Trial Outcomes & Findings for Open Label Treatment Extension Study With SAR245408 or SAR245409 as a Monotherapy or as a Combination Regimen (NCT NCT01587040)
NCT ID: NCT01587040
Last Updated: 2022-04-19
Results Overview
Any untoward medical occurrence in a participant who received IMP was considered an AE without regard to possibility of causal relationship with this treatment. Serious adverse event (SAE): any untoward medical occurrence that resulted in any of the following outcomes: death, life-threatening, required initial/prolonged in-patient hospitalization, persistent/significant disability/incapacity, congenital anomaly/birth defect/considered as medically important event. TEAEs: AEs that developed/worsened/became serious during on-treatment period (time from IMP until 30 days after last dose of any IMP). Any TEAE included participants with both SAE \& non-SAEs. TEAE included participants with any treatment-emergent SAE (TESAE). TEAEs that led to death, dose reduction and/or delay, discontinuation \& AEs related to treatment were reported. Grades (3=severe, 4=life-threatening/disabling) represents severity of AEs.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
61 participants
Primary outcome timeframe
From Baseline up to 30 days after the last dose (maximum exposure: 1959 days)
Results posted on
2022-04-19
Participant Flow
The study was conducted at 21 centers in 4 countries between 20 July 2012 and 23 May 2018. Participants who received SAR245408/SAR245409 (IMP) in parental studies (TED12471 \[NCT01596270\], ARD11437 \[NCT01082068\], TED12863 \[NCT01943838\]) were included in study. A total of 67 participants were screened and 61 participants were enrolled in this study.
Participants who received IMP for \<2 cycles in parental study, and participants who took a daily dose of IMP higher than their established dose entered treatment-extension study on Day 1 of initiation period; participants who received IMP \>=2 cycles in parental study entered treatment-extension study on Day 1 of extension period.
Participant milestones
| Measure |
SAR245408: Monotherapy
Participants received SAR245408 400 milligrams (mg) once daily or at the established dose as monotherapy in the parental study until disease progression, unacceptable toxicity, withdrawal of consent, or until commercial supplies of SAR245408 were available (up to 1959 days).
|
SAR245408: Combination Regimen
Participants received SAR245408 400 mg once daily or at the established dose as combination regimen in the parental study until disease progression, unacceptable toxicity, withdrawal of consent, or until commercial supplies of SAR245408 were available (up to 1959 days). Commercially available drugs were used as combination medications with SAR245408 (depending on the parental study, the following drugs were used in combination with SAR245408: paclitaxel and carboplatin, letrozole, trastuzumab, paclitaxel and trastuzumab).
|
SAR245409: Monotherapy
Participants received SAR245409 50 mg twice daily or at the established dose as monotherapy in the parental study until disease progression, unacceptable toxicity, withdrawal of consent, or until commercial supplies of SAR245409 were available (up to 1917 days).
|
SAR245409: Combination Regimen
Participants received SAR245409 50 mg twice daily or at the established dose as combination regimen in the parental study until disease progression, unacceptable toxicity, withdrawal of consent, or until commercial supplies of SAR245409 were available (up to 1917 days). Commercially available drugs were used as combination medications with SAR245409 (depending on the parental study, the following drugs were used in combination with SAR245409: letrozole, temozolomide, rituximab, bendamustine and rituximab).
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
17
|
3
|
37
|
4
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
17
|
3
|
37
|
4
|
Reasons for withdrawal
| Measure |
SAR245408: Monotherapy
Participants received SAR245408 400 milligrams (mg) once daily or at the established dose as monotherapy in the parental study until disease progression, unacceptable toxicity, withdrawal of consent, or until commercial supplies of SAR245408 were available (up to 1959 days).
|
SAR245408: Combination Regimen
Participants received SAR245408 400 mg once daily or at the established dose as combination regimen in the parental study until disease progression, unacceptable toxicity, withdrawal of consent, or until commercial supplies of SAR245408 were available (up to 1959 days). Commercially available drugs were used as combination medications with SAR245408 (depending on the parental study, the following drugs were used in combination with SAR245408: paclitaxel and carboplatin, letrozole, trastuzumab, paclitaxel and trastuzumab).
|
SAR245409: Monotherapy
Participants received SAR245409 50 mg twice daily or at the established dose as monotherapy in the parental study until disease progression, unacceptable toxicity, withdrawal of consent, or until commercial supplies of SAR245409 were available (up to 1917 days).
|
SAR245409: Combination Regimen
Participants received SAR245409 50 mg twice daily or at the established dose as combination regimen in the parental study until disease progression, unacceptable toxicity, withdrawal of consent, or until commercial supplies of SAR245409 were available (up to 1917 days). Commercially available drugs were used as combination medications with SAR245409 (depending on the parental study, the following drugs were used in combination with SAR245409: letrozole, temozolomide, rituximab, bendamustine and rituximab).
|
|---|---|---|---|---|
|
Overall Study
Protocol Violation
|
0
|
0
|
1
|
0
|
|
Overall Study
Adverse Event
|
0
|
1
|
10
|
0
|
|
Overall Study
Disease progression
|
12
|
1
|
15
|
3
|
|
Overall Study
Other than specified
|
5
|
1
|
11
|
1
|
Baseline Characteristics
Open Label Treatment Extension Study With SAR245408 or SAR245409 as a Monotherapy or as a Combination Regimen
Baseline characteristics by cohort
| Measure |
SAR245408: Monotherapy
n=17 Participants
Participants received SAR245408 400 mg once daily or at the established dose as monotherapy in the parental study until disease progression, unacceptable toxicity, withdrawal of consent, or until commercial supplies of SAR245408 were available (up to 1959 days).
|
SAR245408: Combination Regimen
n=3 Participants
Participants received SAR245408 400 mg once daily or at the established dose as combination regimen in the parental study until disease progression, unacceptable toxicity, withdrawal of consent, or until commercial supplies of SAR245408 were available (up to 1959 days). Commercially available drugs were used as combination medications with SAR245408 (depending on the parental study, the following drugs were used in combination with SAR245408: paclitaxel and carboplatin, letrozole, trastuzumab, paclitaxel and trastuzumab).
|
SAR245409: Monotherapy
n=37 Participants
Participants received SAR245409 50 mg twice daily or at the established dose as monotherapy in the parental study until disease progression, unacceptable toxicity, withdrawal of consent, or until commercial supplies of SAR245409 were available (up to 1917 days).
|
SAR245409: Combination Regimen
n=4 Participants
Participants received SAR245409 50 mg twice daily or at the established dose as combination regimen in the parental study until disease progression, unacceptable toxicity, withdrawal of consent, or until commercial supplies of SAR245409 were available (up to 1917 days). Commercially available drugs were used as combination medications with SAR245409 (depending on the parental study, the following drugs were used in combination with SAR245409: letrozole, temozolomide, rituximab, bendamustine and rituximab).
|
Total
n=61 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
61.6 years
STANDARD_DEVIATION 13.1 • n=5 Participants
|
53.7 years
STANDARD_DEVIATION 2.1 • n=7 Participants
|
62.4 years
STANDARD_DEVIATION 12.0 • n=5 Participants
|
50.0 years
STANDARD_DEVIATION 15.8 • n=4 Participants
|
61.0 years
STANDARD_DEVIATION 12.5 • n=21 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
31 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
30 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
17 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
58 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
14 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
51 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: From Baseline up to 30 days after the last dose (maximum exposure: 1959 days)Population: Analysis was performed on safety population that included all participants who took at least 1 dose of study drug during the study.
