Trial Outcomes & Findings for Testing the Combination of Cediranib and Olaparib in Comparison to Each Drug Alone or Other Chemotherapy in Recurrent Platinum-Resistant Ovarian Cancer (NCT NCT02502266)
NCT ID: NCT02502266
Last Updated: 2025-12-01
Results Overview
Progression free survival (PFS) was defined as the number of months between study enrollment and documentation of disease progression (RECIST 1.1) or death from any cause. Patients still alive and disease free at the last follow-up were censored on the date of last CT Scan, or the CT Scan date prior to two missed assessments. Disease progression is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE2/PHASE3
Target enrollment
582 participants
Primary outcome timeframe
The protocol required lesion assessments every 9 weeks from cycle 1, day 1 for the first year, then every 12 weeks thereafter until disease progression. Approximately 42 months.
Results posted on
2025-12-01
Participant Flow
Study opened on 05 Feb 2016. Phase 2 accrual completed on 16 Jun 2017 with 213 patients randomly assigned to 4 treatment arms. Enrollment to Arm IV (olaparib) was suspended after DMC review and 52 patients on Arm IV during phase 2 not included in phase 3 analysis. Phase 3 accrual started on 17 Dec 2018 with 349 patients including 4 Japanese patients enrolled to Phase 3 three arms by 02 Oct 2020. After that, 20 Japanese patients were enrolled but not included in the phase 3 analysis.
Participant milestones
| Measure |
Arm I (Reference Regimen)
Patients undergo physician's choice of standard of care chemotherapy, comprising either paclitaxel IV over 60 minutes on days 1, 8, 15, and 22 every 28 days (Regimen I); pegylated liposomal doxorubicin hydrochloride IV over 60 minutes on day 1 every 28 days (Regimen II); or topotecan hydrochloride IV over 30 minutes on days 1, 8, and 15 every 28 days or days 1-5 every 21 days (Regimen III). Treatment continues in the absence of disease progression or unacceptable toxicity. No modification of the assigned regimens, such as additional drugs (gemcitabine, or bevacizumab) is allowed. Patients also undergo CT and MRI throughout the study. (12/05/2016)
Computed Tomography: Undergo CT
Magnetic Resonance Imaging: Undergo MRI
Paclitaxel: Given IV
Pegylated Liposomal Doxorubicin Hydrochloride: Given IV
Questionnaire Administration: Ancillary studies
Topotecan: Given IV
Topotecan Hydrochloride: Given IV
|
Arm II (Cediranib Maleate, Olaparib)
Patients receive cediranib maleate PO QD and olaparib PO BID. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT and MRI throughout the study.
Cediranib: Given PO
Cediranib Maleate: Given PO
Computed Tomography: Undergo CT
Magnetic Resonance Imaging: Undergo MRI
Olaparib: Given PO
Questionnaire Administration: Ancillary studies
|
Arm III (Cediranib Maleate)
Patients receive cediranib maleate PO daily continuously. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT and MRI throughout the study.
Cediranib: Given PO
Cediranib Maleate: Given PO
Computed Tomography: Undergo CT
Magnetic Resonance Imaging: Undergo MRI
Questionnaire Administration: Ancillary studies
|
Arm IV (Olaparib) (Phase II Only)
Patients receive olaparib PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT and MRI throughout the study. (In July 2018, the Data Monitoring Committee voted to exclude the olaparib alone regimen).
Computed Tomography: Undergo CT
Magnetic Resonance Imaging: Undergo MRI
Olaparib: Given PO
Questionnaire Administration: Ancillary studies
|
Arm V (Arm I Regimen: JP Patients Enrolled After P3 Cutoff)
Patients undergo physician's choice of standard of care chemotherapy, comprising either paclitaxel intravenously (IV) over 60 minutes on days 1, 8, 15, and 22 every 28 days (Regimen I); pegylated liposomal doxorubicin hydrochloride IV over 60 minutes on day 1 every 28 days (Regimen II); or topotecan hydrochloride IV over 30 minutes on days 1, 8, and 15 every 28 days or days 1-5 every 21 days (Regimen III). Treatment continues in the absence of disease progression or unacceptable toxicity. No modification of the assigned regimens, such as additional drugs (gemcitabine, or bevacizumab) is allowed. Patients also undergo computed tomography (CT) and magnetic resonance imaging (MRI) throughout the study. (12/05/2016) Patients enrolled from Japan after the Phase III cutoff.
|
Arm VI: (Arm II Regimen: JP Patients Enrolled After P3 Cutoff)
Patients receive cediranib maleate orally (PO) once daily (QD) and olaparib PO twice daily (BID). Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT and MRI throughout the study. Patients enrolled from Japan after the Phase III cutoff.
|
Arm VII: (Arm III Regimen: JP Patients Enrolled After P3 Cutoff)
Patients receive cediranib maleate PO daily continuously. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT and MRI throughout the study. Patients enrolled from Japan after the Phase III cutoff.
|
|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
173
|
167
|
170
|
52
|
5
|
8
|
7
|
|
Overall Study
COMPLETED
|
124
|
146
|
139
|
0
|
3
|
5
|
6
|
|
Overall Study
NOT COMPLETED
|
49
|
21
|
31
|
52
|
2
|
3
|
1
|
Reasons for withdrawal
| Measure |
Arm I (Reference Regimen)
Patients undergo physician's choice of standard of care chemotherapy, comprising either paclitaxel IV over 60 minutes on days 1, 8, 15, and 22 every 28 days (Regimen I); pegylated liposomal doxorubicin hydrochloride IV over 60 minutes on day 1 every 28 days (Regimen II); or topotecan hydrochloride IV over 30 minutes on days 1, 8, and 15 every 28 days or days 1-5 every 21 days (Regimen III). Treatment continues in the absence of disease progression or unacceptable toxicity. No modification of the assigned regimens, such as additional drugs (gemcitabine, or bevacizumab) is allowed. Patients also undergo CT and MRI throughout the study. (12/05/2016)
Computed Tomography: Undergo CT
Magnetic Resonance Imaging: Undergo MRI
Paclitaxel: Given IV
Pegylated Liposomal Doxorubicin Hydrochloride: Given IV
Questionnaire Administration: Ancillary studies
Topotecan: Given IV
Topotecan Hydrochloride: Given IV
|
Arm II (Cediranib Maleate, Olaparib)
Patients receive cediranib maleate PO QD and olaparib PO BID. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT and MRI throughout the study.
Cediranib: Given PO
Cediranib Maleate: Given PO
Computed Tomography: Undergo CT
Magnetic Resonance Imaging: Undergo MRI
Olaparib: Given PO
Questionnaire Administration: Ancillary studies
|
Arm III (Cediranib Maleate)
Patients receive cediranib maleate PO daily continuously. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT and MRI throughout the study.
Cediranib: Given PO
Cediranib Maleate: Given PO
Computed Tomography: Undergo CT
Magnetic Resonance Imaging: Undergo MRI
Questionnaire Administration: Ancillary studies
|
Arm IV (Olaparib) (Phase II Only)
Patients receive olaparib PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT and MRI throughout the study. (In July 2018, the Data Monitoring Committee voted to exclude the olaparib alone regimen).
Computed Tomography: Undergo CT
Magnetic Resonance Imaging: Undergo MRI
Olaparib: Given PO
Questionnaire Administration: Ancillary studies
|
Arm V (Arm I Regimen: JP Patients Enrolled After P3 Cutoff)
Patients undergo physician's choice of standard of care chemotherapy, comprising either paclitaxel intravenously (IV) over 60 minutes on days 1, 8, 15, and 22 every 28 days (Regimen I); pegylated liposomal doxorubicin hydrochloride IV over 60 minutes on day 1 every 28 days (Regimen II); or topotecan hydrochloride IV over 30 minutes on days 1, 8, and 15 every 28 days or days 1-5 every 21 days (Regimen III). Treatment continues in the absence of disease progression or unacceptable toxicity. No modification of the assigned regimens, such as additional drugs (gemcitabine, or bevacizumab) is allowed. Patients also undergo computed tomography (CT) and magnetic resonance imaging (MRI) throughout the study. (12/05/2016) Patients enrolled from Japan after the Phase III cutoff.
|
Arm VI: (Arm II Regimen: JP Patients Enrolled After P3 Cutoff)
Patients receive cediranib maleate orally (PO) once daily (QD) and olaparib PO twice daily (BID). Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT and MRI throughout the study. Patients enrolled from Japan after the Phase III cutoff.
|
Arm VII: (Arm III Regimen: JP Patients Enrolled After P3 Cutoff)
Patients receive cediranib maleate PO daily continuously. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT and MRI throughout the study. Patients enrolled from Japan after the Phase III cutoff.
|
|---|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
0
|
0
|
0
|
1
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
30
|
15
|
16
|
0
|
0
|
0
|
0
|
|
Overall Study
Still on Treatment
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Overall Study
Other Reasons
|
19
|
6
|
14
|
0
|
1
|
1
|
0
|
|
Overall Study
Arm 4 Discontinued
|
0
|
0
|
0
|
52
|
0
|
0
|
0
|
|
Overall Study
Never treated
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Testing the Combination of Cediranib and Olaparib in Comparison to Each Drug Alone or Other Chemotherapy in Recurrent Platinum-Resistant Ovarian Cancer
Baseline characteristics by cohort
| Measure |
Arm I (Reference Regimen)
n=173 Participants
Patients undergo physician's choice of standard of care chemotherapy, comprising either paclitaxel IV over 60 minutes on days 1, 8, 15, and 22 every 28 days (Regimen I); pegylated liposomal doxorubicin hydrochloride IV over 60 minutes on day 1 every 28 days (Regimen II); or topotecan hydrochloride IV over 30 minutes on days 1, 8, and 15 every 28 days or days 1-5 every 21 days (Regimen III). Treatment continues in the absence of disease progression or unacceptable toxicity. No modification of the assigned regimens, such as additional drugs (gemcitabine, or bevacizumab) is allowed. Patients also undergo CT and MRI throughout the study. (12/05/2016)
Computed Tomography: Undergo CT
Magnetic Resonance Imaging: Undergo MRI
Paclitaxel: Given IV
Pegylated Liposomal Doxorubicin Hydrochloride: Given IV
Questionnaire Administration: Ancillary studies
Topotecan: Given IV
Topotecan Hydrochloride: Given IV
|
Arm II (Cediranib Maleate, Olaparib)
n=167 Participants
Patients receive cediranib maleate PO QD and olaparib PO BID. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT and MRI throughout the study.
Cediranib: Given PO
Cediranib Maleate: Given PO
Computed Tomography: Undergo CT
Magnetic Resonance Imaging: Undergo MRI
Olaparib: Given PO
Questionnaire Administration: Ancillary studies
|
Arm III (Cediranib Maleate)
n=170 Participants
Patients receive cediranib maleate PO daily continuously. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT and MRI throughout the study.
Cediranib: Given PO
Cediranib Maleate: Given PO
Computed Tomography: Undergo CT
Magnetic Resonance Imaging: Undergo MRI
Questionnaire Administration: Ancillary studies
|
Arm IV (Olaparib) (Phase II Only)
n=52 Participants
Patients receive olaparib PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT and MRI throughout the study. (In July 2018, the Data Monitoring Committee voted to exclude the olaparib alone regimen).
