Trial Outcomes & Findings for CPI-613, Cytarabine, and Mitoxantrone Hydrochloride in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia or Granulocytic Sarcoma (NCT NCT02484391)
NCT ID: NCT02484391
Last Updated: 2024-09-19
Results Overview
Feasibility is determined by the percentage of patients eligible for maintenance therapy who complete at least 3 cycles, if ≥50% of eligible patients complete 3 cycles of maintenance therapy we will consider this regimen feasible for future study.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
48 participants
Primary outcome timeframe
Up to 12 weeks of maintenance therapy
Results posted on
2024-09-19
Participant Flow
Participant milestones
| Measure |
1500
1500 mg/m2 devimistat
|
2000
2000 mg/m2 devimistat
|
2500
2500 mg/m2 devimistat
|
|---|---|---|---|
|
Overall Study
STARTED
|
21
|
20
|
7
|
|
Overall Study
Achieved Remission
|
9
|
7
|
5
|
|
Overall Study
Received Maintenance Therapy
|
0
|
0
|
2
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
21
|
20
|
7
|
Reasons for withdrawal
| Measure |
1500
1500 mg/m2 devimistat
|
2000
2000 mg/m2 devimistat
|
2500
2500 mg/m2 devimistat
|
|---|---|---|---|
|
Overall Study
Lack of Efficacy
|
15
|
14
|
3
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
2
|
|
Overall Study
Physician Decision
|
1
|
3
|
0
|
|
Overall Study
Went to Transplant
|
5
|
3
|
2
|
Baseline Characteristics
CPI-613, Cytarabine, and Mitoxantrone Hydrochloride in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia or Granulocytic Sarcoma
Baseline characteristics by cohort
| Measure |
1500
n=21 Participants
1500 mg/m2 devimistat
|
2000
n=20 Participants
2000 mg/m2 devimistat
|
2500
n=7 Participants
2500 mg/m2 devimistat
|
Total
n=48 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
61 years
n=5 Participants
|
65.5 years
n=7 Participants
|
64 years
n=5 Participants
|
64 years
n=4 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
28 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
18 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
40 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Up to 12 weeks of maintenance therapyPopulation: None of the 9 participants in the 1500 mg arm and the 7 participants in the 2000 mg arm started maintenance, only 2 out of the 5 participants in the 2500 mg arm started maintenance. None of participants completed three cycles of maintenance.
Feasibility is determined by the percentage of patients eligible for maintenance therapy who complete at least 3 cycles, if ≥50% of eligible patients complete 3 cycles of maintenance therapy we will consider this regimen feasible for future study.
Outcome measures
| Measure |
1500
1500 mg/m2 devimistat
|
2000
2000 mg/m2 devimistat
|
2500
n=2 Participants
2500 mg/m2 devimistat
|
|---|---|---|---|
|
Feasibility of Administering CPI-613 in Combination With High Dose Cytarabine and Mitoxantrone During Induction, Consolidation and Maintenance Therapies, Defined as Percentage of Patients Eligible for Maintenance Therapy Who Complete at Least 3 Courses
Completed 3 cycles of maintenance therapy
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Feasibility of Administering CPI-613 in Combination With High Dose Cytarabine and Mitoxantrone During Induction, Consolidation and Maintenance Therapies, Defined as Percentage of Patients Eligible for Maintenance Therapy Who Complete at Least 3 Courses
Started maintenance therapy
|
0 Participants
|
0 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Up to 6 monthsThe frequency of toxicities experienced by the participants will be presented by type and grade in an effort to monitor and report safety of the treatment. Showing grade 2 and greater event and the highest grade of each type per participant so that a participant is only evaluated once per toxicity type. Reporting events where at least 10% (n=5) of study participants reported a grade 2 or greater event.
