Trial Outcomes & Findings for Cobimetinib in Newly Diagnosed or HMA-treated CMML Patients With RAS Pathway Mutations (NCT NCT04409639)
NCT ID: NCT04409639
Last Updated: 2026-04-24
Results Overview
To assess the efficacy of cobimetinib in patients with newly diagnosed and HMA- refractory chronic myelomonocytic leukemia (CMML). Overall response rate (ORR) is defined as the proportion of patients achieving complete remission, complete cytogenetic remission, partial remission, marrow response, and clinical benefit according to the 2015 MDS/MPN-IWG criteria. This was assessed from the dose of study medication to the decision to end treatment or up to 12 months of treatment, whichever came first.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE2
Target enrollment
14 participants
Primary outcome timeframe
From 1st dose of study medication to decision to end treatment or up to 12 months of treatment, whichever came first
Results posted on
2026-04-24
Participant Flow
Participant milestones
| Measure |
HMA Refractory
Patients treated with hypomethylating agent (HMA) refractory chronic myelomonocytic leukemia (CMML; 2022 WHO classification) with RAS pathway activation.
Experimental: Treatment: All Patients Cobimetinib is taken on a 28-day cycle. Each dose consists of three 20 mg tablets (60 mg) and should be taken once daily for 21 consecutive days (Days 1 to 21-treatment period); followed by a 7-day break (Days 22 to 28-treatment break). Each subsequent cobimetinib treatment cycle should start after a 7-day treatment break has elapsed.
|
Newly Diagnosed
Patients with newly diagnosed chronic myelomonocytic leukemia (CMML; 2022 WHO classification) with RAS pathway activation.
Experimental: Treatment: All Patients Cobimetinib is taken on a 28-day cycle. Each dose consists of three 20 mg tablets (60 mg) and should be taken once daily for 21 consecutive days (Days 1 to 21-treatment period); followed by a 7-day break (Days 22 to 28-treatment break). Each subsequent cobimetinib treatment cycle should start after a 7-day treatment break has elapsed.
|
|---|---|---|
|
Overall Study
STARTED
|
5
|
9
|
|
Overall Study
COMPLETED
|
1
|
5
|
|
Overall Study
NOT COMPLETED
|
4
|
4
|
Reasons for withdrawal
| Measure |
HMA Refractory
Patients treated with hypomethylating agent (HMA) refractory chronic myelomonocytic leukemia (CMML; 2022 WHO classification) with RAS pathway activation.
Experimental: Treatment: All Patients Cobimetinib is taken on a 28-day cycle. Each dose consists of three 20 mg tablets (60 mg) and should be taken once daily for 21 consecutive days (Days 1 to 21-treatment period); followed by a 7-day break (Days 22 to 28-treatment break). Each subsequent cobimetinib treatment cycle should start after a 7-day treatment break has elapsed.
|
Newly Diagnosed
Patients with newly diagnosed chronic myelomonocytic leukemia (CMML; 2022 WHO classification) with RAS pathway activation.
Experimental: Treatment: All Patients Cobimetinib is taken on a 28-day cycle. Each dose consists of three 20 mg tablets (60 mg) and should be taken once daily for 21 consecutive days (Days 1 to 21-treatment period); followed by a 7-day break (Days 22 to 28-treatment break). Each subsequent cobimetinib treatment cycle should start after a 7-day treatment break has elapsed.
|
|---|---|---|
|
Overall Study
Disease Progression
|
2
|
0
|
|
Overall Study
Death
|
1
|
0
|
|
Overall Study
Adverse Event
|
1
|
3
|
|
Overall Study
Non Compliance
|
0
|
1
|
Baseline Characteristics
Cobimetinib in Newly Diagnosed or HMA-treated CMML Patients With RAS Pathway Mutations
Baseline characteristics by cohort
| Measure |
HMA Refractory
n=5 Participants
Patients treated with hypomethylating agent (HMA) refractory chronic myelomonocytic leukemia (CMML; 2022 WHO classification) with RAS pathway activation.
Experimental: Treatment: All Patients Cobimetinib is taken on a 28-day cycle. Each dose consists of three 20 mg tablets (60 mg) and should be taken once daily for 21 consecutive days (Days 1 to 21-treatment period); followed by a 7-day break (Days 22 to 28-treatment break). Each subsequent cobimetinib treatment cycle should start after a 7-day treatment break has elapsed.
|
Newly Diagnosed
n=9 Participants
Patients with newly diagnosed chronic myelomonocytic leukemia (CMML; 2022 WHO classification) with RAS pathway activation.
