Trial Outcomes & Findings for Lower or Standard Dose Regorafenib in Treating Patients With Refractory Metastatic Colorectal Cancer (NCT NCT02368886)
NCT ID: NCT02368886
Last Updated: 2025-06-18
Results Overview
Fisher exact test will be used to detect a difference course 3 between arms (starting low dose \[pooled arm A1 and A2\] versus \[vs.\] standard dose \[pooled arm B1 and B2\]). The proportion of patients who complete 2 courses of protocol treatment and initiate course 3 will be computed by arm with its 95% confidence interval using exact method.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
123 participants
Primary outcome timeframe
At 8 weeks
Results posted on
2025-06-18
Participant Flow
Participant milestones
| Measure |
Arm A1 (Regorafenib Dose Escalation + Pre-emptive Strategy)
In the regorafenib dose escalation group, the starting dose of regorafenib was 80 mg/day in week 1, 120 mg/day in week 2, and 160 mg/day in week 3 for cycle 1. Weekly incremental dose-escalation occurred if no significant drug-related toxicities (SDRTs) were observed. In cycle 2, patients received the highest tolerated dose from cycle 1. Patients also received prophylactic 0.05% clobetasol cream twice daily applied to palms and soles starting at cycle 1 day 1 for prevention of HFSR (pre-emptive strategy).
|
Arm A2 (Regorafenib Dose Escalation + Reactive Strategy)
In the regorafenib dose escalation group, the starting dose of regorafenib was 80 mg/day in week 1, 120 mg/day in week 2, and 160 mg/day in week 3 for cycle 1. Weekly incremental dose-escalation occurred if no significant drug-related toxicities (SDRTs) were observed. In cycle 2, patients received the highest tolerated dose from cycle 1. Patients also had the clobetasol cream applied when HFSR developed (reactive strategy).
|
Arm B1 (Regorafenib Standard Dose + Pre-emptive Strategy)
In the regorafenib standard dose group, the regorafenib dose schedule of 160 mg/day started on day 1 and continued for 21 every 28 days. The dose of 160 mg as the standard dose was used since it is the approved and most commonly used dose/schedule in clinical practice based on the results of randomized trials.Patients also received prophylactic 0.05% clobetasol cream twice daily applied to palms and soles starting at cycle 1 day 1 for prevention of HFSR (pre-emptive strategy).
|
Arm B2 (Regorafenib Standard Dose + Reactive Strategy)
In the regorafenib standard dose group, the regorafenib dose schedule of 160 mg/day started on day 1 and continued for 21 every 28 days. The dose of 160 mg as the standard dose was used since it is the approved and most commonly used dose/schedule in clinical practice based on the results of randomized trials. Patients also had the clobetasol cream applied when HFSR developed (reactive strategy).
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
29
|
27
|
34
|
33
|
|
Overall Study
COMPLETED
|
28
|
26
|
33
|
29
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
1
|
4
|
Reasons for withdrawal
| Measure |
Arm A1 (Regorafenib Dose Escalation + Pre-emptive Strategy)
In the regorafenib dose escalation group, the starting dose of regorafenib was 80 mg/day in week 1, 120 mg/day in week 2, and 160 mg/day in week 3 for cycle 1. Weekly incremental dose-escalation occurred if no significant drug-related toxicities (SDRTs) were observed. In cycle 2, patients received the highest tolerated dose from cycle 1. Patients also received prophylactic 0.05% clobetasol cream twice daily applied to palms and soles starting at cycle 1 day 1 for prevention of HFSR (pre-emptive strategy).
|
Arm A2 (Regorafenib Dose Escalation + Reactive Strategy)
In the regorafenib dose escalation group, the starting dose of regorafenib was 80 mg/day in week 1, 120 mg/day in week 2, and 160 mg/day in week 3 for cycle 1. Weekly incremental dose-escalation occurred if no significant drug-related toxicities (SDRTs) were observed. In cycle 2, patients received the highest tolerated dose from cycle 1. Patients also had the clobetasol cream applied when HFSR developed (reactive strategy).
|
Arm B1 (Regorafenib Standard Dose + Pre-emptive Strategy)
In the regorafenib standard dose group, the regorafenib dose schedule of 160 mg/day started on day 1 and continued for 21 every 28 days. The dose of 160 mg as the standard dose was used since it is the approved and most commonly used dose/schedule in clinical practice based on the results of randomized trials.Patients also received prophylactic 0.05% clobetasol cream twice daily applied to palms and soles starting at cycle 1 day 1 for prevention of HFSR (pre-emptive strategy).
|
Arm B2 (Regorafenib Standard Dose + Reactive Strategy)
In the regorafenib standard dose group, the regorafenib dose schedule of 160 mg/day started on day 1 and continued for 21 every 28 days. The dose of 160 mg as the standard dose was used since it is the approved and most commonly used dose/schedule in clinical practice based on the results of randomized trials. Patients also had the clobetasol cream applied when HFSR developed (reactive strategy).
|
|---|---|---|---|---|
|
Overall Study
Cancel
|
1
|
1
|
1
|
3
|
|
Overall Study
Ineligible
|
0
|
0
|
0
|
1
|
Baseline Characteristics
Lower or Standard Dose Regorafenib in Treating Patients With Refractory Metastatic Colorectal Cancer
Baseline characteristics by cohort
| Measure |
Arm A1 (Regorafenib Dose Escalation + Pre-emptive Strategy)
n=28 Participants
In the regorafenib dose escalation group, the starting dose of regorafenib was 80 mg/day in week 1, 120 mg/day in week 2, and 160 mg/day in week 3 for cycle 1. Weekly incremental dose-escalation occurred if no significant drug-related toxicities (SDRTs) were observed. In cycle 2, patients received the highest tolerated dose from cycle 1. Patients also received prophylactic 0.05% clobetasol cream twice daily applied to palms and soles starting at cycle 1 day 1 for prevention of HFSR (pre-emptive strategy).
|
Arm A2 (Regorafenib Dose Escalation + Reactive Strategy)
n=26 Participants
In the regorafenib dose escalation group, the starting dose of regorafenib was 80 mg/day in week 1, 120 mg/day in week 2, and 160 mg/day in week 3 for cycle 1. Weekly incremental dose-escalation occurred if no significant drug-related toxicities (SDRTs) were observed. In cycle 2, patients received the highest tolerated dose from cycle 1. Patients also had the clobetasol cream applied when HFSR developed (reactive strategy).
|
Arm B1 (Regorafenib Standard Dose + Pre-emptive Strategy)
n=33 Participants
In the regorafenib standard dose group, the regorafenib dose schedule of 160 mg/day started on day 1 and continued for 21 every 28 days. The dose of 160 mg as the standard dose was used since it is the approved and most commonly used dose/schedule in clinical practice based on the results of randomized trials.Patients also received prophylactic 0.05% clobetasol cream twice daily applied to palms and soles starting at cycle 1 day 1 for prevention of HFSR (pre-emptive strategy).
|
Arm B2 (Regorafenib Standard Dose + Reactive Strategy)
n=29 Participants
In the regorafenib standard dose group, the regorafenib dose schedule of 160 mg/day started on day 1 and continued for 21 every 28 days. The dose of 160 mg as the standard dose was used since it is the approved and most commonly used dose/schedule in clinical practice based on the results of randomized trials. Patients also had the clobetasol cream applied when HFSR developed (reactive strategy).
|
Total
n=116 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
65 years
n=99 Participants
|
57 years
n=107 Participants
|
61 years
n=206 Participants
|
62 years
n=7 Participants
|
61 years
n=31 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
17 Participants
n=206 Participants
|
10 Participants
n=7 Participants
|
45 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
19 Participants
n=7 Participants
|
71 Participants
n=31 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=31 Participants
|
|
Race (NIH/OMB)
White
|
25 Participants
n=99 Participants
|
19 Participants
n=107 Participants
|
31 Participants
n=206 Participants
|
24 Participants
n=7 Participants
|
99 Participants
n=31 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=31 Participants
|
|
Region of Enrollment
United States
|
28 Participants
n=99 Participants
|
26 Participants
n=107 Participants
|
33 Participants
n=206 Participants
|
29 Participants
n=7 Participants
|
116 Participants
n=31 Participants
|
|
ECOG Performance Status
0
|
9 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
8 Participants
n=7 Participants
|
43 Participants
n=31 Participants
|
|
ECOG Performance Status
1
|
19 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
18 Participants
n=206 Participants
|
21 Participants
n=7 Participants
|
73 Participants
n=31 Participants
|
PRIMARY outcome
Timeframe: At 8 weeksPopulation: The data for the pre-emptive and reactive treatment with clobatasol were pooled for the comparison of the two dosing strategies (regorafenib dose escalation group (Arms A1 + A2) versus regorafenib standard dose group (Arms B1 + B2)).