Outcome measures
| Measure |
1500
n=21 Participants
1500 mg/m2 devimistat
|
2000
n=20 Participants
2000 mg/m2 devimistat
|
2500
n=7 Participants
2500 mg/m2 devimistat
|
|---|---|---|---|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Abdominal pain · Not observed or Grade 1
|
18 Participants
|
18 Participants
|
1 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Activated partial thromboplastin time prolonged · Grade 2
|
2 Participants
|
0 Participants
|
1 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Activated partial thromboplastin time prolonged · Grade 3
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Activated partial thromboplastin time prolonged · Grade 5
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Activated partial thromboplastin time prolonged · Not observed or Grade 1
|
17 Participants
|
20 Participants
|
6 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Acute kidney injury · Grade 2
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Acute kidney injury · Grade 3
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Acute kidney injury · Grade 4
|
3 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Acute kidney injury · Not observed or Grade 1
|
16 Participants
|
19 Participants
|
6 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Agitation · Grade 2
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Agitation · Not observed or Grade 1
|
17 Participants
|
19 Participants
|
7 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Gastrointestinal disorders - Other · Grade 4
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Mucositis oral · Grade 5
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Activated partial thromboplastin time prolonged · Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Chills · Grade 3
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Chills · Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Sinusitis · Grade 5
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Sinusitis · Not observed or Grade 1
|
18 Participants
|
19 Participants
|
6 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Electrocardiogram QT corrected interval prolonged · Not observed or Grade 1
|
19 Participants
|
15 Participants
|
3 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Chills · Grade 5
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Epistaxis · Grade 2
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Chills · Not observed or Grade 1
|
18 Participants
|
18 Participants
|
7 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Chronic kidney disease · Grade 2
|
3 Participants
|
11 Participants
|
2 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Chronic kidney disease · Grade 3
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Epistaxis · Grade 3
|
2 Participants
|
1 Participants
|
1 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Abdominal pain · Grade 2
|
3 Participants
|
1 Participants
|
5 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Abdominal pain · Grade 3
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Abdominal pain · Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Abdominal pain · Grade 5
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Agitation · Grade 5
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Alanine aminotransferase increased · Grade 2
|
3 Participants
|
2 Participants
|
1 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Acute kidney injury · Grade 5
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Agitation · Grade 3
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Agitation · Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Hyponatremia · Grade 4
|
3 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Hyponatremia · Grade 5
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Hyponatremia · Not observed or Grade 1
|
16 Participants
|
20 Participants
|
6 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Hypophosphatemia · Grade 2
|
7 Participants
|
8 Participants
|
0 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Hypophosphatemia · Grade 3
|
6 Participants
|
6 Participants
|
6 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Hypophosphatemia · Grade 4
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Hypophosphatemia · Grade 5
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Hypophosphatemia · Not observed or Grade 1
|
8 Participants
|
4 Participants
|
1 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Hypotension · Grade 2
|
2 Participants
|
3 Participants
|
4 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Hypotension · Grade 3
|
2 Participants
|
2 Participants
|
0 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Hypotension · Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Hypotension · Grade 5
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Hypotension · Not observed or Grade 1
|
17 Participants
|
15 Participants
|
3 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Hypoxia · Grade 2
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Hypoxia · Grade 3
|
2 Participants
|
3 Participants
|
1 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Hypoxia · Grade 4
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Hypoxia · Grade 5
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Hypoxia · Not observed or Grade 1
|
18 Participants
|
15 Participants
|
6 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Infections and infestations - Other · Grade 2
|
2 Participants
|
3 Participants
|
0 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Infections and infestations - Other · Grade 3
|
2 Participants
|
5 Participants
|
3 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Infections and infestations - Other · Grade 4
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Infections and infestations - Other · Grade 5
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Infections and infestations - Other · Not observed or Grade 1
|
16 Participants
|
12 Participants
|
4 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Insomnia · Grade 2
|
4 Participants
|
4 Participants
|
0 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Insomnia · Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Insomnia · Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Insomnia · Grade 5
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Insomnia · Not observed or Grade 1
|
17 Participants
|
16 Participants
|
7 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Lung infection · Grade 2
|
4 Participants
|
2 Participants
|
0 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Lung infection · Grade 3
|
1 Participants
|
9 Participants
|
2 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Lung infection · Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Lung infection · Grade 5
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Lung infection · Not observed or Grade 1
|
15 Participants
|
9 Participants
|
5 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Lymphocyte count decreased · Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Lymphocyte count decreased · Grade 3
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Lymphocyte count decreased · Grade 4
|
21 Participants
|
19 Participants
|
7 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Lymphocyte count decreased · Grade 5
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Lymphocyte count decreased · Not observed or Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Mucositis oral · Grade 2
|
1 Participants
|
2 Participants
|
0 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Mucositis oral · Grade 3
|
0 Participants
|
2 Participants
|
1 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Mucositis oral · Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Mucositis oral · Not observed or Grade 1
|
20 Participants
|
16 Participants
|
6 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Nausea · Grade 2
|
6 Participants
|
8 Participants
|
