Trial Outcomes & Findings for An Extension Treatment Protocol for Subjects Who Have Participated in a Study of Tivozanib Versus Sorafenib in Kidney Carcinoma (Protocol AV-951-09-301). (NCT NCT01076010)
NCT ID: NCT01076010
Last Updated: 2020-10-05
Results Overview
Number of days subjects received treatment who were from Protocol AV-951-09-301 who either continued on tivozanib in this trial (subjects with first-line experience on tivozanib treatment), who crossed over from sorafenib to tivozanib in this trial (crossover subjects) participated in, and who continued on sorafenib in this trial (subjects with first-line experience on sorafenib treatment). Subjects could be discontinued due to unacceptable toxicities or clinical or documented PD
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
277 participants
Primary outcome timeframe
From enrollment to until all subjects discontinue (due to documented progressive disease [PD] or unacceptable toxicities) or until 3 years after the first subject was enrolled in Protocol AV-951-09-902
Results posted on
2020-10-05
Participant Flow
Subjects were enrolled at 55 sites in 14 countries. Study Period from 24 May 2010 (First Subject Dosed) to 04 July 2014 (Last Subject Last Visit).
All participants underwent inclusion and exclusion criteria assessment and all eligible subjects signed the informed consent before undergoing any study related procedures. All the study assessments were performed as per the schedule of assessment.
Participant milestones
| Measure |
Sorafenib Crossover to Tivozanib
The subjects who failed sorafenib (had Response Evaluation Criteria in Solid Tumors \[RECIST\] - defined progressive disease) on the parent protocol AV-951-09-301 will be offered tivozanib hydrochloride on Protocol AV- 951-09-902.
|
First Line Tivozanib.
The subjects who were randomized to tivozanib (continued from the parent Protocol AV-951-09-301) and demonstrated clinical benefit and acceptable tolerability in Protocol AV-951-09-301.
|
First Line Sorafenib.
The subjects who were randomized to sorafenib (continued from the parent Protocol AV-951-09-301) and demonstrated clinical benefit and acceptable tolerability were to be offered long-term access to sorafenib.
|
|---|---|---|---|
|
Overall Study
STARTED
|
161
|
88
|
28
|
|
Overall Study
COMPLETED
|
36
|
49
|
26
|
|
Overall Study
NOT COMPLETED
|
125
|
39
|
2
|
Reasons for withdrawal
| Measure |
Sorafenib Crossover to Tivozanib
The subjects who failed sorafenib (had Response Evaluation Criteria in Solid Tumors \[RECIST\] - defined progressive disease) on the parent protocol AV-951-09-301 will be offered tivozanib hydrochloride on Protocol AV- 951-09-902.
|
First Line Tivozanib.
The subjects who were randomized to tivozanib (continued from the parent Protocol AV-951-09-301) and demonstrated clinical benefit and acceptable tolerability in Protocol AV-951-09-301.
|
First Line Sorafenib.
The subjects who were randomized to sorafenib (continued from the parent Protocol AV-951-09-301) and demonstrated clinical benefit and acceptable tolerability were to be offered long-term access to sorafenib.
|
|---|---|---|---|
|
Overall Study
Death
|
15
|
1
|
0
|
|
Overall Study
Adverse Event
|
7
|
2
|
0
|
|
Overall Study
Progressive disease
|
90
|
30
|
1
|
|
Overall Study
Lack of Efficacy
|
4
|
0
|
0
|
|
Overall Study
Treatment Interruption for > 2 Weeks
|
0
|
1
|
0
|
|
Overall Study
Significant Surgical Procedure
|
0
|
1
|
0
|
|
Overall Study
Protocol Violation
|
0
|
1
|
0
|
|
Overall Study
Noncompliance
|
1
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
3
|
0
|
1
|
|
Overall Study
Other
|
5
|
2
|
0
|
Baseline Characteristics
An Extension Treatment Protocol for Subjects Who Have Participated in a Study of Tivozanib Versus Sorafenib in Kidney Carcinoma (Protocol AV-951-09-301).
Baseline characteristics by cohort
| Measure |
Sorafenib Crossover to Tivozanib
n=161 Participants
The subjects who failed sorafenib (had Response Evaluation Criteria in Solid Tumors \[RECIST\] - defined progressive disease) on the parent protocol AV-951-09-301 will be offered tivozanib hydrochloride on Protocol AV- 951-09-902.
|
First Line Tivozanib
n=88 Participants
The subjects who were randomized to tivozanib (continued from the parent Protocol AV-951-09-301) and demonstrated clinical benefit and acceptable tolerability in Protocol AV-951-09-301.
|
First Line Sorafenib
n=28 Participants
The subjects who were randomized to sorafenib (continued from the parent Protocol AV-951-09-301) and demonstrated clinical benefit and acceptable tolerability were to be offered long-term access to sorafenib.
