have increased the daily dose to 18 mg, provided they had no ongoing Grade 2 or higher treatment-related TEAEs, and they had been compliant with taking the study drug.
|
Cohort A-ID + Cohort B-ID + Cohort A-CD
Participants with FGFR3 mutations or fusions (Cohort A) or with all other FGF/FGFR alterations (Cohort B) self-administered oral pemigatinib at a starting dose of 13.5 mg QD on an ID (2-weeks-on/1-week-off therapy) schedule (Cohort A-ID and Cohort B-ID) in 21-day cycles or on a CD (no planned dose hold) schedule (Cohort A-CD). Participants who did not reach the target serum phosphate level of \> 5.5 mg/dL could have increased the daily dose to 18 mg, provided they had no ongoing Grade 2 or higher treatment-related TEAEs, and they had been compliant with taking the study drug.
|
|---|---|---|---|---|---|---|---|---|
|
ORR in Participants With FGFR3 Mutations or Fusions on an ID Regimen
|
—
|
23.3 percentage of participants
Interval 15.54 to 32.66
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: up to 1198 daysPopulation: Efficacy Evaluable Population. The confidence interval was calculated based on the exact method for binomial distribution.
ORR was defined as the percentage of participants with a best overall response of CR or PR at any post-Baseline visit prior to first PD, per RECIST v1.1. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to \<10 millimeters (mm). PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. Response was based on review of scans by an independent centralized radiological review committee. Response was confirmed.
Outcome measures
| Measure |
Other-CD
Participants with no FGF/FGFR alterations or with an undetermined FGF/FGFR status self-administered oral pemigatinib at a starting dose of 13.5 mg QD on a continuous dose (CD) (no planned dose hold) schedule in 21-day cycles. Participants who did not reach the target serum phosphate level of \> 5.5 mg/dL could have increased the daily dose to 18 mg, provided they had no ongoing Grade 2 or higher treatment-related TEAEs, and they had been compliant with taking the study drug.
|
Cohort A-ID: FGFR3 Mutations or Fusions
Participants with fibroblast growth factor (FGF) receptor 3 (FGFR3) mutations or fusions self-administered oral pemigatinib at a starting dose of 13.5 milligrams (mg) once daily (QD) on an intermittent dose (ID) (2-weeks-on/1-week-off therapy) schedule in 21-day cycles. Participants who did not reach the target serum phosphate level of \> 5.5 mg/deciliter (dL) could have increased the daily dose to 18 mg, provided they had no ongoing Grade 2 or higher treatment-related treatment-emergent adverse events (TEAEs), and they had been compliant with taking the study drug.
|
Cohort B-ID: All Other FGF/FGFR Alterations
n=44 Participants
Participants with all other FGF/FGFR alterations self-administered oral pemigatinib at a starting dose of 13.5 mg QD on an ID (2-weeks-on/1-week-off therapy) schedule in 21-day cycles. Participants who did not reach the target serum phosphate level of \> 5.5 mg/dL could have increased the daily dose to 18 mg, provided they had no ongoing Grade 2 or higher treatment-related TEAEs, and they had been compliant with taking the study drug.
|
Other-ID
Participants with no FGF/FGFR alterations or with an undetermined FGF/FGFR status self-administered oral pemigatinib at a starting dose of 13.5 mg QD on an ID (2-weeks-on/1-week-off therapy) schedule in 21-day cycles. Participants who did not reach the target serum phosphate level of \> 5.5 mg/dL could have increased the daily dose to 18 mg, provided they had no ongoing Grade 2 or higher treatment-related TEAEs, and they had been compliant with taking the study drug.
|
Cohort A-CD: FGFR3 Mutations or Fusions
Participants with FGFR3 mutations or fusions self-administered oral pemigatinib at a starting dose of 13.5 mg QD on a continuous dose (CD) (no planned dose hold) schedule in 21-day cycles. Participants who did not reach the target serum phosphate level of \> 5.5 mg/dL could have increased the daily dose to 18 mg, provided they had no ongoing Grade 2 or higher treatment-related TEAEs, and they had been compliant with taking the study drug.
|
Cohort A-ID + Cohort B-ID
Participants with FGFR3 mutations or fusions (Cohort A) or with all other FGF/FGFR alterations (Cohort B) self-administered oral pemigatinib at a starting dose of 13.5 mg QD on an ID (2-weeks-on/1-week-off therapy) schedule in 21-day cycles. Participants who did not reach the target serum phosphate level of \> 5.5 mg/dL could have increased the daily dose to 18 mg, provided they had no ongoing Grade 2 or higher treatment-related TEAEs, and they had been compliant with taking the study drug.
|
Cohort A-ID + Cohort A-CD
Participants with FGFR3 mutations or fusions self-administered oral pemigatinib at a starting dose of 13.5 mg QD on an ID (2-weeks-on/1-week-off therapy) schedule (Cohort A-ID) or on a CD (no planned dose hold) schedule (Cohort A-CD) in 21-day cycles. Participants who did not reach the target serum phosphate level of \> 5.5 mg/dL could have increased the daily dose to 18 mg, provided they had no ongoing Grade 2 or higher treatment-related TEAEs, and they had been compliant with taking the study drug.
|
Cohort A-ID + Cohort B-ID + Cohort A-CD
Participants with FGFR3 mutations or fusions (Cohort A) or with all other FGF/FGFR alterations (Cohort B) self-administered oral pemigatinib at a starting dose of 13.5 mg QD on an ID (2-weeks-on/1-week-off therapy) schedule (Cohort A-ID and Cohort B-ID) in 21-day cycles or on a CD (no planned dose hold) schedule (Cohort A-CD). Participants who did not reach the target serum phosphate level of \> 5.5 mg/dL could have increased the daily dose to 18 mg, provided they had no ongoing Grade 2 or higher treatment-related TEAEs, and they had been compliant with taking the study drug.
|
|---|---|---|---|---|---|---|---|---|
|
ORR in Participants With All Other FGF/FGFR Alterations
|
—
|
—
|
6.8 percentage of participants
Interval 1.43 to 18.66
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: up to 1198 daysPopulation: Efficacy Evaluable Population. The confidence interval was calculated based on the exact method for binomial distribution.
ORR was defined as the percentage of participants with a best overall response of CR or PR at any post-Baseline visit prior to first PD, per RECIST v1.1. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to \<10 millimeters (mm). PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. Response was based on review of scans by an independent centralized radiological review committee. Response was confirmed.
Outcome measures
| Measure |
Other-CD
Participants with no FGF/FGFR alterations or with an undetermined FGF/FGFR status self-administered oral pemigatinib at a starting dose of 13.5 mg QD on a continuous dose (CD) (no planned dose hold) schedule in 21-day cycles. Participants who did not reach the target serum phosphate level of \> 5.5 mg/dL could have increased the daily dose to 18 mg, provided they had no ongoing Grade 2 or higher treatment-related TEAEs, and they had been compliant with taking the study drug.
|
Cohort A-ID: FGFR3 Mutations or Fusions
Participants with fibroblast growth factor (FGF) receptor 3 (FGFR3) mutations or fusions self-administered oral pemigatinib at a starting dose of 13.5 milligrams (mg) once daily (QD) on an intermittent dose (ID) (2-weeks-on/1-week-off therapy) schedule in 21-day cycles. Participants who did not reach the target serum phosphate level of \> 5.5 mg/deciliter (dL) could have increased the daily dose to 18 mg, provided they had no ongoing Grade 2 or higher treatment-related treatment-emergent adverse events (TEAEs), and they had been compliant with taking the study drug.
|
Cohort B-ID: All Other FGF/FGFR Alterations
Participants with all other FGF/FGFR alterations self-administered oral pemigatinib at a starting dose of 13.5 mg QD on an ID (2-weeks-on/1-week-off therapy) schedule in 21-day cycles. Participants who did not reach the target serum phosphate level of \> 5.5 mg/dL could have increased the daily dose to 18 mg, provided they had no ongoing Grade 2 or higher treatment-related TEAEs, and they had been compliant with taking the study drug.
|
Other-ID
Participants with no FGF/FGFR alterations or with an undetermined FGF/FGFR status self-administered oral pemigatinib at a starting dose of 13.5 mg QD on an ID (2-weeks-on/1-week-off therapy) schedule in 21-day cycles. Participants who did not reach the target serum phosphate level of \> 5.5 mg/dL could have increased the daily dose to 18 mg, provided they had no ongoing Grade 2 or higher treatment-related TEAEs, and they had been compliant with taking the study drug.
|
Cohort A-CD: FGFR3 Mutations or Fusions
Participants with FGFR3 mutations or fusions self-administered oral pemigatinib at a starting dose of 13.5 mg QD on a continuous dose (CD) (no planned dose hold) schedule in 21-day cycles. Participants who did not reach the target serum phosphate level of \> 5.5 mg/dL could have increased the daily dose to 18 mg, provided they had no ongoing Grade 2 or higher treatment-related TEAEs, and they had been compliant with taking the study drug.
|
Cohort A-ID + Cohort B-ID
n=147 Participants
Participants with FGFR3 mutations or fusions (Cohort A) or with all other FGF/FGFR alterations (Cohort B) self-administered oral pemigatinib at a starting dose of 13.5 mg QD on an ID (2-weeks-on/1-week-off therapy) schedule in 21-day cycles. Participants who did not reach the target serum phosphate level of \> 5.5 mg/dL could have increased the daily dose to 18 mg, provided they had no ongoing Grade 2 or higher treatment-related TEAEs, and they had been compliant with taking the study drug.
|
Cohort A-ID + Cohort A-CD
n=204 Participants
Participants with FGFR3 mutations or fusions self-administered oral pemigatinib at a starting dose of 13.5 mg QD on an ID (2-weeks-on/1-week-off therapy) schedule (Cohort A-ID) or on a CD (no planned dose hold) schedule (Cohort A-CD) in 21-day cycles. Participants who did not reach the target serum phosphate level of \> 5.5 mg/dL could have increased the daily dose to 18 mg, provided they had no ongoing Grade 2 or higher treatment-related TEAEs, and they had been compliant with taking the study drug.