Fisher exact test will be used to detect a difference course 3 between arms (starting low dose \[pooled arm A1 and A2\] versus \[vs.\] standard dose \[pooled arm B1 and B2\]). The proportion of patients who complete 2 courses of protocol treatment and initiate course 3 will be computed by arm with its 95% confidence interval using exact method.
Outcome measures
| Measure |
Regorafenib Dose Escalation Group
n=54 Participants
In the regorafenib dose escalation group, the starting dose of regorafenib was 80 mg/day in week 1, 120 mg/day in week 2, and 160 mg/day in week 3 for cycle 1. Weekly incremental dose-escalation occurred if no significant drug-related toxicities (SDRTs) were observed. In cycle 2, patients received the highest tolerated dose from cycle 1. Patients also received prophylactic 0.05% clobetasol cream twice daily applied to palms and soles starting at cycle 1 day 1 for prevention of HFSR (pre-emptive strategy) or had the clobetasol cream applied when HFSR developed (reactive strategy).
|
Regorafenib Standard Dose Group
n=62 Participants
In the regorafenib standard dose group, the regorafenib dose schedule of 160 mg/day started on day 1 and continued for 21 every 28 days. The dose of 160 mg as the standard dose was used since it is the approved and most commonly used dose/schedule in clinical practice based on the results of randomized trials.Patients also received prophylactic 0.05% clobetasol cream twice daily applied to palms and soles starting at cycle 1 day 1 for prevention of HFSR (pre-emptive strategy) or had the clobetasol cream applied when HFSR developed (reactive strategy).
|
Arm B1 (Regorafenib Standard Dose + Pre-emptive Strategy)
In the regorafenib standard dose group, the regorafenib dose schedule of 160 mg/day started on day 1 and continued for 21 every 28 days. The dose of 160 mg as the standard dose was used since it is the approved and most commonly used dose/schedule in clinical practice based on the results of randomized trials.Patients also received prophylactic 0.05% clobetasol cream twice daily applied to palms and soles starting at cycle 1 day 1 for prevention of HFSR (pre-emptive strategy).
|
Arm B2 (Regorafenib Standard Dose + Reactive Strategy)
In the regorafenib standard dose group, the regorafenib dose schedule of 160 mg/day started on day 1 and continued for 21 every 28 days. The dose of 160 mg as the standard dose was used since it is the approved and most commonly used dose/schedule in clinical practice based on the results of randomized trials. Patients also had the clobetasol cream applied when HFSR developed (reactive strategy).
|
|---|---|---|---|---|
|
Proportion of Patients in Each Arm Who Complete 2 Cycles of Protocol Treatment and Initiate Cycle 3
|
0.43 proportion of patients
Interval 0.29 to 0.56
|
0.26 proportion of patients
Interval 0.15 to 0.37
|
—
|
—
|
SECONDARY outcome
Timeframe: Time from randomization to death due to any cause, assessed up to 2 yearsPopulation: The data for the pre-emptive and reactive treatment with clobatasol were pooled for the comparison of the two dosing strategies (regorafenib dose escalation group (Arms A1 + A2) versus regorafenib standard dose group (Arms B1 + B2)).
OS is defined as the time from randomization to death due to any cause and will be estimated with Kaplan-Meier survival curves and differences between regorafenib arms (A vs. B) tested using log-rank tests, though these analyses are not powered for formal non-inferiority assessments.
Outcome measures
| Measure |
Regorafenib Dose Escalation Group
n=54 Participants
In the regorafenib dose escalation group, the starting dose of regorafenib was 80 mg/day in week 1, 120 mg/day in week 2, and 160 mg/day in week 3 for cycle 1. Weekly incremental dose-escalation occurred if no significant drug-related toxicities (SDRTs) were observed. In cycle 2, patients received the highest tolerated dose from cycle 1. Patients also received prophylactic 0.05% clobetasol cream twice daily applied to palms and soles starting at cycle 1 day 1 for prevention of HFSR (pre-emptive strategy) or had the clobetasol cream applied when HFSR developed (reactive strategy).
|
Regorafenib Standard Dose Group
n=62 Participants
In the regorafenib standard dose group, the regorafenib dose schedule of 160 mg/day started on day 1 and continued for 21 every 28 days. The dose of 160 mg as the standard dose was used since it is the approved and most commonly used dose/schedule in clinical practice based on the results of randomized trials.Patients also received prophylactic 0.05% clobetasol cream twice daily applied to palms and soles starting at cycle 1 day 1 for prevention of HFSR (pre-emptive strategy) or had the clobetasol cream applied when HFSR developed (reactive strategy).
|
Arm B1 (Regorafenib Standard Dose + Pre-emptive Strategy)
In the regorafenib standard dose group, the regorafenib dose schedule of 160 mg/day started on day 1 and continued for 21 every 28 days. The dose of 160 mg as the standard dose was used since it is the approved and most commonly used dose/schedule in clinical practice based on the results of randomized trials.Patients also received prophylactic 0.05% clobetasol cream twice daily applied to palms and soles starting at cycle 1 day 1 for prevention of HFSR (pre-emptive strategy).
|
Arm B2 (Regorafenib Standard Dose + Reactive Strategy)
In the regorafenib standard dose group, the regorafenib dose schedule of 160 mg/day started on day 1 and continued for 21 every 28 days. The dose of 160 mg as the standard dose was used since it is the approved and most commonly used dose/schedule in clinical practice based on the results of randomized trials. Patients also had the clobetasol cream applied when HFSR developed (reactive strategy).
|
|---|---|---|---|---|
|
Overall Survival (OS)
|
9.8 months
Interval 7.5 to 11.9
|
6.0 months
Interval 4.9 to 10.2
|
—
|
—
|
SECONDARY outcome
Timeframe: Time from randomization to the earlier of disease progression or death due to any cause, where progressed disease (PD) is defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, assessed up to 2 yearsPFS is defined as the time from randomization to the earlier of disease progression or death due to any cause, where progressed disease (PD) is defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 and will be estimated with Kaplan-Meier survival curves and differences between regorafenib arms (A vs. B) tested using log-rank tests, though these analyses are not powered for formal non-inferiority assessments.
Outcome measures
| Measure |
Regorafenib Dose Escalation Group
n=54 Participants
In the regorafenib dose escalation group, the starting dose of regorafenib was 80 mg/day in week 1, 120 mg/day in week 2, and 160 mg/day in week 3 for cycle 1. Weekly incremental dose-escalation occurred if no significant drug-related toxicities (SDRTs) were observed. In cycle 2, patients received the highest tolerated dose from cycle 1. Patients also received prophylactic 0.05% clobetasol cream twice daily applied to palms and soles starting at cycle 1 day 1 for prevention of HFSR (pre-emptive strategy) or had the clobetasol cream applied when HFSR developed (reactive strategy).
|
Regorafenib Standard Dose Group
n=62 Participants
In the regorafenib standard dose group, the regorafenib dose schedule of 160 mg/day started on day 1 and continued for 21 every 28 days. The dose of 160 mg as the standard dose was used since it is the approved and most commonly used dose/schedule in clinical practice based on the results of randomized trials.Patients also received prophylactic 0.05% clobetasol cream twice daily applied to palms and soles starting at cycle 1 day 1 for prevention of HFSR (pre-emptive strategy) or had the clobetasol cream applied when HFSR developed (reactive strategy).
|
Arm B1 (Regorafenib Standard Dose + Pre-emptive Strategy)
In the regorafenib standard dose group, the regorafenib dose schedule of 160 mg/day started on day 1 and continued for 21 every 28 days. The dose of 160 mg as the standard dose was used since it is the approved and most commonly used dose/schedule in clinical practice based on the results of randomized trials.Patients also received prophylactic 0.05% clobetasol cream twice daily applied to palms and soles starting at cycle 1 day 1 for prevention of HFSR (pre-emptive strategy).
|
Arm B2 (Regorafenib Standard Dose + Reactive Strategy)
In the regorafenib standard dose group, the regorafenib dose schedule of 160 mg/day started on day 1 and continued for 21 every 28 days. The dose of 160 mg as the standard dose was used since it is the approved and most commonly used dose/schedule in clinical practice based on the results of randomized trials. Patients also had the clobetasol cream applied when HFSR developed (reactive strategy).
|
|---|---|---|---|---|
|
Progression Free Survival (PFS)
|
2.8 months
Interval 2.0 to 5.0
|
2.0 months
Interval 1.8 to 2.8
|
—
|
—
|
SECONDARY outcome
Timeframe: Time from randomization to disease progression, where PD is defined by RECIST 1.1, assessed up to 2 yearsPopulation: The data for the pre-emptive and reactive treatment with clobatasol were pooled for the comparison of the two dosing strategies (regorafenib dose escalation group (Arms A1 + A2) versus regorafenib standard dose group (Arms B1 + B2)).