Experimental: Treatment: All Patients Cobimetinib is taken on a 28-day cycle. Each dose consists of three 20 mg tablets (60 mg) and should be taken once daily for 21 consecutive days (Days 1 to 21-treatment period); followed by a 7-day break (Days 22 to 28-treatment break). Each subsequent cobimetinib treatment cycle should start after a 7-day treatment break has elapsed.
|
Total
n=14 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=2 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=3 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=2 Participants
|
1 Participants
n=1 Participants
|
1 Participants
n=3 Participants
|
|
Age, Categorical
>=65 years
|
5 Participants
n=2 Participants
|
8 Participants
n=1 Participants
|
13 Participants
n=3 Participants
|
|
Age, Continuous
|
72.2 years
STANDARD_DEVIATION 2.28 • n=2 Participants
|
72.0 years
STANDARD_DEVIATION 9.11 • n=1 Participants
|
72.07 years
STANDARD_DEVIATION 7.26 • n=3 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=2 Participants
|
4 Participants
n=1 Participants
|
8 Participants
n=3 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=2 Participants
|
5 Participants
n=1 Participants
|
6 Participants
n=3 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=2 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=3 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=2 Participants
|
9 Participants
n=1 Participants
|
14 Participants
n=3 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=2 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=3 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=2 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=3 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=2 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=3 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=2 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=3 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=2 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=3 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=2 Participants
|
9 Participants
n=1 Participants
|
14 Participants
n=3 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=2 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=3 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=2 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=3 Participants
|
|
Region of Enrollment
United States
|
5 participants
n=2 Participants
|
9 participants
n=1 Participants
|
14 participants
n=3 Participants
|
|
Eastern Cooperative Oncology Group (ECOG)
0 Fully active
|
1 Participants
n=2 Participants
|
4 Participants
n=1 Participants
|
5 Participants
n=3 Participants
|
|
Eastern Cooperative Oncology Group (ECOG)
1 Restricted
|
3 Participants
n=2 Participants
|
3 Participants
n=1 Participants
|
6 Participants
n=3 Participants
|
|
Eastern Cooperative Oncology Group (ECOG)
2 Ambulatory
|
1 Participants
n=2 Participants
|
2 Participants
n=1 Participants
|
3 Participants
n=3 Participants
|
|
Eastern Cooperative Oncology Group (ECOG)
3 Capable of limited selfcare
|
0 Participants
n=2 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=3 Participants
|
|
Eastern Cooperative Oncology Group (ECOG)
4 Completely disabled
|
0 Participants
n=2 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=3 Participants
|
|
Eastern Cooperative Oncology Group (ECOG)
5 Dead
|
00 Participants
n=2 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=3 Participants
|
|
Chronic Myelomonocytic Leukemia -Specific Prognostic Scoring System (CPSS) Cytogenetic Risk Group
Low
|
2 Participants
n=2 Participants
|
3 Participants
n=1 Participants
|
5 Participants
n=3 Participants
|
|
Chronic Myelomonocytic Leukemia -Specific Prognostic Scoring System (CPSS) Cytogenetic Risk Group
Intermediate
|
3 Participants
n=2 Participants
|
5 Participants
n=1 Participants
|
8 Participants
n=3 Participants
|
|
Chronic Myelomonocytic Leukemia -Specific Prognostic Scoring System (CPSS) Cytogenetic Risk Group
High
|
0 Participants
n=2 Participants
|
1 Participants
n=1 Participants
|
1 Participants
n=3 Participants
|
|
Genetic risk group
Low (0)
|
3 Participants
n=2 Participants
|
3 Participants
n=1 Participants
|
6 Participants
n=3 Participants
|
|
Genetic risk group
Intermediate-1 (1)
|
1 Participants
n=2 Participants
|
3 Participants
n=1 Participants
|
4 Participants
n=3 Participants
|
|
Genetic risk group
Intermediate-2 (2)
|
1 Participants
n=2 Participants
|
2 Participants
n=1 Participants
|
3 Participants
n=3 Participants
|
|
Genetic risk group
High (>=3)
|
0 Participants
n=2 Participants
|
1 Participants
n=1 Participants
|
1 Participants
n=3 Participants
|
|
CPSS-Molecular risk group score:
Low (0)
|
3 Participants
n=2 Participants
|
1 Participants
n=1 Participants
|
4 Participants
n=3 Participants
|
|
CPSS-Molecular risk group score:
4Intermediate-1 (1)
|
1 Participants
n=2 Participants
|
2 Participants
n=1 Participants
|
3 Participants
n=3 Participants
|
|
CPSS-Molecular risk group score:
Intermediate-2 (2-3)
|
0 Participants
n=2 Participants
|
4 Participants
n=1 Participants
|
4 Participants
n=3 Participants
|
|
CPSS-Molecular risk group score:
High (>=4)
|
1 Participants
n=2 Participants
|
2 Participants
n=1 Participants
|
3 Participants
n=3 Participants
|
|
Previous Cancer Diagnosis
Yes
|
2 Participants
n=2 Participants
|
1 Participants
n=1 Participants
|
3 Participants
n=3 Participants
|
|
Previous Cancer Diagnosis
No
|
3 Participants
n=2 Participants
|
8 Participants
n=1 Participants
|
11 Participants
n=3 Participants
|
|
Smoking History
Non-Smoker
|
4 Participants
n=2 Participants
|
3 Participants
n=1 Participants
|
7 Participants
n=3 Participants
|
|
Smoking History
Current Smoker
|
1 Participants
n=2 Participants
|
1 Participants
n=1 Participants
|
2 Participants
n=3 Participants
|
|
Smoking History
Former Smoker
|
0 Participants
n=2 Participants
|
5 Participants
n=1 Participants
|
5 Participants
n=3 Participants
|
|
Hypertension
Yes
|
4 Participants
n=2 Participants
|
3 Participants
n=1 Participants
|
7 Participants
n=3 Participants
|
|
Hypertension
No
|
1 Participants
n=2 Participants
|
6 Participants
n=1 Participants
|
7 Participants
n=3 Participants
|
PRIMARY outcome
Timeframe: From 1st dose of study medication to decision to end treatment or up to 12 months of treatment, whichever came firstPopulation: The EOT disease assessment was not done for one patient in error. One patient was not able to travel to the study site for the EOT disease assessment due to illness.