|
Cohort A-ID + Cohort B-ID + Cohort A-CD
n=248 Participants
Participants with FGFR3 mutations or fusions (Cohort A) or with all other FGF/FGFR alterations (Cohort B) self-administered oral pemigatinib at a starting dose of 13.5 mg QD on an ID (2-weeks-on/1-week-off therapy) schedule (Cohort A-ID and Cohort B-ID) in 21-day cycles or on a CD (no planned dose hold) schedule (Cohort A-CD). Participants who did not reach the target serum phosphate level of \> 5.5 mg/dL could have increased the daily dose to 18 mg, provided they had no ongoing Grade 2 or higher treatment-related TEAEs, and they had been compliant with taking the study drug.
|
|---|---|---|---|---|---|---|---|---|
|
ORR in All Participants on an ID or CD Regimen in Combined Cohorts
|
—
|
—
|
—
|
—
|
—
|
18.4 percentage of participants
Interval 12.47 to 25.59
|
20.6 percentage of participants
Interval 15.26 to 26.79
|
18.1 percentage of participants
Interval 13.55 to 23.52
|
SECONDARY outcome
Timeframe: up to approximately 25 weeksPopulation: Safety Population: all participants enrolled in the study who had received at least 1 dose of study drug
An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related, that occurred after a participant provided informed consent. Abnormal laboratory values or test results occurring after informed consent constituted AEs only if they induced clinical signs or symptoms, were considered clinically meaningful, required therapy (e.g., hematologic abnormality that required transfusion), or required changes in the study drug(s). A TEAE was any AE either reported for the first time or the worsening of a pre-existing event after the first dose of study drug and within 30 days of the last dose of study drug.
Outcome measures
| Measure |
Other-CD
n=3 Participants
Participants with no FGF/FGFR alterations or with an undetermined FGF/FGFR status self-administered oral pemigatinib at a starting dose of 13.5 mg QD on a continuous dose (CD) (no planned dose hold) schedule in 21-day cycles. Participants who did not reach the target serum phosphate level of \> 5.5 mg/dL could have increased the daily dose to 18 mg, provided they had no ongoing Grade 2 or higher treatment-related TEAEs, and they had been compliant with taking the study drug.
|
Cohort A-ID: FGFR3 Mutations or Fusions
n=103 Participants
Participants with fibroblast growth factor (FGF) receptor 3 (FGFR3) mutations or fusions self-administered oral pemigatinib at a starting dose of 13.5 milligrams (mg) once daily (QD) on an intermittent dose (ID) (2-weeks-on/1-week-off therapy) schedule in 21-day cycles. Participants who did not reach the target serum phosphate level of \> 5.5 mg/deciliter (dL) could have increased the daily dose to 18 mg, provided they had no ongoing Grade 2 or higher treatment-related treatment-emergent adverse events (TEAEs), and they had been compliant with taking the study drug.
|
Cohort B-ID: All Other FGF/FGFR Alterations
n=44 Participants
Participants with all other FGF/FGFR alterations self-administered oral pemigatinib at a starting dose of 13.5 mg QD on an ID (2-weeks-on/1-week-off therapy) schedule in 21-day cycles. Participants who did not reach the target serum phosphate level of \> 5.5 mg/dL could have increased the daily dose to 18 mg, provided they had no ongoing Grade 2 or higher treatment-related TEAEs, and they had been compliant with taking the study drug.
|
Other-ID
n=9 Participants
Participants with no FGF/FGFR alterations or with an undetermined FGF/FGFR status self-administered oral pemigatinib at a starting dose of 13.5 mg QD on an ID (2-weeks-on/1-week-off therapy) schedule in 21-day cycles. Participants who did not reach the target serum phosphate level of \> 5.5 mg/dL could have increased the daily dose to 18 mg, provided they had no ongoing Grade 2 or higher treatment-related TEAEs, and they had been compliant with taking the study drug.
|
Cohort A-CD: FGFR3 Mutations or Fusions
n=101 Participants
Participants with FGFR3 mutations or fusions self-administered oral pemigatinib at a starting dose of 13.5 mg QD on a continuous dose (CD) (no planned dose hold) schedule in 21-day cycles. Participants who did not reach the target serum phosphate level of \> 5.5 mg/dL could have increased the daily dose to 18 mg, provided they had no ongoing Grade 2 or higher treatment-related TEAEs, and they had been compliant with taking the study drug.
|
Cohort A-ID + Cohort B-ID
Participants with FGFR3 mutations or fusions (Cohort A) or with all other FGF/FGFR alterations (Cohort B) self-administered oral pemigatinib at a starting dose of 13.5 mg QD on an ID (2-weeks-on/1-week-off therapy) schedule in 21-day cycles. Participants who did not reach the target serum phosphate level of \> 5.5 mg/dL could have increased the daily dose to 18 mg, provided they had no ongoing Grade 2 or higher treatment-related TEAEs, and they had been compliant with taking the study drug.
|
Cohort A-ID + Cohort A-CD
Participants with FGFR3 mutations or fusions self-administered oral pemigatinib at a starting dose of 13.5 mg QD on an ID (2-weeks-on/1-week-off therapy) schedule (Cohort A-ID) or on a CD (no planned dose hold) schedule (Cohort A-CD) in 21-day cycles. Participants who did not reach the target serum phosphate level of \> 5.5 mg/dL could have increased the daily dose to 18 mg, provided they had no ongoing Grade 2 or higher treatment-related TEAEs, and they had been compliant with taking the study drug.
|
Cohort A-ID + Cohort B-ID + Cohort A-CD
Participants with FGFR3 mutations or fusions (Cohort A) or with all other FGF/FGFR alterations (Cohort B) self-administered oral pemigatinib at a starting dose of 13.5 mg QD on an ID (2-weeks-on/1-week-off therapy) schedule (Cohort A-ID and Cohort B-ID) in 21-day cycles or on a CD (no planned dose hold) schedule (Cohort A-CD). Participants who did not reach the target serum phosphate level of \> 5.5 mg/dL could have increased the daily dose to 18 mg, provided they had no ongoing Grade 2 or higher treatment-related TEAEs, and they had been compliant with taking the study drug.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Any Treatment-emergent Adverse Event (TEAE)
|
3 Participants
|
103 Participants
|
44 Participants
|
9 Participants
|
100 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: up to 1138 daysPopulation: Efficacy Evaluable Population. The "Other-ID" and "Other-CD" treatment groups were not included in the Efficacy Evaluable Population. The 95% confidence interval was calculated using the Brookmeyer and Crowley's method.
PFS was defined as the length of time from the start of the study drug (Day 1) to the earlier of death or disease progression by RECIST v1.1, as assessed by the independent centralized radiological review committee.
Outcome measures
| Measure |
Other-CD
Participants with no FGF/FGFR alterations or with an undetermined FGF/FGFR status self-administered oral pemigatinib at a starting dose of 13.5 mg QD on a continuous dose (CD) (no planned dose hold) schedule in 21-day cycles. Participants who did not reach the target serum phosphate level of \> 5.5 mg/dL could have increased the daily dose to 18 mg, provided they had no ongoing Grade 2 or higher treatment-related TEAEs, and they had been compliant with taking the study drug.
|
Cohort A-ID: FGFR3 Mutations or Fusions
n=103 Participants
Participants with fibroblast growth factor (FGF) receptor 3 (FGFR3) mutations or fusions self-administered oral pemigatinib at a starting dose of 13.5 milligrams (mg) once daily (QD) on an intermittent dose (ID) (2-weeks-on/1-week-off therapy) schedule in 21-day cycles. Participants who did not reach the target serum phosphate level of \> 5.5 mg/deciliter (dL) could have increased the daily dose to 18 mg, provided they had no ongoing Grade 2 or higher treatment-related treatment-emergent adverse events (TEAEs), and they had been compliant with taking the study drug.
|
Cohort B-ID: All Other FGF/FGFR Alterations
n=44 Participants
Participants with all other FGF/FGFR alterations self-administered oral pemigatinib at a starting dose of 13.5 mg QD on an ID (2-weeks-on/1-week-off therapy) schedule in 21-day cycles. Participants who did not reach the target serum phosphate level of \> 5.5 mg/dL could have increased the daily dose to 18 mg, provided they had no ongoing Grade 2 or higher treatment-related TEAEs, and they had been compliant with taking the study drug.
|
Other-ID
Participants with no FGF/FGFR alterations or with an undetermined FGF/FGFR status self-administered oral pemigatinib at a starting dose of 13.5 mg QD on an ID (2-weeks-on/1-week-off therapy) schedule in 21-day cycles. Participants who did not reach the target serum phosphate level of \> 5.5 mg/dL could have increased the daily dose to 18 mg, provided they had no ongoing Grade 2 or higher treatment-related TEAEs, and they had been compliant with taking the study drug.
|
Cohort A-CD: FGFR3 Mutations or Fusions
n=101 Participants
Participants with FGFR3 mutations or fusions self-administered oral pemigatinib at a starting dose of 13.5 mg QD on a continuous dose (CD) (no planned dose hold) schedule in 21-day cycles. Participants who did not reach the target serum phosphate level of \> 5.5 mg/dL could have increased the daily dose to 18 mg, provided they had no ongoing Grade 2 or higher treatment-related TEAEs, and they had been compliant with taking the study drug.
|
Cohort A-ID + Cohort B-ID
Participants with FGFR3 mutations or fusions (Cohort A) or with all other FGF/FGFR alterations (Cohort B) self-administered oral pemigatinib at a starting dose of 13.5 mg QD on an ID (2-weeks-on/1-week-off therapy) schedule in 21-day cycles. Participants who did not reach the target serum phosphate level of \> 5.5 mg/dL could have increased the daily dose to 18 mg, provided they had no ongoing Grade 2 or higher treatment-related TEAEs, and they had been compliant with taking the study drug.