TTP is defined as the time from randomization to disease progression, where PD is defined by RECIST 1.1 and will be estimated with Kaplan-Meier survival curves and differences between regorafenib arms (A vs. B) tested using log-rank tests, though these analyses are not powered for formal non-inferiority assessments.
Outcome measures
| Measure |
Regorafenib Dose Escalation Group
n=54 Participants
In the regorafenib dose escalation group, the starting dose of regorafenib was 80 mg/day in week 1, 120 mg/day in week 2, and 160 mg/day in week 3 for cycle 1. Weekly incremental dose-escalation occurred if no significant drug-related toxicities (SDRTs) were observed. In cycle 2, patients received the highest tolerated dose from cycle 1. Patients also received prophylactic 0.05% clobetasol cream twice daily applied to palms and soles starting at cycle 1 day 1 for prevention of HFSR (pre-emptive strategy) or had the clobetasol cream applied when HFSR developed (reactive strategy).
|
Regorafenib Standard Dose Group
n=62 Participants
In the regorafenib standard dose group, the regorafenib dose schedule of 160 mg/day started on day 1 and continued for 21 every 28 days. The dose of 160 mg as the standard dose was used since it is the approved and most commonly used dose/schedule in clinical practice based on the results of randomized trials.Patients also received prophylactic 0.05% clobetasol cream twice daily applied to palms and soles starting at cycle 1 day 1 for prevention of HFSR (pre-emptive strategy) or had the clobetasol cream applied when HFSR developed (reactive strategy).
|
Arm B1 (Regorafenib Standard Dose + Pre-emptive Strategy)
In the regorafenib standard dose group, the regorafenib dose schedule of 160 mg/day started on day 1 and continued for 21 every 28 days. The dose of 160 mg as the standard dose was used since it is the approved and most commonly used dose/schedule in clinical practice based on the results of randomized trials.Patients also received prophylactic 0.05% clobetasol cream twice daily applied to palms and soles starting at cycle 1 day 1 for prevention of HFSR (pre-emptive strategy).
|
Arm B2 (Regorafenib Standard Dose + Reactive Strategy)
In the regorafenib standard dose group, the regorafenib dose schedule of 160 mg/day started on day 1 and continued for 21 every 28 days. The dose of 160 mg as the standard dose was used since it is the approved and most commonly used dose/schedule in clinical practice based on the results of randomized trials. Patients also had the clobetasol cream applied when HFSR developed (reactive strategy).
|
|---|---|---|---|---|
|
Time to Progression (TTP)
|
2.8 months
Interval 1.9 to 5.7
|
2.0 months
Interval 1.8 to 3.3
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 8 weeksPopulation: The data for the pre-emptive \& reactive treatment with clobatasol were pooled for the comparison of the two dosing strategies ((Arms A1 + A2) versus (Arms B1 + B2)). There are patients off-protocol treatment during cycle 1; therefore, we do not have cycle 2 dosing information for those patients who are off-protocol treatment during cycle 1.
Will be summarized with descriptive statistics and compared between regorafenib arms (A vs. B).
Outcome measures
| Measure |
Regorafenib Dose Escalation Group
n=54 Participants
In the regorafenib dose escalation group, the starting dose of regorafenib was 80 mg/day in week 1, 120 mg/day in week 2, and 160 mg/day in week 3 for cycle 1. Weekly incremental dose-escalation occurred if no significant drug-related toxicities (SDRTs) were observed. In cycle 2, patients received the highest tolerated dose from cycle 1. Patients also received prophylactic 0.05% clobetasol cream twice daily applied to palms and soles starting at cycle 1 day 1 for prevention of HFSR (pre-emptive strategy) or had the clobetasol cream applied when HFSR developed (reactive strategy).
|
Regorafenib Standard Dose Group
n=62 Participants
In the regorafenib standard dose group, the regorafenib dose schedule of 160 mg/day started on day 1 and continued for 21 every 28 days. The dose of 160 mg as the standard dose was used since it is the approved and most commonly used dose/schedule in clinical practice based on the results of randomized trials.Patients also received prophylactic 0.05% clobetasol cream twice daily applied to palms and soles starting at cycle 1 day 1 for prevention of HFSR (pre-emptive strategy) or had the clobetasol cream applied when HFSR developed (reactive strategy).
|
Arm B1 (Regorafenib Standard Dose + Pre-emptive Strategy)
In the regorafenib standard dose group, the regorafenib dose schedule of 160 mg/day started on day 1 and continued for 21 every 28 days. The dose of 160 mg as the standard dose was used since it is the approved and most commonly used dose/schedule in clinical practice based on the results of randomized trials.Patients also received prophylactic 0.05% clobetasol cream twice daily applied to palms and soles starting at cycle 1 day 1 for prevention of HFSR (pre-emptive strategy).
|
Arm B2 (Regorafenib Standard Dose + Reactive Strategy)
In the regorafenib standard dose group, the regorafenib dose schedule of 160 mg/day started on day 1 and continued for 21 every 28 days. The dose of 160 mg as the standard dose was used since it is the approved and most commonly used dose/schedule in clinical practice based on the results of randomized trials. Patients also had the clobetasol cream applied when HFSR developed (reactive strategy).
|
|---|---|---|---|---|
|
Cumulative (Total) Dose of Regorafenib Received by Patients in the First Two Cycles
Cycle 1
|
91.8 mg/day
Standard Deviation 33.4
|
133.1 mg/day
Standard Deviation 34.6
|
—
|
—
|
|
Cumulative (Total) Dose of Regorafenib Received by Patients in the First Two Cycles
Cycle 2
|
121.3 mg/day
Standard Deviation 40.0
|
117.3 mg/day
Standard Deviation 48.9
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 8 weeksPopulation: The data for the pre-emptive \& reactive treatment with clobatasol were pooled for the comparison of the two dosing strategies ((Arms A1 + A2) versus (Arms B1 + B2)).
Dose intensity of regorafenib received by patients in the first two cycles as measured by the percentage (%) of planned dose received
Outcome measures
| Measure |
Regorafenib Dose Escalation Group
n=54 Participants
In the regorafenib dose escalation group, the starting dose of regorafenib was 80 mg/day in week 1, 120 mg/day in week 2, and 160 mg/day in week 3 for cycle 1. Weekly incremental dose-escalation occurred if no significant drug-related toxicities (SDRTs) were observed. In cycle 2, patients received the highest tolerated dose from cycle 1. Patients also received prophylactic 0.05% clobetasol cream twice daily applied to palms and soles starting at cycle 1 day 1 for prevention of HFSR (pre-emptive strategy) or had the clobetasol cream applied when HFSR developed (reactive strategy).
|
Regorafenib Standard Dose Group
n=62 Participants
In the regorafenib standard dose group, the regorafenib dose schedule of 160 mg/day started on day 1 and continued for 21 every 28 days. The dose of 160 mg as the standard dose was used since it is the approved and most commonly used dose/schedule in clinical practice based on the results of randomized trials.Patients also received prophylactic 0.05% clobetasol cream twice daily applied to palms and soles starting at cycle 1 day 1 for prevention of HFSR (pre-emptive strategy) or had the clobetasol cream applied when HFSR developed (reactive strategy).