4 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Nausea · Grade 3
|
0 Participants
|
5 Participants
|
3 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Nausea · Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Nausea · Grade 5
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Nausea · Not observed or Grade 1
|
15 Participants
|
7 Participants
|
0 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Neck pain · Grade 2
|
2 Participants
|
0 Participants
|
1 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Neck pain · Grade 3
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Neck pain · Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Neck pain · Grade 5
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Neck pain · Not observed or Grade 1
|
18 Participants
|
19 Participants
|
6 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Neutrophil count decreased · Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Neutrophil count decreased · Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Neutrophil count decreased · Grade 4
|
21 Participants
|
19 Participants
|
7 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Neutrophil count decreased · Grade 5
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Neutrophil count decreased · Not observed or Grade 1
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Non-cardiac chest pain · Grade 2
|
2 Participants
|
2 Participants
|
1 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Non-cardiac chest pain · Grade 3
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Non-cardiac chest pain · Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Non-cardiac chest pain · Grade 5
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Non-cardiac chest pain · Not observed or Grade 1
|
18 Participants
|
17 Participants
|
6 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Oral pain · Grade 2
|
0 Participants
|
3 Participants
|
1 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Oral pain · Grade 3
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Oral pain · Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Oral pain · Grade 5
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Oral pain · Not observed or Grade 1
|
21 Participants
|
16 Participants
|
6 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Pain · Grade 2
|
4 Participants
|
1 Participants
|
2 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Pain · Grade 3
|
1 Participants
|
1 Participants
|
3 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Pain · Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Pain · Grade 5
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Pain · Not observed or Grade 1
|
16 Participants
|
18 Participants
|
2 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Pain in extremity · Grade 2
|
4 Participants
|
0 Participants
|
1 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Pain in extremity · Grade 3
|
0 Participants
|
1 Participants
|
3 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Pain in extremity · Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Pain in extremity · Grade 5
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Pain in extremity · Not observed or Grade 1
|
17 Participants
|
19 Participants
|
3 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Platelet count decreased · Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Alanine aminotransferase increased · Grade 3
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Platelet count decreased · Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Platelet count decreased · Grade 4
|
21 Participants
|
20 Participants
|
7 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Alanine aminotransferase increased · Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Alanine aminotransferase increased · Grade 5
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Alanine aminotransferase increased · Not observed or Grade 1
|
17 Participants
|
17 Participants
|
5 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Alkalosis · Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Alkalosis · Grade 3
|
2 Participants
|
3 Participants
|
0 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Alkalosis · Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Alkalosis · Grade 5
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Platelet count decreased · Grade 5
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Alkalosis · Not observed or Grade 1
|
19 Participants
|
17 Participants
|
7 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Anemia · Grade 2
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Platelet count decreased · Not observed or Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Anemia · Grade 3
|
19 Participants
|
19 Participants
|
6 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Proteinuria · Grade 2
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Anemia · Grade 4
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Anemia · Grade 5
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Proteinuria · Grade 3
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Proteinuria · Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Proteinuria · Grade 5
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Proteinuria · Not observed or Grade 1
|
18 Participants
|
19 Participants
|
6 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Anemia · Not observed or Grade 1
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Anorexia · Grade 2
|
9 Participants
|
8 Participants
|
4 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Anorexia · Grade 3
|
4 Participants
|
8 Participants
|
2 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Anorexia · Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Anorexia · Grade 5
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Anorexia · Not observed or Grade 1
|
8 Participants
|
4 Participants
|
1 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Anxiety · Grade 2
|
5 Participants
|
7 Participants
|
5 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Anxiety · Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Anxiety · Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Anxiety · Grade 5
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Anxiety · Not observed or Grade 1
|
16 Participants
|
13 Participants
|
2 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Aspartate aminotransferase increased · Grade 2
|
2 Participants
|
3 Participants
|
1 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Aspartate aminotransferase increased · Grade 3
|
3 Participants
|
1 Participants
|
1 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Aspartate aminotransferase increased · Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Aspartate aminotransferase increased · Grade 5
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Aspartate aminotransferase increased · Not observed or Grade 1
|
16 Participants
|
16 Participants
|
5 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Back pain · Grade 2
|
2 Participants
|
5 Participants
|
4 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Back pain · Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Back pain · Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Back pain · Grade 5
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Back pain · Not observed or Grade 1
|
19 Participants
|
15 Participants
|
3 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Blood and lymphatic system disorders - Other · Grade 2
|
4 Participants
|
1 Participants
|
0 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Skin and subcutaneous tissue disorders - Other · Grade 2
|
1 Participants
|
3 Participants
|
1 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Blood and lymphatic system disorders - Other · Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Blood and lymphatic system disorders - Other · Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Blood and lymphatic system disorders - Other · Grade 5