|
Total
n=277 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
120 Participants
n=99 Participants
|
58 Participants
n=107 Participants
|
17 Participants
n=206 Participants
|
195 Participants
n=7 Participants
|
|
Age, Categorical
>=65 years
|
41 Participants
n=99 Participants
|
30 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
82 Participants
n=7 Participants
|
|
Sex: Female, Male
Female
|
46 Participants
n=99 Participants
|
33 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
88 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
115 Participants
n=99 Participants
|
55 Participants
n=107 Participants
|
19 Participants
n=206 Participants
|
189 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
7 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
9 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
154 Participants
n=99 Participants
|
84 Participants
n=107 Participants
|
28 Participants
n=206 Participants
|
266 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Asian
|
5 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
6 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
White
|
156 Participants
n=99 Participants
|
87 Participants
n=107 Participants
|
28 Participants
n=206 Participants
|
271 Participants
n=7 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
PRIMARY outcome
Timeframe: From enrollment to until all subjects discontinue (due to documented progressive disease [PD] or unacceptable toxicities) or until 3 years after the first subject was enrolled in Protocol AV-951-09-902Number of days subjects received treatment who were from Protocol AV-951-09-301 who either continued on tivozanib in this trial (subjects with first-line experience on tivozanib treatment), who crossed over from sorafenib to tivozanib in this trial (crossover subjects) participated in, and who continued on sorafenib in this trial (subjects with first-line experience on sorafenib treatment). Subjects could be discontinued due to unacceptable toxicities or clinical or documented PD
Outcome measures
| Measure |
Sorafenib Crossover to Tivozanib
n=161 Participants
The subjects who failed sorafenib (had Response Evaluation Criteria in Solid Tumors \[RECIST\] - defined progressive disease) on the parent protocol AV-951-09-301 will be offered tivozanib hydrochloride on Protocol AV- 951-09-902.
|
First Line Tivozanib.
n=88 Participants
The subjects who were randomized to tivozanib (continued from the parent Protocol AV-951-09-301) and demonstrated clinical benefit and acceptable tolerability in Protocol AV-951-09-301.
|
First Line Sorafenib.
n=28 Participants
The subjects who were randomized to sorafenib (continued from the parent Protocol AV-951-09-301) and demonstrated clinical benefit and acceptable tolerability were to be offered long-term access to sorafenib.
|
|---|---|---|---|
|
Number of Days Subjects Received Treatment in Each Treatment Arm
Duration of Treatment
|
290 Days
Standard Deviation 234.37
|
325.3 Days
Standard Deviation 137.79
|
369.4 Days
Standard Deviation 107.6
|
|
Number of Days Subjects Received Treatment in Each Treatment Arm
Total Days Receiving Drug
|
222.36 Days
Standard Deviation 181.722
|
241.0 Days
Standard Deviation 105.928
|
368.14 Days
Standard Deviation 107.946
|
PRIMARY outcome
Timeframe: From enrollment to until all subjects discontinue (due to documented PD or unacceptable toxicities) or until 3 years after the first subject was enrolled in Protocol AV-951-09-902Number of cycles subjects received who were from Protocol AV-951-09-301 who either continued on tivozanib in this trial (subjects with first-line experience on tivozanib treatment), who crossed over from sorafenib to tivozanib in this trial (crossover subjects) participated in, and who continued on sorafenib in this trial (subjects with first-line experience on sorafenib treatment). Subjects could be discontinued due to unacceptable toxicities or clinical or documented PD
Outcome measures
| Measure |
Sorafenib Crossover to Tivozanib
n=161 Participants
The subjects who failed sorafenib (had Response Evaluation Criteria in Solid Tumors \[RECIST\] - defined progressive disease) on the parent protocol AV-951-09-301 will be offered tivozanib hydrochloride on Protocol AV- 951-09-902.
|
First Line Tivozanib.
n=88 Participants
The subjects who were randomized to tivozanib (continued from the parent Protocol AV-951-09-301) and demonstrated clinical benefit and acceptable tolerability in Protocol AV-951-09-301.
|
First Line Sorafenib.
n=28 Participants
The subjects who were randomized to sorafenib (continued from the parent Protocol AV-951-09-301) and demonstrated clinical benefit and acceptable tolerability were to be offered long-term access to sorafenib.