Any untoward medical occurrence in a participant who received IMP was considered an AE without regard to possibility of causal relationship with this treatment. Serious adverse event (SAE): any untoward medical occurrence that resulted in any of the following outcomes: death, life-threatening, required initial/prolonged in-patient hospitalization, persistent/significant disability/incapacity, congenital anomaly/birth defect/considered as medically important event. TEAEs: AEs that developed/worsened/became serious during on-treatment period (time from IMP until 30 days after last dose of any IMP). Any TEAE included participants with both SAE \& non-SAEs. TEAE included participants with any treatment-emergent SAE (TESAE). TEAEs that led to death, dose reduction and/or delay, discontinuation \& AEs related to treatment were reported. Grades (3=severe, 4=life-threatening/disabling) represents severity of AEs.
Outcome measures
| Measure |
SAR245408: Monotherapy
n=17 Participants
Participants received SAR245408 400 mg once daily or at the established dose as monotherapy in the parental study until disease progression, unacceptable toxicity, withdrawal of consent, or until commercial supplies of SAR245408 were available (up to 1959 days).
|
SAR245408: Combination Regimen
n=3 Participants
Participants received SAR245408 400 mg once daily or at the established dose as combination regimen in the parental study until disease progression, unacceptable toxicity, withdrawal of consent, or until commercial supplies of SAR245408 were available (up to 1959 days). Commercially available drugs were used as combination medications with SAR245408 (depending on the parental study, the following drugs were used in combination with SAR245408: paclitaxel and carboplatin, letrozole, trastuzumab, paclitaxel and trastuzumab).
|
SAR245409: Monotherapy
n=37 Participants
Participants received SAR245409 50 mg twice daily or at the established dose as monotherapy in the parental study until disease progression, unacceptable toxicity, withdrawal of consent, or until commercial supplies of SAR245409 were available (up to 1917 days).
|
SAR245409: Combination Regimen
n=4 Participants
Participants received SAR245409 50 mg twice daily or at the established dose as combination regimen in the parental study until disease progression, unacceptable toxicity, withdrawal of consent, or until commercial supplies of SAR245409 were available (up to 1917 days). Commercially available drugs were used as combination medications with SAR245409 (depending on the parental study, the following drugs were used in combination with SAR245409: letrozole, temozolomide, rituximab, bendamustine and rituximab).
|
|---|---|---|---|---|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Any TEAE
|
16 Participants
|
3 Participants
|
35 Participants
|
3 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Any Grade 3-4 TEAEs
|
12 Participants
|
2 Participants
|
19 Participants
|
1 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Any Grade 3-4 related TEAE
|
3 Participants
|
0 Participants
|
11 Participants
|
0 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Any Serious TEAE
|
9 Participants
|
1 Participants
|
10 Participants
|
0 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Any Grade 3-4 TESAE
|
9 Participants
|
1 Participants
|
9 Participants
|
0 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Any related TESAE
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Any Grade 3-4 related TESAE
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Any TEAE leading to death
|
0 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Any TEAE leading to permanent discontinuation
|
1 Participants
|
1 Participants
|
8 Participants
|
0 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Any TEAE leading to dose reduction
|
3 Participants
|
1 Participants
|
9 Participants
|
1 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Any TEAE leading to dose delay or interruption
|
6 Participants
|
2 Participants
|
16 Participants
|
0 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Any related TEAEs
|
12 Participants
|
3 Participants
|
23 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: From Baseline up to 30 days after the last dose (maximum exposure: 1959 days)Population: Analysis was performed on safety population. Here, "Overall number of participants analyzed" = participants with available data for this outcome measure.
Hematological parameters assessed were anemia, neutropenia and thrombocytopenia. Parameters were assessed as per the National Cancer Institute Common Terminology Criteria for Adverse Experience version 4.03 (NCI-CTCAE v 4.03), where Grade 1 = Mild; Grade 2 = Moderate; Grade 3 = Severe; Grade 4 = Potentially Life Threatening. Grade refers to the severity of the AEs.
Outcome measures
| Measure |
SAR245408: Monotherapy
n=16 Participants
Participants received SAR245408 400 mg once daily or at the established dose as monotherapy in the parental study until disease progression, unacceptable toxicity, withdrawal of consent, or until commercial supplies of SAR245408 were available (up to 1959 days).
|
SAR245408: Combination Regimen
n=3 Participants
Participants received SAR245408 400 mg once daily or at the established dose as combination regimen in the parental study until disease progression, unacceptable toxicity, withdrawal of consent, or until commercial supplies of SAR245408 were available (up to 1959 days). Commercially available drugs were used as combination medications with SAR245408 (depending on the parental study, the following drugs were used in combination with SAR245408: paclitaxel and carboplatin, letrozole, trastuzumab, paclitaxel and trastuzumab).
|
SAR245409: Monotherapy
n=36 Participants
Participants received SAR245409 50 mg twice daily or at the established dose as monotherapy in the parental study until disease progression, unacceptable toxicity, withdrawal of consent, or until commercial supplies of SAR245409 were available (up to 1917 days).
|
SAR245409: Combination Regimen
n=4 Participants
Participants received SAR245409 50 mg twice daily or at the established dose as combination regimen in the parental study until disease progression, unacceptable toxicity, withdrawal of consent, or until commercial supplies of SAR245409 were available (up to 1917 days). Commercially available drugs were used as combination medications with SAR245409 (depending on the parental study, the following drugs were used in combination with SAR245409: letrozole, temozolomide, rituximab, bendamustine and rituximab).
|
|---|---|---|---|---|
|
Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Hematological Parameters
Anemia: All grades
|
13 Participants
|
1 Participants
|
23 Participants
|
1 Participants
|
|
Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Hematological Parameters
Anemia: Grade 1
|
6 Participants
|
1 Participants
|
18 Participants
|
1 Participants
|
|
Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Hematological Parameters
Anemia: Grade 2
|
3 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Hematological Parameters
Anemia: Grade 3
|
4 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
|
Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Hematological Parameters
Anemia: Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Hematological Parameters
Neutropenia: All grades
|
7 Participants
|
0 Participants
|
10 Participants
|
1 Participants
|
|
Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Hematological Parameters
Neutropenia: Grade 1
|
2 Participants
|
0 Participants
|
5 Participants
|
1 Participants
|
|
Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Hematological Parameters
Neutropenia: Grade 2
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Hematological Parameters
Neutropenia: Grade 3
|
2 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Hematological Parameters
Neutropenia: Grade 4
|
1 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Hematological Parameters
Thrombocytopenia: All grades
|
8 Participants
|
0 Participants
|
20 Participants
|
3 Participants
|
|
Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Hematological Parameters
Thrombocytopenia: Grade 1
|
5 Participants
|
0 Participants
|
17 Participants
|
3 Participants
|
|
Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Hematological Parameters
Thrombocytopenia: Grade 2
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Hematological Parameters
Thrombocytopenia: Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Hematological Parameters
Thrombocytopenia: Grade 4
|
3 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: From Baseline up to 30 days after the last dose (maximum exposure: 1959 days)Population: Analysis was performed on safety population. Here, "number analyzed"= participants with available data for specified category.