|
Cohort A-ID + Cohort A-CD
Participants with FGFR3 mutations or fusions self-administered oral pemigatinib at a starting dose of 13.5 mg QD on an ID (2-weeks-on/1-week-off therapy) schedule (Cohort A-ID) or on a CD (no planned dose hold) schedule (Cohort A-CD) in 21-day cycles. Participants who did not reach the target serum phosphate level of \> 5.5 mg/dL could have increased the daily dose to 18 mg, provided they had no ongoing Grade 2 or higher treatment-related TEAEs, and they had been compliant with taking the study drug.
|
Cohort A-ID + Cohort B-ID + Cohort A-CD
Participants with FGFR3 mutations or fusions (Cohort A) or with all other FGF/FGFR alterations (Cohort B) self-administered oral pemigatinib at a starting dose of 13.5 mg QD on an ID (2-weeks-on/1-week-off therapy) schedule (Cohort A-ID and Cohort B-ID) in 21-day cycles or on a CD (no planned dose hold) schedule (Cohort A-CD). Participants who did not reach the target serum phosphate level of \> 5.5 mg/dL could have increased the daily dose to 18 mg, provided they had no ongoing Grade 2 or higher treatment-related TEAEs, and they had been compliant with taking the study drug.
|
|---|---|---|---|---|---|---|---|---|
|
Progression-free Survival (PFS)
|
—
|
4.27 months
Interval 3.91 to 6.05
|
2.04 months
Interval 1.87 to 2.17
|
—
|
4.04 months
Interval 3.45 to 4.17
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: up to 1075 daysPopulation: Efficacy Evaluable Population. The "Other-ID" and "Other-CD" treatment groups were not included in the Efficacy Evaluable Population. Only participants with a CR or PR were analyzed. The 95% confidence interval was calculated using the Brookmeyer and Crowley's method.
DOR was defined as the time from the first overall response contributing to an objective response (CR or PR) to the earlier of death or first overall response of PD occurring after the first overall response contributing to the objective response. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to \<10 millimeters (mm). PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions. Response was based on review of scans by an independent centralized radiological review committee. Response was confirmed
Outcome measures
| Measure |
Other-CD
Participants with no FGF/FGFR alterations or with an undetermined FGF/FGFR status self-administered oral pemigatinib at a starting dose of 13.5 mg QD on a continuous dose (CD) (no planned dose hold) schedule in 21-day cycles. Participants who did not reach the target serum phosphate level of \> 5.5 mg/dL could have increased the daily dose to 18 mg, provided they had no ongoing Grade 2 or higher treatment-related TEAEs, and they had been compliant with taking the study drug.
|
Cohort A-ID: FGFR3 Mutations or Fusions
n=24 Participants
Participants with fibroblast growth factor (FGF) receptor 3 (FGFR3) mutations or fusions self-administered oral pemigatinib at a starting dose of 13.5 milligrams (mg) once daily (QD) on an intermittent dose (ID) (2-weeks-on/1-week-off therapy) schedule in 21-day cycles. Participants who did not reach the target serum phosphate level of \> 5.5 mg/deciliter (dL) could have increased the daily dose to 18 mg, provided they had no ongoing Grade 2 or higher treatment-related treatment-emergent adverse events (TEAEs), and they had been compliant with taking the study drug.
|
Cohort B-ID: All Other FGF/FGFR Alterations
n=3 Participants
Participants with all other FGF/FGFR alterations self-administered oral pemigatinib at a starting dose of 13.5 mg QD on an ID (2-weeks-on/1-week-off therapy) schedule in 21-day cycles. Participants who did not reach the target serum phosphate level of \> 5.5 mg/dL could have increased the daily dose to 18 mg, provided they had no ongoing Grade 2 or higher treatment-related TEAEs, and they had been compliant with taking the study drug.
|
Other-ID
Participants with no FGF/FGFR alterations or with an undetermined FGF/FGFR status self-administered oral pemigatinib at a starting dose of 13.5 mg QD on an ID (2-weeks-on/1-week-off therapy) schedule in 21-day cycles. Participants who did not reach the target serum phosphate level of \> 5.5 mg/dL could have increased the daily dose to 18 mg, provided they had no ongoing Grade 2 or higher treatment-related TEAEs, and they had been compliant with taking the study drug.
|
Cohort A-CD: FGFR3 Mutations or Fusions
n=18 Participants
Participants with FGFR3 mutations or fusions self-administered oral pemigatinib at a starting dose of 13.5 mg QD on a continuous dose (CD) (no planned dose hold) schedule in 21-day cycles. Participants who did not reach the target serum phosphate level of \> 5.5 mg/dL could have increased the daily dose to 18 mg, provided they had no ongoing Grade 2 or higher treatment-related TEAEs, and they had been compliant with taking the study drug.
|
Cohort A-ID + Cohort B-ID
Participants with FGFR3 mutations or fusions (Cohort A) or with all other FGF/FGFR alterations (Cohort B) self-administered oral pemigatinib at a starting dose of 13.5 mg QD on an ID (2-weeks-on/1-week-off therapy) schedule in 21-day cycles. Participants who did not reach the target serum phosphate level of \> 5.5 mg/dL could have increased the daily dose to 18 mg, provided they had no ongoing Grade 2 or higher treatment-related TEAEs, and they had been compliant with taking the study drug.
|
Cohort A-ID + Cohort A-CD
Participants with FGFR3 mutations or fusions self-administered oral pemigatinib at a starting dose of 13.5 mg QD on an ID (2-weeks-on/1-week-off therapy) schedule (Cohort A-ID) or on a CD (no planned dose hold) schedule (Cohort A-CD) in 21-day cycles. Participants who did not reach the target serum phosphate level of \> 5.5 mg/dL could have increased the daily dose to 18 mg, provided they had no ongoing Grade 2 or higher treatment-related TEAEs, and they had been compliant with taking the study drug.
|
Cohort A-ID + Cohort B-ID + Cohort A-CD
Participants with FGFR3 mutations or fusions (Cohort A) or with all other FGF/FGFR alterations (Cohort B) self-administered oral pemigatinib at a starting dose of 13.5 mg QD on an ID (2-weeks-on/1-week-off therapy) schedule (Cohort A-ID and Cohort B-ID) in 21-day cycles or on a CD (no planned dose hold) schedule (Cohort A-CD). Participants who did not reach the target serum phosphate level of \> 5.5 mg/dL could have increased the daily dose to 18 mg, provided they had no ongoing Grade 2 or higher treatment-related TEAEs, and they had been compliant with taking the study drug.
|
|---|---|---|---|---|---|---|---|---|
|
Duration of Response (DOR)
|
—
|
6.21 months
Interval 4.6 to 7.95
|
10.02 months
Interval 8.38 to
The upper limit of the confidence interval was not estimable because too few participants had disease progression or died.
|
—
|
6.23 months
Interval 4.14 to 8.25
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: up to 1610 daysPopulation: Efficacy Evaluable Population. The "Other-ID" and "Other-CD" treatment groups were not included in the Efficacy Evaluable Population. The 95% confidence interval was calculated using the Brookmeyer and Crowley's method.
Overall survival was defined as the length of time from the start of the study drug (Day 1) until the date of death due to any cause.
Outcome measures
| Measure |
Other-CD
Participants with no FGF/FGFR alterations or with an undetermined FGF/FGFR status self-administered oral pemigatinib at a starting dose of 13.5 mg QD on a continuous dose (CD) (no planned dose hold) schedule in 21-day cycles. Participants who did not reach the target serum phosphate level of \> 5.5 mg/dL could have increased the daily dose to 18 mg, provided they had no ongoing Grade 2 or higher treatment-related TEAEs, and they had been compliant with taking the study drug.
|
Cohort A-ID: FGFR3 Mutations or Fusions
n=103 Participants
Participants with fibroblast growth factor (FGF) receptor 3 (FGFR3) mutations or fusions self-administered oral pemigatinib at a starting dose of 13.5 milligrams (mg) once daily (QD) on an intermittent dose (ID) (2-weeks-on/1-week-off therapy) schedule in 21-day cycles. Participants who did not reach the target serum phosphate level of \> 5.5 mg/deciliter (dL) could have increased the daily dose to 18 mg, provided they had no ongoing Grade 2 or higher treatment-related treatment-emergent adverse events (TEAEs), and they had been compliant with taking the study drug.
|
Cohort B-ID: All Other FGF/FGFR Alterations
n=44 Participants
Participants with all other FGF/FGFR alterations self-administered oral pemigatinib at a starting dose of 13.5 mg QD on an ID (2-weeks-on/1-week-off therapy) schedule in 21-day cycles. Participants who did not reach the target serum phosphate level of \> 5.5 mg/dL could have increased the daily dose to 18 mg, provided they had no ongoing Grade 2 or higher treatment-related TEAEs, and they had been compliant with taking the study drug.
|
Other-ID
Participants with no FGF/FGFR alterations or with an undetermined FGF/FGFR status self-administered oral pemigatinib at a starting dose of 13.5 mg QD on an ID (2-weeks-on/1-week-off therapy) schedule in 21-day cycles. Participants who did not reach the target serum phosphate level of \> 5.5 mg/dL could have increased the daily dose to 18 mg, provided they had no ongoing Grade 2 or higher treatment-related TEAEs, and they had been compliant with taking the study drug.
|
Cohort A-CD: FGFR3 Mutations or Fusions
n=101 Participants
Participants with FGFR3 mutations or fusions self-administered oral pemigatinib at a starting dose of 13.5 mg QD on a continuous dose (CD) (no planned dose hold) schedule in 21-day cycles. Participants who did not reach the target serum phosphate level of \> 5.5 mg/dL could have increased the daily dose to 18 mg, provided they had no ongoing Grade 2 or higher treatment-related TEAEs, and they had been compliant with taking the study drug.
|
Cohort A-ID + Cohort B-ID
Participants with FGFR3 mutations or fusions (Cohort A) or with all other FGF/FGFR alterations (Cohort B) self-administered oral pemigatinib at a starting dose of 13.5 mg QD on an ID (2-weeks-on/1-week-off therapy) schedule in 21-day cycles. Participants who did not reach the target serum phosphate level of \> 5.5 mg/dL could have increased the daily dose to 18 mg, provided they had no ongoing Grade 2 or higher treatment-related TEAEs, and they had been compliant with taking the study drug.