|
|---|---|---|---|
|
Number of Cycles Subjects Received Treatment in Each Treatment Arm
|
10.6 Number of cycles started
Standard Deviation 8.36
|
11.8 Number of cycles started
Standard Deviation 4.85
|
13.2 Number of cycles started
Standard Deviation 3.83
|
PRIMARY outcome
Timeframe: From enrollment to until all subjects discontinue (due to documented PD or unacceptable toxicities) or until 3 years after the first subject was enrolled in Protocol AV-951-09-902The total dose administered to subjects who were from Protocol AV-951-09-301 who either continued on tivozanib in this trial (subjects with first-line experience on tivozanib treatment), who crossed over from sorafenib to tivozanib in this trial (crossover subjects) participated in, and who continued on sorafenib in this trial (subjects with first-line experience on sorafenib treatment). Subjects could be discontinued due to unacceptable toxicities or clinical or documented PD
Outcome measures
| Measure |
Sorafenib Crossover to Tivozanib
n=161 Participants
The subjects who failed sorafenib (had Response Evaluation Criteria in Solid Tumors \[RECIST\] - defined progressive disease) on the parent protocol AV-951-09-301 will be offered tivozanib hydrochloride on Protocol AV- 951-09-902.
|
First Line Tivozanib.
n=88 Participants
The subjects who were randomized to tivozanib (continued from the parent Protocol AV-951-09-301) and demonstrated clinical benefit and acceptable tolerability in Protocol AV-951-09-301.
|
First Line Sorafenib.
n=28 Participants
The subjects who were randomized to sorafenib (continued from the parent Protocol AV-951-09-301) and demonstrated clinical benefit and acceptable tolerability were to be offered long-term access to sorafenib.
|
|---|---|---|---|
|
Total Dose Administered to Subjects in Each Treatment Arm (mg)
|
318.84 mg
Standard Deviation 256.241
|
344.58 mg
Standard Deviation 152.131
|
244014.29 mg
Standard Deviation 116816.715
|
PRIMARY outcome
Timeframe: From enrollment to until all subjects discontinue (due to documented PD or unacceptable toxicities) or until 3 years after the first subject was enrolled in Protocol AV-951-09-902The average daily dose administered to subjects who were from Protocol AV-951-09-301 who either continued on tivozanib in this trial (subjects with first-line experience on tivozanib treatment), who crossed over from sorafenib to tivozanib in this trial (crossover subjects) participated in, and who continued on sorafenib in this trial (subjects with first-line experience on sorafenib treatment). Subjects could be discontinued due to unacceptable toxicities or clinical or documented PD
Outcome measures
| Measure |
Sorafenib Crossover to Tivozanib
n=161 Participants
The subjects who failed sorafenib (had Response Evaluation Criteria in Solid Tumors \[RECIST\] - defined progressive disease) on the parent protocol AV-951-09-301 will be offered tivozanib hydrochloride on Protocol AV- 951-09-902.
|
First Line Tivozanib.
n=88 Participants
The subjects who were randomized to tivozanib (continued from the parent Protocol AV-951-09-301) and demonstrated clinical benefit and acceptable tolerability in Protocol AV-951-09-301.
|
First Line Sorafenib.
n=28 Participants
The subjects who were randomized to sorafenib (continued from the parent Protocol AV-951-09-301) and demonstrated clinical benefit and acceptable tolerability were to be offered long-term access to sorafenib.
|
|---|---|---|---|
|
Average Daily Dose Administered to Subjects in Each Treatment Arm
|
1.46 mg/day
Standard Deviation 0.121
|
1.40 mg/day
Standard Deviation 0.196
|
651.47 mg/day
Standard Deviation 225.410
|
PRIMARY outcome
Timeframe: From enrollment to until all subjects discontinue (due to documented PD or unacceptable toxicities) or until 3 years after the first subject was enrolled in Protocol AV-951-09-902RDI is defined as 100% times the actual dose intensity divided by the intended dose intensity. The RDI of subjects who were from Protocol AV-951-09-301 who either continued on tivozanib in this trial (subjects with first-line experience on tivozanib treatment), who crossed over from sorafenib to tivozanib in this trial (crossover subjects) participated in, and who continued on sorafenib in this trial (subjects with first-line experience on sorafenib treatment). Subjects could be discontinued due to unacceptable toxicities or clinical or documented PD
Outcome measures
| Measure |
Sorafenib Crossover to Tivozanib
n=161 Participants
The subjects who failed sorafenib (had Response Evaluation Criteria in Solid Tumors \[RECIST\] - defined progressive disease) on the parent protocol AV-951-09-301 will be offered tivozanib hydrochloride on Protocol AV- 951-09-902.
|
First Line Tivozanib.
n=88 Participants
The subjects who were randomized to tivozanib (continued from the parent Protocol AV-951-09-301) and demonstrated clinical benefit and acceptable tolerability in Protocol AV-951-09-301.
|
First Line Sorafenib.
n=28 Participants
The subjects who were randomized to sorafenib (continued from the parent Protocol AV-951-09-301) and demonstrated clinical benefit and acceptable tolerability were to be offered long-term access to sorafenib.