|
Arm B1 (Regorafenib Standard Dose + Pre-emptive Strategy)
In the regorafenib standard dose group, the regorafenib dose schedule of 160 mg/day started on day 1 and continued for 21 every 28 days. The dose of 160 mg as the standard dose was used since it is the approved and most commonly used dose/schedule in clinical practice based on the results of randomized trials.Patients also received prophylactic 0.05% clobetasol cream twice daily applied to palms and soles starting at cycle 1 day 1 for prevention of HFSR (pre-emptive strategy).
|
Arm B2 (Regorafenib Standard Dose + Reactive Strategy)
In the regorafenib standard dose group, the regorafenib dose schedule of 160 mg/day started on day 1 and continued for 21 every 28 days. The dose of 160 mg as the standard dose was used since it is the approved and most commonly used dose/schedule in clinical practice based on the results of randomized trials. Patients also had the clobetasol cream applied when HFSR developed (reactive strategy).
|
|---|---|---|---|---|
|
Dose Intensity of Regorafenib Received by Patients in the First Two Cycles as Measured by the Percentage of Planned Dose Received
|
76.2 percentage of planned dose received
Standard Deviation 25.3
|
76.0 percentage of planned dose received
Standard Deviation 21.0
|
—
|
—
|
SECONDARY outcome
Timeframe: 2 yearsWill be computed with 95% confidence intervals.
Outcome measures
| Measure |
Regorafenib Dose Escalation Group
n=28 Participants
In the regorafenib dose escalation group, the starting dose of regorafenib was 80 mg/day in week 1, 120 mg/day in week 2, and 160 mg/day in week 3 for cycle 1. Weekly incremental dose-escalation occurred if no significant drug-related toxicities (SDRTs) were observed. In cycle 2, patients received the highest tolerated dose from cycle 1. Patients also received prophylactic 0.05% clobetasol cream twice daily applied to palms and soles starting at cycle 1 day 1 for prevention of HFSR (pre-emptive strategy) or had the clobetasol cream applied when HFSR developed (reactive strategy).
|
Regorafenib Standard Dose Group
n=26 Participants
In the regorafenib standard dose group, the regorafenib dose schedule of 160 mg/day started on day 1 and continued for 21 every 28 days. The dose of 160 mg as the standard dose was used since it is the approved and most commonly used dose/schedule in clinical practice based on the results of randomized trials.Patients also received prophylactic 0.05% clobetasol cream twice daily applied to palms and soles starting at cycle 1 day 1 for prevention of HFSR (pre-emptive strategy) or had the clobetasol cream applied when HFSR developed (reactive strategy).
|
Arm B1 (Regorafenib Standard Dose + Pre-emptive Strategy)
n=33 Participants
In the regorafenib standard dose group, the regorafenib dose schedule of 160 mg/day started on day 1 and continued for 21 every 28 days. The dose of 160 mg as the standard dose was used since it is the approved and most commonly used dose/schedule in clinical practice based on the results of randomized trials.Patients also received prophylactic 0.05% clobetasol cream twice daily applied to palms and soles starting at cycle 1 day 1 for prevention of HFSR (pre-emptive strategy).
|
Arm B2 (Regorafenib Standard Dose + Reactive Strategy)
n=29 Participants
In the regorafenib standard dose group, the regorafenib dose schedule of 160 mg/day started on day 1 and continued for 21 every 28 days. The dose of 160 mg as the standard dose was used since it is the approved and most commonly used dose/schedule in clinical practice based on the results of randomized trials. Patients also had the clobetasol cream applied when HFSR developed (reactive strategy).
|
|---|---|---|---|---|
|
Proportion of Patients Overall and Within Each Arm Experiencing Grade 3 or 4 Hand and Foot Syndrome (HFS)
|
0.1786 proportion of participants
Interval 0.0606 to 0.3689
|
0.1154 proportion of participants
Interval 0.0245 to 0.3015
|
0.1515 proportion of participants
Interval 0.0511 to 0.319
|
0.1724 proportion of participants
Interval 0.0585 to 0.3577
|
SECONDARY outcome
Timeframe: 8 weeksPopulation: Only patients that completed a post-baseline HFS14 assessment were included in analysis.
Patients will be descriptively compared between treatment arms and between HFS treatment strategies (pre-emptive vs. reactive) according to self-reported outcomes given on the HFS14 questionnaire. Results from the course 1 and 2 HSF14 questionnaires will also be summarized descriptively as they relate to the pre-emptive versus reactive palmar-plantar erythrodysesthesia syndrome (PPES) strategies. Total HFS-14 score was calculated by summing the scores of all items and adjusting to 100 by applying a rule of three. Total scores have a range of 2-100, with the higher the score, the greater the QoL impairment.
Outcome measures
| Measure |
Regorafenib Dose Escalation Group
n=17 Participants
In the regorafenib dose escalation group, the starting dose of regorafenib was 80 mg/day in week 1, 120 mg/day in week 2, and 160 mg/day in week 3 for cycle 1. Weekly incremental dose-escalation occurred if no significant drug-related toxicities (SDRTs) were observed. In cycle 2, patients received the highest tolerated dose from cycle 1. Patients also received prophylactic 0.05% clobetasol cream twice daily applied to palms and soles starting at cycle 1 day 1 for prevention of HFSR (pre-emptive strategy) or had the clobetasol cream applied when HFSR developed (reactive strategy).
|
Regorafenib Standard Dose Group
n=11 Participants
In the regorafenib standard dose group, the regorafenib dose schedule of 160 mg/day started on day 1 and continued for 21 every 28 days. The dose of 160 mg as the standard dose was used since it is the approved and most commonly used dose/schedule in clinical practice based on the results of randomized trials.Patients also received prophylactic 0.05% clobetasol cream twice daily applied to palms and soles starting at cycle 1 day 1 for prevention of HFSR (pre-emptive strategy) or had the clobetasol cream applied when HFSR developed (reactive strategy).
|
Arm B1 (Regorafenib Standard Dose + Pre-emptive Strategy)
n=11 Participants
In the regorafenib standard dose group, the regorafenib dose schedule of 160 mg/day started on day 1 and continued for 21 every 28 days. The dose of 160 mg as the standard dose was used since it is the approved and most commonly used dose/schedule in clinical practice based on the results of randomized trials.Patients also received prophylactic 0.05% clobetasol cream twice daily applied to palms and soles starting at cycle 1 day 1 for prevention of HFSR (pre-emptive strategy).
|
Arm B2 (Regorafenib Standard Dose + Reactive Strategy)
n=14 Participants
In the regorafenib standard dose group, the regorafenib dose schedule of 160 mg/day started on day 1 and continued for 21 every 28 days. The dose of 160 mg as the standard dose was used since it is the approved and most commonly used dose/schedule in clinical practice based on the results of randomized trials. Patients also had the clobetasol cream applied when HFSR developed (reactive strategy).
|
|---|---|---|---|---|
|
Quality of Life (QOL) (According to the HFS14 Total Score)
|
20.8 score on a scale
Standard Deviation 19.05
|
29.5 score on a scale
Standard Deviation 21.97
|
15.8 score on a scale
Standard Deviation 14.65
|
21.8 score on a scale
Standard Deviation 26.38
|
SECONDARY outcome
Timeframe: Baseline to 8 weeksChanges in QOL (according to the LASA questionnaire as measured by the overall QOL question) from baseline will be compared between the treatment arms using the Kruskal-Wallis test.