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Blood and lymphatic system disorders - Other · Not observed or Grade 1
|
17 Participants
|
19 Participants
|
7 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Blood bilirubin increased · Grade 2
|
5 Participants
|
5 Participants
|
2 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Blood bilirubin increased · Grade 3
|
2 Participants
|
5 Participants
|
0 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Blood bilirubin increased · Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Blood bilirubin increased · Grade 5
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Blood bilirubin increased · Not observed or Grade 1
|
14 Participants
|
10 Participants
|
5 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Cardiac troponin I increased · Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Cardiac troponin I increased · Grade 3
|
3 Participants
|
2 Participants
|
0 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Cardiac troponin I increased · Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Cardiac troponin I increased · Grade 5
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Cardiac troponin I increased · Not observed or Grade 1
|
18 Participants
|
18 Participants
|
7 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Catheter related infection · Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Catheter related infection · Grade 3
|
2 Participants
|
6 Participants
|
0 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Catheter related infection · Grade 4
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Catheter related infection · Grade 5
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Catheter related infection · Not observed or Grade 1
|
18 Participants
|
13 Participants
|
7 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Chills · Grade 2
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Chronic kidney disease · Grade 4
|
2 Participants
|
0 Participants
|
1 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Chronic kidney disease · Grade 5
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Chronic kidney disease · Not observed or Grade 1
|
15 Participants
|
9 Participants
|
4 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Confusion · Grade 2
|
4 Participants
|
2 Participants
|
2 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Confusion · Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Confusion · Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Confusion · Grade 5
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Confusion · Not observed or Grade 1
|
17 Participants
|
18 Participants
|
5 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Creatinine increased · Grade 2
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Creatinine increased · Grade 3
|
3 Participants
|
0 Participants
|
1 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Creatinine increased · Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Creatinine increased · Grade 5
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Creatinine increased · Not observed or Grade 1
|
16 Participants
|
20 Participants
|
6 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Dehydration · Grade 2
|
1 Participants
|
1 Participants
|
2 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Dehydration · Grade 3
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Dehydration · Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Dehydration · Grade 5
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Dehydration · Not observed or Grade 1
|
20 Participants
|
19 Participants
|
4 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Delirium · Grade 2
|
4 Participants
|
1 Participants
|
0 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Delirium · Grade 3
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Delirium · Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Delirium · Grade 5
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Delirium · Not observed or Grade 1
|
15 Participants
|
19 Participants
|
7 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Depression · Grade 2
|
2 Participants
|
3 Participants
|
2 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Depression · Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Depression · Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Depression · Grade 5
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Depression · Not observed or Grade 1
|
19 Participants
|
17 Participants
|
5 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Diarrhea · Grade 2
|
5 Participants
|
9 Participants
|
2 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Diarrhea · Grade 3
|
5 Participants
|
6 Participants
|
4 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Diarrhea · Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Hypertension · Grade 2
|
3 Participants
|
2 Participants
|
2 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Diarrhea · Grade 5
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Diarrhea · Not observed or Grade 1
|
11 Participants
|
5 Participants
|
1 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Disseminated intravascular coagulation · Grade 2
|
14 Participants
|
18 Participants
|
7 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Disseminated intravascular coagulation · Grade 3
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Disseminated intravascular coagulation · Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Disseminated intravascular coagulation · Grade 5
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Disseminated intravascular coagulation · Not observed or Grade 1
|
6 Participants
|
2 Participants
|
0 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Dysgeusia · Grade 2
|
1 Participants
|
4 Participants
|
0 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Dysgeusia · Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Dysgeusia · Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Dysgeusia · Grade 5
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Dysgeusia · Not observed or Grade 1
|
20 Participants
|
16 Participants
|
7 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Dysphagia · Grade 2
|
5 Participants
|
1 Participants
|
0 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Dysphagia · Grade 3
|
2 Participants
|
1 Participants
|
1 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Dysphagia · Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Dysphagia · Grade 5
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Dysphagia · Not observed or Grade 1
|
14 Participants
|
18 Participants
|
6 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Dyspnea · Grade 2
|
3 Participants
|
6 Participants
|
0 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Dyspnea · Grade 3
|
2 Participants
|
4 Participants
|
1 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Dyspnea · Grade 4
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Dyspnea · Grade 5
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Dyspnea · Not observed or Grade 1
|
15 Participants
|
9 Participants
|
6 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Edema limbs · Grade 2
|
4 Participants
|
2 Participants
|
0 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Edema limbs · Grade 3
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Edema limbs · Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Edema limbs · Grade 5
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Edema limbs · Not observed or Grade 1
|
17 Participants
|
18 Participants
|
6 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Ejection fraction decreased · Grade 2
|
2 Participants
|
5 Participants
|
1 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Ejection fraction decreased · Grade 3
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Ejection fraction decreased · Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Ejection fraction decreased · Grade 5