|
|---|---|---|---|
|
Relative Dose Intensity (RDI) of Treatment Administered to Subjects in Each Treatment Arm
|
95.21 percentage of dose
Standard Deviation 9.393
|
91.12 percentage of dose
Standard Deviation 14.762
|
80.60 percentage of dose
Standard Deviation 28.603
|
PRIMARY outcome
Timeframe: From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlierPopulation: Number of subjects with adverse events
Number of subjects with Treatment-Related Adverse Events (AEs) as assessed by Common Terminology Criteria for Adverse Events v3.0
Outcome measures
| Measure |
Sorafenib Crossover to Tivozanib
n=161 Participants
The subjects who failed sorafenib (had Response Evaluation Criteria in Solid Tumors \[RECIST\] - defined progressive disease) on the parent protocol AV-951-09-301 will be offered tivozanib hydrochloride on Protocol AV- 951-09-902.
|
First Line Tivozanib.
n=88 Participants
The subjects who were randomized to tivozanib (continued from the parent Protocol AV-951-09-301) and demonstrated clinical benefit and acceptable tolerability in Protocol AV-951-09-301.
|
First Line Sorafenib.
n=28 Participants
The subjects who were randomized to sorafenib (continued from the parent Protocol AV-951-09-301) and demonstrated clinical benefit and acceptable tolerability were to be offered long-term access to sorafenib.
|
|---|---|---|---|
|
Number of Subjects With Adverse Events
AE
|
124 Participants
|
85 Participants
|
28 Participants
|
|
Number of Subjects With Adverse Events
AE Leading to Study Drug Dose Reduction
|
11 Participants
|
11 Participants
|
10 Participants
|
|
Number of Subjects With Adverse Events
Any AE of Grade 3 or Higher
|
77 Participants
|
55 Participants
|
19 Participants
|
|
Number of Subjects With Adverse Events
Any Treatment-Related AE
|
86 Participants
|
76 Participants
|
27 Participants
|
|
Number of Subjects With Adverse Events
Any Treatment-Related Any Treatment AE ≥ Grade 3
|
39 Participants
|
35 Participants
|
15 Participants
|
|
Number of Subjects With Adverse Events
Any AE With Outcome of Death
|
21 Participants
|
3 Participants
|
0 Participants
|
|
Number of Subjects With Adverse Events
Any treatment-Related AE With Outcome of death
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Adverse Events
Any serious adverse event (SAE)
|
49 Participants
|
17 Participants
|
4 Participants
|
|
Number of Subjects With Adverse Events
Any treatment-related SAE
|
7 Participants
|
7 Participants
|
2 Participants
|
|
Number of Subjects With Adverse Events
AE leading to study drug discontinuation (AEDC)
|
19 Participants
|
4 Participants
|
0 Participants
|
|
Number of Subjects With Adverse Events
Any treatment-related AEDC
|
3 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Adverse Events
AE leading to study drug interruption
|
27 Participants
|
26 Participants
|
12 Participants
|
|
Number of Subjects With Adverse Events
Treatment-related AE - study drug interruption
|
13 Participants
|
17 Participants
|
10 Participants
|
|
Number of Subjects With Adverse Events
Treatment related AE - Study Drug Dose Reduction
|
9 Participants
|
11 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: From Day 1 to the end of treatment (EOT) Visit, approximately every 8 weeksORR is defined as the proportion of subjects with confirmed complete response (CR) or confirmed partial response (PR) according to RECIST (Version 1.0), relative to the total population of dosed subjects. CR is disappearance of all target and non-target lesions and normalization of tumor marker levels. At least a 30% decrease in the sum of the loading dose (LD) of target lesions, taking as reference the baseline sum LD. To allow long-term access to sorafenib for subjects who participated in Protocol AV-951-09-301 (NCT01030783), and demonstrated clinical benefit and acceptable tolerability to sorafenib.
Outcome measures
| Measure |
Sorafenib Crossover to Tivozanib
n=161 Participants
The subjects who failed sorafenib (had Response Evaluation Criteria in Solid Tumors \[RECIST\] - defined progressive disease) on the parent protocol AV-951-09-301 will be offered tivozanib hydrochloride on Protocol AV- 951-09-902.
|
First Line Tivozanib.
n=88 Participants
The subjects who were randomized to tivozanib (continued from the parent Protocol AV-951-09-301) and demonstrated clinical benefit and acceptable tolerability in Protocol AV-951-09-301.
|
First Line Sorafenib.
n=28 Participants
The subjects who were randomized to sorafenib (continued from the parent Protocol AV-951-09-301) and demonstrated clinical benefit and acceptable tolerability were to be offered long-term access to sorafenib.