Outcome measures
| Measure |
Regorafenib Dose Escalation Group
n=20 Participants
In the regorafenib dose escalation group, the starting dose of regorafenib was 80 mg/day in week 1, 120 mg/day in week 2, and 160 mg/day in week 3 for cycle 1. Weekly incremental dose-escalation occurred if no significant drug-related toxicities (SDRTs) were observed. In cycle 2, patients received the highest tolerated dose from cycle 1. Patients also received prophylactic 0.05% clobetasol cream twice daily applied to palms and soles starting at cycle 1 day 1 for prevention of HFSR (pre-emptive strategy) or had the clobetasol cream applied when HFSR developed (reactive strategy).
|
Regorafenib Standard Dose Group
n=11 Participants
In the regorafenib standard dose group, the regorafenib dose schedule of 160 mg/day started on day 1 and continued for 21 every 28 days. The dose of 160 mg as the standard dose was used since it is the approved and most commonly used dose/schedule in clinical practice based on the results of randomized trials.Patients also received prophylactic 0.05% clobetasol cream twice daily applied to palms and soles starting at cycle 1 day 1 for prevention of HFSR (pre-emptive strategy) or had the clobetasol cream applied when HFSR developed (reactive strategy).
|
Arm B1 (Regorafenib Standard Dose + Pre-emptive Strategy)
n=14 Participants
In the regorafenib standard dose group, the regorafenib dose schedule of 160 mg/day started on day 1 and continued for 21 every 28 days. The dose of 160 mg as the standard dose was used since it is the approved and most commonly used dose/schedule in clinical practice based on the results of randomized trials.Patients also received prophylactic 0.05% clobetasol cream twice daily applied to palms and soles starting at cycle 1 day 1 for prevention of HFSR (pre-emptive strategy).
|
Arm B2 (Regorafenib Standard Dose + Reactive Strategy)
n=16 Participants
In the regorafenib standard dose group, the regorafenib dose schedule of 160 mg/day started on day 1 and continued for 21 every 28 days. The dose of 160 mg as the standard dose was used since it is the approved and most commonly used dose/schedule in clinical practice based on the results of randomized trials. Patients also had the clobetasol cream applied when HFSR developed (reactive strategy).
|
|---|---|---|---|---|
|
Changes in QOL (According to the Linear Analogue Self-Assessment [LASA] Questionnaire)
|
-0.9 LASA overall score change from baseline
Standard Deviation 1.12
|
-0.3 LASA overall score change from baseline
Standard Deviation 1.42
|
-0.7 LASA overall score change from baseline
Standard Deviation 2.09
|
-0.9 LASA overall score change from baseline
Standard Deviation 1.96
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, prior to treatment, days 7, 14, and 21 prior to treatment (course 1), and days 1 and 21 prior to treatment (course 2)After quantitation, the average trough concentration, calculated from all available data, will be calculated. This average trough concentration will be correlated with toxicity and efficacy endpoints. Further descriptive characteristics of the pharmacokinetics will also be calculated, an example includes (but is not limited to) within-patient variability in the trough concentrations pharmacokinetic parameters will also be calculated, both overall and within courses, as a ratio of the maximum:minimum value.
Outcome measures
Outcome data not reported
Adverse Events
Arm A1 (Regorafenib Dose Escalation + Pre-emptive Strategy)
Serious events: 4 serious events
Other events: 28 other events
Deaths: 0 deaths
Arm A2 (Regorafenib Dose Escalation + Reactive Strategy)
Serious events: 10 serious events
Other events: 24 other events
Deaths: 3 deaths
Arm B1 (Regorafenib Standard Dose + Pre-emptive Strategy)
Serious events: 10 serious events
Other events: 31 other events
Deaths: 3 deaths
Arm B2 (Regorafenib Standard Dose + Reactive Strategy)
Serious events: 10 serious events
Other events: 30 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Arm A1 (Regorafenib Dose Escalation + Pre-emptive Strategy)
n=28 participants at risk
In the regorafenib dose escalation group, the starting dose of regorafenib was 80 mg/day in week 1, 120 mg/day in week 2, and 160 mg/day in week 3 for cycle 1. Weekly incremental dose-escalation occurred if no significant drug-related toxicities (SDRTs) were observed. In cycle 2, patients received the highest tolerated dose from cycle 1. Patients also received prophylactic 0.05% clobetasol cream twice daily applied to palms and soles starting at cycle 1 day 1 for prevention of HFSR (pre-emptive strategy).
|
Arm A2 (Regorafenib Dose Escalation + Reactive Strategy)
n=26 participants at risk
In the regorafenib dose escalation group, the starting dose of regorafenib was 80 mg/day in week 1, 120 mg/day in week 2, and 160 mg/day in week 3 for cycle 1. Weekly incremental dose-escalation occurred if no significant drug-related toxicities (SDRTs) were observed. In cycle 2, patients received the highest tolerated dose from cycle 1. Patients also had the clobetasol cream applied when HFSR developed (reactive strategy).
|
Arm B1 (Regorafenib Standard Dose + Pre-emptive Strategy)
n=33 participants at risk
In the regorafenib standard dose group, the regorafenib dose schedule of 160 mg/day started on day 1 and continued for 21 every 28 days. The dose of 160 mg as the standard dose was used since it is the approved and most commonly used dose/schedule in clinical practice based on the results of randomized trials. Patients also received prophylactic 0.05% clobetasol cream twice daily applied to palms and soles starting at cycle 1 day 1 for prevention of HFSR (pre-emptive strategy).
|
Arm B2 (Regorafenib Standard Dose + Reactive Strategy)
n=30 participants at risk
In the regorafenib standard dose group, the regorafenib dose schedule of 160 mg/day started on day 1 and continued for 21 every 28 days. The dose of 160 mg as the standard dose was used since it is the approved and most commonly used dose/schedule in clinical practice based on the results of randomized trials. Patients also had the clobetasol cream applied when HFSR developed (reactive strategy).
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
3.6%
1/28 • Number of events 1 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
0.00%
0/26 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
0.00%
0/33 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
0.00%
0/30 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/28 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
0.00%
0/26 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
3.0%
1/33 • Number of events 1 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
0.00%
0/30 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/28 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
3.8%
1/26 • Number of events 1 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
0.00%
0/33 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
0.00%
0/30 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
|
Gastrointestinal disorders
Abdominal pain
|
7.1%
2/28 • Number of events 2 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
19.2%
5/26 • Number of events 5 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
9.1%
3/33 • Number of events 3 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
3.3%
1/30 • Number of events 1 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
|
Gastrointestinal disorders
Ascites
|
3.6%
1/28 • Number of events 1 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
0.00%
0/26 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
0.00%
0/33 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
0.00%
0/30 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/28 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
3.8%
1/26 • Number of events 1 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
0.00%
0/33 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
0.00%
0/30 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
|
Gastrointestinal disorders
Colonic obstruction
|
3.6%
1/28 • Number of events 1 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
7.7%
2/26 • Number of events 2 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
0.00%
0/33 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
0.00%
0/30 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/28 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
3.8%
1/26 • Number of events 1 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
0.00%
0/33 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
0.00%
0/30 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
|
Gastrointestinal disorders
Lower gastrointestinal hemorrhage
|
0.00%
0/28 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
0.00%
0/26 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
3.0%
1/33 • Number of events 1 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
0.00%
0/30 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/28 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
7.7%
2/26 • Number of events 2 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
0.00%
0/33 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
0.00%
0/30 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
|
Gastrointestinal disorders
Rectal fistula
|
0.00%
0/28 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
3.8%
1/26 • Number of events 1 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
0.00%
0/33 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
0.00%
0/30 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
|
Gastrointestinal disorders
Rectal obstruction
|
0.00%
0/28 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
3.8%
1/26 • Number of events 1 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
0.00%
0/33 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
0.00%
0/30 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/28 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
0.00%
0/26 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
0.00%
0/33 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
3.3%
1/30 • Number of events 1 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
|
General disorders
Death NOS
|
0.00%
0/28 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
3.8%
1/26 • Number of events 1 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
3.0%
1/33 • Number of events 1 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
0.00%
0/30 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
|
General disorders
Fatigue
|
3.6%
1/28 • Number of events 1 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
3.8%
1/26 • Number of events 1 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
6.1%
2/33 • Number of events 3 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
0.00%
0/30 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
|
General disorders
Pain
|
0.00%
0/28 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
0.00%
0/26 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
0.00%
0/33 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
3.3%
1/30 • Number of events 1 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
|
Infections and infestations
Abdominal infection
|
3.6%
1/28 • Number of events 1 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
0.00%
0/26 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
0.00%
0/33 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
0.00%
0/30 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
|
Infections and infestations
Infections and infestations - Other, specify
|
0.00%
0/28 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
0.00%
0/26 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
3.0%
1/33 • Number of events 1 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
0.00%
0/30 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
|
Infections and infestations
Lung infection
|
0.00%
0/28 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
3.8%
1/26 • Number of events 1 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
0.00%
0/33 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
0.00%
0/30 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
|
Infections and infestations
Sepsis
|
0.00%
0/28 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
