Trial Outcomes & Findings for Durvalumab And Radiation Therapy Followed by Adjuvant Durvalumab in Patients With Urothelial Cancer (T2-4 N0-2 M0) of the Bladder (NCT NCT02891161)
NCT ID: NCT02891161
Last Updated: 2024-11-27
Results Overview
To assess the safety of combining durvalumab with RT in that DLT rate is lower than than 33% based on CTCAEv4.0
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
26 participants
Primary outcome timeframe
Begin W1 and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 2 years or until unacceptable toxicity.
Results posted on
2024-11-27
Participant Flow
Participant milestones
| Measure |
Arm Ib: Safety Run In Phase Ib
Subjects will receive durvalumab 1500mg Q4 weekly with RT to gross disease over 36 fractions. Durvalumab will start on Day 1. RT to start on Day 1 or 2. Subjects will receive adjuvant durvalumab monotherapy Q4 week, up to 12 months. Durvalumab monotherapy to start 4 weeks post completion of durvalumab and RT.
durvalumab: 1500 mg Q4 weekly
Radiation Therapy: 64.8 Gy, 36 daily fractions on weekdays over about 7 weeks
|
Arm II: Investigational Treatment Phase II
Subjects will receive durvalumab 1500mg Q4 weekly with RT to gross disease over 36 fractions. Durvalumab will start on Day 1. RT to start on Day 1 or 2. Subjects will receive adjuvant durvalumab monotherapy Q4 week, up to 12 months. Adjuvant durvalumab monotherapy to start 4 weeks post completion of durvalumab and RT.
durvalumab: 1500 mg Q4 weekly
|
|---|---|---|
|
Study Treatment
STARTED
|
6
|
20
|
|
Study Treatment
COMPLETED
|
2
|
7
|
|
Study Treatment
NOT COMPLETED
|
4
|
13
|
|
Follow up
STARTED
|
6
|
20
|
|
Follow up
COMPLETED
|
2
|
3
|
|
Follow up
NOT COMPLETED
|
4
|
17
|
Reasons for withdrawal
| Measure |
Arm Ib: Safety Run In Phase Ib
Subjects will receive durvalumab 1500mg Q4 weekly with RT to gross disease over 36 fractions. Durvalumab will start on Day 1. RT to start on Day 1 or 2. Subjects will receive adjuvant durvalumab monotherapy Q4 week, up to 12 months. Durvalumab monotherapy to start 4 weeks post completion of durvalumab and RT.
durvalumab: 1500 mg Q4 weekly
Radiation Therapy: 64.8 Gy, 36 daily fractions on weekdays over about 7 weeks
|
Arm II: Investigational Treatment Phase II
Subjects will receive durvalumab 1500mg Q4 weekly with RT to gross disease over 36 fractions. Durvalumab will start on Day 1. RT to start on Day 1 or 2. Subjects will receive adjuvant durvalumab monotherapy Q4 week, up to 12 months. Adjuvant durvalumab monotherapy to start 4 weeks post completion of durvalumab and RT.
durvalumab: 1500 mg Q4 weekly
|
|---|---|---|
|
Study Treatment
Disease Progression
|
2
|
4
|
|
Study Treatment
AE/Side Effects/Complications
|
1
|
5
|
|
Study Treatment
Patient withdrawal After Therapy Start
|
1
|
4
|
|
Follow up
Death
|
4
|
8
|
|
Follow up
Refused to Follow up
|
0
|
2
|
|
Follow up
Symptomatic deterioration
|
0
|
1
|
|
Follow up
Study terminated
|
0
|
6
|
Baseline Characteristics
Durvalumab And Radiation Therapy Followed by Adjuvant Durvalumab in Patients With Urothelial Cancer (T2-4 N0-2 M0) of the Bladder
Baseline characteristics by cohort
| Measure |
Arm Ib: Safety Run In Phase Ib
n=6 Participants
Subjects will receive durvalumab 1500mg Q4 weekly with RT to gross disease over 36 fractions. Durvalumab will start on Day 1. RT to start on Day 1 or 2. Subjects will receive adjuvant durvalumab monotherapy Q4 week, up to 12 months. Durvalumab monotherapy to start 4 weeks post completion of durvalumab and RT.
durvalumab: 1500 mg Q4 weekly
Radiation Therapy: 64.8 Gy, 36 daily fractions on weekdays over about 7 weeks
|
Arm II: Investigational Treatment Phase II
n=20 Participants
Subjects will receive durvalumab 1500mg Q4 weekly with RT to gross disease over 36 fractions. Durvalumab will start on Day 1. RT to start on Day 1 or 2. Subjects will receive adjuvant durvalumab monotherapy Q4 week, up to 12 months. Adjuvant durvalumab monotherapy to start 4 weeks post completion of durvalumab and RT.
durvalumab: 1500 mg Q4 weekly
|
Total
n=26 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
69.5 years
STANDARD_DEVIATION 14.05 • n=5 Participants
|
76.6 years
STANDARD_DEVIATION 7.44 • n=7 Participants
|
75 years
STANDARD_DEVIATION 9.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Non-Hispanic
|
5 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Unknown
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Tumor Node Metastasis (TNM) stage at screening
T2N0M0
|
0 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Tumor Node Metastasis (TNM) stage at screening
T2N1M0
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Tumor Node Metastasis (TNM) stage at screening
T2N2M0
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Tumor Node Metastasis (TNM) stage at screening
T3N0M0
|
1 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Tumor Node Metastasis (TNM) stage at screening
T3N2M0
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Tumor Node Metastasis (TNM) stage at screening
T4N0M0
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Tumor Node Metastasis (TNM) stage at screening
T4N1M0
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Tumor Node Metastasis (TNM) stage at screening
T4N2M0
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Tumor Node Metastasis (TNM) stage at screening
T4NXMX
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Unresectable
Subject's tumor is unresectable at screening.