Computed Tomography: Undergo CT
Magnetic Resonance Imaging: Undergo MRI
Olaparib: Given PO
Questionnaire Administration: Ancillary studies
|
Arm V (Arm I Regimen: JP Patients Enrolled After P3 Cutoff)
n=5 Participants
Patients undergo physician's choice of standard of care chemotherapy, comprising either paclitaxel intravenously (IV) over 60 minutes on days 1, 8, 15, and 22 every 28 days (Regimen I); pegylated liposomal doxorubicin hydrochloride IV over 60 minutes on day 1 every 28 days (Regimen II); or topotecan hydrochloride IV over 30 minutes on days 1, 8, and 15 every 28 days or days 1-5 every 21 days (Regimen III). Treatment continues in the absence of disease progression or unacceptable toxicity. No modification of the assigned regimens, such as additional drugs (gemcitabine, or bevacizumab) is allowed. Patients also undergo computed tomography (CT) and magnetic resonance imaging (MRI) throughout the study. (12/05/2016) Patients enrolled from Japan after the Phase III cutoff.
|
Arm VI: (Arm II Regimen: JP Patients Enrolled After P3 Cutoff)
n=8 Participants
Patients receive cediranib maleate orally (PO) once daily (QD) and olaparib PO twice daily (BID). Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT and MRI throughout the study. Patients enrolled from Japan after the Phase III cutoff.
|
Arm VII: (Arm III Regimen: JP Patients Enrolled After P3 Cutoff)
n=7 Participants
Patients receive cediranib maleate PO daily continuously. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT and MRI throughout the study. Patients enrolled from Japan after the Phase III cutoff
|
Total
n=582 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|
|
Age, Customized
20-29 years
|
1 Participants
n=121 Participants
|
1 Participants
n=122 Participants
|
0 Participants
n=243 Participants
|
1 Participants
n=24 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=12 Participants
|
3 Participants
n=53 Participants
|
|
Age, Customized
30-39 years
|
4 Participants
n=121 Participants
|
1 Participants
n=122 Participants
|
0 Participants
n=243 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=12 Participants
|
5 Participants
n=53 Participants
|
|
Age, Customized
40-49 years
|
9 Participants
n=121 Participants
|
14 Participants
n=122 Participants
|
14 Participants
n=243 Participants
|
4 Participants
n=24 Participants
|
1 Participants
n=8 Participants
|
1 Participants
n=40 Participants
|
1 Participants
n=12 Participants
|
44 Participants
n=53 Participants
|
|
Age, Customized
50-59 years
|
41 Participants
n=121 Participants
|
34 Participants
n=122 Participants
|
36 Participants
n=243 Participants
|
13 Participants
n=24 Participants
|
1 Participants
n=8 Participants
|
2 Participants
n=40 Participants
|
2 Participants
n=12 Participants
|
129 Participants
n=53 Participants
|
|
Age, Customized
60-69 years
|
63 Participants
n=121 Participants
|
60 Participants
n=122 Participants
|
72 Participants
n=243 Participants
|
22 Participants
n=24 Participants
|
0 Participants
n=8 Participants
|
3 Participants
n=40 Participants
|
3 Participants
n=12 Participants
|
223 Participants
n=53 Participants
|
|
Age, Customized
70-79 years
|
48 Participants
n=121 Participants
|
48 Participants
n=122 Participants
|
45 Participants
n=243 Participants
|
11 Participants
n=24 Participants
|
3 Participants
n=8 Participants
|
2 Participants
n=40 Participants
|
1 Participants
n=12 Participants
|
158 Participants
n=53 Participants
|
|
Age, Customized
>= 80 years
|
7 Participants
n=121 Participants
|
9 Participants
n=122 Participants
|
3 Participants
n=243 Participants
|
1 Participants
n=24 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=12 Participants
|
20 Participants
n=53 Participants
|
|
Sex: Female, Male
Female
|
173 Participants
n=121 Participants
|
167 Participants
n=122 Participants
|
170 Participants
n=243 Participants
|
52 Participants
n=24 Participants
|
5 Participants
n=8 Participants
|
8 Participants
n=40 Participants
|
7 Participants
n=12 Participants
|
582 Participants
n=53 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=121 Participants
|
0 Participants
n=122 Participants
|
0 Participants
n=243 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=53 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=121 Participants
|
6 Participants
n=122 Participants
|
3 Participants
n=243 Participants
|
4 Participants
n=24 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=12 Participants
|
19 Participants
n=53 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
161 Participants
n=121 Participants
|
157 Participants
n=122 Participants
|
165 Participants
n=243 Participants
|
46 Participants
n=24 Participants
|
5 Participants
n=8 Participants
|
8 Participants
n=40 Participants
|
7 Participants
n=12 Participants
|
549 Participants
n=53 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
6 Participants
n=121 Participants
|
4 Participants
n=122 Participants
|
2 Participants
n=243 Participants
|
2 Participants
n=24 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=12 Participants
|
14 Participants
n=53 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=121 Participants
|
2 Participants
n=122 Participants
|
3 Participants
n=243 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=12 Participants
|
6 Participants
n=53 Participants
|
|
Race (NIH/OMB)
Asian
|
19 Participants
n=121 Participants
|
12 Participants
n=122 Participants
|
11 Participants
n=243 Participants
|
0 Participants
n=24 Participants
|
5 Participants
n=8 Participants
|
8 Participants
n=40 Participants
|
7 Participants
n=12 Participants
|
62 Participants
n=53 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=121 Participants
|
0 Participants
n=122 Participants
|
0 Participants
n=243 Participants
|
2 Participants
n=24 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=12 Participants
|
2 Participants
n=53 Participants
|
|
Race (NIH/OMB)
Black or African American
|
11 Participants
n=121 Participants
|
6 Participants
n=122 Participants
|
11 Participants
n=243 Participants
|
4 Participants
n=24 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=12 Participants
|
32 Participants
n=53 Participants
|
|
Race (NIH/OMB)
White
|
135 Participants
n=121 Participants
|
142 Participants
n=122 Participants
|
142 Participants
n=243 Participants
|
45 Participants
n=24 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=12 Participants
|
464 Participants
n=53 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=121 Participants
|
0 Participants
n=122 Participants
|
0 Participants
n=243 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=53 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
7 Participants
n=121 Participants
|
5 Participants
n=122 Participants
|
3 Participants
n=243 Participants
|
1 Participants
n=24 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=12 Participants
|
16 Participants
n=53 Participants
|
PRIMARY outcome
Timeframe: The protocol required lesion assessments every 9 weeks from cycle 1, day 1 for the first year, then every 12 weeks thereafter until disease progression. Approximately 42 months.Population: All subjects randomized at Phase II.
Progression free survival (PFS) was defined as the number of months between study enrollment and documentation of disease progression (RECIST 1.1) or death from any cause. Patients still alive and disease free at the last follow-up were censored on the date of last CT Scan, or the CT Scan date prior to two missed assessments. Disease progression is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).
Outcome measures
| Measure |
Arm III (Cediranib Maleate)
n=53 Participants
Patients receive cediranib maleate PO daily continuously. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT and MRI throughout the study.
Cediranib: Given PO
Cediranib Maleate: Given PO
Computed Tomography: Undergo CT
Magnetic Resonance Imaging: Undergo MRI
Questionnaire Administration: Ancillary studies
|
Arm I (Reference Regimen)
n=53 Participants
Patients undergo physician's choice of standard of care chemotherapy, comprising either paclitaxel IV over 60 minutes on days 1, 8, 15, and 22 every 28 days (Regimen I); pegylated liposomal doxorubicin hydrochloride IV over 60 minutes on day 1 every 28 days (Regimen II); or topotecan hydrochloride IV over 30 minutes on days 1, 8, and 15 every 28 days or days 1-5 every 21 days (Regimen III). Treatment continues in the absence of disease progression or unacceptable toxicity. No modification of the assigned regimens, such as additional drugs (gemcitabine, or bevacizumab) is allowed. Patients also undergo CT and MRI throughout the study. (12/05/2016)
Computed Tomography: Undergo CT
Magnetic Resonance Imaging: Undergo MRI
Paclitaxel: Given IV
Pegylated Liposomal Doxorubicin Hydrochloride: Given IV
Questionnaire Administration: Ancillary studies
Topotecan: Given IV
Topotecan Hydrochloride: Given IV
|
Arm II (Cediranib Maleate, Olaparib)
n=55 Participants
Patients receive cediranib maleate PO QD and olaparib PO BID. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT and MRI throughout the study.
Cediranib: Given PO
Cediranib Maleate: Given PO
Computed Tomography: Undergo CT
Magnetic Resonance Imaging: Undergo MRI
Olaparib: Given PO
Questionnaire Administration: Ancillary studies
|
Arm IV (Olaparib) (Phase II Only)
n=52 Participants
Patients receive olaparib PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT and MRI throughout the study. (In July 2018, the Data Monitoring Committee voted to exclude the olaparib alone regimen).
Computed Tomography: Undergo CT
Magnetic Resonance Imaging: Undergo MRI
Olaparib: Given PO
Questionnaire Administration: Ancillary studies
|
Arm VI: (Arm II Regimen: JP Patients Enrolled After P3 Cutoff)
Patients receive cediranib maleate orally (PO) once daily (QD) and olaparib PO twice daily (BID). Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT and MRI throughout the study. Patients enrolled from Japan after the Phase III cutoff.
|
Arm VII: (Arm III Regimen: JP Patients Enrolled After P3 Cutoff)
Patients receive cediranib maleate PO daily continuously. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT and MRI throughout the study. Patients enrolled from Japan after the Phase III cutoff.
|
Arm VII: (Arm III Regimen: JP Patients Enrolled After P3 Cutoff)
Patients receive cediranib maleate PO daily continuously. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT and MRI throughout the study. Patients enrolled from Japan after the Phase III cutoff.
|
|---|---|---|---|---|---|---|---|
|
Progression-free Survival (PFS) (Phase II Only)
|
3.4 Months
Interval 2.3 to 4.8
|
2.3 Months
Interval 2.1 to 4.2
|
6.2 Months
Interval 3.9 to 8.2
|
2.3 Months
Interval 2.0 to 2.8
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: The protocol required lesion assessments every 9 weeks from cycle 1, day 1 for the first year, then every 12 weeks thereafter until disease progression. Approximately 42 months.Population: All randomized subjects in Arms I - VII (excluding Arm IV). Arm 4 (Olaparib alone) was not continued in the Phase III part for its lack of efficacy after the completion of the Phase II portion. No further analyses were performed or reported for this arm. The primary endpoint analysis also did not include 20 Japanese patients who were enrolled after the primary Phase III endpoint was reached.
Progression free survival (PFS) was defined as the number of months between study enrollment and documentation of disease progression (RECIST 1.1) or death from any cause. Patients still alive and disease free at the last follow-up were censored on the date of last CT Scan, or the CT Scan date prior to two missed assessments. Disease progression is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).
Outcome measures
| Measure |
Arm III (Cediranib Maleate)
n=170 Participants
Patients receive cediranib maleate PO daily continuously. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT and MRI throughout the study.