3.8%
1/26 • Number of events 1 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
0.00%
0/33 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
3.3%
1/30 • Number of events 1 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
|
Infections and infestations
Urinary tract infection
|
3.6%
1/28 • Number of events 1 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
0.00%
0/26 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
0.00%
0/33 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
0.00%
0/30 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
|
Investigations
Alanine aminotransferase increased
|
7.1%
2/28 • Number of events 2 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
0.00%
0/26 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
0.00%
0/33 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
0.00%
0/30 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
|
Investigations
Alkaline phosphatase increased
|
7.1%
2/28 • Number of events 2 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
0.00%
0/26 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
0.00%
0/33 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
0.00%
0/30 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
|
Investigations
Aspartate aminotransferase increased
|
7.1%
2/28 • Number of events 2 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
0.00%
0/26 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
0.00%
0/33 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
0.00%
0/30 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
|
Investigations
Blood bilirubin increased
|
3.6%
1/28 • Number of events 1 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
0.00%
0/26 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
0.00%
0/33 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
0.00%
0/30 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
|
Investigations
INR increased
|
0.00%
0/28 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
0.00%
0/26 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
0.00%
0/33 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
3.3%
1/30 • Number of events 1 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
|
Investigations
Investigations - Other, specify
|
3.6%
1/28 • Number of events 1 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
0.00%
0/26 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
0.00%
0/33 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
0.00%
0/30 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
|
Investigations
Platelet count decreased
|
3.6%
1/28 • Number of events 1 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
0.00%
0/26 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
0.00%
0/33 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
0.00%
0/30 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/28 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
3.8%
1/26 • Number of events 1 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
0.00%
0/33 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
3.3%
1/30 • Number of events 1 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/28 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
3.8%
1/26 • Number of events 1 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
6.1%
2/33 • Number of events 2 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
3.3%
1/30 • Number of events 1 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
3.6%
1/28 • Number of events 1 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
0.00%
0/26 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
0.00%
0/33 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
0.00%
0/30 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
3.6%
1/28 • Number of events 1 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
0.00%
0/26 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
0.00%
0/33 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
0.00%
0/30 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
7.1%
2/28 • Number of events 2 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
0.00%
0/26 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
0.00%
0/33 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
0.00%
0/30 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
3.6%
1/28 • Number of events 1 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
3.8%
1/26 • Number of events 1 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
0.00%
0/33 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
0.00%
0/30 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
7.1%
2/28 • Number of events 2 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
0.00%
0/26 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
3.0%
1/33 • Number of events 1 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
0.00%
0/30 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
3.6%
1/28 • Number of events 1 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
0.00%
0/26 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
0.00%
0/33 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
0.00%
0/30 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
0.00%
0/28 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
3.8%
1/26 • Number of events 1 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
0.00%
0/33 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
0.00%
0/30 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
0.00%
0/28 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
3.8%
1/26 • Number of events 1 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
3.0%
1/33 • Number of events 1 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
0.00%
0/30 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/28 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
0.00%
0/26 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
0.00%
0/33 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
3.3%
1/30 • Number of events 1 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify
|
0.00%
0/28 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
7.7%
2/26 • Number of events 2 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
3.0%
1/33 • Number of events 1 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
3.3%
1/30 • Number of events 1 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/28 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
0.00%
0/26 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
0.00%
0/33 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
3.3%
1/30 • Number of events 1 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
|
Nervous system disorders
Syncope
|
0.00%
0/28 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
3.8%
1/26 • Number of events 1 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
0.00%
0/33 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
0.00%
0/30 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
|
Nervous system disorders
Transient ischemic attacks
|
0.00%
0/28 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
0.00%
0/26 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
3.0%
1/33 • Number of events 1 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
0.00%
0/30 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
|
Psychiatric disorders
Confusion
|
0.00%
0/28 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
0.00%
0/26 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
0.00%
0/33 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
3.3%
1/30 • Number of events 1 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
|
Renal and urinary disorders
Urinary retention
|
3.6%
1/28 • Number of events 1 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
0.00%
0/26 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
0.00%
0/33 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
0.00%
0/30 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
|
Respiratory, thoracic and mediastinal disorders
Adult respiratory distress syndrome
|
0.00%
0/28 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
3.8%
1/26 • Number of events 1 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
0.00%
0/33 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
0.00%
0/30 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/28 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
3.8%
1/26 • Number of events 1 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
3.0%
1/33 • Number of events 1 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
6.7%
2/30 • Number of events 2 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/28 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
0.00%
0/26 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
3.0%
1/33 • Number of events 1 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
0.00%
0/30 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/28 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
3.8%
1/26 • Number of events 1 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
0.00%
0/33 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
3.3%
1/30 • Number of events 1 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysesthesia syndrome
|
0.00%
0/28 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
3.8%
1/26 • Number of events 2 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
0.00%
0/33 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
0.00%
0/30 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/28 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
0.00%
0/26 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
0.00%
0/33 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
3.3%
1/30 • Number of events 1 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
|
Vascular disorders
Thromboembolic event
|
3.6%
1/28 • Number of events 1 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
0.00%
0/26 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
0.00%
0/33 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
0.00%
0/30 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
Other adverse events
| Measure |
Arm A1 (Regorafenib Dose Escalation + Pre-emptive Strategy)
n=28 participants at risk
In the regorafenib dose escalation group, the starting dose of regorafenib was 80 mg/day in week 1, 120 mg/day in week 2, and 160 mg/day in week 3 for cycle 1. Weekly incremental dose-escalation occurred if no significant drug-related toxicities (SDRTs) were observed. In cycle 2, patients received the highest tolerated dose from cycle 1. Patients also received prophylactic 0.05% clobetasol cream twice daily applied to palms and soles starting at cycle 1 day 1 for prevention of HFSR (pre-emptive strategy).
|
Arm A2 (Regorafenib Dose Escalation + Reactive Strategy)
n=26 participants at risk
In the regorafenib dose escalation group, the starting dose of regorafenib was 80 mg/day in week 1, 120 mg/day in week 2, and 160 mg/day in week 3 for cycle 1. Weekly incremental dose-escalation occurred if no significant drug-related toxicities (SDRTs) were observed. In cycle 2, patients received the highest tolerated dose from cycle 1. Patients also had the clobetasol cream applied when HFSR developed (reactive strategy).
|
Arm B1 (Regorafenib Standard Dose + Pre-emptive Strategy)
n=33 participants at risk
In the regorafenib standard dose group, the regorafenib dose schedule of 160 mg/day started on day 1 and continued for 21 every 28 days. The dose of 160 mg as the standard dose was used since it is the approved and most commonly used dose/schedule in clinical practice based on the results of randomized trials. Patients also received prophylactic 0.05% clobetasol cream twice daily applied to palms and soles starting at cycle 1 day 1 for prevention of HFSR (pre-emptive strategy).
|
Arm B2 (Regorafenib Standard Dose + Reactive Strategy)
n=30 participants at risk
In the regorafenib standard dose group, the regorafenib dose schedule of 160 mg/day started on day 1 and continued for 21 every 28 days. The dose of 160 mg as the standard dose was used since it is the approved and most commonly used dose/schedule in clinical practice based on the results of randomized trials. Patients also had the clobetasol cream applied when HFSR developed (reactive strategy).