|
3 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Unresectable
Subject's tumor is not unresectable at screening.
|
3 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Unfit for surgery
Subject is medically unfit for surgery at screening
|
2 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Unfit for surgery
Subject is not medically unfit for surgery at screening
|
4 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Cisplatin ineligible
Subject is cisplatin ineligible at screening
|
4 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Cisplatin ineligible
Subject is not cisplatin ineligible at screening
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
ECOG status
0-1
|
5 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
ECOG status
2
|
1 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Begin W1 and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 2 years or until unacceptable toxicity.To assess the safety of combining durvalumab with RT in that DLT rate is lower than than 33% based on CTCAEv4.0
Outcome measures
| Measure |
Arm Ib: Safety Run In Phase Ib
n=6 Participants
Subjects will receive durvalumab 1500mg Q4 weekly with RT to gross disease over 36 fractions. Durvalumab will start on Day 1. RT to start on Day 1 or 2. Subjects will receive adjuvant durvalumab monotherapy Q4 week, up to 12 months. Durvalumab monotherapy to start 4 weeks post completion of durvalumab and RT.
durvalumab: 1500 mg Q4 weekly
Radiation Therapy: 64.8 Gy, 36 daily fractions on weekdays over about 7 weeks
|
|---|---|
|
Phase Ib: Safety Assessment - Evaluation of DLT (Dose Limiting Toxicity) Rate
|
0 Participants
|
PRIMARY outcome
Timeframe: From C1D1 to Progression or until death for 1 yearPopulation: All Phase Ib and Phase II subjects were analyzed together.
Progression free survival rate at one year is defined as the probability that a patient remains free of progression of disease (SD+CR+PR) by modified RECIST 1.1 and cystoscopy at 1 year from the start of durvalumab treatment, D1 of durvaRT. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
Outcome measures
| Measure |
Arm Ib: Safety Run In Phase Ib
n=26 Participants
Subjects will receive durvalumab 1500mg Q4 weekly with RT to gross disease over 36 fractions. Durvalumab will start on Day 1. RT to start on Day 1 or 2. Subjects will receive adjuvant durvalumab monotherapy Q4 week, up to 12 months. Durvalumab monotherapy to start 4 weeks post completion of durvalumab and RT.
durvalumab: 1500 mg Q4 weekly
Radiation Therapy: 64.8 Gy, 36 daily fractions on weekdays over about 7 weeks
|
|---|---|
|
All Phases: Progression Free Survival Rate at 1 Year
|
71.5 percentage of participants
Interval 55.6 to 91.9
|
PRIMARY outcome
Timeframe: From C1D1 until death or up to a maximum of 39 months.The number of all subjects is reported with stable disease (SD) for 8 weeks, or partial response (PR), or complete response (CR) according to modified RECIST 1.1 and cystoscopy, from the start of treatment until disease progression/recurrence (taking as reference for progressive disease the smallest measurements recorded since the start of treatment). Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Stable Disease(SD), neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started;Disease Control Rate (DCR) = CR + PR+SD
Outcome measures
| Measure |
Arm Ib: Safety Run In Phase Ib
n=20 Participants
Subjects will receive durvalumab 1500mg Q4 weekly with RT to gross disease over 36 fractions. Durvalumab will start on Day 1. RT to start on Day 1 or 2. Subjects will receive adjuvant durvalumab monotherapy Q4 week, up to 12 months. Durvalumab monotherapy to start 4 weeks post completion of durvalumab and RT.
durvalumab: 1500 mg Q4 weekly
Radiation Therapy: 64.8 Gy, 36 daily fractions on weekdays over about 7 weeks
|
|---|---|
|
Phase II: Disease Control Rate to Concurrent durvaRT Followed by Durvalumab
|
13 Participants
|
SECONDARY outcome
Timeframe: From C1D1 until death or up to a maximum of 39 monthsPopulation: Phase Ib and Phase II subjects were analyzed together.
We will be determining the disease control rate, defined as percentage of patients achieving CR, PR, SD post completion of concurrent durvaRT. This will give us some preliminary evidence for efficacy of durvaRT combination. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Stable Disease(SD), neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started;Disease Control Rate (DCR) = CR + PR+SD
Outcome measures
| Measure |
Arm Ib: Safety Run In Phase Ib
n=26 Participants
Subjects will receive durvalumab 1500mg Q4 weekly with RT to gross disease over 36 fractions. Durvalumab will start on Day 1. RT to start on Day 1 or 2. Subjects will receive adjuvant durvalumab monotherapy Q4 week, up to 12 months. Durvalumab monotherapy to start 4 weeks post completion of durvalumab and RT.
durvalumab: 1500 mg Q4 weekly
Radiation Therapy: 64.8 Gy, 36 daily fractions on weekdays over about 7 weeks
|
|---|---|
|
All Phases: DCR Post Completion of Concurrent durvaRT
|
72.7 percentage of participants
Interval 51.8 to 86.8
|
SECONDARY outcome
Timeframe: From C1D1 to PD or until death or up to a maximum of 37 months.Population: Phase Ib and Phase II subjects were analyzed together
Median progression free survival will be determined for all subjects.