Biochemical parameters assessed were hyperglycemia, aspartate aminotransferase (ASAT) increased, alanine aminotransferase (ALAT) increased, hyperbilirubinemia, hypocalcemia, creatinine increased. Parameters were assessed as per the NCI-CTCAE v 4.03, where Grade 1 = Mild; Grade 2 = Moderate; Grade 3 = Severe; Grade 4 = Potentially Life Threatening. Grade refers to the severity of the AEs.
Outcome measures
| Measure |
SAR245408: Monotherapy
n=17 Participants
Participants received SAR245408 400 mg once daily or at the established dose as monotherapy in the parental study until disease progression, unacceptable toxicity, withdrawal of consent, or until commercial supplies of SAR245408 were available (up to 1959 days).
|
SAR245408: Combination Regimen
n=3 Participants
Participants received SAR245408 400 mg once daily or at the established dose as combination regimen in the parental study until disease progression, unacceptable toxicity, withdrawal of consent, or until commercial supplies of SAR245408 were available (up to 1959 days). Commercially available drugs were used as combination medications with SAR245408 (depending on the parental study, the following drugs were used in combination with SAR245408: paclitaxel and carboplatin, letrozole, trastuzumab, paclitaxel and trastuzumab).
|
SAR245409: Monotherapy
n=37 Participants
Participants received SAR245409 50 mg twice daily or at the established dose as monotherapy in the parental study until disease progression, unacceptable toxicity, withdrawal of consent, or until commercial supplies of SAR245409 were available (up to 1917 days).
|
SAR245409: Combination Regimen
n=4 Participants
Participants received SAR245409 50 mg twice daily or at the established dose as combination regimen in the parental study until disease progression, unacceptable toxicity, withdrawal of consent, or until commercial supplies of SAR245409 were available (up to 1917 days). Commercially available drugs were used as combination medications with SAR245409 (depending on the parental study, the following drugs were used in combination with SAR245409: letrozole, temozolomide, rituximab, bendamustine and rituximab).
|
|---|---|---|---|---|
|
Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Biochemical Parameters
Hypocalcemia: Grade 2
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Biochemical Parameters
Hypocalcemia: Grade 3
|
1 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Biochemical Parameters
Hyperglycemia: All Grades
|
13 Participants
|
3 Participants
|
25 Participants
|
1 Participants
|
|
Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Biochemical Parameters
Hyperglycemia: Grade 1
|
11 Participants
|
2 Participants
|
19 Participants
|
1 Participants
|
|
Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Biochemical Parameters
Hyperglycemia: Grade 2
|
0 Participants
|
1 Participants
|
6 Participants
|
0 Participants
|
|
Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Biochemical Parameters
Hyperglycemia: Grade 3
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Biochemical Parameters
Hyperglycemia: Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Biochemical Parameters
ASAT Increased: All Grades
|
7 Participants
|
2 Participants
|
20 Participants
|
1 Participants
|
|
Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Biochemical Parameters
ASAT Increased: Grade 1
|
6 Participants
|
1 Participants
|
16 Participants
|
1 Participants
|
|
Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Biochemical Parameters
ASAT Increased: Grade 2
|
1 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Biochemical Parameters
ASAT Increased: Grade 3
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Biochemical Parameters
ASAT Increased: Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Biochemical Parameters
ALAT Increased: All Grades
|
5 Participants
|
2 Participants
|
12 Participants
|
0 Participants
|
|
Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Biochemical Parameters
ALAT Increased: Grade 1
|
4 Participants
|
1 Participants
|
8 Participants
|
0 Participants
|
|
Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Biochemical Parameters
ALAT Increased: Grade 2
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Biochemical Parameters
ALAT Increased: Grade 3
|
0 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
|
Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Biochemical Parameters
ALAT Increased: Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Biochemical Parameters
Blood Bilirubin Increased:All Grades
|
1 Participants
|
0 Participants
|
9 Participants
|
1 Participants
|
|
Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Biochemical Parameters
Blood Bilirubin Increased:Grade 1
|
0 Participants
|
0 Participants
|
4 Participants
|
1 Participants
|
|
Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Biochemical Parameters
Blood Bilirubin Increased:Grade 2
|
0 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
|
Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Biochemical Parameters
Blood Bilirubin Increased:Grade 3
|
1 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Biochemical Parameters
Blood Bilirubin Increased:Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Biochemical Parameters
Hypocalcemia: All Grades
|
6 Participants
|
1 Participants
|
7 Participants
|
0 Participants
|
|
Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Biochemical Parameters
Hypocalcemia: Grade 1
|
4 Participants
|
1 Participants
|
5 Participants
|
0 Participants
|
|
Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Biochemical Parameters
Hypocalcemia: Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Biochemical Parameters
Creatinine increased: All Grades
|
5 Participants
|
1 Participants
|
15 Participants
|
0 Participants
|
|
Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Biochemical Parameters
Creatinine increased: Grade 1
|
3 Participants
|
1 Participants
|
8 Participants
|
0 Participants
|
|
Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Biochemical Parameters
Creatinine increased: Grade 2
|
1 Participants
|
0 Participants
|
4 Participants
|
0 Participants
|
|
Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Biochemical Parameters
Creatinine increased: Grade 3
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Biochemical Parameters
Creatinine increased: Grade 4
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
Adverse Events
SAR245408: Monotherapy
Serious events: 9 serious events
Other events: 15 other events
Deaths: 1 deaths
SAR245408: Combination Regimen
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
SAR245409: Monotherapy
Serious events: 10 serious events
Other events: 34 other events
Deaths: 3 deaths
SAR245409: Combination Regimen
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
SAR245408: Monotherapy
n=17 participants at risk
Participants received SAR245408 400 mg once daily or at the established dose as monotherapy in the parental study until disease progression, unacceptable toxicity, withdrawal of consent, or until commercial supplies of SAR245408 were available (up to 1959 days).
|
SAR245408: Combination Regimen
n=3 participants at risk
Participants received SAR245408 400 mg once daily or at the established dose as combination regimen in the parental study until disease progression, unacceptable toxicity, withdrawal of consent, or until commercial supplies of SAR245408 were available (up to 1959 days). Commercially available drugs were used as combination medications with SAR245408 (depending on the parental study, the following drugs were used in combination with SAR245408: paclitaxel and carboplatin, letrozole, trastuzumab, paclitaxel and trastuzumab).
|
SAR245409: Monotherapy
n=37 participants at risk
Participants received SAR245409 50 mg twice daily or at the established dose as monotherapy in the parental study until disease progression, unacceptable toxicity, withdrawal of consent, or until commercial supplies of SAR245409 were available (up to 1917 days).
|
SAR245409: Combination Regimen
n=4 participants at risk
Participants received SAR245409 50 mg twice daily or at the established dose as combination regimen in the parental study until disease progression, unacceptable toxicity, withdrawal of consent, or until commercial supplies of SAR245409 were available (up to 1917 days). Commercially available drugs were used as combination medications with SAR245409 (depending on the parental study, the following drugs were used in combination with SAR245409: letrozole, temozolomide, rituximab, bendamustine and rituximab).