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Ejection fraction decreased · Not observed or Grade 1
|
18 Participants
|
15 Participants
|
6 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Electrocardiogram QT corrected interval prolonged · Grade 2
|
2 Participants
|
4 Participants
|
4 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Electrocardiogram QT corrected interval prolonged · Grade 3
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Electrocardiogram QT corrected interval prolonged · Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Electrocardiogram QT corrected interval prolonged · Grade 5
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Epistaxis · Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Epistaxis · Grade 5
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Epistaxis · Not observed or Grade 1
|
18 Participants
|
18 Participants
|
6 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Fatigue · Grade 2
|
8 Participants
|
10 Participants
|
3 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Pulmonary edema · Grade 2
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Fatigue · Grade 3
|
2 Participants
|
4 Participants
|
3 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Fatigue · Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Fatigue · Grade 5
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Fatigue · Not observed or Grade 1
|
11 Participants
|
6 Participants
|
1 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Febrile neutropenia · Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Febrile neutropenia · Grade 3
|
6 Participants
|
13 Participants
|
4 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Febrile neutropenia · Grade 4
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Febrile neutropenia · Grade 5
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Febrile neutropenia · Not observed or Grade 1
|
15 Participants
|
6 Participants
|
3 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Fever · Grade 2
|
12 Participants
|
9 Participants
|
3 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Pulmonary edema · Grade 3
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Pulmonary edema · Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Fever · Grade 3
|
0 Participants
|
3 Participants
|
0 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Fever · Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Pulmonary edema · Grade 5
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Pulmonary edema · Not observed or Grade 1
|
18 Participants
|
18 Participants
|
7 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Respiratory failure · Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Fever · Grade 5
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Respiratory failure · Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Fever · Not observed or Grade 1
|
9 Participants
|
8 Participants
|
4 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Respiratory failure · Grade 4
|
5 Participants
|
2 Participants
|
0 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Respiratory failure · Grade 5
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Respiratory failure · Not observed or Grade 1
|
16 Participants
|
18 Participants
|
7 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Gastrointestinal disorders - Other · Grade 2
|
1 Participants
|
3 Participants
|
5 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Gastrointestinal disorders - Other · Grade 3
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Respiratory, thoracic and mediastinal disorders - Other · Grade 2
|
4 Participants
|
1 Participants
|
0 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Respiratory, thoracic and mediastinal disorders - Other · Grade 3
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Respiratory, thoracic and mediastinal disorders - Other · Grade 4
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Respiratory, thoracic and mediastinal disorders - Other · Grade 5
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Respiratory, thoracic and mediastinal disorders - Other · Not observed or Grade 1
|
15 Participants
|
18 Participants
|
7 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Gastrointestinal disorders - Other · Grade 5
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Sinus tachycardia · Grade 2
|
4 Participants
|
1 Participants
|
0 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Gastrointestinal disorders - Other · Not observed or Grade 1
|
20 Participants
|
14 Participants
|
2 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Sinus tachycardia · Grade 3
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Sinus tachycardia · Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Sinus tachycardia · Grade 5
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Generalized muscle weakness · Grade 2
|
4 Participants
|
2 Participants
|
3 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Generalized muscle weakness · Grade 3
|
2 Participants
|
5 Participants
|
1 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Sinus tachycardia · Not observed or Grade 1
|
16 Participants
|
19 Participants
|
7 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Generalized muscle weakness · Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Sinusitis · Grade 2
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Generalized muscle weakness · Grade 5
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Generalized muscle weakness · Not observed or Grade 1
|
15 Participants
|
13 Participants
|
3 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Headache · Grade 2
|
3 Participants
|
4 Participants
|
1 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Sinusitis · Grade 3
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Headache · Grade 3
|
2 Participants
|
2 Participants
|
3 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Headache · Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Headache · Grade 5
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Headache · Not observed or Grade 1
|
16 Participants
|
14 Participants
|
3 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Hyperglycemia · Grade 2
|
6 Participants
|
6 Participants
|
0 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Hyperglycemia · Grade 3
|
5 Participants
|
3 Participants
|
2 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Hyperglycemia · Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Hyperglycemia · Grade 5
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Sinusitis · Grade 4
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Hyperglycemia · Not observed or Grade 1
|
10 Participants
|
11 Participants
|
5 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Skin and subcutaneous tissue disorders - Other · Grade 3
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Hypertension · Grade 3
|
5 Participants
|
3 Participants
|
0 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Skin and subcutaneous tissue disorders - Other · Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Hypertension · Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Skin and subcutaneous tissue disorders - Other · Grade 5
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Hypertension · Grade 5
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Skin and subcutaneous tissue disorders - Other · Not observed or Grade 1
|
19 Participants
|
16 Participants
|
6 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Somnolence · Grade 2
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Somnolence · Grade 3
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Somnolence · Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Hypertension · Not observed or Grade 1
|
13 Participants
|
15 Participants
|
5 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Hypoalbuminemia · Grade 2
|
13 Participants
|
16 Participants
|
3 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Somnolence · Grade 5