Outcome measures
| Measure |
Arm Ib: Safety Run In Phase Ib
n=26 Participants
Subjects will receive durvalumab 1500mg Q4 weekly with RT to gross disease over 36 fractions. Durvalumab will start on Day 1. RT to start on Day 1 or 2. Subjects will receive adjuvant durvalumab monotherapy Q4 week, up to 12 months. Durvalumab monotherapy to start 4 weeks post completion of durvalumab and RT.
durvalumab: 1500 mg Q4 weekly
Radiation Therapy: 64.8 Gy, 36 daily fractions on weekdays over about 7 weeks
|
|---|---|
|
All Phases : Median Progression Free Survival (PFS) Time
|
21.8 months
Interval 14.8 to
upper limit was not reached due to insufficient number of participants with events.
|
SECONDARY outcome
Timeframe: From C1D1 until CR or death or up to a maximum of 39 months.Estimate the rate of CR is one of the secondary objectives for phase II part of this study. This will help us determine the actual effectiveness of durvaRT approach. CR will be determined with the help of imaging and cystoscopy post completion of durvaRT per modified RECIST 1.1. Number of subjects reporting CR will be reported here. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions.
Outcome measures
| Measure |
Arm Ib: Safety Run In Phase Ib
n=20 Participants
Subjects will receive durvalumab 1500mg Q4 weekly with RT to gross disease over 36 fractions. Durvalumab will start on Day 1. RT to start on Day 1 or 2. Subjects will receive adjuvant durvalumab monotherapy Q4 week, up to 12 months. Durvalumab monotherapy to start 4 weeks post completion of durvalumab and RT.
durvalumab: 1500 mg Q4 weekly
Radiation Therapy: 64.8 Gy, 36 daily fractions on weekdays over about 7 weeks
|
|---|---|
|
Phase II: Complete Remission
|
17 Participants
|
SECONDARY outcome
Timeframe: From C1D1 until death or 39 months.Population: Phase Ib and Phase II subjects were analyzed together.
Estimate the overall survival (OS), defined as time from start of treatment, D1, to the date of death due to any cause. OS is defined, as time from start of treatment to the date of death due to any cause, or to the date of censoring at the last time the subject was known to be alive in intention-to-treat population. OS is one of the secondary objectives of this study. This is an immunotherapy based clinical trial and it is prudent to determine the OS to reflect the long-term benefit from this therapeutic approach.
Outcome measures
| Measure |
Arm Ib: Safety Run In Phase Ib
n=26 Participants
Subjects will receive durvalumab 1500mg Q4 weekly with RT to gross disease over 36 fractions. Durvalumab will start on Day 1. RT to start on Day 1 or 2. Subjects will receive adjuvant durvalumab monotherapy Q4 week, up to 12 months. Durvalumab monotherapy to start 4 weeks post completion of durvalumab and RT.
durvalumab: 1500 mg Q4 weekly
Radiation Therapy: 64.8 Gy, 36 daily fractions on weekdays over about 7 weeks
|
|---|---|
|
All Phases: Overall Survival
|
30.8 months
Interval 21.8 to
upper limit was not reached due to insufficient number of participants with events.
|
Adverse Events
Arm Ib: Safety Run In Phase Ib
Serious events: 4 serious events
Other events: 6 other events
Deaths: 4 deaths
Arm II: Investigational Treatment Phase II
Serious events: 8 serious events
Other events: 20 other events
Deaths: 8 deaths
Serious adverse events
| Measure |
Arm Ib: Safety Run In Phase Ib
n=6 participants at risk
Subjects will receive durvalumab 1500mg Q4 weekly with RT to gross disease over 36 fractions. Durvalumab will start on Day 1. RT to start on Day 1 or 2. Subjects will receive adjuvant durvalumab monotherapy Q4 week, up to 12 months. Durvalumab monotherapy to start 4 weeks post completion of durvalumab and RT.
durvalumab: 1500 mg Q4 weekly
Radiation Therapy: 64.8 Gy, 36 daily fractions on weekdays over about 7 weeks
|
Arm II: Investigational Treatment Phase II
n=20 participants at risk
Subjects will receive durvalumab 1500mg Q4 weekly with RT to gross disease over 36 fractions. Durvalumab will start on Day 1. RT to start on Day 1 or 2. Subjects will receive adjuvant durvalumab monotherapy Q4 week, up to 12 months. Adjuvant durvalumab monotherapy to start 4 weeks post completion of durvalumab and RT.
durvalumab: 1500 mg Q4 weekly
|
|---|---|---|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
16.7%
1/6 • Number of events 1 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
0.00%
0/20 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Metabolism and nutrition disorders
DEHYDRATION
|
16.7%
1/6 • Number of events 1 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
0.00%
0/20 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Gastrointestinal disorders
ESOPHAGITIS
|
16.7%
1/6 • Number of events 1 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
0.00%
0/20 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Gastrointestinal disorders
GASTRITIS
|
16.7%
1/6 • Number of events 1 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
0.00%
0/20 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Injury, poisoning and procedural complications
HIP FRACTURE
|
16.7%
1/6 • Number of events 1 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
0.00%
0/20 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Cardiac disorders
MYOCARDIAL INFARCTION
|
16.7%
1/6 • Number of events 1 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
0.00%
0/20 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Gastrointestinal disorders
OBSTRUCTION GASTRIC
|
16.7%
1/6 • Number of events 1 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
0.00%
0/20 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Renal and urinary disorders
RENAL AND URINARY DISORDERS
|
16.7%
1/6 • Number of events 1 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
0.00%
0/20 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY FAILURE
|
16.7%
1/6 • Number of events 1 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
0.00%
0/20 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Infections and infestations
SEPSIS
|
16.7%
1/6 • Number of events 2 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
0.00%
0/20 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Skin and subcutaneous tissue disorders
SKIN AND SUBCUTANEOUS TISSUE DISORDERS
|
16.7%
1/6 • Number of events 1 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
0.00%
0/20 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Nervous system disorders
STROKE
|
16.7%
1/6 • Number of events 1 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
0.00%
0/20 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Vascular disorders
THROMBOEMBOLIC EVENT
|
16.7%
1/6 • Number of events 1 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
0.00%
0/20 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Infections and infestations
URINARY TRACT INFECTION
|
33.3%
2/6 • Number of events 2 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
5.0%
1/20 • Number of events 2 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Renal and urinary disorders
ACUTE KIDNEY INJURY
|
0.00%
0/6 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
10.0%
2/20 • Number of events 2 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Blood and lymphatic system disorders
ANEMIA
|
0.00%
0/6 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
5.0%
1/20 • Number of events 1 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Cardiac disorders
ATRIOVENTRICULAR BLOCK COMPLETE
|
0.00%
0/6 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
5.0%
1/20 • Number of events 1 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Cardiac disorders
CARDIAC DISORDERS
|
0.00%
0/6 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
5.0%
1/20 • Number of events 2 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Psychiatric disorders
DELIRIUM