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
11.8%
2/17 • Number of events 2 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/37 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Blood and lymphatic system disorders
Neutropenia
|
5.9%
1/17 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
2.7%
1/37 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
5.9%
1/17 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/37 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Cardiac disorders
Angina Unstable
|
5.9%
1/17 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/37 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/17 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
2.7%
1/37 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Gastrointestinal disorders
Gastritis
|
5.9%
1/17 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/37 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Gastrointestinal disorders
Intestinal Obstruction
|
5.9%
1/17 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/37 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Gastrointestinal disorders
Upper Gastrointestinal Haemorrhage
|
5.9%
1/17 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/37 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
General disorders
Disease Progression
|
0.00%
0/17 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
5.4%
2/37 • Number of events 2 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
General disorders
Pyrexia
|
0.00%
0/17 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
5.4%
2/37 • Number of events 2 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
General disorders
Systemic Inflammatory Response Syndrome
|
0.00%
0/17 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
2.7%
1/37 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Hepatobiliary disorders
Cholangitis Acute
|
0.00%
0/17 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
2.7%
1/37 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Hepatobiliary disorders
Cholecystitis Acute
|
0.00%
0/17 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
2.7%
1/37 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Infections and infestations
Abscess Limb
|
5.9%
1/17 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/37 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Infections and infestations
Acute Sinusitis
|
0.00%
0/17 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
2.7%
1/37 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Infections and infestations
Catheter Site Infection
|
0.00%
0/17 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
33.3%
1/3 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/37 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Infections and infestations
Cellulitis
|
5.9%
1/17 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/37 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Infections and infestations
Intervertebral Discitis
|
0.00%
0/17 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
2.7%
1/37 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Infections and infestations
Osteomyelitis
|
0.00%
0/17 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
2.7%
1/37 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Infections and infestations
Pneumonia
|
11.8%
2/17 • Number of events 2 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
5.4%
2/37 • Number of events 2 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Infections and infestations
Sepsis
|
0.00%
0/17 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
5.4%
2/37 • Number of events 2 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Infections and infestations
Staphylococcal Skin Infection
|
5.9%
1/17 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/37 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Infections and infestations
Urinary Tract Infection
|
5.9%
1/17 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
5.4%
2/37 • Number of events 2 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Infections and infestations
Wound Infection
|
0.00%
0/17 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
2.7%
1/37 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Injury, poisoning and procedural complications
Femur Fracture
|
5.9%
1/17 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/37 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Investigations
Alanine Aminotransferase Increased
|
0.00%
0/17 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
2.7%
1/37 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Investigations
Lipase Increased
|
0.00%
0/17 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
2.7%
1/37 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Investigations
Troponin Increased
|
0.00%
0/17 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
2.7%
1/37 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/17 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
2.7%
1/37 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Metabolism and nutrition disorders
Tumour Lysis Syndrome
|
0.00%
0/17 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
2.7%
1/37 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute Leukaemia
|
0.00%
0/17 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
2.7%
1/37 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute Myeloid Leukaemia
|
5.9%
1/17 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/37 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/17 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
2.7%
1/37 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Nervous system disorders
Haemorrhage Intracranial
|
5.9%
1/17 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
2.7%
1/37 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Nervous system disorders
Headache
|
5.9%
1/17 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/37 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Nervous system disorders
Syncope
|
0.00%
0/17 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
2.7%
1/37 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Renal and urinary disorders
Acute Kidney Injury
|
0.00%
0/17 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
2.7%
1/37 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Renal and urinary disorders
Renal Colic
|
0.00%
0/17 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
2.7%
1/37 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic Obstructive Pulmonary Disease
|
0.00%
0/17 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
2.7%
1/37 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
5.9%
1/17 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/37 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
11.8%
2/17 • Number of events 2 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/37 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Distress
|
5.9%
1/17 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/37 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Vascular disorders
Haematoma
|
5.9%
1/17 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/37 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Vascular disorders
Hypotension
|
5.9%
1/17 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/37 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
Other adverse events
| Measure |
SAR245408: Monotherapy
n=17 participants at risk
Participants received SAR245408 400 mg once daily or at the established dose as monotherapy in the parental study until disease progression, unacceptable toxicity, withdrawal of consent, or until commercial supplies of SAR245408 were available (up to 1959 days).
|
SAR245408: Combination Regimen
n=3 participants at risk
Participants received SAR245408 400 mg once daily or at the established dose as combination regimen in the parental study until disease progression, unacceptable toxicity, withdrawal of consent, or until commercial supplies of SAR245408 were available (up to 1959 days). Commercially available drugs were used as combination medications with SAR245408 (depending on the parental study, the following drugs were used in combination with SAR245408: paclitaxel and carboplatin, letrozole, trastuzumab, paclitaxel and trastuzumab).
|
SAR245409: Monotherapy
n=37 participants at risk
Participants received SAR245409 50 mg twice daily or at the established dose as monotherapy in the parental study until disease progression, unacceptable toxicity, withdrawal of consent, or until commercial supplies of SAR245409 were available (up to 1917 days).
|
SAR245409: Combination Regimen
n=4 participants at risk
Participants received SAR245409 50 mg twice daily or at the established dose as combination regimen in the parental study until disease progression, unacceptable toxicity, withdrawal of consent, or until commercial supplies of SAR245409 were available (up to 1917 days). Commercially available drugs were used as combination medications with SAR245409 (depending on the parental study, the following drugs were used in combination with SAR245409: letrozole, temozolomide, rituximab, bendamustine and rituximab).
|
|---|---|---|---|---|
|
General disorders
Gait Disturbance
|
0.00%
0/17 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
2.7%
1/37 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
General disorders
General Physical Health Deterioration
|
5.9%
1/17 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/37 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
General disorders
Localised Oedema
|
0.00%
0/17 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
2.7%
1/37 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Blood and lymphatic system disorders
Anaemia
|
17.6%
3/17 • Number of events 4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
33.3%
1/3 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
5.4%
2/37 • Number of events 2 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Blood and lymphatic system disorders
Iron Deficiency Anaemia
|
5.9%
1/17 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/37 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/17 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
2.7%
1/37 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/17 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
2.7%
1/37 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/17 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
2.7%
1/37 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
25.0%
1/4 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Blood and lymphatic system disorders
Neutropenia
|
5.9%
1/17 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
5.4%
2/37 • Number of events 2 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Blood and lymphatic system disorders
Splenomegaly
|
0.00%
0/17 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
2.7%
1/37 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
11.8%
2/17 • Number of events 3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/37 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
25.0%
1/4 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/17 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
5.4%
2/37 • Number of events 2 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Cardiac disorders
Cardiac Arrest
|
0.00%
0/17 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
2.7%
1/37 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Cardiac disorders
Cardiomegaly
|
0.00%
0/17 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
2.7%
1/37 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Cardiac disorders
Coronary Artery Disease
|
11.8%
2/17 • Number of events 2 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/37 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Cardiac disorders
Pericardial Effusion
|
0.00%
0/17 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
2.7%
1/37 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Cardiac disorders
Sinus Bradycardia
|
0.00%
0/17 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
5.4%
2/37 • Number of events 2 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/17 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
5.4%
2/37 • Number of events 2 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Cardiac disorders
Ventricular Extrasystoles
|
0.00%
0/17 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
2.7%
1/37 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Cardiac disorders
Ventricular Tachycardia
|
0.00%
0/17 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
2.7%
1/37 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Ear and labyrinth disorders
Cerumen Impaction
|
5.9%
1/17 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/37 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Ear and labyrinth disorders
Deafness Unilateral
|
5.9%
1/17 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/37 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Ear and labyrinth disorders
Ear Discomfort
|
0.00%
0/17 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
2.7%
1/37 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Ear and labyrinth disorders
Hyperacusis
|
0.00%