Cediranib: Given PO
Cediranib Maleate: Given PO
Computed Tomography: Undergo CT
Magnetic Resonance Imaging: Undergo MRI
Questionnaire Administration: Ancillary studies
|
Arm I (Reference Regimen)
n=173 Participants
Patients undergo physician's choice of standard of care chemotherapy, comprising either paclitaxel IV over 60 minutes on days 1, 8, 15, and 22 every 28 days (Regimen I); pegylated liposomal doxorubicin hydrochloride IV over 60 minutes on day 1 every 28 days (Regimen II); or topotecan hydrochloride IV over 30 minutes on days 1, 8, and 15 every 28 days or days 1-5 every 21 days (Regimen III). Treatment continues in the absence of disease progression or unacceptable toxicity. No modification of the assigned regimens, such as additional drugs (gemcitabine, or bevacizumab) is allowed. Patients also undergo CT and MRI throughout the study. (12/05/2016)
Computed Tomography: Undergo CT
Magnetic Resonance Imaging: Undergo MRI
Paclitaxel: Given IV
Pegylated Liposomal Doxorubicin Hydrochloride: Given IV
Questionnaire Administration: Ancillary studies
Topotecan: Given IV
Topotecan Hydrochloride: Given IV
|
Arm II (Cediranib Maleate, Olaparib)
n=167 Participants
Patients receive cediranib maleate PO QD and olaparib PO BID. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT and MRI throughout the study.
Cediranib: Given PO
Cediranib Maleate: Given PO
Computed Tomography: Undergo CT
Magnetic Resonance Imaging: Undergo MRI
Olaparib: Given PO
Questionnaire Administration: Ancillary studies
|
Arm IV (Olaparib) (Phase II Only)
n=5 Participants
Patients receive olaparib PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT and MRI throughout the study. (In July 2018, the Data Monitoring Committee voted to exclude the olaparib alone regimen).
Computed Tomography: Undergo CT
Magnetic Resonance Imaging: Undergo MRI
Olaparib: Given PO
Questionnaire Administration: Ancillary studies
|
Arm VI: (Arm II Regimen: JP Patients Enrolled After P3 Cutoff)
n=8 Participants
Patients receive cediranib maleate orally (PO) once daily (QD) and olaparib PO twice daily (BID). Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT and MRI throughout the study. Patients enrolled from Japan after the Phase III cutoff.
|
Arm VII: (Arm III Regimen: JP Patients Enrolled After P3 Cutoff)
n=7 Participants
Patients receive cediranib maleate PO daily continuously. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT and MRI throughout the study. Patients enrolled from Japan after the Phase III cutoff.
|
Arm VII: (Arm III Regimen: JP Patients Enrolled After P3 Cutoff)
Patients receive cediranib maleate PO daily continuously. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT and MRI throughout the study. Patients enrolled from Japan after the Phase III cutoff.
|
|---|---|---|---|---|---|---|---|
|
Progression-free Survival (PFS) (Phase III Only)
|
4.0 months
Interval 3.2 to 4.3
|
3.4 months
Interval 2.4 to 4.3
|
5.2 months
Interval 4.2 to 6.2
|
4.2 months
Interval 2.1 to
The sample size is not sufficient for the estimation of the upper bound of the CI.
|
5.3 months
Interval 2.5 to 12.6
|
4.1 months
Interval 2.3 to 4.8
|
—
|
PRIMARY outcome
Timeframe: Time from study enrollment to death due to any cause, assessed up to 5 yearsPopulation: All randomized subjects in Arms I - VII (excluding Arm IV). Arm 4 (Olaparib alone) was not continued in the Phase III part for its lack of efficacy after the completion of the Phase II portion. No further analyses were performed or reported for this arm. Twenty Japanese patients who were enrolled after the primary Phase III endpoint was reached were not included in the analysis for overall survival.
Overall survival will be evaluated. To allow for better understanding of time to subsequent therapy and OS, patients on experimental study drug(s) or standard chemotherapy arm will be followed after progression, with data capture to include the date of initiation of the subsequent therapy, detailed information on the type of subsequent therapy received, and time to progression on the subsequent therapy.
Outcome measures
| Measure |
Arm III (Cediranib Maleate)
n=170 Participants
Patients receive cediranib maleate PO daily continuously. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT and MRI throughout the study.
Cediranib: Given PO
Cediranib Maleate: Given PO
Computed Tomography: Undergo CT
Magnetic Resonance Imaging: Undergo MRI
Questionnaire Administration: Ancillary studies
|
Arm I (Reference Regimen)
n=173 Participants
Patients undergo physician's choice of standard of care chemotherapy, comprising either paclitaxel IV over 60 minutes on days 1, 8, 15, and 22 every 28 days (Regimen I); pegylated liposomal doxorubicin hydrochloride IV over 60 minutes on day 1 every 28 days (Regimen II); or topotecan hydrochloride IV over 30 minutes on days 1, 8, and 15 every 28 days or days 1-5 every 21 days (Regimen III). Treatment continues in the absence of disease progression or unacceptable toxicity. No modification of the assigned regimens, such as additional drugs (gemcitabine, or bevacizumab) is allowed. Patients also undergo CT and MRI throughout the study. (12/05/2016)
Computed Tomography: Undergo CT
Magnetic Resonance Imaging: Undergo MRI
Paclitaxel: Given IV
Pegylated Liposomal Doxorubicin Hydrochloride: Given IV
Questionnaire Administration: Ancillary studies
Topotecan: Given IV
Topotecan Hydrochloride: Given IV
|
Arm II (Cediranib Maleate, Olaparib)
n=167 Participants
Patients receive cediranib maleate PO QD and olaparib PO BID. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT and MRI throughout the study.
Cediranib: Given PO
Cediranib Maleate: Given PO
Computed Tomography: Undergo CT
Magnetic Resonance Imaging: Undergo MRI
Olaparib: Given PO
Questionnaire Administration: Ancillary studies
|
Arm IV (Olaparib) (Phase II Only)
n=5 Participants
Patients receive olaparib PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT and MRI throughout the study. (In July 2018, the Data Monitoring Committee voted to exclude the olaparib alone regimen).
Computed Tomography: Undergo CT
Magnetic Resonance Imaging: Undergo MRI
Olaparib: Given PO
Questionnaire Administration: Ancillary studies
|
Arm VI: (Arm II Regimen: JP Patients Enrolled After P3 Cutoff)
n=8 Participants
Patients receive cediranib maleate orally (PO) once daily (QD) and olaparib PO twice daily (BID). Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT and MRI throughout the study. Patients enrolled from Japan after the Phase III cutoff.
|
Arm VII: (Arm III Regimen: JP Patients Enrolled After P3 Cutoff)
n=7 Participants
Patients receive cediranib maleate PO daily continuously. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT and MRI throughout the study. Patients enrolled from Japan after the Phase III cutoff.
|
Arm VII: (Arm III Regimen: JP Patients Enrolled After P3 Cutoff)
Patients receive cediranib maleate PO daily continuously. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT and MRI throughout the study. Patients enrolled from Japan after the Phase III cutoff.
|
|---|---|---|---|---|---|---|---|
|
Overall Survival (OS) (Phase III Only)
|
10.5 months
Interval 9.1 to 12.3
|
13.6 months
Interval 11.6 to 15.8
|
12.8 months
Interval 10.1 to 15.3
|
14.9 months
Interval 10.4 to
The sample size is not sufficient for the estimation of the upper bound of the CI.
|
18.0 months
Interval 2.8 to
The sample size is not sufficient for the estimation of the upper bound of the CI.
|
5.8 months
Interval 3.6 to 17.5
|
—
|
SECONDARY outcome
Timeframe: Up to 5 yearsPopulation: Patients randomized at phase II and with measurable disease.
The Response Rates were estimated as the binomial proportion of patients with Best Overall Response of Complete or Partial response according to RECIST 1.1 criteria. A Complete response (CR) is defined as the complete disappearance of all target lesions, while a Partial response (PR) is defined as at least a 30% decrease in the sum of the longest diameters of target lesions compared to the baseline measurement; essentially, the tumor shrinks significantly but does not completely disappear. Overall response (OR) = CR + PR.
Outcome measures
| Measure |
Arm III (Cediranib Maleate)
n=51 Participants
Patients receive cediranib maleate PO daily continuously. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT and MRI throughout the study.
Cediranib: Given PO
Cediranib Maleate: Given PO
Computed Tomography: Undergo CT
Magnetic Resonance Imaging: Undergo MRI
Questionnaire Administration: Ancillary studies
|
Arm I (Reference Regimen)
n=46 Participants
Patients undergo physician's choice of standard of care chemotherapy, comprising either paclitaxel IV over 60 minutes on days 1, 8, 15, and 22 every 28 days (Regimen I); pegylated liposomal doxorubicin hydrochloride IV over 60 minutes on day 1 every 28 days (Regimen II); or topotecan hydrochloride IV over 30 minutes on days 1, 8, and 15 every 28 days or days 1-5 every 21 days (Regimen III). Treatment continues in the absence of disease progression or unacceptable toxicity. No modification of the assigned regimens, such as additional drugs (gemcitabine, or bevacizumab) is allowed. Patients also undergo CT and MRI throughout the study. (12/05/2016)
Computed Tomography: Undergo CT
Magnetic Resonance Imaging: Undergo MRI
Paclitaxel: Given IV
Pegylated Liposomal Doxorubicin Hydrochloride: Given IV
Questionnaire Administration: Ancillary studies
Topotecan: Given IV
Topotecan Hydrochloride: Given IV
|
Arm II (Cediranib Maleate, Olaparib)
n=53 Participants
Patients receive cediranib maleate PO QD and olaparib PO BID. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT and MRI throughout the study.
Cediranib: Given PO
Cediranib Maleate: Given PO
Computed Tomography: Undergo CT
Magnetic Resonance Imaging: Undergo MRI
Olaparib: Given PO
Questionnaire Administration: Ancillary studies
|
Arm IV (Olaparib) (Phase II Only)
n=49 Participants
Patients receive olaparib PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT and MRI throughout the study. (In July 2018, the Data Monitoring Committee voted to exclude the olaparib alone regimen).
Computed Tomography: Undergo CT
Magnetic Resonance Imaging: Undergo MRI
Olaparib: Given PO
Questionnaire Administration: Ancillary studies
|
Arm VI: (Arm II Regimen: JP Patients Enrolled After P3 Cutoff)
Patients receive cediranib maleate orally (PO) once daily (QD) and olaparib PO twice daily (BID). Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT and MRI throughout the study. Patients enrolled from Japan after the Phase III cutoff.
|
Arm VII: (Arm III Regimen: JP Patients Enrolled After P3 Cutoff)
Patients receive cediranib maleate PO daily continuously. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT and MRI throughout the study. Patients enrolled from Japan after the Phase III cutoff.
|
Arm VII: (Arm III Regimen: JP Patients Enrolled After P3 Cutoff)
Patients receive cediranib maleate PO daily continuously. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT and MRI throughout the study. Patients enrolled from Japan after the Phase III cutoff.
|
|---|---|---|---|---|---|---|---|
|
Objective Response Rate (Complete Response and Partial Response) (Phase II Only)
|
9 Participants
|
4 Participants
|
17 Participants
|
3 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 5 yearsPopulation: Patients with measurable disease in Arms I - VII (excluding Arm IV). Arm 4 (Olaparib alone) was not continued in the Phase III part for its lack of efficacy after the completion of the Phase II portion. No further analyses were performed or reported for this arm. Twenty Japanese patients who were enrolled after the primary Phase III endpoint was reached were not included in the analysis of overall response rates.
The Response Rates were estimated as the binomial proportion of patients with Best Overall Response of Complete or Partial response according to RECIST 1.1 criteria. A Complete response (CR) is defined as the complete disappearance of all target lesions, while a Partial response (PR) is defined as at least a 30% decrease in the sum of the longest diameters of target lesions compared to the baseline measurement; essentially, the tumor shrinks significantly but does not completely disappear. Overall response (OR) = CR + PR.