|
Cohort A-ID + Cohort A-CD
Participants with FGFR3 mutations or fusions self-administered oral pemigatinib at a starting dose of 13.5 mg QD on an ID (2-weeks-on/1-week-off therapy) schedule (Cohort A-ID) or on a CD (no planned dose hold) schedule (Cohort A-CD) in 21-day cycles. Participants who did not reach the target serum phosphate level of \> 5.5 mg/dL could have increased the daily dose to 18 mg, provided they had no ongoing Grade 2 or higher treatment-related TEAEs, and they had been compliant with taking the study drug.
|
Cohort A-ID + Cohort B-ID + Cohort A-CD
Participants with FGFR3 mutations or fusions (Cohort A) or with all other FGF/FGFR alterations (Cohort B) self-administered oral pemigatinib at a starting dose of 13.5 mg QD on an ID (2-weeks-on/1-week-off therapy) schedule (Cohort A-ID and Cohort B-ID) in 21-day cycles or on a CD (no planned dose hold) schedule (Cohort A-CD). Participants who did not reach the target serum phosphate level of \> 5.5 mg/dL could have increased the daily dose to 18 mg, provided they had no ongoing Grade 2 or higher treatment-related TEAEs, and they had been compliant with taking the study drug.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Survival
|
—
|
8.90 months
Interval 7.46 to 15.18
|
9.13 months
Interval 5.52 to 17.05
|
—
|
6.80 months
Interval 5.26 to 9.1
|
—
|
—
|
—
|
Adverse Events
Cohort A-ID: FGFR3 Mutations or Fusions
Serious events: 45 serious events
Other events: 101 other events
Deaths: 88 deaths
Cohort B-ID: All Other FGF/FGFR Alterations
Serious events: 26 serious events
Other events: 43 other events
Deaths: 39 deaths
Other-ID
Serious events: 3 serious events
Other events: 9 other events
Deaths: 8 deaths
Cohort A-CD: FGFR3 Mutations or Fusions
Serious events: 48 serious events
Other events: 99 other events
Deaths: 83 deaths
Other-CD
Serious events: 1 serious events
Other events: 3 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Cohort A-ID: FGFR3 Mutations or Fusions
n=103 participants at risk
Participants with fibroblast growth factor (FGF) receptor 3 (FGFR3) mutations or fusions self-administered oral pemigatinib at a starting dose of 13.5 milligrams (mg) once daily (QD) on an intermittent dose (ID) (2-weeks-on/1-week-off therapy) schedule in 21-day cycles. Participants who did not reach the target serum phosphate level of \> 5.5 mg/deciliter (dL) could have increased the daily dose to 18 mg, provided they had no ongoing Grade 2 or higher treatment-related treatment-emergent adverse events (TEAEs), and they had been compliant with taking the study drug.
|
Cohort B-ID: All Other FGF/FGFR Alterations
n=44 participants at risk
Participants with all other FGF/FGFR alterations self-administered oral pemigatinib at a starting dose of 13.5 mg QD on an ID (2-weeks-on/1-week-off therapy) schedule in 21-day cycles. Participants who did not reach the target serum phosphate level of \> 5.5 mg/dL could have increased the daily dose to 18 mg, provided they had no ongoing Grade 2 or higher treatment-related TEAEs, and they had been compliant with taking the study drug.
|
Other-ID
n=9 participants at risk
Participants with no FGF/FGFR alterations or with an undetermined FGF/FGFR status self-administered oral pemigatinib at a starting dose of 13.5 mg QD on an ID (2-weeks-on/1-week-off therapy) schedule in 21-day cycles. Participants who did not reach the target serum phosphate level of \> 5.5 mg/dL could have increased the daily dose to 18 mg, provided they had no ongoing Grade 2 or higher treatment-related TEAEs, and they had been compliant with taking the study drug.
|
Cohort A-CD: FGFR3 Mutations or Fusions
n=101 participants at risk
Participants with FGFR3 mutations or fusions self-administered oral pemigatinib at a starting dose of 13.5 mg QD on a continuous dose (CD) (no planned dose hold) schedule in 21-day cycles. Participants who did not reach the target serum phosphate level of \> 5.5 mg/dL could have increased the daily dose to 18 mg, provided they had no ongoing Grade 2 or higher treatment-related TEAEs, and they had been compliant with taking the study drug.
|
Other-CD
n=3 participants at risk
Participants with no FGF/FGFR alterations or with an undetermined FGF/FGFR status self-administered oral pemigatinib at a starting dose of 13.5 mg QD on a continuous dose (CD) (no planned dose hold) schedule in 21-day cycles. Participants who did not reach the target serum phosphate level of \> 5.5 mg/dL could have increased the daily dose to 18 mg, provided they had no ongoing Grade 2 or higher treatment-related TEAEs, and they had been compliant with taking the study drug.
|
|---|---|---|---|---|---|
|
General disorders
Malaise
|
0.00%
0/103 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
2.3%
1/44 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/9 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/101 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/3 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/103 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/44 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/9 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.99%
1/101 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/3 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
|
Gastrointestinal disorders
Abdominal pain
|
1.9%
2/103 • Number of events 3 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
2.3%
1/44 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/9 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.99%
1/101 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/3 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
|
Renal and urinary disorders
Acute kidney injury
|
2.9%
3/103 • Number of events 3 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
9.1%
4/44 • Number of events 4 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/9 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
2.0%
2/101 • Number of events 2 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/3 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/103 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
2.3%
1/44 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/9 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
2.0%
2/101 • Number of events 2 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
33.3%
1/3 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
|
Immune system disorders
Anaphylactic shock
|
0.00%
0/103 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/44 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/9 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.99%
1/101 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/3 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
|
Injury, poisoning and procedural complications
Anastomotic haemorrhage
|
0.97%
1/103 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/44 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/9 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/101 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/3 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
|
Cardiac disorders
Angina pectoris
|
0.97%
1/103 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/44 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/9 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/101 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/3 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.97%
1/103 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/44 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/9 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/101 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/3 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.97%
1/103 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/44 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/9 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/101 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/3 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
|
General disorders
Asthenia
|
0.00%
0/103 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/44 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/9 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.99%
1/101 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/3 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.9%
2/103 • Number of events 2 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
4.5%
2/44 • Number of events 2 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/9 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.99%
1/101 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
33.3%
1/3 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
|
Infections and infestations
Bacteraemia
|
0.97%
1/103 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/44 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/9 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/101 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/3 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
|
Renal and urinary disorders
Bladder mass
|
0.00%
0/103 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/44 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/9 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.99%
1/101 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/3 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
|
Renal and urinary disorders
Bladder outlet obstruction
|
0.97%
1/103 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/44 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/9 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/101 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/3 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
|
Investigations
Blood creatinine increased
|
0.97%
1/103 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
2.3%
1/44 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/9 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.99%
1/101 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/3 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
|
Investigations
Blood urine present
|
0.00%
0/103 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
2.3%
1/44 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/9 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/101 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/3 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/103 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/44 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/9 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.99%
1/101 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/3 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/103 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/44 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/9 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.99%
1/101 • Number of events 2 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/3 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
|
Infections and infestations
COVID-19
|
0.00%
0/103 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/44 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/9 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.99%
1/101 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/3 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
0.97%
1/103 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/44 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/9 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/101 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/3 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/103 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/44 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/9 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.99%
1/101 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/3 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
|
General disorders
Catheter site inflammation
|
0.00%
0/103 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/44 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/9 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.99%
1/101 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/3 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
|
Nervous system disorders
Cerebellar haemorrhage
|
0.00%
0/103 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/44 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/9 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.99%
1/101 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/3 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.97%
1/103 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/44 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/9 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/101 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/3 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.97%
1/103 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/44 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/9 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/101 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/3 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
|
Eye disorders
Chorioretinopathy
|
0.97%
1/103 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/44 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/9 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/101 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/3 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.00%
0/103 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
2.3%
1/44 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/9 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/101 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/3 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
|
Nervous system disorders
Cognitive disorder
|
0.97%
1/103 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/44 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/9 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.99%
1/101 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/3 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
|
Gastrointestinal disorders
Colitis
|
0.97%
1/103 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/44 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/9 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/101 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/3 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
|
Gastrointestinal disorders
Constipation
|
1.9%
2/103 • Number of events 2 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
6.8%
3/44 • Number of events 3 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/9 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/101 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/3 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
|
Cardiac disorders
Coronary artery stenosis
|
0.97%
1/103 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/44 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/9 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/101 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/3 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/103 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/44 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
11.1%
1/9 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/101 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/3 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
|
Injury, poisoning and procedural complications
Craniocerebral injury
|
0.00%
0/103 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/44 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/9 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.99%
1/101 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/3 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
|
Infections and infestations
Cytomegalovirus infection
|
0.00%
0/103 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/44 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/9 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.99%
1/101 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/3 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.97%
1/103 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
2.3%
1/44 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/9 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.99%
1/101 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/3 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/103 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
2.3%
1/44 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/9 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/101 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/3 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
|
Psychiatric disorders
Delirium
|
0.00%
0/103 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
2.3%
1/44 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/9 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/101 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/3 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
|
Eye disorders
Detachment of retinal pigment epithelium
|
0.00%
0/103 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/44 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/9 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.99%
1/101 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/3 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
|
Infections and infestations
Device related infection
|
0.00%
0/103 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
2.3%
1/44 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/9 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
2.0%
2/101 • Number of events 2 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/3 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
|
Gastrointestinal disorders
Diarrhoea
|
1.9%
2/103 • Number of events 2 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/44 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/9 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/101 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/3 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
|
General disorders
Disease progression
|
1.9%
2/103 • Number of events 2 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/44 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/9 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
2.0%
2/101 • Number of events 2 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/3 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.9%
2/103 • Number of events 2 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/44 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/9 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/101 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/3 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.97%
1/103 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/44 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/9 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/101 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/3 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
|
Infections and infestations
Empyema
|
0.00%
0/103 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
2.3%
1/44 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/9 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/101 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/3 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.00%
0/103 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/44 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/9 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.99%
1/101 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/3 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
|
Injury, poisoning and procedural complications
Fall
|
0.97%
1/103 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/44 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/9 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/101 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/3 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
|
General disorders
Fatigue
|
0.97%
1/103 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
2.3%
1/44 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/9 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/101 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/3 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
|
Infections and infestations
Febrile infection
|
0.97%
1/103 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/44 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/9 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/101 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/3 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.97%
1/103 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/44 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/9 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.99%
1/101 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/3 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
|
Injury, poisoning and procedural complications
Fractured sacrum
|
0.97%
1/103 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/44 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/9 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/101 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/3 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
|
General disorders
Gait disturbance
|
0.00%
0/103 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
2.3%
1/44 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/9 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/101 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/3 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
|
Hepatobiliary disorders
Gallbladder enlargement
|
0.00%
0/103 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
2.3%
1/44 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/9 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/101 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/3 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
|
Infections and infestations
Gastroenteritis salmonella
|
0.00%
0/103 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/44 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/9 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.99%
1/101 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/3 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
|
Gastrointestinal disorders
Gastrointestinal obstruction
|
0.00%
0/103 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/44 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/9 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.99%
1/101 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/3 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
|
General disorders
General physical health deterioration
|
4.9%
5/103 • Number of events 5 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
6.8%
3/44 • Number of events 3 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/9 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
5.0%
5/101 • Number of events 5 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/3 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
|
Gastrointestinal disorders
Haematemesis
|
0.00%
0/103 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/44 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/9 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.99%
1/101 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/3 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
|
Renal and urinary disorders
Haematuria
|
3.9%
4/103 • Number of events 4 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
2.3%
1/44 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
11.1%
1/9 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/101 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/3 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
|
Investigations
Hepatic enzyme increased
|
0.97%
1/103 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/44 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/9 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/101 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/3 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
|
Infections and infestations
Herpes simplex
|
0.00%
0/103 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/44 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/9 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.99%
1/101 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/3 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/103 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
2.3%
1/44 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/9 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/101 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/3 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/103 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/44 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/9 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
2.0%
2/101 • Number of events 2 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/3 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
1.9%
2/103 • Number of events 2 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/44 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/9 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.99%
1/101 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/3 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
|
Endocrine disorders
Hypercalcaemia of malignancy
|
0.00%