0/17 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
2.7%
1/37 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Ear and labyrinth disorders
Hypoacusis
|
5.9%
1/17 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
2.7%
1/37 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/17 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
2.7%
1/37 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/17 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
5.4%
2/37 • Number of events 2 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/17 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
2.7%
1/37 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/17 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
5.4%
2/37 • Number of events 2 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Eye disorders
Cataract
|
0.00%
0/17 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
8.1%
3/37 • Number of events 3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Eye disorders
Corneal Scar
|
0.00%
0/17 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
2.7%
1/37 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Eye disorders
Dry Eye
|
0.00%
0/17 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
33.3%
1/3 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/37 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Eye disorders
Retinal Vein Occlusion
|
0.00%
0/17 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
2.7%
1/37 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Eye disorders
Visual Impairment
|
5.9%
1/17 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
2.7%
1/37 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Eye disorders
Vitreous Floaters
|
0.00%
0/17 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
2.7%
1/37 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Gastrointestinal disorders
Abdominal Distension
|
5.9%
1/17 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
5.4%
2/37 • Number of events 2 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/17 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
8.1%
3/37 • Number of events 3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Gastrointestinal disorders
Abdominal Pain Lower
|
5.9%
1/17 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/37 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Gastrointestinal disorders
Abdominal Tenderness
|
0.00%
0/17 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
2.7%
1/37 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Gastrointestinal disorders
Abdominal Wall Haematoma
|
0.00%
0/17 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
2.7%
1/37 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Gastrointestinal disorders
Anal Incontinence
|
0.00%
0/17 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
2.7%
1/37 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/17 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
2.7%
1/37 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Gastrointestinal disorders
Chapped Lips
|
5.9%
1/17 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/37 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Gastrointestinal disorders
Constipation
|
23.5%
4/17 • Number of events 4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
33.3%
1/3 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
18.9%
7/37 • Number of events 7 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
25.0%
1/4 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Gastrointestinal disorders
Diarrhoea
|
41.2%
7/17 • Number of events 8 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
66.7%
2/3 • Number of events 2 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
37.8%
14/37 • Number of events 14 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
75.0%
3/4 • Number of events 3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/17 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
5.4%
2/37 • Number of events 2 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/17 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
2.7%
1/37 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Gastrointestinal disorders
Faeces Discoloured
|
5.9%
1/17 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/37 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Gastrointestinal disorders
Flatulence
|
5.9%
1/17 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/37 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Gastrointestinal disorders
Gastrooesophageal Reflux Disease
|
17.6%
3/17 • Number of events 4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
5.4%
2/37 • Number of events 2 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Gastrointestinal disorders
Hypoaesthesia Oral
|
0.00%
0/17 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
2.7%
1/37 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Gastrointestinal disorders
Nausea
|
29.4%
5/17 • Number of events 5 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
66.7%
2/3 • Number of events 2 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
27.0%
10/37 • Number of events 10 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Gastrointestinal disorders
Pancreatic Failure
|
5.9%
1/17 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/37 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Gastrointestinal disorders
Peptic Ulcer Haemorrhage
|
5.9%
1/17 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/37 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Gastrointestinal disorders
Salivary Gland Enlargement
|
0.00%
0/17 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
2.7%
1/37 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Gastrointestinal disorders
Short-Bowel Syndrome
|
5.9%
1/17 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/37 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Gastrointestinal disorders
Vomiting
|
11.8%
2/17 • Number of events 2 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
66.7%
2/3 • Number of events 2 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
18.9%
7/37 • Number of events 7 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
25.0%
1/4 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
General disorders
Asthenia
|
0.00%
0/17 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
8.1%
3/37 • Number of events 3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
General disorders
Catheter Site Discharge
|
0.00%
0/17 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
2.7%
1/37 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
General disorders
Chest Pain
|
0.00%
0/17 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
33.3%
1/3 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
2.7%
1/37 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
General disorders
Chills
|
5.9%
1/17 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
2.7%
1/37 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
General disorders
Face Oedema
|
0.00%
0/17 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
33.3%
1/3 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/37 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
General disorders
Facial Pain
|
0.00%
0/17 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/37 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
25.0%
1/4 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
General disorders
Fatigue
|
47.1%
8/17 • Number of events 9 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
33.3%
1/3 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
21.6%
8/37 • Number of events 8 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
General disorders
Malaise
|
0.00%
0/17 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
2.7%
1/37 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
General disorders
Mucosal Inflammation
|
0.00%
0/17 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
2.7%
1/37 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
General disorders
Non-Cardiac Chest Pain
|
5.9%
1/17 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
8.1%
3/37 • Number of events 3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
General disorders
Oedema Peripheral
|
17.6%
3/17 • Number of events 3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
33.3%
1/3 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
10.8%
4/37 • Number of events 4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
General disorders
Pain
|
5.9%
1/17 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/37 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
General disorders
Performance Status Decreased
|
0.00%
0/17 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
2.7%
1/37 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
General disorders
Peripheral Swelling
|
0.00%
0/17 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
2.7%
1/37 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
General disorders
Pyrexia
|
23.5%
4/17 • Number of events 4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
33.3%
1/3 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
16.2%
6/37 • Number of events 6 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
General disorders
Suprapubic Pain
|
0.00%
0/17 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
2.7%
1/37 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Immune system disorders
Contrast Media Allergy
|
0.00%
0/17 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
2.7%
1/37 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Immune system disorders
Drug Hypersensitivity
|
5.9%
1/17 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/37 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Immune system disorders
Hypersensitivity
|
5.9%
1/17 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/37 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Infections and infestations
Abscess Limb
|
5.9%
1/17 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/37 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Infections and infestations
Bronchitis
|
5.9%
1/17 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
10.8%
4/37 • Number of events 5 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Infections and infestations
Cellulitis
|
5.9%
1/17 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/37 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Infections and infestations
Chronic Sinusitis
|
11.8%
2/17 • Number of events 2 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/37 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Infections and infestations
Conjunctivitis
|
5.9%
1/17 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/37 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Infections and infestations
Eye Infection
|
0.00%
0/17 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
2.7%
1/37 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Infections and infestations
Fungal Skin Infection
|
0.00%
0/17 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
2.7%
1/37 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/17 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
8.1%
3/37 • Number of events 3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Infections and infestations
Gastrointestinal Viral Infection
|
5.9%
1/17 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
2.7%
1/37 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Infections and infestations
Hepatitis C
|
0.00%
0/17 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
2.7%
1/37 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Infections and infestations
Herpes Zoster
|
5.9%
1/17 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/37 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Infections and infestations
Hordeolum
|
5.9%
1/17 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/37 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Infections and infestations
Influenza
|
0.00%
0/17 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
5.4%
2/37 • Number of events 2 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Infections and infestations
Lower Respiratory Tract Infection
|
5.9%
1/17 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/37 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/17 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
5.4%
2/37 • Number of events 2 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Infections and infestations
Onychomycosis
|
0.00%
0/17 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
2.7%
1/37 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Infections and infestations
Oral Candidiasis
|
5.9%
1/17 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/37 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/17 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
5.4%
2/37 • Number of events 2 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Infections and infestations
Postoperative Wound Infection
|
0.00%
0/17 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
2.7%
1/37 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Infections and infestations
Respiratory Tract Infection
|
0.00%
0/17 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