|
|---|---|---|---|
|
Number of Subjects With Objective Response Rate (ORR) Who Continued Treatment With Tivozanib or Sorafenib and Who Received Tivozanib After Failure of Sorafenib
Overall Confirmed Objective Response Rate
|
29 Participants
|
49 Participants
|
16 Participants
|
|
Number of Subjects With Objective Response Rate (ORR) Who Continued Treatment With Tivozanib or Sorafenib and Who Received Tivozanib After Failure of Sorafenib
Overall Unconfirmed Objective Response Rate
|
43 Participants
|
55 Participants
|
16 Participants
|
SECONDARY outcome
Timeframe: From the first documentation of objective tumor response to the first documentation of objective tumor progression, assessed up to treatment discontinuation or to death due to any reason or maximum up to 3 years, whichever occurs earlierDR was defined as the time from the first documentation of objective tumor response (confirmed CR or confirmed PR) according to RECIST (Version 1.0) to the first documentation of objective tumor progression or to death due to any reason. DR was calculated for the subgroup of subjects with a confirmed objective tumor response (PR or CR). CR is Disappearance of all target and non-target lesions and normalization of tumor marker levels. PR is At least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. Number of subjects with disease progression or death and censored endpoints were summarized and statistical analysis were performed for duration of response.
Outcome measures
| Measure |
Sorafenib Crossover to Tivozanib
n=29 Participants
The subjects who failed sorafenib (had Response Evaluation Criteria in Solid Tumors \[RECIST\] - defined progressive disease) on the parent protocol AV-951-09-301 will be offered tivozanib hydrochloride on Protocol AV- 951-09-902.
|
First Line Tivozanib.
n=49 Participants
The subjects who were randomized to tivozanib (continued from the parent Protocol AV-951-09-301) and demonstrated clinical benefit and acceptable tolerability in Protocol AV-951-09-301.
|
First Line Sorafenib.
n=16 Participants
The subjects who were randomized to sorafenib (continued from the parent Protocol AV-951-09-301) and demonstrated clinical benefit and acceptable tolerability were to be offered long-term access to sorafenib.
|
|---|---|---|---|
|
Duration of Response (DR)
Subjects who had disease progression or died
|
10 Participants
|
11 Participants
|
0 Participants
|
|
Duration of Response (DR)
Subjects with censored endpoints
|
19 Participants
|
38 Participants
|
16 Participants
|
SECONDARY outcome
Timeframe: From the date of first dose of study drug (tivozanib or sorafenib) in the AV-951-09-902 study to the first documentation of objective tumor progression or death due to any reason or maximum up to 3 years, whichever occurred firstPFS was defined as the date of first dose of study drug to the first documentation of objective tumor progression or death due to any reason, whichever occurred first. For the crossover subjects and subjects with first-line experience on tivozanib treatment, the timeframe for PFS assessment started from the date of first dose of tivozanib in the AV-951-09-902 study. For subjects with first-line experience on sorafenib treatment, the timeframe for PFS assessment started from the date of first dose of sorafenib in the AV-951-09-902. Number of subjects with disease progression or death was summarized and statistical analysis were performed for PFS.
Outcome measures
| Measure |
Sorafenib Crossover to Tivozanib
n=161 Participants
The subjects who failed sorafenib (had Response Evaluation Criteria in Solid Tumors \[RECIST\] - defined progressive disease) on the parent protocol AV-951-09-301 will be offered tivozanib hydrochloride on Protocol AV- 951-09-902.
|
First Line Tivozanib.
n=88 Participants
The subjects who were randomized to tivozanib (continued from the parent Protocol AV-951-09-301) and demonstrated clinical benefit and acceptable tolerability in Protocol AV-951-09-301.
|
First Line Sorafenib.
n=28 Participants
The subjects who were randomized to sorafenib (continued from the parent Protocol AV-951-09-301) and demonstrated clinical benefit and acceptable tolerability were to be offered long-term access to sorafenib.
|
|---|---|---|---|
|
Progression-free Survival (PFS)
Subjects who had disease progression or died
|
108 Participants
|
35 Participants
|
1 Participants
|
|
Progression-free Survival (PFS)
Subjects with censored endpoints
|
53 Participants
|
53 Participants
|
27 Participants
|
SECONDARY outcome
Timeframe: From the date of first dose of study drug (tivozanib or sorafenib) in the AV-951-09-902 study to death due to any reason or maximum up to 3 years, whichever occurred firstOS was defined as the time from the first dose of study drug (tivozanib or sorafenib) date on this study to date of death due to any cause. Number of subjects died or alive was summarized and statistical analysis were performed for OS.
Outcome measures
| Measure |
Sorafenib Crossover to Tivozanib
n=161 Participants
The subjects who failed sorafenib (had Response Evaluation Criteria in Solid Tumors \[RECIST\] - defined progressive disease) on the parent protocol AV-951-09-301 will be offered tivozanib hydrochloride on Protocol AV- 951-09-902.
|
First Line Tivozanib.
n=88 Participants
The subjects who were randomized to tivozanib (continued from the parent Protocol AV-951-09-301) and demonstrated clinical benefit and acceptable tolerability in Protocol AV-951-09-301.
|
First Line Sorafenib.
n=28 Participants
The subjects who were randomized to sorafenib (continued from the parent Protocol AV-951-09-301) and demonstrated clinical benefit and acceptable tolerability were to be offered long-term access to sorafenib.