Outcome measures
| Measure |
Arm III (Cediranib Maleate)
n=96 Participants
Patients receive cediranib maleate PO daily continuously. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT and MRI throughout the study.
Cediranib: Given PO
Cediranib Maleate: Given PO
Computed Tomography: Undergo CT
Magnetic Resonance Imaging: Undergo MRI
Questionnaire Administration: Ancillary studies
|
Arm I (Reference Regimen)
n=93 Participants
Patients undergo physician's choice of standard of care chemotherapy, comprising either paclitaxel IV over 60 minutes on days 1, 8, 15, and 22 every 28 days (Regimen I); pegylated liposomal doxorubicin hydrochloride IV over 60 minutes on day 1 every 28 days (Regimen II); or topotecan hydrochloride IV over 30 minutes on days 1, 8, and 15 every 28 days or days 1-5 every 21 days (Regimen III). Treatment continues in the absence of disease progression or unacceptable toxicity. No modification of the assigned regimens, such as additional drugs (gemcitabine, or bevacizumab) is allowed. Patients also undergo CT and MRI throughout the study. (12/05/2016)
Computed Tomography: Undergo CT
Magnetic Resonance Imaging: Undergo MRI
Paclitaxel: Given IV
Pegylated Liposomal Doxorubicin Hydrochloride: Given IV
Questionnaire Administration: Ancillary studies
Topotecan: Given IV
Topotecan Hydrochloride: Given IV
|
Arm II (Cediranib Maleate, Olaparib)
n=90 Participants
Patients receive cediranib maleate PO QD and olaparib PO BID. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT and MRI throughout the study.
Cediranib: Given PO
Cediranib Maleate: Given PO
Computed Tomography: Undergo CT
Magnetic Resonance Imaging: Undergo MRI
Olaparib: Given PO
Questionnaire Administration: Ancillary studies
|
Arm IV (Olaparib) (Phase II Only)
n=5 Participants
Patients receive olaparib PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT and MRI throughout the study. (In July 2018, the Data Monitoring Committee voted to exclude the olaparib alone regimen).
Computed Tomography: Undergo CT
Magnetic Resonance Imaging: Undergo MRI
Olaparib: Given PO
Questionnaire Administration: Ancillary studies
|
Arm VI: (Arm II Regimen: JP Patients Enrolled After P3 Cutoff)
n=8 Participants
Patients receive cediranib maleate orally (PO) once daily (QD) and olaparib PO twice daily (BID). Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT and MRI throughout the study. Patients enrolled from Japan after the Phase III cutoff.
|
Arm VII: (Arm III Regimen: JP Patients Enrolled After P3 Cutoff)
n=7 Participants
Patients receive cediranib maleate PO daily continuously. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT and MRI throughout the study. Patients enrolled from Japan after the Phase III cutoff.
|
Arm VII: (Arm III Regimen: JP Patients Enrolled After P3 Cutoff)
Patients receive cediranib maleate PO daily continuously. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT and MRI throughout the study. Patients enrolled from Japan after the Phase III cutoff.
|
|---|---|---|---|---|---|---|---|
|
Objective Response Rate (Complete Response and Partial Response for Phase III Only)
|
23 Participants
|
15 Participants
|
32 Participants
|
0 Participants
|
3 Participants
|
2 Participants
|
—
|
SECONDARY outcome
Timeframe: Up to 5 yearsPopulation: Randomized and treated patients in Arms I - VII. Arm 4 (Olaparib alone) was not continued in the Phase III part for its lack of efficacy after the completion of the Phase II portion. No further analyses were performed or reported for this arm. Twenty Japanese patients who were enrolled after the primary Phase III endpoint was reached were not included in the analysis of adverse events.
Adverse events will be categorized by CTCAE V4.0. This outcome will report the count of participants who experienced a grade 3 (or higher) adverse event.
Outcome measures
| Measure |
Arm III (Cediranib Maleate)
n=162 Participants
Patients receive cediranib maleate PO daily continuously. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT and MRI throughout the study.
Cediranib: Given PO
Cediranib Maleate: Given PO
Computed Tomography: Undergo CT
Magnetic Resonance Imaging: Undergo MRI
Questionnaire Administration: Ancillary studies
|
Arm I (Reference Regimen)
n=156 Participants
Patients undergo physician's choice of standard of care chemotherapy, comprising either paclitaxel IV over 60 minutes on days 1, 8, 15, and 22 every 28 days (Regimen I); pegylated liposomal doxorubicin hydrochloride IV over 60 minutes on day 1 every 28 days (Regimen II); or topotecan hydrochloride IV over 30 minutes on days 1, 8, and 15 every 28 days or days 1-5 every 21 days (Regimen III). Treatment continues in the absence of disease progression or unacceptable toxicity. No modification of the assigned regimens, such as additional drugs (gemcitabine, or bevacizumab) is allowed. Patients also undergo CT and MRI throughout the study. (12/05/2016)
Computed Tomography: Undergo CT
Magnetic Resonance Imaging: Undergo MRI
Paclitaxel: Given IV
Pegylated Liposomal Doxorubicin Hydrochloride: Given IV
Questionnaire Administration: Ancillary studies
Topotecan: Given IV
Topotecan Hydrochloride: Given IV
|
Arm II (Cediranib Maleate, Olaparib)
n=163 Participants
Patients receive cediranib maleate PO QD and olaparib PO BID. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT and MRI throughout the study.
Cediranib: Given PO
Cediranib Maleate: Given PO
Computed Tomography: Undergo CT
Magnetic Resonance Imaging: Undergo MRI
Olaparib: Given PO
Questionnaire Administration: Ancillary studies
|
Arm IV (Olaparib) (Phase II Only)
n=49 Participants
Patients receive olaparib PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT and MRI throughout the study. (In July 2018, the Data Monitoring Committee voted to exclude the olaparib alone regimen).
Computed Tomography: Undergo CT
Magnetic Resonance Imaging: Undergo MRI
Olaparib: Given PO
Questionnaire Administration: Ancillary studies
|
Arm VI: (Arm II Regimen: JP Patients Enrolled After P3 Cutoff)
n=5 Participants
Patients receive cediranib maleate orally (PO) once daily (QD) and olaparib PO twice daily (BID). Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT and MRI throughout the study. Patients enrolled from Japan after the Phase III cutoff.
|
Arm VII: (Arm III Regimen: JP Patients Enrolled After P3 Cutoff)
n=7 Participants
Patients receive cediranib maleate PO daily continuously. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT and MRI throughout the study. Patients enrolled from Japan after the Phase III cutoff.
|
Arm VII: (Arm III Regimen: JP Patients Enrolled After P3 Cutoff)
n=7 Participants
Patients receive cediranib maleate PO daily continuously. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT and MRI throughout the study. Patients enrolled from Japan after the Phase III cutoff.
|
|---|---|---|---|---|---|---|---|
|
Incidence of Grade 3 (or Higher) Adverse Events
|
126 Participants
|
88 Participants
|
129 Participants
|
24 Participants
|
3 Participants
|
4 Participants
|
5 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 5 yearsMeasured by the 9-item Disease Related Symptoms (DRS-9) subscale of the National Comprehensive Cancer Network (NCCN)-Functional Assessment of Cancer Therapy (FACT) Ovarian Symptom Index (NFOSI-18).
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 5 yearsA single proportional hazards model will be used to estimate the treatment hazard ratios (and variances) for each of the experimental treatments selected for phase III evaluation relative to the reference treatment (chemotherapy) group. The model will include adjustments for prior platinum-free interval, prior bevacizumab treatment, age at study enrollment, randomly assigned study treatment and BROCA-HR status. The estimated hazard ratio(s) for BROCA-HR and the corresponding confidence intervals will be depicted with a forest plot, and assessed for qualitative interaction(s).
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline up to 5 yearsA proportional hazards model will be used to assess a linear association between the change in circulating endothelial cell values and the log relative hazard of death within each treatment group. Sensitivity analyses will include known prognostic factors in the model. A plot of the martingale residuals or estimated relative hazards by change in circulating endothelial cell quintiles will be used to qualitatively assess the assumption of a linear relationship between the change in circulating endothelial cell values and the log relative hazard.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 5 yearsA proportional hazards model will be used to assess whether the pretreatment values of any of these analytes have a prognostic association with overall survival. The model will include clinical covariates: age, performance status, and the randomly assigned study treatment. Proportional hazards models will be used to assess the relationship between patients' analyte values and log hazard. A proportional hazards model will be used to assess the potential predictive associations between analytes, treatment and survival.
Outcome measures
Outcome data not reported
Adverse Events
Arm I (Reference Regimen)
Serious events: 12 serious events
Other events: 151 other events
Deaths: 137 deaths
Arm II (Cediranib Maleate, Olaparib)
Serious events: 21 serious events
Other events: 162 other events
Deaths: 145 deaths
Arm III (Cediranib Maleate)
Serious events: 19 serious events
Other events: 162 other events
Deaths: 143 deaths
Arm IV (Olaparib) (Phase II Only)
Serious events: 14 serious events
Other events: 46 other events
Deaths: 45 deaths
Arm V (Arm I Regimen: JP Patients Enrolled After P3 Cutoff)
Serious events: 0 serious events
Other events: 5 other events
Deaths: 2 deaths
Arm VI: (Arm II Regimen: JP Patients Enrolled After P3 Cutoff)
Serious events: 0 serious events
Other events: 7 other events
Deaths: 5 deaths
Arm VII: (Arm III Regimen: JP Patients Enrolled After P3 Cutoff)
Serious events: 0 serious events
Other events: 7 other events
Deaths: 6 deaths
Serious adverse events
| Measure |
Arm I (Reference Regimen)
n=156 participants at risk
Patients undergo physician's choice of standard of care chemotherapy, comprising either paclitaxel IV over 60 minutes on days 1, 8, 15, and 22 every 28 days (Regimen I); pegylated liposomal doxorubicin hydrochloride IV over 60 minutes on day 1 every 28 days (Regimen II); or topotecan hydrochloride IV over 30 minutes on days 1, 8, and 15 every 28 days or days 1-5 every 21 days (Regimen III). Treatment continues in the absence of disease progression or unacceptable toxicity. No modification of the assigned regimens, such as additional drugs (gemcitabine, or bevacizumab) is allowed. Patients also undergo CT and MRI throughout the study. (12/05/2016)
Computed Tomography: Undergo CT
Magnetic Resonance Imaging: Undergo MRI
Paclitaxel: Given IV
Pegylated Liposomal Doxorubicin Hydrochloride: Given IV
Questionnaire Administration: Ancillary studies
Topotecan: Given IV
Topotecan Hydrochloride: Given IV
|
Arm II (Cediranib Maleate, Olaparib)
n=163 participants at risk
Patients receive cediranib maleate PO QD and olaparib PO BID. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT and MRI throughout the study.
Cediranib: Given PO
Cediranib Maleate: Given PO
Computed Tomography: Undergo CT
Magnetic Resonance Imaging: Undergo MRI
Olaparib: Given PO
Questionnaire Administration: Ancillary studies
|
Arm III (Cediranib Maleate)
n=162 participants at risk
Patients receive cediranib maleate PO daily continuously. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT and MRI throughout the study.