2.7%
1/37 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/17 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
2.7%
1/37 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Infections and infestations
Sepsis
|
0.00%
0/17 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
2.7%
1/37 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Infections and infestations
Sinusitis
|
5.9%
1/17 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
13.5%
5/37 • Number of events 5 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
25.0%
1/4 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Infections and infestations
Skin Infection
|
0.00%
0/17 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
5.4%
2/37 • Number of events 2 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Infections and infestations
Tooth Abscess
|
5.9%
1/17 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
2.7%
1/37 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Infections and infestations
Tooth Infection
|
5.9%
1/17 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/37 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
25.0%
1/4 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
17.6%
3/17 • Number of events 3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
21.6%
8/37 • Number of events 8 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
25.0%
1/4 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Infections and infestations
Urinary Tract Infection
|
11.8%
2/17 • Number of events 2 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
33.3%
1/3 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
16.2%
6/37 • Number of events 6 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Infections and infestations
Viral Upper Respiratory Tract Infection
|
5.9%
1/17 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/37 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Injury, poisoning and procedural complications
Accidental Overdose
|
0.00%
0/17 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
2.7%
1/37 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Injury, poisoning and procedural complications
Contusion
|
5.9%
1/17 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/37 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Injury, poisoning and procedural complications
Fall
|
11.8%
2/17 • Number of events 2 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
8.1%
3/37 • Number of events 3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Injury, poisoning and procedural complications
Foreign Body In Eye
|
0.00%
0/17 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
2.7%
1/37 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Injury, poisoning and procedural complications
Incision Site Pain
|
0.00%
0/17 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
2.7%
1/37 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Injury, poisoning and procedural complications
Ligament Injury
|
0.00%
0/17 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
2.7%
1/37 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Injury, poisoning and procedural complications
Limb Injury
|
0.00%
0/17 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
2.7%
1/37 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Injury, poisoning and procedural complications
Muscle Strain
|
0.00%
0/17 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
5.4%
2/37 • Number of events 2 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Injury, poisoning and procedural complications
Rib Fracture
|
0.00%
0/17 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
2.7%
1/37 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Injury, poisoning and procedural complications
Skin Abrasion
|
0.00%
0/17 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
2.7%
1/37 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Injury, poisoning and procedural complications
Spinal Compression Fracture
|
0.00%
0/17 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
33.3%
1/3 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/37 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Injury, poisoning and procedural complications
Wound Dehiscence
|
0.00%
0/17 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
33.3%
1/3 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/37 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Investigations
Activated Partial Thromboplastin Time Prolonged
|
5.9%
1/17 • Number of events 3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/37 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Investigations
Alanine Aminotransferase Increased
|
0.00%
0/17 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
66.7%
2/3 • Number of events 2 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
10.8%
4/37 • Number of events 5 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Investigations
Amylase Increased
|
5.9%
1/17 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
16.2%
6/37 • Number of events 6 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Investigations
Aspartate Aminotransferase Increased
|
0.00%
0/17 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
66.7%
2/3 • Number of events 2 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
8.1%
3/37 • Number of events 3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Investigations
Bilirubin Conjugated Increased
|
0.00%
0/17 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
2.7%
1/37 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Investigations
Blood Alkaline Phosphatase Increased
|
0.00%
0/17 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
33.3%
1/3 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
5.4%
2/37 • Number of events 2 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Investigations
Blood Bilirubin Increased
|
0.00%
0/17 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
2.7%
1/37 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Investigations
Blood Cholesterol Increased
|
0.00%
0/17 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
2.7%
1/37 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Investigations
Blood Creatinine Increased
|
0.00%
0/17 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
8.1%
3/37 • Number of events 3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Investigations
Blood Lactate Dehydrogenase Increased
|
0.00%
0/17 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
2.7%
1/37 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Investigations
Blood Phosphorus Decreased
|
0.00%
0/17 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
2.7%
1/37 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Investigations
Blood Urea Increased
|
0.00%
0/17 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
8.1%
3/37 • Number of events 3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Investigations
Body Temperature Increased
|
0.00%
0/17 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
2.7%
1/37 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Investigations
Breath Sounds Abnormal
|
0.00%
0/17 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
2.7%
1/37 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Investigations
Breath Sounds Absent
|
0.00%
0/17 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
2.7%
1/37 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Investigations
Cardiac Murmur
|
11.8%
2/17 • Number of events 2 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/37 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Investigations
Chest X-Ray Abnormal
|
0.00%
0/17 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
2.7%
1/37 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Investigations
Electrocardiogram Qt Prolonged
|
0.00%
0/17 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
5.4%
2/37 • Number of events 2 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Investigations
Heart Rate Irregular
|
0.00%
0/17 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
2.7%
1/37 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Investigations
International Normalised Ratio Increased
|
0.00%
0/17 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
2.7%
1/37 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Investigations
Lipase Increased
|
11.8%
2/17 • Number of events 2 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
21.6%
8/37 • Number of events 8 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Investigations
Neutrophil Count Decreased
|
5.9%
1/17 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/37 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Investigations
Nuclear Magnetic Resonance Imaging Brain Abnormal
|
0.00%
0/17 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
2.7%
1/37 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Investigations
Platelet Count Decreased
|
0.00%
0/17 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
2.7%
1/37 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Investigations
Procalcitonin Increased
|
0.00%
0/17 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
2.7%
1/37 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Investigations
Protein Urine Present
|
0.00%
0/17 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
2.7%
1/37 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Investigations
Prothrombin Time Prolonged
|
0.00%
0/17 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
2.7%
1/37 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Investigations
Red Blood Cell Count Decreased
|
0.00%
0/17 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
2.7%
1/37 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Investigations
Red Blood Cells Urine
|
0.00%
0/17 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
2.7%
1/37 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Investigations
Urine Analysis Abnormal
|
5.9%
1/17 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/37 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Investigations
Urine Protein/Creatinine Ratio Increased
|
5.9%
1/17 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/37 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Investigations
Vitamin B12 Increased
|
0.00%
0/17 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
2.7%
1/37 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Investigations
Vitamin D Decreased
|
0.00%
0/17 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
2.7%
1/37 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Investigations
Weight Decreased
|
5.9%
1/17 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
10.8%
4/37 • Number of events 4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Investigations
Weight Increased
|
0.00%
0/17 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
2.7%
1/37 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Investigations
White Blood Cell Count Decreased
|
5.9%
1/17 • Number of events 2 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
33.3%
1/3 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
2.7%
1/37 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Investigations
White Blood Cell Count Increased
|
5.9%
1/17 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/37 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Investigations
White Blood Cells Urine
|
0.00%
0/17 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
2.7%
1/37 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Investigations
White Blood Cells Urine Positive
|
0.00%
0/17 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
33.3%
1/3 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/37 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Metabolism and nutrition disorders
Acidosis
|
0.00%
0/17 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
2.7%
1/37 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
11.8%
2/17 • Number of events 2 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
33.3%
1/3 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
13.5%
5/37 • Number of events 5 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Metabolism and nutrition disorders
Dehydration
|
11.8%
2/17 • Number of events 2 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
2.7%
1/37 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Metabolism and nutrition disorders
Diabetes Mellitus
|
0.00%
0/17 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
2.7%
1/37 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Metabolism and nutrition disorders
Gout
|
5.9%
1/17 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
2.7%
1/37 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/17 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
2.7%
1/37 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
5.9%
1/17 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
2.7%
1/37 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
5.9%
1/17 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
33.3%
1/3 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
5.4%
2/37 • Number of events 2 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
5.9%
1/17 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
2.7%