0/103 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/44 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/9 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.99%
1/101 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/3 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.97%
1/103 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/44 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/9 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/101 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/3 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
|
Metabolism and nutrition disorders
Hyperphosphataemia
|
0.97%
1/103 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/44 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/9 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/101 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/3 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
|
Vascular disorders
Hypertension
|
0.97%
1/103 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/44 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/9 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/101 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/3 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.97%
1/103 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/44 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/9 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.99%
1/101 • Number of events 2 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/3 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/103 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
4.5%
2/44 • Number of events 2 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/9 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.99%
1/101 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
33.3%
1/3 • Number of events 2 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
|
Vascular disorders
Hypotension
|
0.00%
0/103 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
2.3%
1/44 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/9 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/101 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/3 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
|
Vascular disorders
Hypovolaemic shock
|
0.00%
0/103 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/44 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/9 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.99%
1/101 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/3 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.97%
1/103 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/44 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/9 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/101 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/3 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.97%
1/103 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/44 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/9 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/101 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/3 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
|
Gastrointestinal disorders
Intestinal infarction
|
0.97%
1/103 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/44 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/9 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/101 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/3 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.97%
1/103 • Number of events 4 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
2.3%
1/44 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/9 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.99%
1/101 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/3 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
|
Eye disorders
Keratitis
|
0.00%
0/103 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/44 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/9 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.99%
1/101 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/3 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
|
Gastrointestinal disorders
Large intestinal obstruction
|
0.00%
0/103 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
2.3%
1/44 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/9 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/101 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/3 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
|
Nervous system disorders
Lethargy
|
0.00%
0/103 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
2.3%
1/44 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/9 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/101 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/3 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/103 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/44 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/9 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.99%
1/101 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/3 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
0.97%
1/103 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/44 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/9 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/101 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/3 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
0.00%
0/103 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
2.3%
1/44 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/9 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/101 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/3 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
|
Psychiatric disorders
Mental status changes
|
0.97%
1/103 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/44 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/9 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/101 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/3 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
|
Nervous system disorders
Motor dysfunction
|
0.97%
1/103 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/44 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/9 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/101 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/3 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.97%
1/103 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
2.3%
1/44 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/9 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/101 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/3 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.97%
1/103 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/44 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/9 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/101 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/3 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/103 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
2.3%
1/44 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/9 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/101 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/3 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
|
Gastrointestinal disorders
Nausea
|
0.97%
1/103 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
6.8%
3/44 • Number of events 3 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/9 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/101 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/3 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/103 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/44 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/9 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.99%
1/101 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/3 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
|
Eye disorders
Optic neuropathy
|
0.97%
1/103 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/44 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/9 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/101 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/3 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
|
General disorders
Pain
|
0.00%
0/103 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
4.5%
2/44 • Number of events 2 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/9 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/101 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/3 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
|
Gastrointestinal disorders
Pancreatic mass
|
0.00%
0/103 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/44 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/9 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.99%
1/101 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/3 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
|
Infections and infestations
Pelvic abscess
|
0.97%
1/103 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/44 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/9 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/101 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/3 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/103 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
2.3%
1/44 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/9 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/101 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/3 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
|
Nervous system disorders
Peripheral nerve paresis
|
0.00%
0/103 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/44 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/9 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.99%
1/101 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/3 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
|
Vascular disorders
Phlebitis
|
0.97%
1/103 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/44 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/9 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/101 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/3 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.97%
1/103 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/44 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/9 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.99%
1/101 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/3 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
|
Infections and infestations
Pneumonia
|
1.9%
2/103 • Number of events 3 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
4.5%
2/44 • Number of events 2 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/9 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/101 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/3 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
|
Infections and infestations
Pneumonia viral
|
0.00%
0/103 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/44 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/9 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.99%
1/101 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/3 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/103 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/44 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/9 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.99%
1/101 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/3 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
|
General disorders
Polyp
|
0.97%
1/103 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/44 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/9 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/101 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/3 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/103 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/44 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/9 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.99%
1/101 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/3 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary haemorrhage
|
0.97%
1/103 • Number of events 2 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/44 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/9 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/101 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/3 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
|
Infections and infestations
Pyelonephritis
|
0.97%
1/103 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/44 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/9 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.99%
1/101 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/3 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
|
Infections and infestations
Pyelonephritis acute
|
0.97%
1/103 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/44 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/9 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/101 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/3 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
|
General disorders
Pyrexia
|
0.97%
1/103 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
2.3%
1/44 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
11.1%
1/9 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.99%
1/101 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/3 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal cancer
|
0.00%
0/103 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/44 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/9 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.99%
1/101 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/3 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/103 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/44 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/9 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
3.0%
3/101 • Number of events 3 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/3 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
|
Renal and urinary disorders
Renal injury
|
0.00%
0/103 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
2.3%
1/44 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/9 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/101 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/3 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.00%
0/103 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/44 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/9 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.99%
1/101 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/3 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
|
Nervous system disorders
Sciatica
|
0.00%
0/103 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
2.3%
1/44 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/9 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/101 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/3 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
|
Infections and infestations
Sepsis
|
0.97%
1/103 • Number of events 2 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
2.3%
1/44 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/9 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
2.0%
2/101 • Number of events 2 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/3 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
|
Infections and infestations
Septic shock
|
0.97%
1/103 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/44 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/9 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/101 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/3 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
|
Skin and subcutaneous tissue disorders
Skin toxicity
|
0.00%
0/103 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/44 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/9 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.99%
1/101 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/3 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
1.9%
2/103 • Number of events 2 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
4.5%
2/44 • Number of events 2 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/9 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/101 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/3 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
|
Nervous system disorders
Spinal cord compression
|
1.9%
2/103 • Number of events 2 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/44 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/9 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/101 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/3 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
|
Infections and infestations
Spinal cord infection
|
0.00%
0/103 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/44 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
11.1%
1/9 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/101 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/3 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.97%
1/103 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/44 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/9 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/101 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/3 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
|
Injury, poisoning and procedural complications
Stomal hernia
|
0.00%
0/103 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/44 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/9 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.99%
1/101 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/3 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/103 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/44 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/9 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.99%
1/101 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/3 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.97%
1/103 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/44 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/9 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/101 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/3 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
|
Gastrointestinal disorders
Subileus
|
0.00%
0/103 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/44 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/9 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
2.0%
2/101 • Number of events 2 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/3 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
|
General disorders
Sudden death
|
0.00%
0/103 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/44 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/9 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.99%
1/101 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/3 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
|
Nervous system disorders
Syncope
|
0.97%
1/103 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/44 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/9 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/101 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/3 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
|
General disorders
Systemic inflammatory response syndrome
|
0.97%
1/103 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/44 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/9 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/101 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/3 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour associated fever
|
0.00%
0/103 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/44 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/9 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.99%
1/101 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/3 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.00%
0/103 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/44 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/9 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.99%
1/101 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/3 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
|
Renal and urinary disorders
Urinary retention
|
0.97%
1/103 • Number of events 2 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
2.3%
1/44 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/9 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/101 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/3 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
|
Infections and infestations
Urinary tract infection
|
5.8%
6/103 • Number of events 6 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
2.3%
1/44 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/9 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
7.9%
8/101 • Number of events 11 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/3 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.00%
0/103 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
2.3%
1/44 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/9 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/101 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/3 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
|
Injury, poisoning and procedural complications
Urinary tract stoma complication
|
0.00%
0/103 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/44 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/9 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.99%
1/101 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/3 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
|
Investigations
Urine output decreased
|
0.97%
1/103 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/44 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/9 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/101 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/3 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
|
Infections and infestations
Urosepsis
|
1.9%
2/103 • Number of events 2 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
2.3%
1/44 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/9 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/101 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/3 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
|
Injury, poisoning and procedural complications
Urostomy complication
|
0.97%
1/103 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
2.3%
1/44 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/9 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/101 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/3 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
|
Vascular disorders
Vasculitis necrotising
|
0.00%
0/103 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
2.3%
1/44 • Number of events 2 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/9 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/101 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/3 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
|
Vascular disorders
Venous thrombosis
|
0.97%
1/103 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/44 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/9 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/101 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/3 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
|
Infections and infestations
Viral oesophagitis
|
0.00%
0/103 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/44 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/9 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.99%
1/101 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/3 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
|
Gastrointestinal disorders
Vomiting
|
0.97%
1/103 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
4.5%
2/44 • Number of events 2 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/9 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/101 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/3 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
|
Investigations
White blood cell count increased
|
0.00%
0/103 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
2.3%
1/44 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/9 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/101 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/3 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
|
Infections and infestations
Wound infection
|
0.00%
0/103 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
2.3%
1/44 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/9 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/101 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/3 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
Other adverse events
| Measure |
Cohort A-ID: FGFR3 Mutations or Fusions
n=103 participants at risk
Participants with fibroblast growth factor (FGF) receptor 3 (FGFR3) mutations or fusions self-administered oral pemigatinib at a starting dose of 13.5 milligrams (mg) once daily (QD) on an intermittent dose (ID) (2-weeks-on/1-week-off therapy) schedule in 21-day cycles. Participants who did not reach the target serum phosphate level of \> 5.5 mg/deciliter (dL) could have increased the daily dose to 18 mg, provided they had no ongoing Grade 2 or higher treatment-related treatment-emergent adverse events (TEAEs), and they had been compliant with taking the study drug.