To assess the efficacy of cobimetinib in patients with newly diagnosed and HMA- refractory chronic myelomonocytic leukemia (CMML). Overall response rate (ORR) is defined as the proportion of patients achieving complete remission, complete cytogenetic remission, partial remission, marrow response, and clinical benefit according to the 2015 MDS/MPN-IWG criteria. This was assessed from the dose of study medication to the decision to end treatment or up to 12 months of treatment, whichever came first.
Outcome measures
| Measure |
HMA Refractory
n=4 Participants
Patients treated with hypomethylating agent (HMA) refractory chronic myelomonocytic leukemia (CMML; 2022 WHO classification) with RAS pathway activation.
Experimental: Treatment: All Patients Cobimetinib is taken on a 28-day cycle. Each dose consists of three 20 mg tablets (60 mg) and should be taken once daily for 21 consecutive days (Days 1 to 21-treatment period); followed by a 7-day break (Days 22 to 28-treatment break). Each subsequent cobimetinib treatment cycle should start after a 7-day treatment break has elapsed.
|
Newly Diagnosed
n=8 Participants
Patients with newly diagnosed chronic myelomonocytic leukemia (CMML; 2022 WHO classification) with RAS pathway activation.
Experimental: Treatment: All Patients Cobimetinib is taken on a 28-day cycle. Each dose consists of three 20 mg tablets (60 mg) and should be taken once daily for 21 consecutive days (Days 1 to 21-treatment period); followed by a 7-day break (Days 22 to 28-treatment break). Each subsequent cobimetinib treatment cycle should start after a 7-day treatment break has elapsed.
|
|---|---|---|
|
Overall Response Rate (ORR)
|
25 percentage of participants
Interval 1.27 to 52.71
|
38 percentage of participants
Interval 11.11 to 59.97
|
SECONDARY outcome
Timeframe: From the start of study treatment to the last dose of study treatment, up to 2.3 yearsTo assess the safety of Cobimetinib treatment in CMML. This outcome measure will report the count of patients who experienced a Grade 3, Grade 4, and Grade 5 treatment-related adverse reaction while on study treatment.
Outcome measures
| Measure |
HMA Refractory
n=5 Participants
Patients treated with hypomethylating agent (HMA) refractory chronic myelomonocytic leukemia (CMML; 2022 WHO classification) with RAS pathway activation.
Experimental: Treatment: All Patients Cobimetinib is taken on a 28-day cycle. Each dose consists of three 20 mg tablets (60 mg) and should be taken once daily for 21 consecutive days (Days 1 to 21-treatment period); followed by a 7-day break (Days 22 to 28-treatment break). Each subsequent cobimetinib treatment cycle should start after a 7-day treatment break has elapsed.
|
Newly Diagnosed
n=9 Participants
Patients with newly diagnosed chronic myelomonocytic leukemia (CMML; 2022 WHO classification) with RAS pathway activation.
Experimental: Treatment: All Patients Cobimetinib is taken on a 28-day cycle. Each dose consists of three 20 mg tablets (60 mg) and should be taken once daily for 21 consecutive days (Days 1 to 21-treatment period); followed by a 7-day break (Days 22 to 28-treatment break). Each subsequent cobimetinib treatment cycle should start after a 7-day treatment break has elapsed.
|
|---|---|---|
|
Related Grade 3-5 Adverse Events
Patients with a Related, Grade 3 Toxicity
|
1 Participants
|
6 Participants
|
|
Related Grade 3-5 Adverse Events
Patients with a Related, Grade 4 Toxicity
|
2 Participants
|
1 Participants
|
|
Related Grade 3-5 Adverse Events
Patients with a Related, Grade 5 Toxicity
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From the start of study treatment, until the last disease assessment, up to 2.6 yearsTo assess the complete response (CR) + partial response (PR) rate (as defined by the 2015 MDS/MPN-IWG criteria) with cobimetinib treatment in CMML. This outcome measure will report the count of patients achieving complete response complete response (CR) or partial response (PR) while on the study.
Outcome measures
| Measure |
HMA Refractory
n=4 Participants
Patients treated with hypomethylating agent (HMA) refractory chronic myelomonocytic leukemia (CMML; 2022 WHO classification) with RAS pathway activation.