1/37 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
0.00%
0/17 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
2.7%
1/37 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Metabolism and nutrition disorders
Hyperphosphataemia
|
0.00%
0/17 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
2.7%
1/37 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/17 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
5.4%
2/37 • Number of events 2 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
5.9%
1/17 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
33.3%
1/3 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
2.7%
1/37 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
5.9%
1/17 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
33.3%
1/3 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
5.4%
2/37 • Number of events 2 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
17.6%
3/17 • Number of events 3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
2.7%
1/37 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
11.8%
2/17 • Number of events 3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
5.4%
2/37 • Number of events 2 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/17 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
5.4%
2/37 • Number of events 2 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Metabolism and nutrition disorders
Metabolic Acidosis
|
0.00%
0/17 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
2.7%
1/37 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Metabolism and nutrition disorders
Vitamin D Deficiency
|
0.00%
0/17 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
2.7%
1/37 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.9%
1/17 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
8.1%
3/37 • Number of events 3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
23.5%
4/17 • Number of events 4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
33.3%
1/3 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
10.8%
4/37 • Number of events 4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.00%
0/17 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
2.7%
1/37 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Musculoskeletal and connective tissue disorders
Flank Pain
|
0.00%
0/17 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
2.7%
1/37 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Musculoskeletal and connective tissue disorders
Groin Pain
|
5.9%
1/17 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/37 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Musculoskeletal and connective tissue disorders
Joint Swelling
|
0.00%
0/17 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
2.7%
1/37 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
17.6%
3/17 • Number of events 3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
2.7%
1/37 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Musculoskeletal and connective tissue disorders
Muscle Twitching
|
0.00%
0/17 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
2.7%
1/37 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Musculoskeletal and connective tissue disorders
Muscular Weakness
|
0.00%
0/17 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
2.7%
1/37 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Chest Pain
|
0.00%
0/17 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
33.3%
1/3 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
5.4%
2/37 • Number of events 2 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
|
0.00%
0/17 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
2.7%
1/37 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/17 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
2.7%
1/37 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
0.00%
0/17 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
2.7%
1/37 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
11.8%
2/17 • Number of events 2 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
5.4%
2/37 • Number of events 2 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
0.00%
0/17 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
2.7%
1/37 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Musculoskeletal and connective tissue disorders
Pain In Extremity
|
5.9%
1/17 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
2.7%
1/37 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Musculoskeletal and connective tissue disorders
Pain In Jaw
|
0.00%
0/17 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
2.7%
1/37 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Musculoskeletal and connective tissue disorders
Pathological Fracture
|
0.00%
0/17 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
2.7%
1/37 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Musculoskeletal and connective tissue disorders
Periarthritis
|
0.00%
0/17 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
33.3%
1/3 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/37 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Musculoskeletal and connective tissue disorders
Pubic Pain
|
0.00%
0/17 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
2.7%
1/37 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Musculoskeletal and connective tissue disorders
Scoliosis
|
0.00%
0/17 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
5.4%
2/37 • Number of events 2 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal Cell Carcinoma
|
0.00%
0/17 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
2.7%
1/37 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous Cell Carcinoma Of Skin
|
0.00%
0/17 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
2.7%
1/37 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour Pain
|
0.00%
0/17 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
2.7%
1/37 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Nervous system disorders
Amnesia
|
5.9%
1/17 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/37 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Nervous system disorders
Aphasia
|
0.00%
0/17 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
2.7%
1/37 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Nervous system disorders
Ataxia
|
0.00%
0/17 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
2.7%
1/37 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Nervous system disorders
Cognitive Disorder
|
0.00%
0/17 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
2.7%
1/37 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Nervous system disorders
Dizziness
|
17.6%
3/17 • Number of events 3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
5.4%
2/37 • Number of events 2 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
25.0%
1/4 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Nervous system disorders
Dizziness Postural
|
0.00%
0/17 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
2.7%
1/37 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Nervous system disorders
Dysarthria
|
0.00%
0/17 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
2.7%
1/37 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Nervous system disorders
Headache
|
5.9%
1/17 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
16.2%
6/37 • Number of events 6 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Nervous system disorders
Hypoaesthesia
|
5.9%
1/17 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
2.7%
1/37 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Nervous system disorders
Lethargy
|
0.00%
0/17 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
5.4%
2/37 • Number of events 2 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Nervous system disorders
Memory Impairment
|
0.00%
0/17 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
2.7%
1/37 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Nervous system disorders
Neuropathy Peripheral
|
11.8%
2/17 • Number of events 2 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
5.4%
2/37 • Number of events 2 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/17 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
8.1%
3/37 • Number of events 3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Nervous system disorders
Partial Seizures
|
0.00%
0/17 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/37 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
25.0%
1/4 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Nervous system disorders
Peripheral Sensory Neuropathy
|
0.00%
0/17 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
66.7%
2/3 • Number of events 2 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
5.4%
2/37 • Number of events 2 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Nervous system disorders
Sciatica
|
5.9%
1/17 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
2.7%
1/37 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Nervous system disorders
Seizure
|
0.00%
0/17 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
2.7%
1/37 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Nervous system disorders
Syncope
|
5.9%
1/17 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/37 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Nervous system disorders
Tremor
|
5.9%
1/17 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
2.7%
1/37 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Nervous system disorders
Visual Field Defect
|
0.00%
0/17 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
2.7%
1/37 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Product Issues
Thrombosis In Device
|
5.9%
1/17 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
2.7%
1/37 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Psychiatric disorders
Anxiety
|
23.5%
4/17 • Number of events 4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
10.8%
4/37 • Number of events 4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Psychiatric disorders
Confusional State
|
0.00%
0/17 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
2.7%
1/37 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Psychiatric disorders
Depression
|
11.8%
2/17 • Number of events 2 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
8.1%
3/37 • Number of events 3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Psychiatric disorders
Emotional Distress
|
0.00%
0/17 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
2.7%
1/37 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Psychiatric disorders
Hallucination
|
5.9%
1/17 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
2.7%
1/37 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Psychiatric disorders
Insomnia
|
11.8%
2/17 • Number of events 2 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
5.4%
2/37 • Number of events 2 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Psychiatric disorders
Post-Traumatic Stress Disorder
|
0.00%
0/17 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
2.7%
1/37 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Renal and urinary disorders
Chronic Kidney Disease
|
0.00%
0/17 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
8.1%
3/37 • Number of events 3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/17 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
33.3%
1/3 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
5.4%
2/37 • Number of events 2 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Renal and urinary disorders
Glycosuria
|
0.00%
0/17 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
2.7%
1/37 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Renal and urinary disorders
Haematuria
|
5.9%
1/17 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
8.1%
3/37 • Number of events 3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Renal and urinary disorders
Haemoglobinuria
|
5.9%
1/17 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/37 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Renal and urinary disorders
Hydronephrosis
|
5.9%
1/17 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
2.7%
1/37 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Renal and urinary disorders
Micturition Urgency
|
0.00%
0/17 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
8.1%
3/37 • Number of events 3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/17 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
8.1%
3/37 • Number of events 3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Renal and urinary disorders
Nocturia
|
0.00%
0/17 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
2.7%
1/37 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Renal and urinary disorders
Oliguria
|
0.00%
0/17 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
2.7%
1/37 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/17 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
5.4%
2/37 • Number of events 2 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Renal and urinary disorders
Proteinuria
|
5.9%
1/17 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
5.4%
2/37 • Number of events 2 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Renal and urinary disorders
Renal Failure
|
0.00%