|
Cohort B-ID: All Other FGF/FGFR Alterations
n=44 participants at risk
Participants with all other FGF/FGFR alterations self-administered oral pemigatinib at a starting dose of 13.5 mg QD on an ID (2-weeks-on/1-week-off therapy) schedule in 21-day cycles. Participants who did not reach the target serum phosphate level of \> 5.5 mg/dL could have increased the daily dose to 18 mg, provided they had no ongoing Grade 2 or higher treatment-related TEAEs, and they had been compliant with taking the study drug.
|
Other-ID
n=9 participants at risk
Participants with no FGF/FGFR alterations or with an undetermined FGF/FGFR status self-administered oral pemigatinib at a starting dose of 13.5 mg QD on an ID (2-weeks-on/1-week-off therapy) schedule in 21-day cycles. Participants who did not reach the target serum phosphate level of \> 5.5 mg/dL could have increased the daily dose to 18 mg, provided they had no ongoing Grade 2 or higher treatment-related TEAEs, and they had been compliant with taking the study drug.
|
Cohort A-CD: FGFR3 Mutations or Fusions
n=101 participants at risk
Participants with FGFR3 mutations or fusions self-administered oral pemigatinib at a starting dose of 13.5 mg QD on a continuous dose (CD) (no planned dose hold) schedule in 21-day cycles. Participants who did not reach the target serum phosphate level of \> 5.5 mg/dL could have increased the daily dose to 18 mg, provided they had no ongoing Grade 2 or higher treatment-related TEAEs, and they had been compliant with taking the study drug.
|
Other-CD
n=3 participants at risk
Participants with no FGF/FGFR alterations or with an undetermined FGF/FGFR status self-administered oral pemigatinib at a starting dose of 13.5 mg QD on a continuous dose (CD) (no planned dose hold) schedule in 21-day cycles. Participants who did not reach the target serum phosphate level of \> 5.5 mg/dL could have increased the daily dose to 18 mg, provided they had no ongoing Grade 2 or higher treatment-related TEAEs, and they had been compliant with taking the study drug.
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
2.9%
3/103 • Number of events 3 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/44 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/9 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
6.9%
7/101 • Number of events 7 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/3 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
|
Infections and infestations
Gingivitis
|
1.9%
2/103 • Number of events 2 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/44 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
11.1%
1/9 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/101 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/3 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
|
Eye disorders
Glaucoma
|
0.00%
0/103 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/44 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
11.1%
1/9 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/101 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/3 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
|
Gastrointestinal disorders
Glossodynia
|
0.97%
1/103 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
2.3%
1/44 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
11.1%
1/9 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.99%
1/101 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/3 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
|
Renal and urinary disorders
Haematuria
|
7.8%
8/103 • Number of events 11 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
13.6%
6/44 • Number of events 7 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
22.2%
2/9 • Number of events 2 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
11.9%
12/101 • Number of events 15 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/3 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
|
Gastrointestinal disorders
Haemorrhoids
|
1.9%
2/103 • Number of events 2 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/44 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
11.1%
1/9 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
2.0%
2/101 • Number of events 2 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/3 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
|
Nervous system disorders
Headache
|
5.8%
6/103 • Number of events 6 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
11.4%
5/44 • Number of events 5 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/9 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
5.0%
5/101 • Number of events 5 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/3 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
10.7%
11/103 • Number of events 12 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
2.3%
1/44 • Number of events 2 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
11.1%
1/9 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
6.9%
7/101 • Number of events 8 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/3 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
|
Metabolism and nutrition disorders
Hypercreatininaemia
|
0.97%
1/103 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/44 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/9 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
5.9%
6/101 • Number of events 6 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/3 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
2.9%
3/103 • Number of events 3 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
6.8%
3/44 • Number of events 3 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
11.1%
1/9 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.99%
1/101 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/3 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
5.8%
6/103 • Number of events 7 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
9.1%
4/44 • Number of events 7 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/9 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
7.9%
8/101 • Number of events 11 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/3 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
|
Metabolism and nutrition disorders
Hyperphosphataemia
|
34.0%
35/103 • Number of events 39 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
29.5%
13/44 • Number of events 15 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
44.4%
4/9 • Number of events 4 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
55.4%
56/101 • Number of events 95 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
66.7%
2/3 • Number of events 2 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
0.97%
1/103 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/44 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
11.1%
1/9 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/101 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/3 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
|
Nervous system disorders
Hypoaesthesia
|
0.97%
1/103 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
2.3%
1/44 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/9 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.99%
1/101 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
33.3%
1/3 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
|
Renal and urinary disorders
Acute kidney injury
|
3.9%
4/103 • Number of events 4 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
11.4%
5/44 • Number of events 6 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
11.1%
1/9 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
4.0%
4/101 • Number of events 4 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/3 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
7.8%
8/103 • Number of events 8 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
9.1%
4/44 • Number of events 4 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/9 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
2.0%
2/101 • Number of events 2 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/3 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
|
Nervous system disorders
Ageusia
|
5.8%
6/103 • Number of events 6 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/44 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
11.1%
1/9 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
3.0%
3/101 • Number of events 4 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/3 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
2.9%
3/103 • Number of events 3 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
6.8%
3/44 • Number of events 3 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
11.1%
1/9 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
2.0%
2/101 • Number of events 2 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
33.3%
1/3 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
6.8%
7/103 • Number of events 9 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
13.6%
6/44 • Number of events 10 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
11.1%
1/9 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
8.9%
9/101 • Number of events 12 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/3 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
12.6%
13/103 • Number of events 20 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
6.8%
3/44 • Number of events 4 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
11.1%
1/9 • Number of events 2 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
4.0%
4/101 • Number of events 4 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/3 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
|
Vascular disorders
Hypotension
|
9.7%
10/103 • Number of events 11 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
6.8%
3/44 • Number of events 3 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/9 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
2.0%
2/101 • Number of events 2 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/3 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/103 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/44 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/9 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/101 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
33.3%
1/3 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
|
Metabolism and nutrition disorders
Hypouricaemia
|
0.00%
0/103 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/44 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/9 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/101 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
33.3%
1/3 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
|
Infections and infestations
Influenza
|
0.00%
0/103 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
4.5%
2/44 • Number of events 2 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/9 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/101 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
33.3%
1/3 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
|
General disorders
Influenza like illness
|
1.9%
2/103 • Number of events 2 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
2.3%
1/44 • Number of events 2 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
11.1%
1/9 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.99%
1/101 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/3 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
|
Psychiatric disorders
Insomnia
|
11.7%
12/103 • Number of events 13 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
2.3%
1/44 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/9 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
5.0%
5/101 • Number of events 5 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/3 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/103 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/44 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/9 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/101 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
33.3%
1/3 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
|
Eye disorders
Keratitis
|
3.9%
4/103 • Number of events 4 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
2.3%
1/44 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
22.2%
2/9 • Number of events 2 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
5.0%
5/101 • Number of events 5 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/3 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
|
Eye disorders
Lacrimation increased
|
1.9%
2/103 • Number of events 3 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
2.3%
1/44 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
11.1%
1/9 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
3.0%
3/101 • Number of events 3 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/3 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
|
Nervous system disorders
Lethargy
|
0.00%
0/103 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
2.3%
1/44 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
11.1%
1/9 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/101 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/3 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
|
Gastrointestinal disorders
Lip pain
|
0.00%
0/103 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
4.5%
2/44 • Number of events 4 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
11.1%
1/9 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/101 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/3 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
|
Investigations
Lymphocyte count decreased
|
2.9%
3/103 • Number of events 3 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
13.6%
6/44 • Number of events 7 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/9 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.99%
1/101 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/3 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
|
Skin and subcutaneous tissue disorders
Madarosis
|
2.9%
3/103 • Number of events 3 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
6.8%
3/44 • Number of events 3 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/9 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
2.0%
2/101 • Number of events 2 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/3 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
|
Eye disorders
Meibomian gland dysfunction
|
1.9%
2/103 • Number of events 2 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/44 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
11.1%
1/9 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/101 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/3 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
|
Gastrointestinal disorders
Mouth ulceration
|
1.9%
2/103 • Number of events 2 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
9.1%
4/44 • Number of events 4 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/9 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.99%
1/101 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/3 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
|
General disorders
Mucosal inflammation
|
1.9%
2/103 • Number of events 2 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/44 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
11.1%
1/9 • Number of events 2 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
2.0%
2/101 • Number of events 2 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/3 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
|
Musculoskeletal and connective tissue disorders
Muscle fatigue
|
0.00%
0/103 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/44 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
11.1%
1/9 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/101 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/3 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
4.9%
5/103 • Number of events 6 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
2.3%
1/44 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
11.1%
1/9 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
5.0%
5/101 • Number of events 5 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
33.3%
1/3 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
8.7%
9/103 • Number of events 11 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/44 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
11.1%
1/9 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
4.0%
4/101 • Number of events 4 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/3 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
5.8%
6/103 • Number of events 8 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
2.3%
1/44 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
22.2%
2/9 • Number of events 2 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.99%
1/101 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/3 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
|
Skin and subcutaneous tissue disorders
Nail discolouration
|
5.8%
6/103 • Number of events 6 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
11.4%
5/44 • Number of events 5 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
11.1%
1/9 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
9.9%
10/101 • Number of events 10 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
33.3%
1/3 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
|
Eye disorders
Trichiasis
|
5.8%
6/103 • Number of events 6 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/44 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/9 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
5.0%
5/101 • Number of events 6 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/3 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
|
Eye disorders
Trichomegaly
|
3.9%
4/103 • Number of events 4 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/44 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
11.1%
1/9 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.99%
1/101 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/3 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/103 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/44 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
11.1%
1/9 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.99%
1/101 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/3 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