|
|---|---|---|---|
|
Overall Survival (OS)
Alive
|
83 Participants
|
78 Participants
|
28 Participants
|
|
Overall Survival (OS)
Died
|
78 Participants
|
10 Participants
|
0 Participants
|
Adverse Events
Sorafenib Crossover to Tivozanib
Serious events: 49 serious events
Other events: 87 other events
Deaths: 0 deaths
First Line Tivozanib
Serious events: 17 serious events
Other events: 82 other events
Deaths: 0 deaths
First Line Sorafenib
Serious events: 4 serious events
Other events: 28 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Sorafenib Crossover to Tivozanib
n=161 participants at risk
The subjects who failed sorafenib (had RECIST-defined progressive disease) on the parent protocol will be offered tivozanib hydrochloride.
|
First Line Tivozanib
n=88 participants at risk
The subjects who were randomized to tivozanib (continued from the parent Protocol AV-951-09-301) and demonstrated clinical benefit and acceptable tolerability in Protocol AV-951-09-301.
|
First Line Sorafenib
n=28 participants at risk
The subjects who were randomized to sorafenib (continued from the parent Protocol AV-951-09-301) and demonstrated clinical benefit and acceptable tolerability were to be offered long-term access to sorafenib.
|
|---|---|---|---|
|
Cardiac disorders
Acute myocardial infarction
|
1.2%
2/161 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
0.00%
0/88 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
0.00%
0/28 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
|
Cardiac disorders
Cardiac failure
|
1.2%
2/161 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
0.00%
0/88 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
0.00%
0/28 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
|
Cardiac disorders
Myocardial infarction
|
1.2%
2/161 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
0.00%
0/88 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
0.00%
0/28 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
|
Cardiac disorders
Arteriosclerosis coronary artery
|
0.62%
1/161 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
1.1%
1/88 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
0.00%
0/28 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.62%
1/161 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
0.00%
0/88 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
0.00%
0/28 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
|
Cardiac disorders
Cardiopulmonary failure
|
0.62%
1/161 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
0.00%
0/88 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
0.00%
0/28 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm progression
|
2.5%
4/161 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
0.00%
0/88 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
0.00%
0/28 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cancer
|
1.9%
3/161 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
0.00%
0/88 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
0.00%
0/28 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to pleura
|
0.62%
1/161 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
0.00%
0/88 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
0.00%
0/28 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to soft tissue
|
0.62%
1/161 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
0.00%
0/88 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
0.00%
0/28 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to the mediastinum
|
0.62%
1/161 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
0.00%
0/88 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
0.00%
0/28 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
1.2%
2/161 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
0.00%
0/88 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
0.00%
0/28 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
1.2%
2/161 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
0.00%
0/88 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
0.00%
0/28 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
|
Respiratory, thoracic and mediastinal disorders
Apnoea
|
0.62%
1/161 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
0.00%
0/88 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
0.00%
0/28 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
0.62%
1/161 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
0.00%
0/88 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
3.6%
1/28 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.62%
1/161 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
0.00%
0/88 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
0.00%
0/28 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.62%
1/161 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
1.1%
1/88 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
0.00%
0/28 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
|
General disorders
Asthenia
|
1.2%
2/161 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
0.00%
0/88 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
0.00%
0/28 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
|
General disorders
Death
|
1.2%
2/161 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
1.1%
1/88 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
0.00%
0/28 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
|
General disorders
Multi-organ failure
|
1.2%
2/161 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
0.00%
0/88 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
0.00%
0/28 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
|
General disorders
Fatigue
|
0.62%
1/161 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
0.00%
0/88 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
0.00%
0/28 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
|
General disorders
General physical health deterioration
|
0.62%
1/161 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
0.00%
0/88 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
0.00%
0/28 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
|
Blood and lymphatic system disorders
Anaemia
|
1.9%
3/161 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
0.00%
0/88 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
0.00%
0/28 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.62%
1/161 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
0.00%
0/88 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
0.00%
0/28 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.62%
1/161 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
0.00%
0/88 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
0.00%
0/28 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.62%
1/161 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
0.00%
0/88 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
0.00%
0/28 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
|
Nervous system disorders
Cerebral infarction
|
0.62%
1/161 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
0.00%
0/88 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
0.00%
0/28 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
|
Nervous system disorders
Ischaemic stroke
|
0.62%
1/161 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
0.00%
0/88 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
0.00%
0/28 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
|
Nervous system disorders
Transient ischaemic attack
|
0.62%
1/161 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
1.1%
1/88 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
0.00%
0/28 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
|
Hepatobiliary disorders
Bile duct stone
|
0.62%
1/161 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
0.00%
0/88 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
0.00%
0/28 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
|
Hepatobiliary disorders
Cholangitis
|
0.62%
1/161 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
0.00%
0/88 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
0.00%
0/28 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
|
Hepatobiliary disorders
Jaundice cholestatic
|
0.62%
1/161 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