Experimental: Treatment: All Patients Cobimetinib is taken on a 28-day cycle. Each dose consists of three 20 mg tablets (60 mg) and should be taken once daily for 21 consecutive days (Days 1 to 21-treatment period); followed by a 7-day break (Days 22 to 28-treatment break). Each subsequent cobimetinib treatment cycle should start after a 7-day treatment break has elapsed.
|
Newly Diagnosed
n=8 Participants
Patients with newly diagnosed chronic myelomonocytic leukemia (CMML; 2022 WHO classification) with RAS pathway activation.
Experimental: Treatment: All Patients Cobimetinib is taken on a 28-day cycle. Each dose consists of three 20 mg tablets (60 mg) and should be taken once daily for 21 consecutive days (Days 1 to 21-treatment period); followed by a 7-day break (Days 22 to 28-treatment break). Each subsequent cobimetinib treatment cycle should start after a 7-day treatment break has elapsed.
|
|---|---|---|
|
Count of Patients Achieving Complete Response Complete Response (CR) or Partial Response (PR)
Achieved CR or PR
|
0 Participants
|
2 Participants
|
|
Count of Patients Achieving Complete Response Complete Response (CR) or Partial Response (PR)
Did not Achieve CR or PR
|
4 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: up to 36 months after the start of therapy, the time of progression, initiation of alternative treatment or death, whichever came firstAssessment of long-term efficacy
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Study anticipated to be 60 months.Assessment of long-term efficacy
Outcome measures
Outcome data not reported
Adverse Events
HMA Refractory
Serious events: 4 serious events
Other events: 5 other events
Deaths: 3 deaths
Newly Diagnosed
Serious events: 3 serious events
Other events: 9 other events
Deaths: 5 deaths
Serious adverse events
| Measure |
HMA Refractory
n=5 participants at risk
Patients treated with hypomethylating agent (HMA) refractory chronic myelomonocytic leukemia (CMML; 2022 WHO classification) with RAS pathway activation.
Experimental: Treatment: All Patients Cobimetinib is taken on a 28-day cycle. Each dose consists of three 20 mg tablets (60 mg) and should be taken once daily for 21 consecutive days (Days 1 to 21-treatment period); followed by a 7-day break (Days 22 to 28-treatment break). Each subsequent cobimetinib treatment cycle should start after a 7-day treatment break has elapsed.
|
Newly Diagnosed
n=9 participants at risk
Patients with newly diagnosed chronic myelomonocytic leukemia (CMML; 2022 WHO classification) with RAS pathway activation.
Experimental: Treatment: All Patients Cobimetinib is taken on a 28-day cycle. Each dose consists of three 20 mg tablets (60 mg) and should be taken once daily for 21 consecutive days (Days 1 to 21-treatment period); followed by a 7-day break (Days 22 to 28-treatment break). Each subsequent cobimetinib treatment cycle should start after a 7-day treatment break has elapsed.
|
|---|---|---|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/5 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
11.1%
1/9 • Number of events 1 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/5 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
11.1%
1/9 • Number of events 1 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/5 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
11.1%
1/9 • Number of events 1 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
|
Psychiatric disorders
Confusion
|
0.00%
0/5 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
11.1%
1/9 • Number of events 1 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
|
Gastrointestinal disorders
Diarrhea
|
20.0%
1/5 • Number of events 1 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
0.00%
0/9 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
20.0%
1/5 • Number of events 1 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
0.00%
0/9 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
|
Injury, poisoning and procedural complications
Fracture
|
0.00%
0/5 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
11.1%
1/9 • Number of events 1 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
|
Gastrointestinal disorders
Hemorrhoidal hemorrhage
|
0.00%
0/5 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
11.1%
1/9 • Number of events 1 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
|
Infections and infestations
Infections and infestations - Other, specify
|
20.0%
1/5 • Number of events 3 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
0.00%
0/9 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
|
Blood and lymphatic system disorders
Leukocytosis
|
40.0%
2/5 • Number of events 2 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
0.00%
0/9 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
|
Gastrointestinal disorders
Lower gastrointestinal hemorrhage
|
0.00%
0/5 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
11.1%
1/9 • Number of events 1 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
|
Infections and infestations
Sepsis
|
20.0%
1/5 • Number of events 1 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
0.00%
0/9 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify
|
20.0%
1/5 • Number of events 1 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
0.00%
0/9 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
Other adverse events
| Measure |
HMA Refractory
n=5 participants at risk
Patients treated with hypomethylating agent (HMA) refractory chronic myelomonocytic leukemia (CMML; 2022 WHO classification) with RAS pathway activation.
Experimental: Treatment: All Patients Cobimetinib is taken on a 28-day cycle. Each dose consists of three 20 mg tablets (60 mg) and should be taken once daily for 21 consecutive days (Days 1 to 21-treatment period); followed by a 7-day break (Days 22 to 28-treatment break). Each subsequent cobimetinib treatment cycle should start after a 7-day treatment break has elapsed.
|
Newly Diagnosed
n=9 participants at risk
Patients with newly diagnosed chronic myelomonocytic leukemia (CMML; 2022 WHO classification) with RAS pathway activation.