|
0.00%
0/6 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
5.0%
1/20 • Number of events 1 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Gastrointestinal disorders
DIARRHEA
|
0.00%
0/6 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
5.0%
1/20 • Number of events 1 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNEA
|
0.00%
0/6 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
5.0%
1/20 • Number of events 1 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Infections and infestations
INFECTIONS AND INFESTATIONS
|
0.00%
0/6 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
5.0%
1/20 • Number of events 4 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Infections and infestations
LUNG INFECTION
|
0.00%
0/6 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
10.0%
2/20 • Number of events 3 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Cardiac disorders
SINUS BRADYCARDIA
|
0.00%
0/6 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
5.0%
1/20 • Number of events 1 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Nervous system disorders
SYNCOPE
|
0.00%
0/6 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
5.0%
1/20 • Number of events 1 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
Other adverse events
| Measure |
Arm Ib: Safety Run In Phase Ib
n=6 participants at risk
Subjects will receive durvalumab 1500mg Q4 weekly with RT to gross disease over 36 fractions. Durvalumab will start on Day 1. RT to start on Day 1 or 2. Subjects will receive adjuvant durvalumab monotherapy Q4 week, up to 12 months. Durvalumab monotherapy to start 4 weeks post completion of durvalumab and RT.
durvalumab: 1500 mg Q4 weekly
Radiation Therapy: 64.8 Gy, 36 daily fractions on weekdays over about 7 weeks
|
Arm II: Investigational Treatment Phase II
n=20 participants at risk
Subjects will receive durvalumab 1500mg Q4 weekly with RT to gross disease over 36 fractions. Durvalumab will start on Day 1. RT to start on Day 1 or 2. Subjects will receive adjuvant durvalumab monotherapy Q4 week, up to 12 months. Adjuvant durvalumab monotherapy to start 4 weeks post completion of durvalumab and RT.
durvalumab: 1500 mg Q4 weekly
|
|---|---|---|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
50.0%
3/6 • Number of events 5 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
20.0%
4/20 • Number of events 4 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Investigations
ALANINE AMINOTRANSFERASE INCREASED
|
33.3%
2/6 • Number of events 2 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
10.0%
2/20 • Number of events 4 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Investigations
ALKALINE PHOSPHATASE INCREASED
|
16.7%
1/6 • Number of events 1 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
0.00%
0/20 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Immune system disorders
ALLERGIC REACTION
|
16.7%
1/6 • Number of events 1 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
0.00%
0/20 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Respiratory, thoracic and mediastinal disorders
ALLERGIC RHINITIS
|
16.7%
1/6 • Number of events 1 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
25.0%
5/20 • Number of events 5 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Blood and lymphatic system disorders
ANEMIA
|
100.0%
6/6 • Number of events 10 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
50.0%
10/20 • Number of events 12 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Metabolism and nutrition disorders
ANOREXIA
|
16.7%
1/6 • Number of events 1 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
25.0%
5/20 • Number of events 6 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Psychiatric disorders
ANXIETY
|
33.3%
2/6 • Number of events 2 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
15.0%
3/20 • Number of events 3 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Musculoskeletal and connective tissue disorders
ARTHRITIS
|
33.3%
2/6 • Number of events 2 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
35.0%
7/20 • Number of events 7 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Investigations
ASPARTATE AMINOTRANSFERASE INCREASED
|
50.0%
3/6 • Number of events 3 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
15.0%
3/20 • Number of events 4 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Cardiac disorders
ATRIAL FIBRILLATION
|
16.7%
1/6 • Number of events 1 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
25.0%
5/20 • Number of events 6 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
33.3%
2/6 • Number of events 2 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
25.0%
5/20 • Number of events 5 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Injury, poisoning and procedural complications
BRUISING
|
16.7%
1/6 • Number of events 2 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
0.00%
0/20 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Cardiac disorders
CARDIAC DISORDERS
|
33.3%
2/6 • Number of events 4 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
30.0%
6/20 • Number of events 10 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Investigations
CHOLESTEROL HIGH
|
16.7%
1/6 • Number of events 1 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
35.0%
7/20 • Number of events 7 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Gastrointestinal disorders
CONSTIPATION
|
83.3%
5/6 • Number of events 5 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
60.0%
12/20 • Number of events 14 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Investigations
CREATININE INCREASED
|
50.0%
3/6 • Number of events 8 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
65.0%
13/20 • Number of events 17 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Renal and urinary disorders
CYSTITIS NONINFECTIVE
|
50.0%
3/6 • Number of events 5 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
30.0%
6/20 • Number of events 8 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Metabolism and nutrition disorders
DEHYDRATION
|
16.7%
1/6 • Number of events 2 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
20.0%
4/20 • Number of events 7 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Psychiatric disorders
DEPRESSION
|
33.3%
2/6 • Number of events 2 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
20.0%
4/20 • Number of events 4 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Injury, poisoning and procedural complications
DERMATITIS RADIATION
|
16.7%
1/6 • Number of events 1 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
5.0%
1/20 • Number of events 1 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Gastrointestinal disorders
DIARRHEA
|
16.7%
1/6 • Number of events 2 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
60.0%
12/20 • Number of events 23 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Nervous system disorders
DIZZINESS
|
16.7%
1/6 • Number of events 1 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
30.0%
6/20 • Number of events 7 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Eye disorders
DRY EYE
|
16.7%
1/6 • Number of events 1 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
0.00%
0/20 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Skin and subcutaneous tissue disorders
DRY SKIN
|
16.7%
1/6 • Number of events 1 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
10.0%
2/20 • Number of events 2 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Gastrointestinal disorders
DUODENAL ULCER
|
16.7%
1/6 • Number of events 1 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
5.0%
1/20 • Number of events 1 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Gastrointestinal disorders
DYSPHAGIA
|
16.7%
1/6 • Number of events 1 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