0.00%
0/88 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
0.00%
0/28 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
|
Infections and infestations
Bronchitis
|
0.62%
1/161 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
0.00%
0/88 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
0.00%
0/28 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
|
Infections and infestations
Sepsis
|
0.62%
1/161 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
0.00%
0/88 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
0.00%
0/28 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.62%
1/161 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
0.00%
0/88 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
0.00%
0/28 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
|
Musculoskeletal and connective tissue disorders
Pathological fracture
|
0.62%
1/161 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
1.1%
1/88 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
0.00%
0/28 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
|
Vascular disorders
Aortic aneurysm
|
0.62%
1/161 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
0.00%
0/88 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
0.00%
0/28 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
|
Vascular disorders
Pelvic venous thrombosis
|
0.62%
1/161 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
0.00%
0/88 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
0.00%
0/28 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
|
Vascular disorders
Vena cava thrombosis
|
0.62%
1/161 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
0.00%
0/88 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
0.00%
0/28 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
|
Endocrine disorders
Myxoedema
|
0.62%
1/161 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
0.00%
0/88 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
0.00%
0/28 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.62%
1/161 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
0.00%
0/88 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
0.00%
0/28 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
|
Injury, poisoning and procedural complications
Head injury
|
0.62%
1/161 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
0.00%
0/88 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
0.00%
0/28 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
|
Investigations
Body temperature increased
|
0.62%
1/161 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
0.00%
0/88 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
0.00%
0/28 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
|
Psychiatric disorders
Delusional disorder, somatic type
|
0.62%
1/161 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
0.00%
0/88 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
0.00%
0/28 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.62%
1/161 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
0.00%
0/88 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
0.00%
0/28 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/161 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
1.1%
1/88 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
0.00%
0/28 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.00%
0/161 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
1.1%
1/88 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
0.00%
0/28 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
|
Nervous system disorders
Loss of consciousness
|
0.00%
0/161 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
1.1%
1/88 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
0.00%
0/28 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
|
Reproductive system and breast disorders
Pelvic fluid collection
|
0.00%
0/161 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
1.1%
1/88 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
0.00%
0/28 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
|
Reproductive system and breast disorders
Postmenopausal haemorrhage
|
0.00%
0/161 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
1.1%
1/88 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
0.00%
0/28 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.00%
0/161 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
1.1%
1/88 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
0.00%
0/28 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
|
Vascular disorders
Hypertension
|
0.00%
0/161 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
1.1%
1/88 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
0.00%
0/28 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
|
Vascular disorders
Hypertensive crisis
|
0.00%
0/161 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
1.1%
1/88 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
0.00%
0/28 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/161 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
1.1%
1/88 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
0.00%
0/28 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
|
Eye disorders
cataract
|
0.00%
0/161 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
1.1%
1/88 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
0.00%
0/28 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
|
Gastrointestinal disorders
Small intestinal haemorrhage
|
0.00%
0/161 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
1.1%
1/88 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
0.00%
0/28 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
|
Infections and infestations
Parotitis
|
0.00%
0/161 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
1.1%
1/88 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
0.00%
0/28 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
|
Infections and infestations
Pneumonia viral
|
0.00%
0/161 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
1.1%
1/88 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
0.00%
0/28 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.00%
0/161 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
1.1%
1/88 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
0.00%
0/28 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
|
Renal and urinary disorders
Renal failure acute
|
0.00%
0/161 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
1.1%
1/88 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
3.6%
1/28 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
|
Gastrointestinal disorders
Salivary gland mass
|
0.00%
0/161 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
0.00%
0/88 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
3.6%
1/28 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
|
Infections and infestations
Device related infection
|
0.00%
0/161 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
0.00%
0/88 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
3.6%
1/28 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/161 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
0.00%
0/88 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
3.6%
1/28 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
|
Vascular disorders
Peripheral ischaemia
|
0.00%
0/161 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
0.00%
0/88 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
3.6%
1/28 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
Other adverse events
| Measure |
Sorafenib Crossover to Tivozanib
n=161 participants at risk
The subjects who failed sorafenib (had RECIST-defined progressive disease) on the parent protocol will be offered tivozanib hydrochloride.
|
First Line Tivozanib
n=88 participants at risk
The subjects who were randomized to tivozanib (continued from the parent Protocol AV-951-09-301) and demonstrated clinical benefit and acceptable tolerability in Protocol AV-951-09-301.
|
First Line Sorafenib
n=28 participants at risk
The subjects who were randomized to sorafenib (continued from the parent Protocol AV-951-09-301) and demonstrated clinical benefit and acceptable tolerability were to be offered long-term access to sorafenib.