Experimental: Treatment: All Patients Cobimetinib is taken on a 28-day cycle. Each dose consists of three 20 mg tablets (60 mg) and should be taken once daily for 21 consecutive days (Days 1 to 21-treatment period); followed by a 7-day break (Days 22 to 28-treatment break). Each subsequent cobimetinib treatment cycle should start after a 7-day treatment break has elapsed.
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal distension
|
20.0%
1/5 • Number of events 1 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
0.00%
0/9 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
|
Gastrointestinal disorders
Abdominal pain
|
40.0%
2/5 • Number of events 8 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
0.00%
0/9 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
|
Renal and urinary disorders
Acute kidney injury
|
40.0%
2/5 • Number of events 3 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
0.00%
0/9 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
|
Endocrine disorders
Adrenal insufficiency
|
20.0%
1/5 • Number of events 1 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
0.00%
0/9 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
0.00%
0/5 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
11.1%
1/9 • Number of events 1 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/5 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
33.3%
3/9 • Number of events 4 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
|
Psychiatric disorders
Anxiety
|
40.0%
2/5 • Number of events 2 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
11.1%
1/9 • Number of events 1 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
|
Gastrointestinal disorders
Ascites
|
20.0%
1/5 • Number of events 1 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
0.00%
0/9 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
|
Investigations
Aspartate aminotransferase increased
|
20.0%
1/5 • Number of events 1 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
0.00%
0/9 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/5 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
22.2%
2/9 • Number of events 2 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/5 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
22.2%
2/9 • Number of events 4 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
|
Infections and infestations
Bacteremia
|
20.0%
1/5 • Number of events 1 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
0.00%
0/9 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
|
Gastrointestinal disorders
Bloating
|
20.0%
1/5 • Number of events 1 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
0.00%
0/9 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders - Other, specify
|
40.0%
2/5 • Number of events 4 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
0.00%
0/9 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/5 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
11.1%
1/9 • Number of events 1 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
|
Injury, poisoning and procedural complications
Bruising
|
40.0%
2/5 • Number of events 2 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
22.2%
2/9 • Number of events 2 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
|
Injury, poisoning and procedural complications
Burn
|
20.0%
1/5 • Number of events 1 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
0.00%
0/9 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
|
Musculoskeletal and connective tissue disorders
Buttock pain
|
20.0%
1/5 • Number of events 1 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
0.00%
0/9 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
|
Investigations
Cardiac troponin T increased
|
20.0%
1/5 • Number of events 1 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
0.00%
0/9 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
|
General disorders
Chills
|
60.0%
3/5 • Number of events 4 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
0.00%
0/9 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
|
Nervous system disorders
Concentration impairment
|
0.00%
0/5 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
11.1%
1/9 • Number of events 1 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
|
Psychiatric disorders
Confusion
|
20.0%
1/5 • Number of events 1 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
11.1%
1/9 • Number of events 2 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
|
Infections and infestations
Conjunctivitis
|
20.0%
1/5 • Number of events 1 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
11.1%
1/9 • Number of events 1 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
|
Gastrointestinal disorders
Constipation
|
40.0%
2/5 • Number of events 2 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
11.1%
1/9 • Number of events 1 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
40.0%
2/5 • Number of events 3 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
0.00%
0/9 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
|
Investigations
CPK increased
|
20.0%
1/5 • Number of events 1 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
11.1%
1/9 • Number of events 4 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
|
Metabolism and nutrition disorders
Dehydration
|
20.0%
1/5 • Number of events 2 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
0.00%
0/9 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
|
Gastrointestinal disorders
Diarrhea
|
80.0%
4/5 • Number of events 10 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
88.9%
8/9 • Number of events 15 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
|
Nervous system disorders
Dizziness
|
60.0%
3/5 • Number of events 6 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
33.3%
3/9 • Number of events 5 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
|
Eye disorders
Dry eye
|
20.0%
1/5 • Number of events 1 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
0.00%
0/9 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
|
Gastrointestinal disorders
Dry mouth
|
40.0%
2/5 • Number of events 4 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
0.00%
0/9 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
20.0%
1/5 • Number of events 1 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
44.4%
4/9 • Number of events 4 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
|
Nervous system disorders
Dysarthria
|
20.0%
1/5 • Number of events 1 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
0.00%
0/9 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
|
Nervous system disorders
Dysgeusia
|
20.0%
1/5 • Number of events 1 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
11.1%
1/9 • Number of events 1 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
|
Gastrointestinal disorders
Dysphagia
|
20.0%
1/5 • Number of events 1 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
22.2%
2/9 • Number of events 2 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
60.0%
3/5 • Number of events 5 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
33.3%
3/9 • Number of events 3 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
|
Renal and urinary disorders
Dysuria
|
20.0%
1/5 • Number of events 1 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
11.1%
1/9 • Number of events 1 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
|
Ear and labyrinth disorders
Ear and labyrinth disorders - Other, specify
|
20.0%
1/5 • Number of events 1 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
0.00%
0/9 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/5 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
22.2%
2/9 • Number of events 2 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/5 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