5.0%
1/20 • Number of events 1 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNEA
|
33.3%
2/6 • Number of events 2 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
25.0%
5/20 • Number of events 6 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
General disorders
EDEMA LIMBS
|
50.0%
3/6 • Number of events 6 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
55.0%
11/20 • Number of events 16 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Endocrine disorders
ENDOCRINE DISORDERS
|
33.3%
2/6 • Number of events 2 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
20.0%
4/20 • Number of events 4 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Reproductive system and breast disorders
ERECTILE DYSFUNCTION
|
16.7%
1/6 • Number of events 1 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
0.00%
0/20 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Gastrointestinal disorders
ESOPHAGITIS
|
16.7%
1/6 • Number of events 2 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
0.00%
0/20 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
General disorders
FATIGUE
|
83.3%
5/6 • Number of events 9 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
75.0%
15/20 • Number of events 21 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Gastrointestinal disorders
FECAL INCONTINENCE
|
16.7%
1/6 • Number of events 1 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
5.0%
1/20 • Number of events 1 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Musculoskeletal and connective tissue disorders
FLANK PAIN
|
16.7%
1/6 • Number of events 1 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
15.0%
3/20 • Number of events 3 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Gastrointestinal disorders
GASTRITIS
|
16.7%
1/6 • Number of events 2 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
0.00%
0/20 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Gastrointestinal disorders
GASTROESOPHAGEAL REFLUX DISEASE
|
33.3%
2/6 • Number of events 2 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
55.0%
11/20 • Number of events 13 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Gastrointestinal disorders
GASTROINTESTINAL DISORDERS
|
66.7%
4/6 • Number of events 4 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
30.0%
6/20 • Number of events 8 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Musculoskeletal and connective tissue disorders
GENERALIZED MUSCLE WEAKNESS
|
16.7%
1/6 • Number of events 1 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
10.0%
2/20 • Number of events 3 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Investigations
GGT INCREASED
|
33.3%
2/6 • Number of events 3 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
0.00%
0/20 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Nervous system disorders
HEADACHE
|
16.7%
1/6 • Number of events 1 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
20.0%
4/20 • Number of events 4 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Ear and labyrinth disorders
HEARING IMPAIRED
|
33.3%
2/6 • Number of events 2 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
15.0%
3/20 • Number of events 3 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Cardiac disorders
HEART FAILURE
|
16.7%
1/6 • Number of events 1 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
0.00%
0/20 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Renal and urinary disorders
HEMATURIA
|
50.0%
3/6 • Number of events 6 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
50.0%
10/20 • Number of events 16 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Hepatobiliary disorders
HEPATOBILIARY DISORDERS
|
16.7%
1/6 • Number of events 1 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
5.0%
1/20 • Number of events 1 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Metabolism and nutrition disorders
HYPERCALCEMIA
|
33.3%
2/6 • Number of events 3 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
20.0%
4/20 • Number of events 5 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Metabolism and nutrition disorders
HYPERGLYCEMIA
|
50.0%
3/6 • Number of events 5 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
15.0%
3/20 • Number of events 4 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Metabolism and nutrition disorders
HYPERKALEMIA
|
50.0%
3/6 • Number of events 3 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
35.0%
7/20 • Number of events 22 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Vascular disorders
HYPERTENSION
|
50.0%
3/6 • Number of events 3 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
85.0%
17/20 • Number of events 45 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Metabolism and nutrition disorders
HYPERTRIGLYCERIDEMIA
|
16.7%
1/6 • Number of events 1 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
0.00%
0/20 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Metabolism and nutrition disorders
HYPERURICEMIA
|
33.3%
2/6 • Number of events 3 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
40.0%
8/20 • Number of events 15 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Metabolism and nutrition disorders
HYPOKALEMIA
|
33.3%
2/6 • Number of events 3 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
10.0%
2/20 • Number of events 2 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Metabolism and nutrition disorders
HYPOMAGNESEMIA
|
33.3%
2/6 • Number of events 2 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
5.0%
1/20 • Number of events 1 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Metabolism and nutrition disorders
HYPONATREMIA
|
66.7%
4/6 • Number of events 4 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
20.0%
4/20 • Number of events 8 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Metabolism and nutrition disorders
HYPOPHOSPHATEMIA
|
16.7%
1/6 • Number of events 3 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
10.0%
2/20 • Number of events 2 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Endocrine disorders
HYPOTHYROIDISM
|
16.7%
1/6 • Number of events 1 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
15.0%
3/20 • Number of events 3 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Respiratory, thoracic and mediastinal disorders
HYPOXIA
|
16.7%
1/6 • Number of events 2 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
5.0%
1/20 • Number of events 1 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Infections and infestations
INFECTIONS AND INFESTATIONS
|
33.3%
2/6 • Number of events 2 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
20.0%
4/20 • Number of events 5 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
General disorders
INFUSION RELATED REACTION
|
16.7%
1/6 • Number of events 1 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
0.00%
0/20 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Injury, poisoning and procedural complications
INJURY, POISONING AND PROCEDURAL COMPLICATIONS
|
16.7%
1/6 • Number of events 1 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
20.0%
4/20 • Number of events 4 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Psychiatric disorders
INSOMNIA
|
16.7%
1/6 • Number of events 1 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
25.0%
5/20 • Number of events 6 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Investigations
INVESTIGATIONS
|
16.7%
1/6 • Number of events 1 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
25.0%
5/20 • Number of events 6 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Respiratory, thoracic and mediastinal disorders
LARYNGEAL EDEMA
|
16.7%
1/6 • Number of events 1 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
0.00%
0/20 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Investigations