Cediranib: Given PO
Cediranib Maleate: Given PO
Computed Tomography: Undergo CT
Magnetic Resonance Imaging: Undergo MRI
Questionnaire Administration: Ancillary studies
|
Arm IV (Olaparib) (Phase II Only)
n=49 participants at risk
Patients receive olaparib PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT and MRI throughout the study. (In July 2018, the Data Monitoring Committee voted to exclude the olaparib alone regimen).
Computed Tomography: Undergo CT
Magnetic Resonance Imaging: Undergo MRI
Olaparib: Given PO
Questionnaire Administration: Ancillary studies
|
Arm V (Arm I Regimen: JP Patients Enrolled After P3 Cutoff)
n=5 participants at risk
Patients undergo physician's choice of standard of care chemotherapy, comprising either paclitaxel intravenously (IV) over 60 minutes on days 1, 8, 15, and 22 every 28 days (Regimen I); pegylated liposomal doxorubicin hydrochloride IV over 60 minutes on day 1 every 28 days (Regimen II); or topotecan hydrochloride IV over 30 minutes on days 1, 8, and 15 every 28 days or days 1-5 every 21 days (Regimen III). Treatment continues in the absence of disease progression or unacceptable toxicity. No modification of the assigned regimens, such as additional drugs (gemcitabine, or bevacizumab) is allowed. Patients also undergo computed tomography (CT) and magnetic resonance imaging (MRI) throughout the study. (12/05/2016) Patients enrolled from Japan after the Phase III cutoff.
|
Arm VI: (Arm II Regimen: JP Patients Enrolled After P3 Cutoff)
n=7 participants at risk
Patients receive cediranib maleate orally (PO) once daily (QD) and olaparib PO twice daily (BID). Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT and MRI throughout the study. Patients enrolled from Japan after the Phase III cutoff.
|
Arm VII: (Arm III Regimen: JP Patients Enrolled After P3 Cutoff)
n=7 participants at risk
Patients receive cediranib maleate PO daily continuously. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT and MRI throughout the study. Patients enrolled from Japan after the Phase III cutoff.
|
|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
0.64%
1/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
10.2%
5/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.61%
1/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.61%
1/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.61%
1/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.62%
1/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Gastrointestinal disorders
Abdominal distension
|
0.64%
1/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
2.0%
1/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Gastrointestinal disorders
Abdominal pain
|
1.9%
3/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
2.5%
4/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
2.5%
4/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
4.1%
2/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Gastrointestinal disorders
Anal pain
|
0.00%
0/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.62%
1/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
2.0%
1/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.61%
1/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Gastrointestinal disorders
Colonic obstruction
|
0.00%
0/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.61%
1/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.62%
1/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Gastrointestinal disorders
Colonic perforation
|
0.64%
1/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Gastrointestinal disorders
Constipation
|
0.64%
1/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.62%
1/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
1.2%
2/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
1.9%
3/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.61%
1/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Gastrointestinal disorders
Esophagitis
|
0.00%
0/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.61%
1/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify
|
0.00%
0/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.62%
1/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Gastrointestinal disorders
Ileal obstruction
|
0.00%
0/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
4.1%
2/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.61%
1/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.62%
1/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
4.1%
2/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Gastrointestinal disorders
Mucositis oral
|
0.00%
0/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.61%
1/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Gastrointestinal disorders
Nausea
|
1.3%
2/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
2.5%
4/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
1.9%
3/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
6.1%
3/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
0.00%
0/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
2.0%
1/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.64%
1/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
1.8%
3/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
1.2%
2/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
2.0%
1/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Gastrointestinal disorders
Small intestinal perforation
|
0.00%
0/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.62%
1/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Gastrointestinal disorders
Vomiting
|
0.64%
1/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
1.8%
3/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
2.5%
4/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
6.1%
3/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
General disorders
Death NOS
|
0.00%
0/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.62%
1/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
General disorders
Edema limbs
|
0.00%
0/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
2.0%
1/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
General disorders
Fatigue
|
0.00%
0/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
1.8%
3/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
1.2%
2/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.62%
1/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.62%
1/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Infections and infestations
Biliary tract infection
|
0.00%
0/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.62%
1/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Infections and infestations
Catheter related infection
|
0.00%
0/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.61%
1/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Infections and infestations
Enterocolitis infectious
|
0.64%
1/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Infections and infestations
Peritoneal infection
|
0.64%
1/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Infections and infestations
Urinary tract infection
|
0.64%
1/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
1.2%
2/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Investigations
Alkaline phosphatase increased
|
0.00%
0/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.62%
1/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
1.2%
2/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Investigations
Creatinine increased
|
0.00%
0/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
2.0%
1/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Investigations
INR increased
|
0.00%
0/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.62%
1/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Investigations
Platelet count decreased
|
0.00%
0/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.62%
1/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
2.0%
1/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Investigations
Weight loss
|
0.00%
0/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.62%
1/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.61%
1/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
1.9%
3/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
2.0%
1/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
1.2%
2/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.62%
1/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.62%
1/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.62%
1/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.64%
1/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
0.00%
0/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.62%
1/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify
|
0.00%
0/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.62%
1/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Nervous system disorders
Cognitive disturbance
|
0.00%
0/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.62%
1/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Nervous system disorders
Depressed level of consciousness
|
0.00%
0/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.62%
1/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Nervous system disorders
Dysarthria
|
0.00%
0/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.62%
1/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.62%
1/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Nervous system disorders
Headache
|
0.00%
0/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
1.2%
2/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Nervous system disorders
Intracranial hemorrhage
|
0.00%
0/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.62%
1/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.62%
1/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Nervous system disorders
Seizure
|
0.00%
0/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.61%
1/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.62%
1/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Nervous system disorders
Stroke
|
0.00%
0/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.62%
1/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Nervous system disorders
Tremor
|
0.00%
0/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.61%
1/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Psychiatric disorders
Confusion
|
0.00%
0/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.62%
1/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
1.2%
2/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.62%
1/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.00%
0/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.62%
1/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.00%
0/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.61%
1/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Reproductive system and breast disorders
Vaginal hemorrhage
|
0.64%
1/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.64%
1/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.62%
1/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
2.0%
1/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.61%
1/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.62%
1/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.64%
1/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.62%
1/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.64%
1/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.62%
1/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
2.0%
1/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Vascular disorders
Hematoma
|
0.64%
1/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Vascular disorders
Hypertension
|
0.00%
0/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.61%
1/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
1.9%
3/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Vascular disorders
Hypotension
|
0.00%
0/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.62%
1/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Vascular disorders
Thromboembolic event
|
0.64%
1/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.62%
1/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
4.1%
2/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Vascular disorders
Visceral arterial ischemia
|
0.00%
0/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.61%
1/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
Other adverse events
| Measure |
Arm I (Reference Regimen)
n=156 participants at risk
Patients undergo physician's choice of standard of care chemotherapy, comprising either paclitaxel IV over 60 minutes on days 1, 8, 15, and 22 every 28 days (Regimen I); pegylated liposomal doxorubicin hydrochloride IV over 60 minutes on day 1 every 28 days (Regimen II); or topotecan hydrochloride IV over 30 minutes on days 1, 8, and 15 every 28 days or days 1-5 every 21 days (Regimen III). Treatment continues in the absence of disease progression or unacceptable toxicity. No modification of the assigned regimens, such as additional drugs (gemcitabine, or bevacizumab) is allowed. Patients also undergo CT and MRI throughout the study. (12/05/2016)
Computed Tomography: Undergo CT
Magnetic Resonance Imaging: Undergo MRI
Paclitaxel: Given IV
Pegylated Liposomal Doxorubicin Hydrochloride: Given IV
Questionnaire Administration: Ancillary studies
Topotecan: Given IV
Topotecan Hydrochloride: Given IV
|
Arm II (Cediranib Maleate, Olaparib)
n=163 participants at risk
Patients receive cediranib maleate PO QD and olaparib PO BID. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT and MRI throughout the study.
Cediranib: Given PO
Cediranib Maleate: Given PO
Computed Tomography: Undergo CT
Magnetic Resonance Imaging: Undergo MRI
Olaparib: Given PO
Questionnaire Administration: Ancillary studies
|
Arm III (Cediranib Maleate)
n=162 participants at risk
Patients receive cediranib maleate PO daily continuously. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT and MRI throughout the study.
Cediranib: Given PO
Cediranib Maleate: Given PO
Computed Tomography: Undergo CT
Magnetic Resonance Imaging: Undergo MRI
Questionnaire Administration: Ancillary studies
|
Arm IV (Olaparib) (Phase II Only)
n=49 participants at risk
Patients receive olaparib PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT and MRI throughout the study. (In July 2018, the Data Monitoring Committee voted to exclude the olaparib alone regimen).
Computed Tomography: Undergo CT
Magnetic Resonance Imaging: Undergo MRI
Olaparib: Given PO
Questionnaire Administration: Ancillary studies
|
Arm V (Arm I Regimen: JP Patients Enrolled After P3 Cutoff)
n=5 participants at risk
Patients undergo physician's choice of standard of care chemotherapy, comprising either paclitaxel intravenously (IV) over 60 minutes on days 1, 8, 15, and 22 every 28 days (Regimen I); pegylated liposomal doxorubicin hydrochloride IV over 60 minutes on day 1 every 28 days (Regimen II); or topotecan hydrochloride IV over 30 minutes on days 1, 8, and 15 every 28 days or days 1-5 every 21 days (Regimen III). Treatment continues in the absence of disease progression or unacceptable toxicity. No modification of the assigned regimens, such as additional drugs (gemcitabine, or bevacizumab) is allowed. Patients also undergo computed tomography (CT) and magnetic resonance imaging (MRI) throughout the study. (12/05/2016) Patients enrolled from Japan after the Phase III cutoff.
|
Arm VI: (Arm II Regimen: JP Patients Enrolled After P3 Cutoff)
n=7 participants at risk
Patients receive cediranib maleate orally (PO) once daily (QD) and olaparib PO twice daily (BID). Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT and MRI throughout the study. Patients enrolled from Japan after the Phase III cutoff.
|
Arm VII: (Arm III Regimen: JP Patients Enrolled After P3 Cutoff)
n=7 participants at risk
Patients receive cediranib maleate PO daily continuously. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT and MRI throughout the study. Patients enrolled from Japan after the Phase III cutoff.