11.1%
1/9 • Number of events 1 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
|
General disorders
Edema face
|
20.0%
1/5 • Number of events 1 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
11.1%
1/9 • Number of events 1 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
|
General disorders
Edema limbs
|
80.0%
4/5 • Number of events 8 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
66.7%
6/9 • Number of events 10 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
|
Investigations
Ejection fraction decreased
|
0.00%
0/5 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
11.1%
1/9 • Number of events 1 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
|
Investigations
Electrocardiogram QT corrected interval prolonged
|
40.0%
2/5 • Number of events 4 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
0.00%
0/9 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
20.0%
1/5 • Number of events 1 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
11.1%
1/9 • Number of events 1 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
|
Skin and subcutaneous tissue disorders
Erythroderma
|
0.00%
0/5 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
11.1%
1/9 • Number of events 1 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
|
Eye disorders
Eye disorders - Other, specify
|
20.0%
1/5 • Number of events 2 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
0.00%
0/9 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
|
Eye disorders
Eye pain
|
0.00%
0/5 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
11.1%
1/9 • Number of events 3 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
|
General disorders
Facial pain
|
0.00%
0/5 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
11.1%
1/9 • Number of events 1 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
|
Injury, poisoning and procedural complications
Fall
|
20.0%
1/5 • Number of events 6 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
22.2%
2/9 • Number of events 4 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
|
General disorders
Fatigue
|
60.0%
3/5 • Number of events 4 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
55.6%
5/9 • Number of events 6 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
|
General disorders
Fever
|
60.0%
3/5 • Number of events 5 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
0.00%
0/9 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
|
Eye disorders
Floaters
|
20.0%
1/5 • Number of events 1 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
0.00%
0/9 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
|
General disorders
Flu like symptoms
|
0.00%
0/5 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
11.1%
1/9 • Number of events 1 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
|
Vascular disorders
Flushing
|
20.0%
1/5 • Number of events 1 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
0.00%
0/9 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
|
Injury, poisoning and procedural complications
Fracture
|
20.0%
1/5 • Number of events 1 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
0.00%
0/9 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
|
General disorders
Gait disturbance
|
0.00%
0/5 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
11.1%
1/9 • Number of events 1 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
|
Gastrointestinal disorders
Gastritis
|
20.0%
1/5 • Number of events 1 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
0.00%
0/9 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
20.0%
1/5 • Number of events 1 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
33.3%
3/9 • Number of events 3 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify
|
60.0%
3/5 • Number of events 8 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
11.1%
1/9 • Number of events 1 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
0.00%
0/5 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
11.1%
1/9 • Number of events 1 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
|
General disorders
General disorders and administration site conditions - Other, specify
|
20.0%
1/5 • Number of events 1 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
0.00%
0/9 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
40.0%
2/5 • Number of events 2 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
22.2%
2/9 • Number of events 2 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
|
Renal and urinary disorders
Glucosuria
|
20.0%
1/5 • Number of events 1 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
0.00%
0/9 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
|
Skin and subcutaneous tissue disorders
Hair color changes
|
0.00%
0/5 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
11.1%
1/9 • Number of events 1 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
|
Skin and subcutaneous tissue disorders
Hair texture abnormal
|
0.00%
0/5 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
11.1%
1/9 • Number of events 1 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
|
Psychiatric disorders
Hallucinations
|
0.00%
0/5 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
11.1%
1/9 • Number of events 1 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
|
Nervous system disorders
Headache
|
60.0%
3/5 • Number of events 5 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
11.1%
1/9 • Number of events 2 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
|
Vascular disorders
Hematoma
|
20.0%
1/5 • Number of events 1 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
11.1%
1/9 • Number of events 1 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
|
Renal and urinary disorders
Hematuria
|
0.00%
0/5 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
11.1%
1/9 • Number of events 1 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
|
Gastrointestinal disorders
Hemorrhoids
|
0.00%
0/5 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
11.1%
1/9 • Number of events 1 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
|
Hepatobiliary disorders
Hepatobiliary disorders - Other, specify
|
0.00%
0/5 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
0.00%
0/9 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
20.0%
1/5 • Number of events 1 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
0.00%
0/9 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
40.0%
2/5 • Number of events 2 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
11.1%
1/9 • Number of events 1 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
20.0%
1/5 • Number of events 1 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
11.1%
1/9 • Number of events 1 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
|
Metabolism and nutrition disorders
Hyperphosphatemia
|
20.0%
1/5 • Number of events 1 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
0.00%
0/9 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
|
Nervous system disorders
Hypersomnia
|
20.0%
1/5 • Number of events 1 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
0.00%
0/9 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
|
Vascular disorders
Hypertension
|
20.0%
1/5 • Number of events 1 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
22.2%
2/9 • Number of events 3 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
|
Skin and subcutaneous tissue disorders
Hypertrichosis
|
0.00%
0/5 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
11.1%
1/9 • Number of events 1 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
20.0%
1/5 • Number of events 1 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
0.00%
0/9 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
20.0%