|
|---|---|---|---|
|
Vascular disorders
Hypertension
|
25.5%
41/161 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
50.0%
44/88 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
57.1%
16/28 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
|
Gastrointestinal disorders
Diarrhoea
|
13.7%
22/161 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
39.8%
35/88 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
42.9%
12/28 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
|
General disorders
Fatigue
|
13.0%
21/161 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
22.7%
20/88 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
10.7%
3/28 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
|
General disorders
Asthenia
|
12.4%
20/161 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
22.7%
20/88 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
10.7%
3/28 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
9.9%
16/161 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
23.9%
21/88 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
57.1%
16/28 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.6%
9/161 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
14.8%
13/88 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
7.1%
2/28 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
|
Metabolism and nutrition disorders
Decreased appetite
|
5.6%
9/161 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
12.5%
11/88 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
7.1%
2/28 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
5.6%
9/161 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
18.2%
16/88 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
0.00%
0/28 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
5.6%
9/161 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
11.4%
10/88 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
10.7%
3/28 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/161 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
23.9%
21/88 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
0.00%
0/28 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
|
Investigations
Weight increased
|
0.00%
0/161 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
0.00%
0/88 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
7.1%
2/28 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
|
Investigations
Weight decreased
|
0.00%
0/161 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
23.9%
21/88 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
32.1%
9/28 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
|
Nervous system disorders
Headache
|
0.00%
0/161 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
15.9%
14/88 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
7.1%
2/28 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/161 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
12.5%
11/88 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
0.00%
0/28 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/161 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
12.5%
11/88 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
0.00%
0/28 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/161 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
11.4%
10/88 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
0.00%
0/28 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/161 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
11.4%
10/88 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
14.3%
4/28 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/161 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
11.4%
10/88 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
10.7%
3/28 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/161 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
10.2%
9/88 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
10.7%
3/28 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/161 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
10.2%
9/88 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
0.00%
0/28 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/161 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
10.2%
9/88 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
0.00%
0/28 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/161 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
10.2%
9/88 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
0.00%
0/28 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
|
Investigations
Blood thyroid stimulating hormone decreased
|
0.00%
0/161 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
9.1%
8/88 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
0.00%
0/28 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/161 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
8.0%
7/88 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
0.00%
0/28 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
|
Investigations
Amylase increased
|
0.00%
0/161 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
6.8%
6/88 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
0.00%
0/28 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
|
Investigations
Lipase increased
|
0.00%
0/161 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
0.00%
0/88 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
7.1%
2/28 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/161 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
6.8%
6/88 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
0.00%
0/28 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/161 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
6.8%
6/88 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
0.00%
0/28 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/161 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
5.7%
5/88 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
0.00%
0/28 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/161 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
5.7%
5/88 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
0.00%
0/28 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
|
General disorders
Oedema peripheral
|
0.00%
0/161 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
5.7%
5/88 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
0.00%
0/28 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
|
Skin and subcutaneous tissue disorders
alopecia
|
0.00%
0/161 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
0.00%
0/88 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
21.4%
6/28 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
|
Investigations
Blood phosphorus decreased
|
0.00%
0/161 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
0.00%
0/88 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
17.9%
5/28 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
|
Skin and subcutaneous tissue disorders
Generalised erythema
|
0.00%
0/161 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
0.00%
0/88 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
14.3%
4/28 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/161 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
0.00%
0/88 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
10.7%
3/28 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/161 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
0.00%
0/88 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
10.7%
3/28 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
0.00%
0/161 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
0.00%
0/88 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
10.7%
3/28 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
|
Investigations
Blood creatinine increased
|
0.00%
0/161 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
0.00%
0/88 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
7.1%
2/28 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/161 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
0.00%
0/88 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
7.1%
2/28 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/161 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
0.00%
0/88 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
7.1%
2/28 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/161 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
0.00%
0/88 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
7.1%
2/28 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/161 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
0.00%
0/88 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
7.1%
2/28 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
|
Infections and infestations
Influenza
|
0.00%
0/161 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
0.00%
0/88 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
7.1%
2/28 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/161 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
0.00%
0/88 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
7.1%
2/28 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
|
General disorders
Pyrexia
|
0.00%
0/161 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
0.00%
0/88 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
7.1%
2/28 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
|
Infections and infestations
Rash pustular
|
0.00%
0/161 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
0.00%
0/88 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
7.1%
2/28 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
0.00%
0/161 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
0.00%
0/88 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
7.1%
2/28 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
|
Nervous system disorders
Somnolence
|
0.00%
0/161 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
0.00%
0/88 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
7.1%
2/28 • From enrollment assessed up to 3 years of treatment or until follow-up (up to 30 days end-of-trial visit after treatment discontinuation), whichever occurs earlier
An AE was defined as any unintended or undesirable, noxious, or pathological change, compared to pre-existing conditions, experienced by a patient during the clinical study or the follow-up period, regardless of relationship to study drug
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place