|
|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Oral pain
|
1.3%
2/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
4.9%
8/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
4.9%
8/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
2.0%
1/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.62%
1/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Gastrointestinal disorders
Periodontal disease
|
0.00%
0/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
14.3%
1/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Gastrointestinal disorders
Rectal fistula
|
0.00%
0/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.61%
1/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
3.8%
6/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
3.1%
5/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
2.0%
1/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Gastrointestinal disorders
Rectal mucositis
|
0.00%
0/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
14.3%
1/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Gastrointestinal disorders
Rectal pain
|
1.3%
2/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.61%
1/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
2.5%
4/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Gastrointestinal disorders
Salivary duct inflammation
|
0.00%
0/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.62%
1/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Gastrointestinal disorders
Stomach pain
|
1.9%
3/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
1.2%
2/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
1.2%
2/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
14.3%
1/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Infections and infestations
Rash pustular
|
0.64%
1/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.62%
1/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Gastrointestinal disorders
Oral hemorrhage
|
0.00%
0/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.61%
1/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
1.2%
2/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
9.0%
14/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
7.4%
12/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
8.0%
13/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
6.1%
3/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Gastrointestinal disorders
Small intestinal perforation
|
0.00%
0/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.62%
1/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Gastrointestinal disorders
Small intestinal stenosis
|
0.00%
0/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.62%
1/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.61%
1/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
2.0%
1/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Gastrointestinal disorders
Vomiting
|
20.5%
32/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
47.9%
78/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
36.4%
59/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
32.7%
16/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
20.0%
1/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
14.3%
1/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
General disorders
Chills
|
0.64%
1/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
4.9%
8/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
2.5%
4/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
4.1%
2/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
General disorders
Death NOS
|
1.3%
2/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.61%
1/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
1.2%
2/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
General disorders
Edema limbs
|
12.8%
20/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
11.7%
19/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
12.3%
20/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
14.3%
7/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
General disorders
Edema trunk
|
2.6%
4/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
General disorders
Facial pain
|
0.64%
1/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
General disorders
Fatigue
|
53.8%
84/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
76.1%
124/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
64.2%
104/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
57.1%
28/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
14.3%
1/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
General disorders
Fever
|
5.8%
9/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
3.7%
6/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
4.9%
8/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
2.0%
1/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
General disorders
Flu like symptoms
|
1.9%
3/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
3.7%
6/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
1.9%
3/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
4.1%
2/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
General disorders
Gait disturbance
|
0.00%
0/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
1.8%
3/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
1.9%
3/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
General disorders
General disorders and administration site conditions - Other, specify
|
1.9%
3/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
3.1%
5/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
2.5%
4/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Infections and infestations
Sepsis
|
0.00%
0/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
1.2%
2/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.62%
1/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
General disorders
Hypothermia
|
0.00%
0/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.61%
1/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.62%
1/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
General disorders
Infusion related reaction
|
3.8%
6/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
General disorders
Infusion site extravasation
|
0.64%
1/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.61%
1/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
20.0%
1/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
14.3%
1/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
General disorders
Injection site reaction
|
0.00%
0/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.61%
1/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.62%
1/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
General disorders
Irritability
|
0.00%
0/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.62%
1/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
General disorders
Localized edema
|
1.3%
2/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
2.0%
1/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
General disorders
Malaise
|
0.64%
1/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
1.8%
3/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.62%
1/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
2.0%
1/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
42.9%
3/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
57.1%
4/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
General disorders
Non-cardiac chest pain
|
2.6%
4/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
3.1%
5/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
2.5%
4/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
2.0%
1/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
General disorders
Pain
|
10.3%
16/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
8.6%
14/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
8.0%
13/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
20.4%
10/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
General disorders
Sudden death NOS
|
0.00%
0/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.62%
1/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
1.2%
2/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
1.2%
2/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
14.3%
1/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Hepatobiliary disorders
Gallbladder perforation
|
0.00%
0/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.61%
1/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Hepatobiliary disorders
Hepatobiliary disorders - Other, specify
|
0.00%
0/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.61%
1/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.62%
1/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Hepatobiliary disorders
Portal vein thrombosis
|
0.64%
1/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Immune system disorders
Allergic reaction
|
1.9%
3/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
3.1%
5/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
1.9%
3/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Infections and infestations
Biliary tract infection
|
0.00%
0/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.62%
1/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Infections and infestations
Bladder infection
|
0.64%
1/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
1.2%
2/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
1.2%
2/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Infections and infestations
Bronchial infection
|
0.00%
0/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
1.2%
2/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
14.3%
1/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Infections and infestations
Catheter related infection
|
0.00%
0/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
1.8%
3/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Infections and infestations
Device related infection
|
0.64%
1/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Infections and infestations
Enterocolitis infectious
|
0.64%
1/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
1.2%
2/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Infections and infestations
Gum infection
|
0.00%
0/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
1.2%
2/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Infections and infestations
Infections and infestations - Other, specify
|
6.4%
10/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
8.0%
13/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
4.9%
8/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Infections and infestations
Lip infection
|
0.00%
0/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.61%
1/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Infections and infestations
Lung infection
|
2.6%
4/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
1.8%
3/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
1.2%
2/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Infections and infestations
Meningitis
|
0.00%
0/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
14.3%
1/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Infections and infestations
Mucosal infection
|
0.64%
1/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
1.2%
2/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Infections and infestations
Nail infection
|
0.00%
0/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.61%
1/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Infections and infestations
Otitis media
|
0.00%
0/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
1.2%
2/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
2.0%
1/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Infections and infestations
Papulopustular rash
|
2.6%
4/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
1.8%
3/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Infections and infestations
Peritoneal infection
|
0.64%
1/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Infections and infestations
Sinusitis
|
3.2%
5/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
3.7%
6/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
1.9%
3/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.62%
1/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Blood and lymphatic system disorders
Anemia
|
41.7%
65/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
21.5%
35/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
13.6%
22/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
55.1%
27/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
20.0%
1/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
14.3%
1/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
14.3%
1/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders - Other, specify
|
3.2%
5/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
2.5%
4/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.62%
1/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.64%
1/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Blood and lymphatic system disorders
Leukocytosis
|
1.3%
2/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.62%
1/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Blood and lymphatic system disorders
Lymph node pain
|
0.64%
1/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Blood and lymphatic system disorders
Thrombotic thrombocytopenic purpura
|
0.00%
0/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.61%
1/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.62%
1/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Cardiac disorders
Atrial fibrillation
|
0.64%
1/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
1.8%
3/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
2.0%
1/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Cardiac disorders
Cardiac disorders - Other, specify
|
0.00%
0/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.61%
1/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
1.2%
2/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
2.0%
1/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Cardiac disorders
Chest pain - cardiac
|
0.64%
1/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.62%
1/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
2.0%
1/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Cardiac disorders
Conduction disorder
|
0.00%
0/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.61%
1/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Cardiac disorders
Heart failure
|
0.00%
0/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.61%
1/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Cardiac disorders
Left ventricular systolic dysfunction
|
0.00%
0/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.61%
1/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Cardiac disorders
Myocardial infarction
|
0.64%
1/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Cardiac disorders
Palpitations
|
1.9%
3/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
1.8%
3/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
1.9%
3/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Cardiac disorders
Pericardial effusion
|
0.64%
1/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.61%
1/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Cardiac disorders
Pulmonary valve disease
|
0.00%
0/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
2.0%
1/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
3.1%
5/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.62%
1/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Cardiac disorders
Sinus tachycardia
|
4.5%
7/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
4.3%
7/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
5.6%
9/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Cardiac disorders
Tricuspid valve disease
|
0.00%
0/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
2.0%
1/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Ear and labyrinth disorders
Ear and labyrinth disorders - Other, specify
|
0.00%
0/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
3.1%
5/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Ear and labyrinth disorders
Ear pain
|
0.64%
1/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
1.8%
3/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.62%
1/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Ear and labyrinth disorders
Hearing impaired
|
0.64%
1/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
1.2%
2/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
2.0%
1/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
14.3%
1/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Ear and labyrinth disorders
Tinnitus
|
3.2%
5/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
1.8%
3/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
2.0%
1/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Ear and labyrinth disorders
Vertigo
|
1.3%
2/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
1.8%
3/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
1.2%
2/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
2.0%
1/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Endocrine disorders
Endocrine disorders - Other, specify
|
0.00%
0/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.61%
1/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
14.3%
1/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
6.7%
11/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
8.6%
14/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Endocrine disorders
Hypoparathyroidism
|
0.00%
0/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.62%
1/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Endocrine disorders
Hypothyroidism
|
0.64%
1/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
27.0%
44/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
34.0%
55/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
2.0%
1/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
42.9%
3/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
42.9%
3/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Eye disorders
Blurred vision
|
1.3%
2/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
4.3%
7/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
6.2%
10/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
4.1%
2/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Eye disorders
Conjunctivitis
|
0.00%
0/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.61%
1/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Eye disorders
Dry eye
|
0.64%
1/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.61%
1/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.62%
1/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Eye disorders
Eye disorders - Other, specify
|
2.6%
4/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
1.8%
3/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
2.0%
1/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Eye disorders
Eye pain
|
0.00%
0/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.61%
1/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Eye disorders
Flashing lights
|
1.3%
2/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.61%
1/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.62%
1/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Eye disorders
Floaters
|
0.00%
0/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
1.2%
2/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.62%
1/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Eye disorders
Glaucoma
|
0.00%
0/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.62%
1/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Eye disorders
Retinal vascular disorder
|
0.00%
0/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.61%
1/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Eye disorders
Vitreous hemorrhage
|
0.00%
0/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.62%
1/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Eye disorders
Watering eyes
|
0.64%
1/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.62%
1/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Gastrointestinal disorders
Abdominal distension
|
5.1%
8/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
7.4%
12/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
3.7%
6/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
6.1%
3/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
14.3%
1/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Gastrointestinal disorders
Abdominal pain
|
30.1%
47/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
37.4%
61/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
40.1%
65/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
30.6%
15/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
14.3%
1/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
14.3%
1/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Gastrointestinal disorders
Anal mucositis
|
0.00%
0/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.61%
1/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Gastrointestinal disorders
Anal pain
|
0.64%
1/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.61%
1/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.62%
1/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
2.0%
1/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Gastrointestinal disorders
Ascites
|
7.7%
12/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
3.7%
6/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
2.5%
4/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
6.1%
3/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Gastrointestinal disorders
Bloating
|
9.0%
14/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
7.4%
12/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
9.3%
15/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
4.1%
2/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.61%
1/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
1.9%
3/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Gastrointestinal disorders
Colonic fistula
|
0.00%
0/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.62%
1/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Gastrointestinal disorders
Colonic hemorrhage
|
0.64%
1/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Gastrointestinal disorders
Colonic obstruction
|
2.6%
4/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
3.1%
5/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
1.2%
2/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Gastrointestinal disorders
Colonic perforation
|
0.64%
1/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
1.2%
2/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Gastrointestinal disorders
Constipation
|
28.2%
44/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
33.1%
54/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
20.4%
33/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
18.4%
9/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
14.3%
1/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
14.3%
1/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.62%
1/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Gastrointestinal disorders
Diarrhea
|
21.8%
34/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
74.8%
122/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
76.5%
124/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
26.5%
13/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
20.0%
1/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
71.4%
5/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
71.4%
5/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Gastrointestinal disorders
Dry mouth
|
1.3%
2/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
12.3%
20/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
15.4%
25/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
2.0%
1/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
14.3%
1/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Gastrointestinal disorders
Duodenal obstruction
|
0.00%
0/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
14.3%
1/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Gastrointestinal disorders
Duodenal perforation
|
0.00%
0/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.62%
1/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Gastrointestinal disorders
Dyspepsia
|
11.5%
18/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
11.0%
18/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
6.8%
11/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
4.1%
2/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Gastrointestinal disorders
Dysphagia
|
2.6%
4/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
4.3%
7/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
4.9%
8/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Gastrointestinal disorders
Enterocolitis
|
0.00%
0/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
1.2%
2/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
1.2%
2/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
14.3%
1/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Gastrointestinal disorders
Esophageal hemorrhage
|
0.00%
0/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.62%
1/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Gastrointestinal disorders
Esophageal pain
|
0.64%