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Somnolence · Not observed or Grade 1
|
18 Participants
|
19 Participants
|
6 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Hypoalbuminemia · Grade 3
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Hypoalbuminemia · Grade 4
|
3 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Sore throat · Grade 2
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Sore throat · Grade 3
|
0 Participants
|
3 Participants
|
1 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Hypoalbuminemia · Grade 5
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Hypoalbuminemia · Not observed or Grade 1
|
4 Participants
|
4 Participants
|
3 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Sore throat · Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Sore throat · Grade 5
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Sore throat · Not observed or Grade 1
|
19 Participants
|
17 Participants
|
6 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Vomiting · Grade 2
|
1 Participants
|
3 Participants
|
2 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Hypocalcemia · Grade 2
|
1 Participants
|
9 Participants
|
3 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Vomiting · Grade 3
|
1 Participants
|
2 Participants
|
1 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Hypocalcemia · Grade 3
|
3 Participants
|
1 Participants
|
1 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Vomiting · Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Vomiting · Grade 5
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Vomiting · Not observed or Grade 1
|
19 Participants
|
15 Participants
|
4 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Hypocalcemia · Grade 4
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Hypocalcemia · Grade 5
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Weight gain · Grade 2
|
4 Participants
|
2 Participants
|
2 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Weight gain · Grade 3
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Hypocalcemia · Not observed or Grade 1
|
15 Participants
|
10 Participants
|
3 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Hypokalemia · Grade 2
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Hypokalemia · Grade 3
|
7 Participants
|
8 Participants
|
3 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Hypokalemia · Grade 4
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Hypokalemia · Grade 5
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Hypokalemia · Not observed or Grade 1
|
12 Participants
|
9 Participants
|
4 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Hypomagnesemia · Grade 2
|
4 Participants
|
1 Participants
|
2 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Hypomagnesemia · Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Hypomagnesemia · Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Hypomagnesemia · Grade 5
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Hypomagnesemia · Not observed or Grade 1
|
17 Participants
|
19 Participants
|
5 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Hyponatremia · Grade 2
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Hyponatremia · Grade 3
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Weight gain · Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Weight gain · Grade 5
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Weight gain · Not observed or Grade 1
|
17 Participants
|
18 Participants
|
4 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Weight loss · Grade 2
|
0 Participants
|
9 Participants
|
2 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Weight loss · Grade 3
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Weight loss · Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Weight loss · Grade 5
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
Weight loss · Not observed or Grade 1
|
21 Participants
|
11 Participants
|
4 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
White blood cell decreased · Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
White blood cell decreased · Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
White blood cell decreased · Grade 4
|
21 Participants
|
19 Participants
|
7 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
White blood cell decreased · Grade 5
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Frequency of Toxicities Experienced by the Participants, Graded Using the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0
White blood cell decreased · Not observed or Grade 1
|
0 Participants
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Time from enrollment on trial to death from any cause, assessed up to 30 months after completion of therapyWill use Kaplan-Meier estimation to analyze overall survival.
Outcome measures
| Measure |
1500
n=21 Participants
1500 mg/m2 devimistat
|
2000
n=20 Participants
2000 mg/m2 devimistat
|
2500
n=7 Participants
2500 mg/m2 devimistat
|
|---|---|---|---|
|
Overall Survival
|
5.4 months
Interval 1.7 to 7.8
|
7.8 months
Interval 1.8 to 14.1
|
10 months
Interval 3.0 to 12.5
|
SECONDARY outcome
Timeframe: Up to 3 yearsConfidence intervals will be calculated around the estimates of the response rate (CR and CRi). Assuming a response rate of 0.5, with 50 participants, 95 percent confidence intervals can be created with a 0.14 margin of error (0.36, 0.64).
Outcome measures
| Measure |
1500
n=21 Participants
1500 mg/m2 devimistat
|
2000
n=20 Participants
2000 mg/m2 devimistat
|
2500
n=7 Participants
2500 mg/m2 devimistat
|
|---|---|---|---|
|
Response Rate (CR and CRi), Assessed by Standard Criteria for AML
|
9 Participants
|
7 Participants
|
5 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 60 daysEarly mortality (death within 60 days of beginning of treatment).
Outcome measures
| Measure |
1500
n=21 Participants
1500 mg/m2 devimistat
|
2000
n=20 Participants
2000 mg/m2 devimistat
|
2500
n=7 Participants
2500 mg/m2 devimistat
|
|---|---|---|---|
|
Early Mortality (Death Within 60 Days of Beginning of Treatment)
Alive at day 60
|
15 Participants
|
14 Participants
|
6 Participants
|
|
Early Mortality (Death Within 60 Days of Beginning of Treatment)
Deceased at day 60
|
6 Participants
|
6 Participants
|
1 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 3 yearsComplete response rates
Outcome measures
| Measure |
1500
n=21 Participants
1500 mg/m2 devimistat
|
2000
n=20 Participants
2000 mg/m2 devimistat
|
2500
n=7 Participants
2500 mg/m2 devimistat
|
|---|---|---|---|
|
Complete Response
|
8 Participants
|
5 Participants
|
2 Participants
|
Adverse Events
1500
Serious events: 21 serious events
Other events: 21 other events
Deaths: 6 deaths
2000
Serious events: 16 serious events
Other events: 20 other events
Deaths: 6 deaths
2500
Serious events: 4 serious events
Other events: 7 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
1500
n=21 participants at risk
1500 mg/m2 devimistat
|
2000
n=20 participants at risk
2000 mg/m2 devimistat
|
2500
n=7 participants at risk
2500 mg/m2 devimistat
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
4.8%
1/21 • Number of events 1 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
0.00%
0/20 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
14.3%
1/7 • Number of events 1 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/21 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
5.0%
1/20 • Number of events 1 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
0.00%
0/7 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
|
Investigations
Lymphocyte count decreased
|
81.0%
17/21 • Number of events 27 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
15.0%
3/20 • Number of events 15 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
14.3%
1/7 • Number of events 5 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
|
Investigations
Neutrophil count decreased
|
71.4%
15/21 • Number of events 24 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