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
14.3%
4/28 • Number of events 5 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
30.8%
8/26 • Number of events 15 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
21.2%
7/33 • Number of events 10 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
20.0%
6/30 • Number of events 8 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders - Other, specify
|
0.00%
0/28 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
0.00%
0/26 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
0.00%
0/33 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
6.7%
2/30 • Number of events 3 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
|
Blood and lymphatic system disorders
Thrombotic thrombocytopenic purpura
|
0.00%
0/28 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
3.8%
1/26 • Number of events 5 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
0.00%
0/33 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
0.00%
0/30 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/28 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
0.00%
0/26 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
3.0%
1/33 • Number of events 1 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
3.3%
1/30 • Number of events 1 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/28 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
0.00%
0/26 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
3.0%
1/33 • Number of events 2 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
0.00%
0/30 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/28 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
3.8%
1/26 • Number of events 1 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
0.00%
0/33 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
0.00%
0/30 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
|
Eye disorders
Watering eyes
|
3.6%
1/28 • Number of events 1 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
0.00%
0/26 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
0.00%
0/33 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
0.00%
0/30 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
|
Gastrointestinal disorders
Abdominal pain
|
7.1%
2/28 • Number of events 3 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
3.8%
1/26 • Number of events 1 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
9.1%
3/33 • Number of events 3 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
6.7%
2/30 • Number of events 2 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/28 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
3.8%
1/26 • Number of events 3 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
0.00%
0/33 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
0.00%
0/30 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
|
Gastrointestinal disorders
Constipation
|
7.1%
2/28 • Number of events 2 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
3.8%
1/26 • Number of events 1 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
3.0%
1/33 • Number of events 1 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
13.3%
4/30 • Number of events 5 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
|
Gastrointestinal disorders
Diarrhea
|
50.0%
14/28 • Number of events 30 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
38.5%
10/26 • Number of events 20 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
51.5%
17/33 • Number of events 37 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
33.3%
10/30 • Number of events 24 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
|
Gastrointestinal disorders
Dry mouth
|
7.1%
2/28 • Number of events 7 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
3.8%
1/26 • Number of events 1 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
0.00%
0/33 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
10.0%
3/30 • Number of events 3 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/28 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
0.00%
0/26 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
0.00%
0/33 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
3.3%
1/30 • Number of events 1 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/28 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
0.00%
0/26 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
3.0%
1/33 • Number of events 1 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
0.00%
0/30 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/28 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
0.00%
0/26 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
3.0%
1/33 • Number of events 5 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
0.00%
0/30 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
0.00%
0/28 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
0.00%
0/26 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
3.0%
1/33 • Number of events 1 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
0.00%
0/30 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify
|
0.00%
0/28 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
0.00%
0/26 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
0.00%
0/33 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
6.7%
2/30 • Number of events 2 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
|
Gastrointestinal disorders
Mucositis oral
|
3.6%
1/28 • Number of events 1 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
15.4%
4/26 • Number of events 5 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
15.2%
5/33 • Number of events 7 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
16.7%
5/30 • Number of events 7 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
|
Gastrointestinal disorders
Nausea
|
28.6%
8/28 • Number of events 16 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
46.2%
12/26 • Number of events 21 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
48.5%
16/33 • Number of events 43 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
43.3%
13/30 • Number of events 17 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/28 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
0.00%
0/26 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
6.1%
2/33 • Number of events 2 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
10.0%
3/30 • Number of events 5 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
|
Gastrointestinal disorders
Stomach pain
|
0.00%
0/28 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
0.00%
0/26 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
0.00%
0/33 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
3.3%
1/30 • Number of events 1 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
|
Gastrointestinal disorders
Vomiting
|
17.9%
5/28 • Number of events 7 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
26.9%
7/26 • Number of events 8 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
27.3%
9/33 • Number of events 12 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
16.7%
5/30 • Number of events 6 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
|
General disorders
Chills
|
3.6%
1/28 • Number of events 2 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
3.8%
1/26 • Number of events 3 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
3.0%
1/33 • Number of events 1 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
6.7%
2/30 • Number of events 2 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
|
General disorders
Edema limbs
|
3.6%
1/28 • Number of events 1 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
3.8%
1/26 • Number of events 1 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
3.0%
1/33 • Number of events 1 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
0.00%
0/30 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
|
General disorders
Fatigue
|
89.3%
25/28 • Number of events 72 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
76.9%
20/26 • Number of events 53 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
78.8%
26/33 • Number of events 83 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
90.0%
27/30 • Number of events 72 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
|
General disorders
Fever
|
3.6%
1/28 • Number of events 2 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
0.00%
0/26 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
3.0%
1/33 • Number of events 1 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
10.0%
3/30 • Number of events 3 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
|
General disorders
General disorders and administration site conditions - Other, specify
|
0.00%
0/28 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
0.00%
0/26 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
6.1%
2/33 • Number of events 3 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
6.7%
2/30 • Number of events 4 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/28 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
0.00%
0/26 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
3.0%
1/33 • Number of events 1 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
0.00%
0/30 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
|
General disorders
Pain
|
14.3%
4/28 • Number of events 4 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
3.8%
1/26 • Number of events 1 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
6.1%
2/33 • Number of events 2 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
3.3%
1/30 • Number of events 1 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
|
Hepatobiliary disorders
Hepatic failure
|
0.00%
0/28 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
0.00%
0/26 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
0.00%
0/33 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
3.3%
1/30 • Number of events 1 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
|
Hepatobiliary disorders
Hepatobiliary disorders - Other, specify
|
0.00%
0/28 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
3.8%
1/26 • Number of events 1 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
0.00%
0/33 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
0.00%
0/30 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
|
Infections and infestations
Sinusitis
|
3.6%
1/28 • Number of events 1 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
0.00%
0/26 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
0.00%
0/33 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
0.00%
0/30 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/28 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
3.8%
1/26 • Number of events 1 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
0.00%
0/33 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
0.00%
0/30 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
|
Investigations
Activated partial thromboplastin time prolonged
|
0.00%
0/28 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
0.00%
0/26 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
3.0%
1/33 • Number of events 1 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
0.00%
0/30 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
|
Investigations
Alanine aminotransferase increased
|
7.1%
2/28 • Number of events 4 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
15.4%
4/26 • Number of events 4 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
18.2%
6/33 • Number of events 13 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
10.0%
3/30 • Number of events 3 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
|
Investigations
Alkaline phosphatase increased
|
10.7%
3/28 • Number of events 4 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
15.4%
4/26 • Number of events 4 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
21.2%
7/33 • Number of events 13 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
16.7%
5/30 • Number of events 6 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
|
Investigations
Aspartate aminotransferase increased
|
7.1%
2/28 • Number of events 3 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
19.2%
5/26 • Number of events 8 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
24.2%
8/33 • Number of events 16 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
26.7%
8/30 • Number of events 9 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
|
Investigations
Blood bilirubin increased
|
10.7%
3/28 • Number of events 5 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
19.2%
5/26 • Number of events 5 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
27.3%
9/33 • Number of events 10 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
30.0%
9/30 • Number of events 10 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
|
Investigations
Creatinine increased
|
0.00%
0/28 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
7.7%
2/26 • Number of events 2 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
3.0%
1/33 • Number of events 1 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
10.0%
3/30 • Number of events 4 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
|
Investigations
Investigations - Other, specify
|
3.6%
1/28 • Number of events 8 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
3.8%
1/26 • Number of events 1 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
6.1%
2/33 • Number of events 5 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
10.0%
3/30 • Number of events 4 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
|
Investigations
Lymphocyte count decreased
|
3.6%
1/28 • Number of events 1 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
15.4%
4/26 • Number of events 5 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
6.1%
2/33 • Number of events 3 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
13.3%
4/30 • Number of events 6 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
|
Investigations
Platelet count decreased
|
14.3%
4/28 • Number of events 4 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
7.7%
2/26 • Number of events 3 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
18.2%
6/33 • Number of events 8 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
6.7%
2/30 • Number of events 2 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
|
Investigations
Weight loss
|
7.1%
2/28 • Number of events 3 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
11.5%
3/26 • Number of events 9 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
18.2%
6/33 • Number of events 9 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
16.7%
5/30 • Number of events 5 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
|
Investigations
White blood cell decreased
|
3.6%
1/28 • Number of events 2 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
3.8%
1/26 • Number of events 1 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
9.1%
3/33 • Number of events 3 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
3.3%
1/30 • Number of events 1 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
|
Metabolism and nutrition disorders
Anorexia
|
28.6%
8/28 • Number of events 11 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
23.1%
6/26 • Number of events 7 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
18.2%
6/33 • Number of events 10 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
43.3%
13/30 • Number of events 20 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/28 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
0.00%
0/26 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
6.1%
2/33 • Number of events 2 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
6.7%
2/30 • Number of events 2 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/28 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
3.8%
1/26 • Number of events 2 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
0.00%
0/33 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
3.3%
1/30 • Number of events 1 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