1/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Gastrointestinal disorders
Esophagitis
|
0.64%
1/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.61%
1/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Gastrointestinal disorders
Fecal incontinence
|
0.64%
1/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
1.2%
2/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Gastrointestinal disorders
Flatulence
|
2.6%
4/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
3.1%
5/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
3.1%
5/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Gastrointestinal disorders
Gastric hemorrhage
|
0.64%
1/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
1.2%
2/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.62%
1/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
10.3%
16/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
8.0%
13/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
6.8%
11/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
4.1%
2/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify
|
3.8%
6/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
5.5%
9/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
3.7%
6/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
2.0%
1/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
0.64%
1/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.61%
1/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Gastrointestinal disorders
Gastroparesis
|
0.00%
0/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
4.1%
2/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Gastrointestinal disorders
Gingival pain
|
0.00%
0/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.61%
1/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.62%
1/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Gastrointestinal disorders
Hemorrhoidal hemorrhage
|
0.00%
0/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.62%
1/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Gastrointestinal disorders
Hemorrhoids
|
0.64%
1/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
6.1%
10/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
1.9%
3/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Gastrointestinal disorders
Ileal obstruction
|
1.3%
2/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.62%
1/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
2.0%
1/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Gastrointestinal disorders
Ileus
|
1.3%
2/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.61%
1/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
1.9%
3/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
4.1%
2/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
14.3%
1/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
14.3%
1/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Gastrointestinal disorders
Intra-abdominal hemorrhage
|
0.00%
0/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.61%
1/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Gastrointestinal disorders
Lower gastrointestinal hemorrhage
|
0.00%
0/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.61%
1/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.62%
1/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Gastrointestinal disorders
Mucositis oral
|
26.3%
41/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
25.8%
42/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
35.2%
57/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
6.1%
3/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
20.0%
1/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
28.6%
2/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
42.9%
3/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Gastrointestinal disorders
Nausea
|
49.4%
77/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
68.1%
111/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
56.2%
91/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
69.4%
34/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
20.0%
1/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
28.6%
2/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
28.6%
2/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Gastrointestinal disorders
Obstruction gastric
|
0.00%
0/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
1.8%
3/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Gastrointestinal disorders
Oral dysesthesia
|
0.00%
0/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
3.1%
5/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
3.1%
5/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Infections and infestations
Skin infection
|
1.9%
3/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
1.8%
3/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
1.9%
3/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
4.1%
2/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Infections and infestations
Tooth infection
|
0.64%
1/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Infections and infestations
Upper respiratory infection
|
2.6%
4/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
4.3%
7/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
1.2%
2/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
4.1%
2/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Infections and infestations
Urinary tract infection
|
10.9%
17/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
16.0%
26/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
15.4%
25/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
6.1%
3/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Infections and infestations
Vaginal infection
|
0.00%
0/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.61%
1/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
2.0%
1/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Infections and infestations
Vulval infection
|
0.00%
0/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.61%
1/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.62%
1/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Infections and infestations
Wound infection
|
0.00%
0/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.61%
1/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Injury, poisoning and procedural complications
Bruising
|
1.9%
3/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
3.1%
5/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
2.5%
4/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
14.3%
1/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Injury, poisoning and procedural complications
Burn
|
0.64%
1/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Injury, poisoning and procedural complications
Fall
|
2.6%
4/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
4.9%
8/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
3.7%
6/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
2.0%
1/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Injury, poisoning and procedural complications
Fracture
|
0.00%
0/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
2.5%
4/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Injury, poisoning and procedural complications
Injury, poisoning and procedural complications - Other, specify
|
0.00%
0/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.61%
1/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.62%
1/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Injury, poisoning and procedural complications
Intestinal stoma site bleeding
|
0.00%
0/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.61%
1/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Injury, poisoning and procedural complications
Prolapse of intestinal stoma
|
0.00%
0/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.61%
1/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.00%
0/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.62%
1/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Injury, poisoning and procedural complications
Vascular access complication
|
0.00%
0/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.61%
1/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Injury, poisoning and procedural complications
Wound complication
|
0.64%
1/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.61%
1/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
0.64%
1/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Investigations
Activated partial thromboplastin time prolonged
|
0.00%
0/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.62%
1/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
2.0%
1/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Investigations
Alanine aminotransferase increased
|
8.3%
13/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
9.8%
16/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
19.1%
31/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
6.1%
3/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
20.0%
1/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
42.9%
3/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
28.6%
2/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Investigations
Alkaline phosphatase increased
|
10.9%
17/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
12.3%
20/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
14.8%
24/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
10.2%
5/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
14.3%
1/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
14.3%
1/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Investigations
Aspartate aminotransferase increased
|
7.7%
12/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
11.7%
19/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
17.9%
29/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
6.1%
3/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
20.0%
1/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
28.6%
2/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
14.3%
1/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Investigations
Blood bilirubin increased
|
1.9%
3/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
4.3%
7/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
8.0%
13/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
4.1%
2/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Investigations
CPK increased
|
0.00%
0/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
14.3%
1/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Investigations
Cardiac troponin I increased
|
0.00%
0/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.61%
1/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.62%
1/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Investigations
Cholesterol high
|
0.00%
0/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.61%
1/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Investigations
Creatinine increased
|
7.1%
11/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
19.0%
31/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
19.1%
31/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
16.3%
8/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
14.3%
1/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Investigations
Ejection fraction decreased
|
0.00%
0/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.61%
1/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
1.2%
2/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Investigations
Electrocardiogram QT corrected interval prolonged
|
0.00%
0/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.61%
1/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Investigations
GGT increased
|
0.00%
0/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.62%
1/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Investigations
Hemoglobin increased
|
0.00%
0/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
4.3%
7/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
5.6%
9/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Investigations
INR increased
|
1.3%
2/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.61%
1/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
1.9%
3/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Investigations
Investigations - Other, specify
|
0.64%
1/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
3.7%
6/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
5.6%
9/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Investigations
Lymphocyte count decreased
|
14.7%
23/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
8.6%
14/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
4.9%
8/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
12.2%
6/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Investigations
Lymphocyte count increased
|
0.64%
1/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.61%
1/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Investigations
Neutrophil count decreased
|
34.6%
54/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
14.1%
23/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
7.4%
12/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
8.2%
4/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
60.0%
3/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
28.6%
2/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
14.3%
1/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Investigations
Platelet count decreased
|
15.4%
24/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
20.9%
34/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
18.5%
30/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
12.2%
6/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
42.9%
3/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
42.9%
3/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Investigations
Weight gain
|
1.9%
3/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.61%
1/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Investigations
Weight loss
|
12.2%
19/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
27.6%
45/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
26.5%
43/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
12.2%
6/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
42.9%
3/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Investigations
White blood cell decreased
|
30.1%
47/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
12.3%
20/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
5.6%
9/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
16.3%
8/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
40.0%
2/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
42.9%
3/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Metabolism and nutrition disorders
Acidosis
|
0.64%
1/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Metabolism and nutrition disorders
Anorexia
|
24.4%
38/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
39.3%
64/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
42.0%
68/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
42.9%
21/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
20.0%
1/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
14.3%
1/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
57.1%
4/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Metabolism and nutrition disorders
Dehydration
|
3.8%
6/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
15.3%
25/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
18.5%
30/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
6.1%
3/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Metabolism and nutrition disorders
Glucose intolerance
|
0.00%
0/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.61%
1/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.62%
1/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
2.0%
1/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
14.3%
1/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
3.8%
6/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
4.3%
7/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
1.9%
3/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
6.1%
3/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
15.4%
24/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
16.0%
26/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
9.9%
16/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
6.1%
3/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
3.2%
5/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
3.7%
6/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
6.2%
10/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
6.1%
3/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
1.3%
2/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.61%
1/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Metabolism and nutrition disorders
Hypernatremia
|
1.3%
2/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
1.2%
2/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
1.9%
3/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
2.0%
1/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
0.00%
0/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
1.2%
2/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.62%
1/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
0.00%
0/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
1.2%
2/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
12.2%
19/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
11.7%
19/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
14.2%
23/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
12.2%
6/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
28.6%
2/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
8.3%
13/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
4.9%
8/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
6.2%
10/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
8.2%
4/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
1.3%
2/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
1.2%
2/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
1.2%
2/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Metabolism and nutrition disorders
Hypokalemia
|
14.1%
22/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
14.7%
24/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
18.5%
30/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
8.2%
4/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
6.4%
10/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
8.6%
14/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
13.0%
21/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
10.2%
5/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Metabolism and nutrition disorders
Hyponatremia
|
10.3%
16/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
16.6%
27/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
16.0%
26/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
20.4%
10/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
2.6%
4/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
1.9%
3/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
4.1%
2/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders - Other, specify
|
0.64%
1/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.61%
1/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
1.9%
3/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
14.3%
1/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
3.8%
6/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
9.8%
16/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
7.4%
12/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
4.1%
2/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.64%
1/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
1.2%
2/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
3.1%
5/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
7.1%
11/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
9.8%
16/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
14.8%
24/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
8.2%
4/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
14.3%
1/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
1.3%
2/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
1.2%
2/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
1.2%
2/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
14.3%
1/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Musculoskeletal and connective tissue disorders
Buttock pain
|
0.64%
1/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.62%
1/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
1.9%
3/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.61%
1/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
6.1%
3/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
3.2%
5/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
1.2%
2/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
3.1%
5/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
2.0%
1/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
4.5%
7/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
11.7%
19/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
14.2%
23/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
6.1%
3/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Musculoskeletal and connective tissue disorders
Joint range of motion decreased
|
0.00%
0/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.62%
1/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness left-sided
|
0.00%
0/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
1.2%
2/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
0.64%
1/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
1.2%
2/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
1.9%
3/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness upper limb
|
0.64%
1/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.62%
1/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, specify
|
0.64%
1/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
6.1%
10/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
3.1%
5/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Nervous system disorders
Aphonia
|
0.00%
0/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.61%
1/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
3.8%
6/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
9.2%
15/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
14.2%
23/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
12.2%
6/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
14.3%
1/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
2.6%
4/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
2.5%
4/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
2.5%
4/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
0.00%
0/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.61%
1/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
6.4%
10/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
12.9%
21/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
8.0%
13/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
8.2%
4/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Leukemia secondary to oncology chemotherapy
|
0.64%
1/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic syndrome
|
0.00%
0/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.62%
1/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify
|
2.6%
4/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
1.8%
3/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
2.5%
4/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
2.0%
1/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
14.3%
1/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor pain
|
0.00%
0/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
14.3%
1/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Nervous system disorders
Amnesia
|
0.00%
0/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.61%
1/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Nervous system disorders
Ataxia
|
0.00%
0/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.62%
1/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Nervous system disorders
Cognitive disturbance
|
0.00%
0/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.62%
1/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Nervous system disorders
Concentration impairment
|
0.00%
0/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
1.8%
3/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Nervous system disorders
Depressed level of consciousness
|
0.00%
0/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.62%
1/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
14.3%
1/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Nervous system disorders
Dizziness
|
5.8%
9/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
16.0%
26/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
16.7%
27/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
6.1%
3/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Nervous system disorders
Dysarthria
|
0.00%
0/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
1.2%
2/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
1.9%
3/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Nervous system disorders
Dysesthesia
|
0.64%
1/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Nervous system disorders