LYMPHOCYTE COUNT DECREASED
|
83.3%
5/6 • Number of events 22 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
40.0%
8/20 • Number of events 19 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Metabolism and nutrition disorders
METABOLISM AND NUTRITION DISORDERS
|
33.3%
2/6 • Number of events 4 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
20.0%
4/20 • Number of events 6 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDER
|
66.7%
4/6 • Number of events 8 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
20.0%
4/20 • Number of events 6 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Infections and infestations
NAIL INFECTION
|
16.7%
1/6 • Number of events 1 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
0.00%
0/20 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Gastrointestinal disorders
NAUSEA
|
50.0%
3/6 • Number of events 5 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
25.0%
5/20 • Number of events 10 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Musculoskeletal and connective tissue disorders
NECK PAIN
|
16.7%
1/6 • Number of events 1 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
5.0%
1/20 • Number of events 1 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Nervous system disorders
NERVOUS SYSTEM DISORDERS
|
16.7%
1/6 • Number of events 3 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
15.0%
3/20 • Number of events 4 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Investigations
NEUTROPHIL COUNT DECREASED
|
16.7%
1/6 • Number of events 1 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
0.00%
0/20 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Metabolism and nutrition disorders
OBESITY
|
33.3%
2/6 • Number of events 2 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
20.0%
4/20 • Number of events 4 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
33.3%
2/6 • Number of events 3 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
40.0%
8/20 • Number of events 9 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Nervous system disorders
PERIPHERAL SENSORY NEUROPATHY
|
16.7%
1/6 • Number of events 1 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
15.0%
3/20 • Number of events 3 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Investigations
PLATELET COUNT DECREASED
|
50.0%
3/6 • Number of events 5 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
10.0%
2/20 • Number of events 2 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Respiratory, thoracic and mediastinal disorders
PLEURAL EFFUSION
|
16.7%
1/6 • Number of events 1 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
0.00%
0/20 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Respiratory, thoracic and mediastinal disorders
PRODUCTIVE COUGH
|
16.7%
1/6 • Number of events 1 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
20.0%
4/20 • Number of events 4 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Renal and urinary disorders
PROTEINURIA
|
16.7%
1/6 • Number of events 2 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
10.0%
2/20 • Number of events 6 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Skin and subcutaneous tissue disorders
PRURITUS
|
16.7%
1/6 • Number of events 1 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
10.0%
2/20 • Number of events 2 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Skin and subcutaneous tissue disorders
RASH ACNEIFORM
|
16.7%
1/6 • Number of events 1 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
10.0%
2/20 • Number of events 4 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Skin and subcutaneous tissue disorders
RASH MACULO-PAPULAR
|
33.3%
2/6 • Number of events 2 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
20.0%
4/20 • Number of events 6 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Gastrointestinal disorders
RECTAL ULCER
|
16.7%
1/6 • Number of events 1 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
0.00%
0/20 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Renal and urinary disorders
RENAL AND URINARY DISORDERS
|
66.7%
4/6 • Number of events 6 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
55.0%
11/20 • Number of events 18 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Reproductive system and breast disorders
REPRODUCTIVE SYSTEM AND BREAST DISORDERS
|
16.7%
1/6 • Number of events 1 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
20.0%
4/20 • Number of events 4 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS
|
33.3%
2/6 • Number of events 2 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
35.0%
7/20 • Number of events 8 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Nervous system disorders
SEIZURE
|
16.7%
1/6 • Number of events 1 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
0.00%
0/20 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Investigations
SERUM AMYLASE INCREASED
|
16.7%
1/6 • Number of events 1 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
25.0%
5/20 • Number of events 7 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Skin and subcutaneous tissue disorders
SKIN AND SUBCUTANEOUS TISSUE DISORDERS
|
50.0%
3/6 • Number of events 7 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
30.0%
6/20 • Number of events 9 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Skin and subcutaneous tissue disorders
SKIN ULCERATION
|
16.7%
1/6 • Number of events 2 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
0.00%
0/20 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Respiratory, thoracic and mediastinal disorders
SLEEP APNEA
|
16.7%
1/6 • Number of events 1 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
25.0%
5/20 • Number of events 5 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Ear and labyrinth disorders
TINNITUS
|
16.7%
1/6 • Number of events 1 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
10.0%
2/20 • Number of events 2 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Gastrointestinal disorders
TOOTHACHE
|
16.7%
1/6 • Number of events 1 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
0.00%
0/20 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Nervous system disorders
TRIGEMINAL NERVE DISORDER
|
16.7%
1/6 • Number of events 1 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
0.00%
0/20 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Renal and urinary disorders
URINARY FREQUENCY
|
66.7%
4/6 • Number of events 5 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
25.0%
5/20 • Number of events 5 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Renal and urinary disorders
URINARY INCONTINENCE
|
16.7%
1/6 • Number of events 1 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
30.0%
6/20 • Number of events 6 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Infections and infestations
URINARY TRACT INFECTION
|
66.7%
4/6 • Number of events 9 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
55.0%
11/20 • Number of events 29 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Renal and urinary disorders
URINARY TRACT OBSTRUCTION
|
16.7%
1/6 • Number of events 1 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
15.0%
3/20 • Number of events 3 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Renal and urinary disorders
URINARY TRACT PAIN
|
33.3%
2/6 • Number of events 2 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
35.0%
7/20 • Number of events 8 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Renal and urinary disorders
URINARY URGENCY
|
50.0%
3/6 • Number of events 3 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
10.0%
2/20 • Number of events 2 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Skin and subcutaneous tissue disorders
URTICARIA
|
16.7%