0/17 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
2.7%
1/37 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Renal and urinary disorders
Urinary Hesitation
|
0.00%
0/17 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
2.7%
1/37 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Renal and urinary disorders
Urinary Incontinence
|
0.00%
0/17 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
5.4%
2/37 • Number of events 2 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Renal and urinary disorders
Urinary Retention
|
0.00%
0/17 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
2.7%
1/37 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Renal and urinary disorders
Urinary Tract Pain
|
0.00%
0/17 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
33.3%
1/3 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/37 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Renal and urinary disorders
Urine Flow Decreased
|
0.00%
0/17 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
2.7%
1/37 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Reproductive system and breast disorders
Benign Prostatic Hyperplasia
|
5.9%
1/17 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/37 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Reproductive system and breast disorders
Prostatic Obstruction
|
0.00%
0/17 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
2.7%
1/37 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Reproductive system and breast disorders
Testicular Swelling
|
0.00%
0/17 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
2.7%
1/37 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
5.9%
1/17 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
2.7%
1/37 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.00%
0/17 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
2.7%
1/37 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/17 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
66.7%
2/3 • Number of events 2 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
21.6%
8/37 • Number of events 8 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/17 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
5.4%
2/37 • Number of events 2 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
17.6%
3/17 • Number of events 3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
33.3%
1/3 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
8.1%
3/37 • Number of events 3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea Exertional
|
5.9%
1/17 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
8.1%
3/37 • Number of events 3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/17 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
2.7%
1/37 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
0.00%
0/17 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
33.3%
1/3 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
5.4%
2/37 • Number of events 2 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
5.9%
1/17 • Number of events 3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
5.4%
2/37 • Number of events 2 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Paranasal Sinus Discomfort
|
0.00%
0/17 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
2.7%
1/37 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
5.9%
1/17 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
5.4%
2/37 • Number of events 2 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/17 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
33.3%
1/3 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/37 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Productive Cough
|
0.00%
0/17 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
10.8%
4/37 • Number of events 4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis Allergic
|
5.9%
1/17 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
8.1%
3/37 • Number of events 3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/17 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
8.1%
3/37 • Number of events 3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Sleep Apnoea Syndrome
|
0.00%
0/17 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
2.7%
1/37 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Tachypnoea
|
0.00%
0/17 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
2.7%
1/37 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Tonsillar Inflammation
|
5.9%
1/17 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/37 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
5.9%
1/17 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
33.3%
1/3 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
5.4%
2/37 • Number of events 2 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Skin and subcutaneous tissue disorders
Actinic Keratosis
|
0.00%
0/17 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
5.4%
2/37 • Number of events 2 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/17 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
8.1%
3/37 • Number of events 3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Skin and subcutaneous tissue disorders
Blister
|
5.9%
1/17 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
33.3%
1/3 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
2.7%
1/37 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Skin and subcutaneous tissue disorders
Decubitus Ulcer
|
0.00%
0/17 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
2.7%
1/37 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Skin and subcutaneous tissue disorders
Dermatitis Acneiform
|
5.9%
1/17 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/37 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
5.9%
1/17 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
8.1%
3/37 • Number of events 3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/17 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
33.3%
1/3 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/37 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
5.9%
1/17 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/37 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Skin and subcutaneous tissue disorders
Ingrowing Nail
|
0.00%
0/17 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
2.7%
1/37 • Number of events 2 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Skin and subcutaneous tissue disorders
Nail Pigmentation
|
0.00%
0/17 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
33.3%
1/3 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/37 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Skin and subcutaneous tissue disorders
Night Sweats
|
5.9%
1/17 • Number of events 2 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
8.1%
3/37 • Number of events 3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Skin and subcutaneous tissue disorders
Onychoclasis
|
5.9%
1/17 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/37 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Skin and subcutaneous tissue disorders
Pain Of Skin
|
0.00%
0/17 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
2.7%
1/37 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Skin and subcutaneous tissue disorders
Palmar-Plantar Erythrodysaesthesia Syndrome
|
5.9%
1/17 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/37 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
0.00%
0/17 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
2.7%
1/37 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Skin and subcutaneous tissue disorders
Photosensitivity Reaction
|
5.9%
1/17 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/37 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Skin and subcutaneous tissue disorders
Precancerous Skin Lesion
|
0.00%
0/17 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
2.7%
1/37 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
5.9%
1/17 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
66.7%
2/3 • Number of events 2 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
5.4%
2/37 • Number of events 2 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Skin and subcutaneous tissue disorders
Pruritus Generalised
|
5.9%
1/17 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
33.3%
1/3 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
5.4%
2/37 • Number of events 2 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.00%
0/17 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
2.7%
1/37 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/17 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
33.3%
1/3 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
2.7%
1/37 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Skin and subcutaneous tissue disorders
Rash Generalised
|
5.9%
1/17 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
2.7%
1/37 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Skin and subcutaneous tissue disorders
Rash Macular
|
11.8%
2/17 • Number of events 2 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/37 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Skin and subcutaneous tissue disorders
Rash Maculo-Papular
|
0.00%
0/17 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
2.7%
1/37 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Skin and subcutaneous tissue disorders
Rash Pruritic
|
0.00%
0/17 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
2.7%
1/37 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Skin and subcutaneous tissue disorders
Scab
|
0.00%
0/17 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
5.4%
2/37 • Number of events 2 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Skin and subcutaneous tissue disorders
Seborrhoeic Dermatitis
|
0.00%
0/17 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
2.7%
1/37 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Skin and subcutaneous tissue disorders
Skin Hyperpigmentation
|
0.00%
0/17 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
33.3%
1/3 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/37 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Skin and subcutaneous tissue disorders
Skin Lesion
|
0.00%
0/17 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
2.7%
1/37 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Skin and subcutaneous tissue disorders
Skin Mass
|
0.00%
0/17 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
2.7%
1/37 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Skin and subcutaneous tissue disorders
Swelling Face
|
0.00%
0/17 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
2.7%
1/37 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
5.9%
1/17 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/37 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Vascular disorders
Brachiocephalic Vein Thrombosis
|
0.00%
0/17 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
33.3%
1/3 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/37 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Vascular disorders
Deep Vein Thrombosis
|
0.00%
0/17 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
5.4%
2/37 • Number of events 2 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Vascular disorders
Flushing
|
0.00%
0/17 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
2.7%
1/37 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Vascular disorders
Hot Flush
|
0.00%
0/17 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
2.7%
1/37 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Vascular disorders
Hypertension
|
29.4%
5/17 • Number of events 5 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
33.3%
1/3 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
21.6%
8/37 • Number of events 8 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Vascular disorders
Hypotension
|
0.00%
0/17 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
2.7%
1/37 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Vascular disorders
Lymphoedema
|
0.00%
0/17 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
2.7%
1/37 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
|
Vascular disorders
Systolic Hypertension
|
0.00%
0/17 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/3 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
2.7%
1/37 • Number of events 1 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
0.00%
0/4 • All AEs were collected from the date of signing the consent up to 30 days after the last dose (maximum of 1959 days) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are TEAEs that is AEs and deaths that developed/worsened during the 'on treatment period' (time from the first dose of any study drug up to 30 days after the last dose of any study drug). Analysis was performed on safety population.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Sponsor supports publication of clinical trial results but may request that investigators temporarily delay or alter publications in order to protect proprietary information. The Sponsor may also require that the results of multicenter studies be published only in their entirety and not as individual site data.
- Publication restrictions are in place
Restriction type: OTHER