Dysgeusia
|
5.8%
9/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
11.7%
19/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
12.3%
20/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
8.2%
4/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
14.3%
1/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Nervous system disorders
Dysphasia
|
0.00%
0/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
1.2%
2/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
2.0%
1/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
1.2%
2/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.62%
1/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Nervous system disorders
Extrapyramidal disorder
|
0.00%
0/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
1.2%
2/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Nervous system disorders
Headache
|
9.6%
15/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
30.7%
50/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
32.7%
53/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
16.3%
8/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Nervous system disorders
Intracranial hemorrhage
|
0.00%
0/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.62%
1/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Nervous system disorders
Lethargy
|
0.64%
1/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
3.1%
5/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.62%
1/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Nervous system disorders
Myelitis
|
0.00%
0/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.62%
1/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Nervous system disorders
Nervous system disorders - Other, specify
|
1.3%
2/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
1.2%
2/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Nervous system disorders
Paresthesia
|
2.6%
4/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
1.2%
2/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
1.2%
2/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Nervous system disorders
Peripheral motor neuropathy
|
1.3%
2/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
1.2%
2/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.62%
1/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
14.7%
23/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
12.9%
21/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
13.0%
21/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
8.2%
4/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
14.3%
1/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Nervous system disorders
Presyncope
|
0.64%
1/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.61%
1/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
1.2%
2/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Nervous system disorders
Reversible posterior leukoencephalopathy syndrome
|
0.00%
0/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
1.2%
2/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.62%
1/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Nervous system disorders
Seizure
|
0.00%
0/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
1.8%
3/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.62%
1/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Nervous system disorders
Sinus pain
|
0.00%
0/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.61%
1/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Nervous system disorders
Somnolence
|
0.00%
0/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.61%
1/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Nervous system disorders
Stroke
|
0.00%
0/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
2.5%
4/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
2.5%
4/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Nervous system disorders
Syncope
|
0.64%
1/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.61%
1/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
1.2%
2/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
2.0%
1/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Nervous system disorders
Transient ischemic attacks
|
0.00%
0/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
1.2%
2/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Nervous system disorders
Tremor
|
2.6%
4/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
1.2%
2/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
1.9%
3/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Nervous system disorders
Vasovagal reaction
|
0.00%
0/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.62%
1/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Psychiatric disorders
Agitation
|
0.64%
1/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
2.0%
1/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Psychiatric disorders
Anxiety
|
5.1%
8/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
12.9%
21/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
4.3%
7/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
8.2%
4/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Psychiatric disorders
Confusion
|
0.64%
1/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
4.3%
7/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
4.3%
7/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Psychiatric disorders
Delirium
|
0.00%
0/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
1.2%
2/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Psychiatric disorders
Depression
|
6.4%
10/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
5.5%
9/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
5.6%
9/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
6.1%
3/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Psychiatric disorders
Hallucinations
|
0.64%
1/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
1.2%
2/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Psychiatric disorders
Insomnia
|
7.1%
11/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
7.4%
12/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
8.0%
13/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
10.2%
5/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
20.0%
1/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
14.3%
1/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Psychiatric disorders
Libido decreased
|
0.00%
0/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.62%
1/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Psychiatric disorders
Personality change
|
0.64%
1/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Psychiatric disorders
Psychiatric disorders - Other, specify
|
0.00%
0/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.62%
1/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Psychiatric disorders
Restlessness
|
0.00%
0/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.62%
1/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Renal and urinary disorders
Acute kidney injury
|
1.3%
2/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
2.5%
4/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
7.4%
12/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Renal and urinary disorders
Bladder spasm
|
0.64%
1/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.61%
1/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
2.0%
1/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Renal and urinary disorders
Chronic kidney disease
|
1.9%
3/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
2.5%
4/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
4.1%
2/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Renal and urinary disorders
Cystitis noninfective
|
0.00%
0/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.61%
1/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Renal and urinary disorders
Hematuria
|
1.9%
3/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
3.7%
6/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
4.3%
7/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Renal and urinary disorders
Proteinuria
|
5.1%
8/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
12.9%
21/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
11.7%
19/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
6.1%
3/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
20.0%
1/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
28.6%
2/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
57.1%
4/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Renal and urinary disorders
Renal and urinary disorders - Other, specify
|
1.3%
2/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
1.2%
2/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
1.9%
3/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Renal and urinary disorders
Renal calculi
|
0.00%
0/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.61%
1/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Renal and urinary disorders
Renal colic
|
0.00%
0/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.61%
1/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Renal and urinary disorders
Urinary frequency
|
4.5%
7/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
2.5%
4/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
3.1%
5/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
2.0%
1/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Renal and urinary disorders
Urinary incontinence
|
4.5%
7/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
1.8%
3/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
1.2%
2/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
2.0%
1/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Renal and urinary disorders
Urinary retention
|
1.3%
2/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.61%
1/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.62%
1/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Renal and urinary disorders
Urinary tract obstruction
|
1.3%
2/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
1.2%
2/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
1.2%
2/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
2.0%
1/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Renal and urinary disorders
Urinary tract pain
|
3.2%
5/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
3.1%
5/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
2.5%
4/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Renal and urinary disorders
Urinary urgency
|
1.9%
3/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
1.2%
2/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.62%
1/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
2.0%
1/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Reproductive system and breast disorders
Breast pain
|
0.64%
1/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.61%
1/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Reproductive system and breast disorders
Dyspareunia
|
0.00%
0/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
2.0%
1/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Reproductive system and breast disorders
Pelvic pain
|
3.2%
5/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
1.2%
2/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
1.9%
3/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Reproductive system and breast disorders
Perineal pain
|
0.00%
0/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.61%
1/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Reproductive system and breast disorders
Reproductive system and breast disorders - Other, specify
|
0.00%
0/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
1.2%
2/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Reproductive system and breast disorders
Uterine hemorrhage
|
0.64%
1/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
2.6%
4/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
4.9%
8/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
1.9%
3/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
4.1%
2/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Reproductive system and breast disorders
Vaginal discharge
|
1.9%
3/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
2.5%
4/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
1.2%
2/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
6.1%
3/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Reproductive system and breast disorders
Vaginal dryness
|
2.6%
4/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.62%
1/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Reproductive system and breast disorders
Vaginal hemorrhage
|
1.3%
2/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
1.8%
3/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
1.9%
3/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
4.1%
2/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Reproductive system and breast disorders
Vaginal inflammation
|
0.64%
1/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Reproductive system and breast disorders
Vaginal pain
|
0.00%
0/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
1.2%
2/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
1.9%
3/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.61%
1/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
3.1%
5/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
2.0%
1/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.64%
1/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
1.2%
2/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.64%
1/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.61%
1/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.62%
1/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Respiratory, thoracic and mediastinal disorders
Bronchopulmonary hemorrhage
|
0.00%
0/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.62%
1/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
15.4%
24/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
11.7%
19/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
16.7%
27/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
10.2%
5/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
24.4%
38/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
28.8%
47/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
24.7%
40/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
30.6%
15/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
1.3%
2/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
5.5%
9/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
3.1%
5/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
14.3%
1/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.64%
1/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
1.2%
2/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
1.9%
3/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
11.0%
18/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
17.3%
28/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
28.6%
2/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
42.9%
3/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
1.3%
2/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.61%
1/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
1.2%
2/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal inflammation
|
0.00%
0/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.61%
1/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
1.9%
3/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
2.5%
4/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
3.1%
5/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
2.0%
1/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal mucositis
|
0.00%
0/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
14.3%
1/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
0.00%
0/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
14.3%
1/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
5.1%
8/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
3.7%
6/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
4.3%
7/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
4.1%
2/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.64%
1/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.61%
1/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.62%
1/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
1.2%
2/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
1.2%
2/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
0.64%
1/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.61%
1/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.62%
1/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
2.0%
1/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
1.9%
3/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.61%
1/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.62%
1/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
2.0%
1/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.00%
0/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.62%
1/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
2.0%
1/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.64%
1/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.61%
1/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
2.0%
1/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, specify
|
0.64%
1/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
1.8%
3/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.62%
1/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
0.00%
0/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.61%
1/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.62%
1/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
3.2%
5/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
4.9%
8/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
7.4%
12/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Respiratory, thoracic and mediastinal disorders
Voice alteration
|
0.00%
0/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
11.0%
18/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
11.1%
18/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.64%
1/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.61%
1/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
9.6%
15/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
4.9%
8/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
1.2%
2/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
4.1%
2/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
14.3%
1/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Skin and subcutaneous tissue disorders
Bullous dermatitis
|
1.9%
3/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
3.8%
6/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
5.5%
9/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
3.7%
6/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
0.64%
1/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.61%
1/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
1.2%
2/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
1.3%
2/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
1.8%
3/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
1.9%
3/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
2.0%
1/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Skin and subcutaneous tissue disorders
Nail discoloration
|
1.9%
3/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
1.2%
2/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.62%
1/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Skin and subcutaneous tissue disorders
Nail loss
|
0.64%
1/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
1.3%
2/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysesthesia syndrome
|
16.7%
26/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
5.5%
9/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
8.6%
14/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
42.9%
3/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
14.3%
1/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Skin and subcutaneous tissue disorders
Periorbital edema
|
0.64%
1/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.61%
1/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Skin and subcutaneous tissue disorders
Purpura
|
0.00%
0/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.61%
1/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.62%
1/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
1.3%
2/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
1.2%
2/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
3.1%
5/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
2.0%
1/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
14.3%
1/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
19.2%
30/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
8.0%
13/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
7.4%
12/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
12.2%
6/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
20.0%
1/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify
|
3.8%
6/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
6.7%
11/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
3.7%
6/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
2.0%
1/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
14.3%
1/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
6.4%
10/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Skin and subcutaneous tissue disorders
Skin hypopigmentation
|
0.64%
1/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Skin and subcutaneous tissue disorders
Skin induration
|
0.00%
0/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.61%
1/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Skin and subcutaneous tissue disorders
Skin ulceration
|
1.9%
3/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
1.8%
3/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.64%
1/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.61%
1/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Surgical and medical procedures
Surgical and medical procedures - Other, specify
|
1.3%
2/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
1.8%
3/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
1.2%
2/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Vascular disorders
Flushing
|
1.3%
2/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.61%
1/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
1.2%
2/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Vascular disorders
Hematoma
|
0.64%
1/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.62%
1/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Vascular disorders
Hot flashes
|
2.6%
4/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
3.7%
6/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.62%
1/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Vascular disorders
Hypertension
|
13.5%
21/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
65.0%
106/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
79.0%
128/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
10.2%
5/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
28.6%
2/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
85.7%
6/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Vascular disorders
Hypotension
|
3.2%
5/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
5.5%
9/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
9.3%
15/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Vascular disorders
Lymphedema
|
0.64%
1/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.62%
1/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
2.0%
1/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Vascular disorders
Phlebitis
|
0.64%
1/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Vascular disorders
Thromboembolic event
|
7.7%
12/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
5.5%
9/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
7.4%
12/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
4.1%
2/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Vascular disorders
Vascular disorders - Other, specify
|
0.64%
1/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Vascular disorders
Vasculitis
|
0.00%
0/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.62%
1/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
|
Vascular disorders
Visceral arterial ischemia
|
0.00%
0/156 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.61%
1/163 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/162 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/49 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/5 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
0.00%
0/7 • Up to 5 years
Adverse events will be categorized by CTCAE V5.0. Adverse events will be summarized by treatment group, system organ class, and preferred term. All-cause mortality population is related to OS and therefore is all randomized patients (ITT) but the reporting population for AE (AE and SAE) is the safety population and is only the set of patients that received treatment (the purpose is to identify adverse events that are potentially related to treatment).
|
Additional Information
Christopher Purdy on behalf of Austin Miller, PhD
NRG Oncology
Phone: (716) 845-1300
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60