1/6 • Number of events 1 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
0.00%
0/20 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Vascular disorders
VASCULAR DISORDERS
|
16.7%
1/6 • Number of events 1 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
15.0%
3/20 • Number of events 4 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Gastrointestinal disorders
VOMITING
|
33.3%
2/6 • Number of events 3 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
20.0%
4/20 • Number of events 8 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Investigations
WEIGHT LOSS
|
33.3%
2/6 • Number of events 2 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
15.0%
3/20 • Number of events 7 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Investigations
WHITE BLOOD CELL DECREASED
|
16.7%
1/6 • Number of events 13 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
15.0%
3/20 • Number of events 3 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Investigations
ACTIVATED PARTIAL THROMBOPLASTIN TIME PROLONGED
|
0.00%
0/6 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
5.0%
1/20 • Number of events 1 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Renal and urinary disorders
ACUTE KIDNEY INJURY
|
0.00%
0/6 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
20.0%
4/20 • Number of events 7 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
0.00%
0/6 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
15.0%
3/20 • Number of events 3 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Cardiac disorders
ATRIOVENTRICULAR BLOCK FIRST DEGREE
|
0.00%
0/6 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
5.0%
1/20 • Number of events 2 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Renal and urinary disorders
BLADDER SPASM
|
0.00%
0/6 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
20.0%
4/20 • Number of events 4 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Eye disorders
BLURRED VISION
|
0.00%
0/6 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
5.0%
1/20 • Number of events 1 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Infections and infestations
BRONCHIAL INFECTION
|
0.00%
0/6 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
5.0%
1/20 • Number of events 1 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Injury, poisoning and procedural complications
BURN
|
0.00%
0/6 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
5.0%
1/20 • Number of events 1 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Investigations
CARDIAC TROPONIN T INCREASED
|
0.00%
0/6 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
5.0%
1/20 • Number of events 1 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Eye disorders
CATARACT
|
0.00%
0/6 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
5.0%
1/20 • Number of events 1 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
General disorders
CHILLS
|
0.00%
0/6 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
20.0%
4/20 • Number of events 5 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Renal and urinary disorders
CHRONIC KIDNEY DISEASE
|
0.00%
0/6 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
40.0%
8/20 • Number of events 8 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Eye disorders
CONJUNCTIVITIS
|
0.00%
0/6 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
5.0%
1/20 • Number of events 1 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
0.00%
0/6 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
15.0%
3/20 • Number of events 4 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Psychiatric disorders
DELIRIUM
|
0.00%
0/6 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
5.0%
1/20 • Number of events 3 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Gastrointestinal disorders
DRY MOUTH
|
0.00%
0/6 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
5.0%
1/20 • Number of events 1 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Nervous system disorders
DYSGEUSIA
|
0.00%
0/6 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
5.0%
1/20 • Number of events 1 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Nervous system disorders
ENCEPHALOPATHY
|
0.00%
0/6 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
5.0%
1/20 • Number of events 1 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Gastrointestinal disorders
ENTEROCOLITIS
|
0.00%
0/6 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
5.0%
1/20 • Number of events 1 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Skin and subcutaneous tissue disorders
ERYTHEMA MULTIFORME
|
0.00%
0/6 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
10.0%
2/20 • Number of events 2 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Eye disorders
EYE DISORDERS
|
0.00%
0/6 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
30.0%
6/20 • Number of events 10 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Injury, poisoning and procedural complications
FALL
|
0.00%
0/6 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
25.0%
5/20 • Number of events 7 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
General disorders
FEVER
|
0.00%
0/6 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
20.0%
4/20 • Number of events 7 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Gastrointestinal disorders
FLATULENCE
|
0.00%
0/6 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
5.0%
1/20 • Number of events 2 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Eye disorders
FLOATERS
|
0.00%
0/6 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
5.0%
1/20 • Number of events 1 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
General disorders
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
|
0.00%
0/6 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
5.0%
1/20 • Number of events 1 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Reproductive system and breast disorders
GENITAL EDEMA
|
0.00%
0/6 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
5.0%
1/20 • Number of events 1 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Eye disorders
GLAUCOMA
|
0.00%
0/6 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
10.0%
2/20 • Number of events 2 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Gastrointestinal disorders
HEMORRHOIDS
|
0.00%
0/6 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
5.0%
1/20 • Number of events 1 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Respiratory, thoracic and mediastinal disorders
HOARSENESS
|
0.00%
0/6 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
5.0%
1/20 • Number of events 1 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Metabolism and nutrition disorders
HYPERNATREMIA
|
0.00%
0/6 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
5.0%
1/20 • Number of events 1 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Endocrine disorders
HYPERTHYROIDISM
|
0.00%
0/6 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
10.0%
2/20 • Number of events 2 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Metabolism and nutrition disorders
HYPOALBUMINEMIA
|
0.00%
0/6 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
10.0%
2/20 • Number of events 2 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Metabolism and nutrition disorders
HYPOCALCEMIA
|
0.00%
0/6 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
5.0%
1/20 • Number of events 1 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Metabolism and nutrition disorders
HYPOGLYCEMIA
|
0.00%
0/6 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
5.0%
1/20 • Number of events 1 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Vascular disorders
HYPOTENSION
|
0.00%
0/6 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
25.0%
5/20 • Number of events 6 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Investigations