1/5 • Number of events 2 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
0.00%
0/9 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
|
Metabolism and nutrition disorders
Hypokalemia
|
20.0%
1/5 • Number of events 2 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
11.1%
1/9 • Number of events 1 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
0.00%
0/5 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
11.1%
1/9 • Number of events 1 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
|
Metabolism and nutrition disorders
Hyponatremia
|
20.0%
1/5 • Number of events 1 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
11.1%
1/9 • Number of events 1 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
|
Vascular disorders
Hypotension
|
20.0%
1/5 • Number of events 5 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
11.1%
1/9 • Number of events 1 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
40.0%
2/5 • Number of events 3 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
0.00%
0/9 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
|
Gastrointestinal disorders
Ileal ulcer
|
20.0%
1/5 • Number of events 1 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
0.00%
0/9 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
|
Infections and infestations
Infections and infestations - Other, specify
|
20.0%
1/5 • Number of events 2 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
33.3%
3/9 • Number of events 3 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
20.0%
1/5 • Number of events 1 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
0.00%
0/9 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
|
Injury, poisoning and procedural complications
Injury, poisoning and procedural complications - Other, specify
|
20.0%
1/5 • Number of events 1 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
0.00%
0/9 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
|
Investigations
Investigations - Other, specify
|
20.0%
1/5 • Number of events 3 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
11.1%
1/9 • Number of events 1 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
|
Musculoskeletal and connective tissue disorders
Joint effusion
|
0.00%
0/5 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
11.1%
1/9 • Number of events 1 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
|
Musculoskeletal and connective tissue disorders
Joint range of motion decreased cervical spine
|
0.00%
0/5 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
11.1%
1/9 • Number of events 1 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
|
Infections and infestations
Kidney infection
|
20.0%
1/5 • Number of events 1 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
0.00%
0/9 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
|
Nervous system disorders
Lethargy
|
20.0%
1/5 • Number of events 1 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
0.00%
0/9 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
|
Blood and lymphatic system disorders
Leukocytosis
|
20.0%
1/5 • Number of events 1 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
0.00%
0/9 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
|
General disorders
Localized edema
|
20.0%
1/5 • Number of events 4 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
11.1%
1/9 • Number of events 1 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
|
Blood and lymphatic system disorders
Lymph node pain
|
0.00%
0/5 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
11.1%
1/9 • Number of events 1 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
|
Nervous system disorders
Memory impairment
|
20.0%
1/5 • Number of events 1 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
0.00%
0/9 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders - Other, specify
|
20.0%
1/5 • Number of events 1 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
0.00%
0/9 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
|
Nervous system disorders
Movements involuntary
|
0.00%
0/5 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
11.1%
1/9 • Number of events 1 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
|
Gastrointestinal disorders
Mucositis oral
|
0.00%
0/5 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
11.1%
1/9 • Number of events 1 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
|
Nervous system disorders
Muscle weakness left-sided
|
0.00%
0/5 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
0.00%
0/9 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
20.0%
1/5 • Number of events 1 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
11.1%
1/9 • Number of events 1 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, specify
|
20.0%
1/5 • Number of events 3 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
0.00%
0/9 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
|
Infections and infestations
Nail infection
|
0.00%
0/5 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
11.1%
1/9 • Number of events 2 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
20.0%
1/5 • Number of events 1 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
0.00%
0/9 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
|
Gastrointestinal disorders
Nausea
|
60.0%
3/5 • Number of events 13 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
22.2%
2/9 • Number of events 4 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
60.0%
3/5 • Number of events 3 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
22.2%
2/9 • Number of events 3 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
|
Nervous system disorders
Nervous system disorders - Other, specify
|
40.0%
2/5 • Number of events 2 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
0.00%
0/9 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
|
Investigations
Neutrophil count decreased
|
20.0%
1/5 • Number of events 1 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
0.00%
0/9 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
|
General disorders
Non-cardiac chest pain
|
20.0%
1/5 • Number of events 2 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
11.1%
1/9 • Number of events 1 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
|
Gastrointestinal disorders
Oral dysesthesia
|
0.00%
0/5 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
11.1%
1/9 • Number of events 1 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
|
Gastrointestinal disorders
Oral hemorrhage
|
20.0%
1/5 • Number of events 1 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
0.00%
0/9 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/5 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
22.2%
2/9 • Number of events 4 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
|
General disorders
Pain
|
40.0%
2/5 • Number of events 3 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
0.00%
0/9 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
20.0%
1/5 • Number of events 1 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
11.1%
1/9 • Number of events 3 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysesthesia syndrome
|
0.00%
0/5 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
22.2%
2/9 • Number of events 2 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
|
Cardiac disorders
Palpitations
|
0.00%
0/5 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
11.1%
1/9 • Number of events 1 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
|
Infections and infestations
Paronychia
|
20.0%
1/5 • Number of events 1 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
0.00%
0/9 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
|
Eye disorders
Periorbital edema
|
0.00%
0/5 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
33.3%