10.0%
2/20 • Number of events 19 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
14.3%
1/7 • Number of events 5 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
|
Investigations
Platelet count decreased
|
76.2%
16/21 • Number of events 31 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
15.0%
3/20 • Number of events 19 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
14.3%
1/7 • Number of events 6 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
|
Investigations
White blood cell decreased
|
76.2%
16/21 • Number of events 27 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
10.0%
2/20 • Number of events 19 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
14.3%
1/7 • Number of events 5 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
|
Metabolism and nutrition disorders
Acidosis
|
0.00%
0/21 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
5.0%
1/20 • Number of events 1 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
0.00%
0/7 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
4.8%
1/21 • Number of events 1 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
0.00%
0/20 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
14.3%
1/7 • Number of events 1 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
14.3%
3/21 • Number of events 3 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
0.00%
0/20 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
0.00%
0/7 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
9.5%
2/21 • Number of events 2 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
0.00%
0/20 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
0.00%
0/7 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/21 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
5.0%
1/20 • Number of events 1 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
0.00%
0/7 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
14.3%
3/21 • Number of events 3 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
0.00%
0/20 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
0.00%
0/7 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
0.00%
0/21 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
5.0%
1/20 • Number of events 1 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
0.00%
0/7 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
|
Cardiac disorders
Cardiac arrest
|
4.8%
1/21 • Number of events 1 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
10.0%
2/20 • Number of events 2 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
0.00%
0/7 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
|
Cardiac disorders
Cardiac disorders - Other:
|
9.5%
2/21 • Number of events 2 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
0.00%
0/20 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
0.00%
0/7 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other:
|
0.00%
0/21 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
5.0%
1/20 • Number of events 1 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
0.00%
0/7 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
|
Infections and infestations
Catheter related infection
|
0.00%
0/21 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
5.0%
1/20 • Number of events 1 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
0.00%
0/7 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
|
Infections and infestations
Hepatic infection
|
4.8%
1/21 • Number of events 1 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
0.00%
0/20 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
0.00%
0/7 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
|
Infections and infestations
Lung infection
|
4.8%
1/21 • Number of events 1 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
0.00%
0/20 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
0.00%
0/7 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
|
Infections and infestations
Sepsis
|
19.0%
4/21 • Number of events 4 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
0.00%
0/20 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
0.00%
0/7 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/21 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
5.0%
1/20 • Number of events 1 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
0.00%
0/7 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/21 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
5.0%
1/20 • Number of events 1 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
0.00%
0/7 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
|
Infections and infestations
Infections and infestations - Other:
|
4.8%
1/21 • Number of events 1 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
0.00%
0/20 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
0.00%
0/7 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchopulmonary hemorrhage
|
0.00%
0/21 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
5.0%
1/20 • Number of events 1 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
0.00%
0/7 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
4.8%
1/21 • Number of events 1 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
5.0%
1/20 • Number of events 1 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
0.00%
0/7 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
4.8%
1/21 • Number of events 1 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
5.0%
1/20 • Number of events 1 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
0.00%
0/7 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
23.8%
5/21 • Number of events 5 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
10.0%
2/20 • Number of events 2 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
0.00%
0/7 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other:
|
4.8%
1/21 • Number of events 1 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
0.00%
0/20 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
0.00%
0/7 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
|
General disorders
Multi-organ failure
|
9.5%
2/21 • Number of events 2 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
0.00%
0/20 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
0.00%
0/7 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
|
Nervous system disorders
Somnolence
|
4.8%
1/21 • Number of events 1 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
0.00%
0/20 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
0.00%
0/7 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
|
Renal and urinary disorders
Acute kidney injury
|
9.5%
2/21 • Number of events 2 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
0.00%
0/20 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
0.00%
0/7 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
|
Renal and urinary disorders
Chronic kidney disease
|
4.8%
1/21 • Number of events 1 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
0.00%
0/20 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
0.00%
0/7 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
|
Renal and urinary disorders
Renal and urinary disorders - Other:
|
4.8%
1/21 • Number of events 1 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
0.00%
0/20 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
0.00%
0/7 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
Other adverse events
| Measure |
1500
n=21 participants at risk
1500 mg/m2 devimistat
|
2000
n=20 participants at risk
2000 mg/m2 devimistat
|
2500
n=7 participants at risk
2500 mg/m2 devimistat
|
|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Skin ulceration
|
9.5%
2/21 • Number of events 2 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
0.00%
0/20 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
14.3%
1/7 • Number of events 1 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
9.5%
2/21 • Number of events 2 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
20.0%