INR INCREASED
|
0.00%
0/6 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
5.0%
1/20 • Number of events 1 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Musculoskeletal and connective tissue disorders
JOINT RANGE OF MOTION DECREASED
|
0.00%
0/6 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
5.0%
1/20 • Number of events 1 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Infections and infestations
KIDNEY INFECTION
|
0.00%
0/6 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
5.0%
1/20 • Number of events 1 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Investigations
LIPASE INCREASED
|
0.00%
0/6 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
20.0%
4/20 • Number of events 16 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Infections and infestations
LUNG INFECTION
|
0.00%
0/6 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
5.0%
1/20 • Number of events 2 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Nervous system disorders
MEMORY IMPAIRMENT
|
0.00%
0/6 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
5.0%
1/20 • Number of events 1 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Cardiac disorders
MOBITZ (TYPE) II ATRIOVENTRICULAR BLOCK
|
0.00%
0/6 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
5.0%
1/20 • Number of events 1 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Cardiac disorders
MYOCARDIAL INFARCTION
|
0.00%
0/6 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
5.0%
1/20 • Number of events 1 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
NEOPLASMS BENIGN, MALIGNANT AND UNSPECIFIED (INCL CYSTS AND POLYPS)
|
0.00%
0/6 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
15.0%
3/20 • Number of events 3 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Nervous system disorders
NEURALGIA
|
0.00%
0/6 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
5.0%
1/20 • Number of events 1 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Musculoskeletal and connective tissue disorders
OSTEOPOROSIS
|
0.00%
0/6 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
5.0%
1/20 • Number of events 1 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
General disorders
PAIN
|
0.00%
0/6 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
20.0%
4/20 • Number of events 4 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Skin and subcutaneous tissue disorders
PAIN OF SKIN
|
0.00%
0/6 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
5.0%
1/20 • Number of events 1 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Cardiac disorders
PALPITATIONS
|
0.00%
0/6 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
5.0%
1/20 • Number of events 1 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Reproductive system and breast disorders
PELVIC PAIN
|
0.00%
0/6 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
10.0%
2/20 • Number of events 2 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Nervous system disorders
PERIPHERAL MOTOR NEUROPATHY
|
0.00%
0/6 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
5.0%
1/20 • Number of events 1 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Infections and infestations
PHARYNGITIS
|
0.00%
0/6 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
5.0%
1/20 • Number of events 1 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Gastrointestinal disorders
PROCTITIS
|
0.00%
0/6 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
5.0%
1/20 • Number of events 1 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY EDEMA
|
0.00%
0/6 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
5.0%
1/20 • Number of events 1 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Eye disorders
RETINOPATHY
|
0.00%
0/6 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
5.0%
1/20 • Number of events 1 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Eye disorders
SCLERAL DISORDER
|
0.00%
0/6 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
5.0%
1/20 • Number of events 2 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Cardiac disorders
SINUS BRADYCARDIA
|
0.00%
0/6 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
15.0%
3/20 • Number of events 5 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Cardiac disorders
SINUS TACHYCARDIA
|
0.00%
0/6 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
5.0%
1/20 • Number of events 1 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Infections and infestations
SINUSITIS
|
0.00%
0/6 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
5.0%
1/20 • Number of events 1 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Infections and infestations
SKIN INFECTION
|
0.00%
0/6 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
5.0%
1/20 • Number of events 1 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Respiratory, thoracic and mediastinal disorders
SORE THROAT
|
0.00%
0/6 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
5.0%
1/20 • Number of events 1 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Injury, poisoning and procedural complications
STOMAL ULCER
|
0.00%
0/6 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
5.0%
1/20 • Number of events 1 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Cardiac disorders
SUPRAVENTRICULAR TACHYCARDIA
|
0.00%
0/6 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
5.0%
1/20 • Number of events 1 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Nervous system disorders
SYNCOPE
|
0.00%
0/6 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
10.0%
2/20 • Number of events 3 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Vascular disorders
THROMBOEMBOLIC EVENT
|
0.00%
0/6 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
15.0%
3/20 • Number of events 3 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Nervous system disorders
TRANSIENT ISCHEMIC ATTACKS
|
0.00%
0/6 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
5.0%
1/20 • Number of events 1 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Nervous system disorders
TREMOR
|
0.00%
0/6 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
5.0%
1/20 • Number of events 1 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Infections and infestations
UPPER RESPIRATORY INFECTION
|
0.00%
0/6 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
20.0%
4/20 • Number of events 4 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Renal and urinary disorders
URINARY RETENTION
|
0.00%
0/6 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
15.0%
3/20 • Number of events 3 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Renal and urinary disorders
URINE DISCOLORATION
|
0.00%
0/6 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
5.0%
1/20 • Number of events 2 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Infections and infestations
VAGINAL INFECTION
|
0.00%
0/6 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
5.0%
1/20 • Number of events 1 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Eye disorders
VITREOUS HEMORRHAGE
|
0.00%
0/6 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
5.0%
1/20 • Number of events 1 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Investigations
WEIGHT GAIN
|
0.00%
0/6 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
15.0%
3/20 • Number of events 4 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
|
Respiratory, thoracic and mediastinal disorders
WHEEZING
|
0.00%
0/6 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
5.0%
1/20 • Number of events 1 • Adverse events were assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity. All-Cause Mortality was assessed from week 1 of treatment and every 2 chemotherapy cycles (2 weeks) thereafter, for up to 39 months or until unacceptable toxicity
An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place