7.8%
8/103 • Number of events 9 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
4.5%
2/44 • Number of events 2 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/9 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
9.9%
10/101 • Number of events 11 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/3 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
|
Gastrointestinal disorders
Abdominal pain
|
19.4%
20/103 • Number of events 28 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
25.0%
11/44 • Number of events 12 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
11.1%
1/9 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
6.9%
7/101 • Number of events 9 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
66.7%
2/3 • Number of events 2 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
4.9%
5/103 • Number of events 5 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
6.8%
3/44 • Number of events 4 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/9 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
5.9%
6/101 • Number of events 7 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/3 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
|
Investigations
Alanine aminotransferase increased
|
2.9%
3/103 • Number of events 3 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
2.3%
1/44 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/9 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
8.9%
9/101 • Number of events 11 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/3 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
47.6%
49/103 • Number of events 50 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
36.4%
16/44 • Number of events 16 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
77.8%
7/9 • Number of events 7 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
37.6%
38/101 • Number of events 38 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
33.3%
1/3 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
|
Blood and lymphatic system disorders
Anaemia
|
18.4%
19/103 • Number of events 22 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
22.7%
10/44 • Number of events 10 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
11.1%
1/9 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
17.8%
18/101 • Number of events 19 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/3 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
|
Psychiatric disorders
Anxiety
|
4.9%
5/103 • Number of events 6 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
2.3%
1/44 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
11.1%
1/9 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.99%
1/101 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/3 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
|
Gastrointestinal disorders
Aphthous ulcer
|
0.97%
1/103 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/44 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
11.1%
1/9 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/101 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/3 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
|
Eye disorders
Arcus lipoides
|
0.97%
1/103 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/44 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/9 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/101 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
33.3%
1/3 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
18.4%
19/103 • Number of events 22 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
13.6%
6/44 • Number of events 7 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
11.1%
1/9 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
18.8%
19/101 • Number of events 22 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/3 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
|
Investigations
Aspartate aminotransferase increased
|
4.9%
5/103 • Number of events 6 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/44 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/9 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
6.9%
7/101 • Number of events 8 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/3 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
|
General disorders
Asthenia
|
27.2%
28/103 • Number of events 31 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
20.5%
9/44 • Number of events 9 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
22.2%
2/9 • Number of events 2 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
31.7%
32/101 • Number of events 37 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/3 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
17.5%
18/103 • Number of events 22 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
13.6%
6/44 • Number of events 6 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
22.2%
2/9 • Number of events 2 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
14.9%
15/101 • Number of events 15 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
33.3%
1/3 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
|
Eye disorders
Blepharitis
|
7.8%
8/103 • Number of events 10 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
2.3%
1/44 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/9 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
8.9%
9/101 • Number of events 9 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
33.3%
1/3 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
|
Investigations
Blood creatinine increased
|
16.5%
17/103 • Number of events 19 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
11.4%
5/44 • Number of events 5 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
22.2%
2/9 • Number of events 2 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
19.8%
20/101 • Number of events 22 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
33.3%
1/3 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
|
Investigations
Blood phosphorus increased
|
8.7%
9/103 • Number of events 11 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
9.1%
4/44 • Number of events 6 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
22.2%
2/9 • Number of events 2 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
12.9%
13/101 • Number of events 23 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
33.3%
1/3 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
|
Cardiac disorders
Bundle branch block left
|
0.00%
0/103 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/44 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/9 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/101 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
33.3%
1/3 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
|
Infections and infestations
Candida infection
|
0.97%
1/103 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/44 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
11.1%
1/9 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/101 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/3 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
|
Eye disorders
Cataract
|
5.8%
6/103 • Number of events 7 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
2.3%
1/44 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/9 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
5.9%
6/101 • Number of events 6 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/3 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
|
Gastrointestinal disorders
Chapped lips
|
0.00%
0/103 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/44 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
11.1%
1/9 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/101 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/3 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
|
General disorders
Chest pain
|
1.9%
2/103 • Number of events 2 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
2.3%
1/44 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
11.1%
1/9 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/101 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/3 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
|
General disorders
Chills
|
1.9%
2/103 • Number of events 2 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
6.8%
3/44 • Number of events 3 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/9 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
2.0%
2/101 • Number of events 2 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/3 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
|
Nervous system disorders
Cognitive disorder
|
0.97%
1/103 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/44 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
11.1%
1/9 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/101 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/3 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
|
Infections and infestations
Conjunctivitis
|
3.9%
4/103 • Number of events 5 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
4.5%
2/44 • Number of events 2 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
11.1%
1/9 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
5.9%
6/101 • Number of events 6 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
33.3%
1/3 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
|
Infections and infestations
Conjunctivitis bacterial
|
0.00%
0/103 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/44 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
11.1%
1/9 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/101 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/3 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
|
Gastrointestinal disorders
Constipation
|
35.0%
36/103 • Number of events 46 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
25.0%
11/44 • Number of events 13 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
44.4%
4/9 • Number of events 4 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
32.7%
33/101 • Number of events 35 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
33.3%
1/3 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.97%
1/103 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/44 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/9 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
2.0%
2/101 • Number of events 2 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
33.3%
1/3 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
|
Eye disorders
Corneal neovascularisation
|
0.97%
1/103 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/44 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/9 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/101 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
33.3%
1/3 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
14.6%
15/103 • Number of events 18 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
6.8%
3/44 • Number of events 3 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/9 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
5.0%
5/101 • Number of events 5 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
33.3%
1/3 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
31.1%
32/103 • Number of events 38 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
25.0%
11/44 • Number of events 12 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
44.4%
4/9 • Number of events 4 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
28.7%
29/101 • Number of events 33 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/3 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
|
Metabolism and nutrition disorders
Dehydration
|
7.8%
8/103 • Number of events 12 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
4.5%
2/44 • Number of events 2 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
11.1%
1/9 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
3.0%
3/101 • Number of events 3 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/3 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
|
Eye disorders
Detachment of macular retinal pigment epithelium
|
0.00%
0/103 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/44 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/9 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/101 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
33.3%
1/3 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
|
Gastrointestinal disorders
Diarrhoea
|
51.5%
53/103 • Number of events 89 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
43.2%
19/44 • Number of events 28 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
66.7%
6/9 • Number of events 8 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
33.7%
34/101 • Number of events 55 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
66.7%
2/3 • Number of events 2 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
|
Nervous system disorders
Disturbance in attention
|
0.00%
0/103 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/44 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
11.1%
1/9 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/101 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/3 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
|
Nervous system disorders
Dizziness
|
11.7%
12/103 • Number of events 14 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
9.1%
4/44 • Number of events 4 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
11.1%
1/9 • Number of events 2 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
4.0%
4/101 • Number of events 6 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/3 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
|
Eye disorders
Dry eye
|
20.4%
21/103 • Number of events 27 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
15.9%
7/44 • Number of events 7 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
44.4%
4/9 • Number of events 4 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
18.8%
19/101 • Number of events 20 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
33.3%
1/3 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
|
Gastrointestinal disorders
Dry mouth
|
32.0%
33/103 • Number of events 35 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
29.5%
13/44 • Number of events 13 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
77.8%
7/9 • Number of events 7 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
38.6%
39/101 • Number of events 39 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
33.3%
1/3 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
20.4%
21/103 • Number of events 23 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
13.6%
6/44 • Number of events 6 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
44.4%
4/9 • Number of events 5 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
21.8%
22/101 • Number of events 23 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
66.7%
2/3 • Number of events 2 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
|
Nervous system disorders
Dysgeusia
|
31.1%
32/103 • Number of events 35 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
20.5%
9/44 • Number of events 10 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
66.7%
6/9 • Number of events 6 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
30.7%
31/101 • Number of events 33 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
33.3%
1/3 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
|
Gastrointestinal disorders
Dyspepsia
|
9.7%
10/103 • Number of events 16 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
2.3%
1/44 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
22.2%
2/9 • Number of events 2 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
6.9%
7/101 • Number of events 7 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/3 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
|
Gastrointestinal disorders
Dysphagia
|
3.9%
4/103 • Number of events 5 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
6.8%
3/44 • Number of events 3 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/9 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
2.0%
2/101 • Number of events 2 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
33.3%
1/3 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
4.9%
5/103 • Number of events 5 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
9.1%
4/44 • Number of events 6 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
11.1%
1/9 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
4.0%
4/101 • Number of events 4 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/3 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
3.9%
4/103 • Number of events 4 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
6.8%
3/44 • Number of events 4 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
11.1%
1/9 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
5.0%
5/101 • Number of events 5 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
33.3%
1/3 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
|
Renal and urinary disorders
Dysuria
|
3.9%
4/103 • Number of events 5 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
2.3%
1/44 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
11.1%
1/9 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
3.0%
3/101 • Number of events 3 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/3 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
12.6%
13/103 • Number of events 15 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
6.8%
3/44 • Number of events 3 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
22.2%
2/9 • Number of events 2 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
13.9%
14/101 • Number of events 18 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/3 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
2.9%
3/103 • Number of events 3 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/44 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
11.1%
1/9 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
2.0%
2/101 • Number of events 3 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/3 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
|
Eye disorders
Eye disorder
|
0.00%
0/103 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/44 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/9 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/101 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
33.3%
1/3 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
|
Eye disorders
Eye haematoma
|
0.00%