3/9 • Number of events 6 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
|
Eye disorders
Photophobia
|
20.0%
1/5 • Number of events 1 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
0.00%
0/9 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
|
Investigations
Platelet count decreased
|
40.0%
2/5 • Number of events 2 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
33.3%
3/9 • Number of events 20 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/5 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
0.00%
0/9 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
|
Nervous system disorders
Presyncope
|
0.00%
0/5 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
11.1%
1/9 • Number of events 1 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
20.0%
1/5 • Number of events 1 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
0.00%
0/9 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/5 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
11.1%
1/9 • Number of events 1 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
20.0%
1/5 • Number of events 1 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
11.1%
1/9 • Number of events 1 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
|
Psychiatric disorders
Psychiatric disorders - Other, specify
|
20.0%
1/5 • Number of events 1 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
0.00%
0/9 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
0.00%
0/5 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
11.1%
1/9 • Number of events 1 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
20.0%
1/5 • Number of events 1 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
33.3%
3/9 • Number of events 4 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
|
Renal and urinary disorders
Renal and urinary disorders - Other, specify
|
20.0%
1/5 • Number of events 1 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
0.00%
0/9 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
|
Renal and urinary disorders
Renal calculi
|
20.0%
1/5 • Number of events 1 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
0.00%
0/9 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, specify
|
20.0%
1/5 • Number of events 4 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
0.00%
0/9 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
|
Infections and infestations
Sepsis
|
20.0%
1/5 • Number of events 1 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
0.00%
0/9 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
|
Cardiac disorders
Sinus tachycardia
|
40.0%
2/5 • Number of events 6 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
11.1%
1/9 • Number of events 2 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify
|
60.0%
3/5 • Number of events 11 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
22.2%
2/9 • Number of events 4 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
|
Infections and infestations
Skin infection
|
0.00%
0/5 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
11.1%
1/9 • Number of events 1 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
|
Skin and subcutaneous tissue disorders
Skin ulceration
|
40.0%
2/5 • Number of events 2 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
11.1%
1/9 • Number of events 1 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
|
Infections and infestations
Soft tissue infection
|
20.0%
1/5 • Number of events 1 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
0.00%
0/9 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
40.0%
2/5 • Number of events 3 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
11.1%
1/9 • Number of events 1 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
|
Surgical and medical procedures
Surgical and medical procedures - Other, specify
|
0.00%
0/5 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
11.1%
1/9 • Number of events 1 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
|
Nervous system disorders
Syncope
|
0.00%
0/5 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
11.1%
1/9 • Number of events 1 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
|
Infections and infestations
Tooth infection
|
20.0%
1/5 • Number of events 1 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
0.00%
0/9 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
|
Nervous system disorders
Tremor
|
20.0%
1/5 • Number of events 1 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
0.00%
0/9 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
|
Musculoskeletal and connective tissue disorders
Trismus
|
20.0%
1/5 • Number of events 1 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
0.00%
0/9 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
|
Infections and infestations
Upper respiratory infection
|
0.00%
0/5 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
55.6%
5/9 • Number of events 8 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
|
Renal and urinary disorders
Urinary frequency
|
40.0%
2/5 • Number of events 4 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
11.1%
1/9 • Number of events 1 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/5 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
11.1%
1/9 • Number of events 1 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
|
Renal and urinary disorders
Urinary retention
|
20.0%
1/5 • Number of events 2 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
0.00%
0/9 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
|
Infections and infestations
Urinary tract infection
|
20.0%
1/5 • Number of events 5 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
0.00%
0/9 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
|
Renal and urinary disorders
Urinary urgency
|
20.0%
1/5 • Number of events 1 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
0.00%
0/9 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
|
Reproductive system and breast disorders
Vaginal discharge
|
0.00%
0/5 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
11.1%
1/9 • Number of events 1 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
|
Infections and infestations
Vaginal infection
|
0.00%
0/5 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
11.1%
1/9 • Number of events 1 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
|
Reproductive system and breast disorders
Vaginal inflammation
|
0.00%
0/5 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
22.2%
2/9 • Number of events 2 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
|
Ear and labyrinth disorders
Vestibular disorder
|
0.00%
0/5 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
11.1%
1/9 • Number of events 1 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
|
Gastrointestinal disorders
Vomiting
|
60.0%
3/5 • Number of events 5 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
33.3%
3/9 • Number of events 6 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
|
Investigations
Weight gain
|
0.00%
0/5 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
0.00%
0/9 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
20.0%
1/5 • Number of events 1 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
0.00%
0/9 • Adverse event collection began with the first dose of the study drug, and ended 30 days after the last dose of the study drug. Collection of serious adverse events will began after the first dose of study drug and ended 90 days after the last dose of study treatment or until new cancer treatment was initiated, whichever occurs first.
Patients will be followed for survival in long-term follow-up for a total of 36 months from the start of therapy
|
Additional Information
IIT Data Management Team
Research Compliance Office, Huntsman Cancer Institute
Phone: 801-213-6215
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place