0.00%
0/28 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
3.8%
1/26 • Number of events 1 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
3.0%
1/33 • Number of events 1 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
3.3%
1/30 • Number of events 1 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
3.6%
1/28 • Number of events 1 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
0.00%
0/26 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
0.00%
0/33 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
0.00%
0/30 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
10.7%
3/28 • Number of events 6 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
7.7%
2/26 • Number of events 2 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
9.1%
3/33 • Number of events 5 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
13.3%
4/30 • Number of events 5 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
7.1%
2/28 • Number of events 3 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
7.7%
2/26 • Number of events 3 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
0.00%
0/33 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
13.3%
4/30 • Number of events 4 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
7.1%
2/28 • Number of events 5 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
0.00%
0/26 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
9.1%
3/33 • Number of events 4 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
10.0%
3/30 • Number of events 3 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
3.6%
1/28 • Number of events 1 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
0.00%
0/26 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
18.2%
6/33 • Number of events 8 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
16.7%
5/30 • Number of events 5 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
0.00%
0/28 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
3.8%
1/26 • Number of events 1 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
0.00%
0/33 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
0.00%
0/30 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders - Other, specify
|
3.6%
1/28 • Number of events 1 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
0.00%
0/26 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
0.00%
0/33 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
6.7%
2/30 • Number of events 2 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/28 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
0.00%
0/26 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
3.0%
1/33 • Number of events 2 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
0.00%
0/30 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/28 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
3.8%
1/26 • Number of events 1 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
9.1%
3/33 • Number of events 4 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
6.7%
2/30 • Number of events 2 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/28 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
3.8%
1/26 • Number of events 1 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
3.0%
1/33 • Number of events 1 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
0.00%
0/30 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
0.00%
0/28 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
0.00%
0/26 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
3.0%
1/33 • Number of events 2 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
0.00%
0/30 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
10.7%
3/28 • Number of events 4 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
7.7%
2/26 • Number of events 2 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
3.0%
1/33 • Number of events 2 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
3.3%
1/30 • Number of events 1 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, specify
|
3.6%
1/28 • Number of events 3 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
0.00%
0/26 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
0.00%
0/33 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
0.00%
0/30 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/28 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
3.8%
1/26 • Number of events 1 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
12.1%
4/33 • Number of events 5 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
10.0%
3/30 • Number of events 3 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
0.00%
0/28 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
0.00%
0/26 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
0.00%
0/33 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
3.3%
1/30 • Number of events 1 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
3.6%
1/28 • Number of events 1 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
11.5%
3/26 • Number of events 3 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
6.1%
2/33 • Number of events 4 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
3.3%
1/30 • Number of events 2 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
|
Nervous system disorders
Cognitive disturbance
|
0.00%
0/28 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
0.00%
0/26 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
3.0%
1/33 • Number of events 1 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
0.00%
0/30 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/28 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
0.00%
0/26 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
3.0%
1/33 • Number of events 1 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
3.3%
1/30 • Number of events 2 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
|
Nervous system disorders
Dysgeusia
|
3.6%
1/28 • Number of events 1 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
0.00%
0/26 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
3.0%
1/33 • Number of events 3 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
6.7%
2/30 • Number of events 2 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/28 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
0.00%
0/26 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
0.00%
0/33 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
3.3%
1/30 • Number of events 1 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
|
Nervous system disorders
Headache
|
10.7%
3/28 • Number of events 3 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
7.7%
2/26 • Number of events 6 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
9.1%
3/33 • Number of events 7 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
0.00%
0/30 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
|
Nervous system disorders
Paresthesia
|
0.00%
0/28 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
0.00%
0/26 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
3.0%
1/33 • Number of events 2 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
0.00%
0/30 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
|
Nervous system disorders
Peripheral motor neuropathy
|
0.00%
0/28 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
3.8%
1/26 • Number of events 1 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
0.00%
0/33 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
3.3%
1/30 • Number of events 1 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
17.9%
5/28 • Number of events 6 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
3.8%
1/26 • Number of events 1 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
12.1%
4/33 • Number of events 8 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
6.7%
2/30 • Number of events 4 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
|
Psychiatric disorders
Insomnia
|
7.1%
2/28 • Number of events 2 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
3.8%
1/26 • Number of events 1 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
0.00%
0/33 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
3.3%
1/30 • Number of events 1 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
|
Psychiatric disorders
Psychiatric disorders - Other, specify
|
0.00%
0/28 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
0.00%
0/26 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
0.00%
0/33 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
3.3%
1/30 • Number of events 1 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
|
Renal and urinary disorders
Hematuria
|
0.00%
0/28 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
0.00%
0/26 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
0.00%
0/33 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
3.3%
1/30 • Number of events 1 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
|
Renal and urinary disorders
Urinary frequency
|
0.00%
0/28 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
0.00%
0/26 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
3.0%
1/33 • Number of events 1 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
0.00%
0/30 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.00%
0/28 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
0.00%
0/26 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
3.0%
1/33 • Number of events 1 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
0.00%
0/30 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
3.6%
1/28 • Number of events 1 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
0.00%
0/26 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
6.1%
2/33 • Number of events 3 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
0.00%
0/30 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
10.7%
3/28 • Number of events 5 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
11.5%
3/26 • Number of events 7 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
15.2%
5/33 • Number of events 5 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
13.3%
4/30 • Number of events 4 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/28 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
0.00%
0/26 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
0.00%
0/33 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
3.3%
1/30 • Number of events 1 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/28 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
0.00%
0/26 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
0.00%
0/33 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
3.3%
1/30 • Number of events 1 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
14.3%
4/28 • Number of events 11 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
15.4%
4/26 • Number of events 8 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
15.2%
5/33 • Number of events 6 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
10.0%
3/30 • Number of events 3 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/28 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
0.00%
0/26 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
3.0%
1/33 • Number of events 1 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
0.00%
0/30 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.00%
0/28 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
0.00%
0/26 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
0.00%
0/33 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
3.3%
1/30 • Number of events 1 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
3.6%
1/28 • Number of events 2 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
0.00%
0/26 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
0.00%
0/33 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
0.00%
0/30 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus disorder
|
3.6%
1/28 • Number of events 1 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
0.00%
0/26 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
0.00%
0/33 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
0.00%
0/30 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
3.6%
1/28 • Number of events 1 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
0.00%
0/26 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
12.1%
4/33 • Number of events 9 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
6.7%
2/30 • Number of events 2 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
3.6%
1/28 • Number of events 3 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
3.8%
1/26 • Number of events 1 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
6.1%
2/33 • Number of events 7 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
3.3%
1/30 • Number of events 1 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
|
Skin and subcutaneous tissue disorders
Nail discoloration
|
0.00%
0/28 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
3.8%
1/26 • Number of events 1 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
0.00%
0/33 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
0.00%
0/30 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
0.00%
0/28 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
0.00%
0/26 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
3.0%
1/33 • Number of events 1 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
3.3%
1/30 • Number of events 1 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysesthesia syndrome
|
64.3%
18/28 • Number of events 37 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
65.4%
17/26 • Number of events 43 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
66.7%
22/33 • Number of events 61 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
73.3%
22/30 • Number of events 42 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/28 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
0.00%
0/26 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
3.0%
1/33 • Number of events 1 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
3.3%
1/30 • Number of events 1 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
28.6%
8/28 • Number of events 16 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
7.7%
2/26 • Number of events 3 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
24.2%
8/33 • Number of events 12 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
26.7%
8/30 • Number of events 11 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify
|
0.00%
0/28 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
0.00%
0/26 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
3.0%
1/33 • Number of events 1 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
3.3%
1/30 • Number of events 1 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
|
Vascular disorders
Hot flashes
|
0.00%
0/28 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
0.00%
0/26 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
0.00%
0/33 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
3.3%
1/30 • Number of events 1 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
|
Vascular disorders
Hypertension
|
75.0%
21/28 • Number of events 46 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
53.8%
14/26 • Number of events 36 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
51.5%
17/33 • Number of events 62 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
63.3%
19/30 • Number of events 44 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
|
Vascular disorders
Thromboembolic event
|
0.00%
0/28 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
3.8%
1/26 • Number of events 2 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
0.00%
0/33 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
0.00%
0/30 • Adverse events were assessed during the active monitoring phase (weekly during Cycles 1 and 2, then every 4 weeks until progression); up to 2 years. The total study duration (accrual and follow-up) is expected to be approximately 2 years.
Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for non-cancel patients. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place