0/103 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/44 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/9 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.99%
1/101 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
33.3%
1/3 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
|
Eye disorders
Eye pain
|
0.97%
1/103 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/44 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
11.1%
1/9 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
2.0%
2/101 • Number of events 4 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/3 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
|
Eye disorders
Eyelid pain
|
0.00%
0/103 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/44 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
11.1%
1/9 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/101 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/3 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
|
General disorders
Fatigue
|
35.0%
36/103 • Number of events 44 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
36.4%
16/44 • Number of events 17 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
33.3%
3/9 • Number of events 3 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
28.7%
29/101 • Number of events 33 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
33.3%
1/3 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
0.00%
0/103 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/44 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
11.1%
1/9 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/101 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/3 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
|
Skin and subcutaneous tissue disorders
Nail dystrophy
|
6.8%
7/103 • Number of events 8 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
4.5%
2/44 • Number of events 2 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
11.1%
1/9 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
5.9%
6/101 • Number of events 6 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/3 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
|
Skin and subcutaneous tissue disorders
Nail toxicity
|
4.9%
5/103 • Number of events 6 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
2.3%
1/44 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/9 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
6.9%
7/101 • Number of events 7 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/3 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal dryness
|
2.9%
3/103 • Number of events 3 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/44 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
22.2%
2/9 • Number of events 2 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
5.0%
5/101 • Number of events 5 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/3 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
|
Gastrointestinal disorders
Nausea
|
27.2%
28/103 • Number of events 39 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
29.5%
13/44 • Number of events 17 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
11.1%
1/9 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
17.8%
18/101 • Number of events 19 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/3 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
4.9%
5/103 • Number of events 5 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
4.5%
2/44 • Number of events 2 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
11.1%
1/9 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/101 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/3 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
|
Nervous system disorders
Neuropathy peripheral
|
3.9%
4/103 • Number of events 4 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
4.5%
2/44 • Number of events 2 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
11.1%
1/9 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.99%
1/101 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
33.3%
1/3 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
|
General disorders
Oedema peripheral
|
5.8%
6/103 • Number of events 6 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
18.2%
8/44 • Number of events 9 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/9 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
9.9%
10/101 • Number of events 10 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/3 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
|
Skin and subcutaneous tissue disorders
Onychalgia
|
3.9%
4/103 • Number of events 6 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
4.5%
2/44 • Number of events 2 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/9 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
5.9%
6/101 • Number of events 6 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
33.3%
1/3 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
|
Skin and subcutaneous tissue disorders
Onycholysis
|
9.7%
10/103 • Number of events 10 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
13.6%
6/44 • Number of events 7 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/9 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
9.9%
10/101 • Number of events 10 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
33.3%
1/3 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
|
Skin and subcutaneous tissue disorders
Onychomadesis
|
5.8%
6/103 • Number of events 7 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
6.8%
3/44 • Number of events 3 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
11.1%
1/9 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
7.9%
8/101 • Number of events 8 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/3 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
|
Infections and infestations
Oral candidiasis
|
2.9%
3/103 • Number of events 4 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
2.3%
1/44 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
11.1%
1/9 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
3.0%
3/101 • Number of events 3 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/3 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
|
Infections and infestations
Oral herpes
|
0.00%
0/103 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/44 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
11.1%
1/9 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/101 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/3 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
|
Gastrointestinal disorders
Oral pain
|
4.9%
5/103 • Number of events 5 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
9.1%
4/44 • Number of events 5 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
11.1%
1/9 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.99%
1/101 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/3 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
5.8%
6/103 • Number of events 7 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
6.8%
3/44 • Number of events 3 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/9 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
5.0%
5/101 • Number of events 5 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/3 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
|
Vascular disorders
Orthostatic hypotension
|
0.97%
1/103 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/44 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
11.1%
1/9 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/101 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/3 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
|
General disorders
Pain
|
5.8%
6/103 • Number of events 6 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
6.8%
3/44 • Number of events 3 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
22.2%
2/9 • Number of events 2 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
3.0%
3/101 • Number of events 3 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/3 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
11.7%
12/103 • Number of events 14 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
9.1%
4/44 • Number of events 5 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
11.1%
1/9 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
14.9%
15/101 • Number of events 18 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
33.3%
1/3 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
7.8%
8/103 • Number of events 10 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
6.8%
3/44 • Number of events 3 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
11.1%
1/9 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
27.7%
28/101 • Number of events 31 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/3 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
|
Infections and infestations
Paronychia
|
2.9%
3/103 • Number of events 3 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
2.3%
1/44 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/9 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
7.9%
8/101 • Number of events 10 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
33.3%
1/3 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
|
Reproductive system and breast disorders
Pelvic pain
|
2.9%
3/103 • Number of events 3 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
6.8%
3/44 • Number of events 3 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/9 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
2.0%
2/101 • Number of events 2 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/3 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.97%
1/103 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/44 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
11.1%
1/9 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
3.0%
3/101 • Number of events 5 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/3 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
|
Renal and urinary disorders
Proteinuria
|
5.8%
6/103 • Number of events 6 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
4.5%
2/44 • Number of events 2 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
11.1%
1/9 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/101 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/3 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
8.7%
9/103 • Number of events 9 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
4.5%
2/44 • Number of events 2 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/9 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
4.0%
4/101 • Number of events 4 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/3 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
|
Eye disorders
Punctate keratitis
|
1.9%
2/103 • Number of events 2 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
2.3%
1/44 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
11.1%
1/9 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
6.9%
7/101 • Number of events 8 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/3 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
|
General disorders
Pyrexia
|
13.6%
14/103 • Number of events 19 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
13.6%
6/44 • Number of events 6 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/9 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
11.9%
12/101 • Number of events 17 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/3 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
|
Skin and subcutaneous tissue disorders
Rash
|
7.8%
8/103 • Number of events 8 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
4.5%
2/44 • Number of events 2 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/9 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
7.9%
8/101 • Number of events 8 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/3 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
|
Eye disorders
Retinal detachment
|
1.9%
2/103 • Number of events 2 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/44 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/9 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
8.9%
9/101 • Number of events 9 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
33.3%
1/3 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
0.97%
1/103 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/44 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
11.1%
1/9 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.99%
1/101 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/3 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
|
Gastrointestinal disorders
Stomatitis
|
46.6%
48/103 • Number of events 70 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
29.5%
13/44 • Number of events 14 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
33.3%
3/9 • Number of events 3 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
44.6%
45/101 • Number of events 56 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
33.3%
1/3 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
|
Eye disorders
Subretinal fluid
|
2.9%
3/103 • Number of events 3 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/44 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
11.1%
1/9 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/101 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/3 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
|
Gastrointestinal disorders
Tooth disorder
|
0.00%
0/103 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/44 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/9 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.99%
1/101 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
33.3%
1/3 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/103 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/44 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
11.1%
1/9 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/101 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/3 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
0.97%
1/103 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/44 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/9 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/101 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
33.3%
1/3 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
|
Infections and infestations
Urinary tract infection
|
24.3%
25/103 • Number of events 31 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
22.7%
10/44 • Number of events 16 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
11.1%
1/9 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
9.9%
10/101 • Number of events 12 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/3 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
|
Eye disorders
Vision blurred
|
5.8%
6/103 • Number of events 7 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
2.3%
1/44 • Number of events 3 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
11.1%
1/9 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
6.9%
7/101 • Number of events 8 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/3 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
|
Eye disorders
Visual acuity reduced
|
4.9%
5/103 • Number of events 5 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/44 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/9 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
9.9%
10/101 • Number of events 10 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/3 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
|
Eye disorders
Visual impairment
|
2.9%
3/103 • Number of events 3 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/44 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/9 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
5.9%
6/101 • Number of events 6 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/3 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
|
Investigations
Vitamin D decreased
|
2.9%
3/103 • Number of events 3 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
2.3%
1/44 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
11.1%
1/9 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
2.0%
2/101 • Number of events 2 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/3 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
3.9%
4/103 • Number of events 5 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
2.3%
1/44 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
11.1%
1/9 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
2.0%
2/101 • Number of events 2 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
33.3%
1/3 • Number of events 2 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
|
Gastrointestinal disorders
Vomiting
|
18.4%
19/103 • Number of events 29 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
22.7%
10/44 • Number of events 15 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/9 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
11.9%
12/101 • Number of events 19 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
33.3%
1/3 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
|
Investigations
Weight decreased
|
18.4%
19/103 • Number of events 21 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
4.5%
2/44 • Number of events 2 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
11.1%
1/9 • Number of events 1 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
11.9%
12/101 • Number of events 12 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
0.00%
0/3 • Adverse events were assessed for up to approximately 25 weeks; All-cause Mortality was assessed for up to 1610 days.
Treatment-emergent adverse events, defined as adverse events either reported for the first time or the worsening of pre-existing events after the first dose of study drug and within 30 days of the last dose of study drug, have been reported.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Following the first publication, the Institution and/or Principal Investigator may publish data or results from the Study, provided, however, that the Institution and/or Principal Investigator submits the proposed publication to the Sponsor for review at least sixty (60) days prior to the date of the proposed publication. Sponsor may remove from the proposed publication any information that is considered confidential and/or proprietary other than Study data and results.
- Publication restrictions are in place
Restriction type: OTHER