4/20 • Number of events 6 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
14.3%
1/7 • Number of events 1 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
|
Blood and lymphatic system disorders
Anemia
|
95.2%
20/21 • Number of events 38 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
95.0%
19/20 • Number of events 36 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
85.7%
6/7 • Number of events 14 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
71.4%
15/21 • Number of events 21 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
90.0%
18/20 • Number of events 27 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
100.0%
7/7 • Number of events 12 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
28.6%
6/21 • Number of events 8 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
65.0%
13/20 • Number of events 14 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
57.1%
4/7 • Number of events 4 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders - Other:
|
9.5%
2/21 • Number of events 2 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
0.00%
0/20 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
0.00%
0/7 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
|
Cardiac disorders
Aortic valve disease
|
0.00%
0/21 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
0.00%
0/20 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
14.3%
1/7 • Number of events 2 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/21 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
10.0%
2/20 • Number of events 2 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
0.00%
0/7 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
|
Cardiac disorders
Atrioventricular block first degree
|
0.00%
0/21 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
10.0%
2/20 • Number of events 2 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
0.00%
0/7 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
|
Cardiac disorders
Chest pain - cardiac
|
0.00%
0/21 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
10.0%
2/20 • Number of events 2 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
0.00%
0/7 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
|
Cardiac disorders
Sinus bradycardia
|
9.5%
2/21 • Number of events 2 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
15.0%
3/20 • Number of events 3 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
14.3%
1/7 • Number of events 2 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
|
Cardiac disorders
Sinus tachycardia
|
38.1%
8/21 • Number of events 9 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
65.0%
13/20 • Number of events 14 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
57.1%
4/7 • Number of events 6 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/21 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
0.00%
0/20 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
14.3%
1/7 • Number of events 1 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
|
Cardiac disorders
Ventricular arrhythmia
|
0.00%
0/21 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
15.0%
3/20 • Number of events 3 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
0.00%
0/7 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
|
Cardiac disorders
Ventricular tachycardia
|
0.00%
0/21 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
10.0%
2/20 • Number of events 2 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
14.3%
1/7 • Number of events 1 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
|
Cardiac disorders
Cardiac disorders - Other:
|
9.5%
2/21 • Number of events 2 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
30.0%
6/20 • Number of events 7 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
14.3%
1/7 • Number of events 2 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
|
Ear and labyrinth disorders
Ear pain
|
19.0%
4/21 • Number of events 4 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
0.00%
0/20 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
0.00%
0/7 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/21 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
0.00%
0/20 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
14.3%
1/7 • Number of events 1 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
|
Eye disorders
Blurred vision
|
0.00%
0/21 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
10.0%
2/20 • Number of events 2 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
14.3%
1/7 • Number of events 1 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
|
Eye disorders
Eye pain
|
9.5%
2/21 • Number of events 2 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
0.00%
0/20 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
0.00%
0/7 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
|
Eye disorders
Photophobia
|
0.00%
0/21 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
0.00%
0/20 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
14.3%
1/7 • Number of events 1 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
|
Eye disorders
Eye disorders - Other:
|
19.0%
4/21 • Number of events 4 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
15.0%
3/20 • Number of events 5 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
14.3%
1/7 • Number of events 1 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
|
Gastrointestinal disorders
Abdominal distension
|
19.0%
4/21 • Number of events 4 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
0.00%
0/20 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
0.00%
0/7 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
|
Gastrointestinal disorders
Abdominal pain
|
28.6%
6/21 • Number of events 10 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
25.0%
5/20 • Number of events 6 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
85.7%
6/7 • Number of events 8 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
|
Gastrointestinal disorders
Anal pain
|
0.00%
0/21 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
10.0%
2/20 • Number of events 3 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
0.00%
0/7 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/21 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
0.00%
0/20 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
14.3%
1/7 • Number of events 1 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
|
Gastrointestinal disorders
Constipation
|
42.9%
9/21 • Number of events 12 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
40.0%
8/20 • Number of events 9 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
57.1%
4/7 • Number of events 6 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/21 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
10.0%
2/20 • Number of events 2 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
0.00%
0/7 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
|
Gastrointestinal disorders
Diarrhea
|
76.2%
16/21 • Number of events 22 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
100.0%
20/20 • Number of events 30 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
100.0%
7/7 • Number of events 11 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
|
Gastrointestinal disorders
Dry mouth
|
42.9%
9/21 • Number of events 10 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
45.0%
9/20 • Number of events 10 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
14.3%
1/7 • Number of events 1 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
|
Gastrointestinal disorders
Dysphagia
|
42.9%
9/21 • Number of events 9 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
20.0%
4/20 • Number of events 4 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
14.3%
1/7 • Number of events 1 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
|
Gastrointestinal disorders
Enterocolitis
|
0.00%
0/21 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
0.00%
0/20 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
14.3%
1/7 • Number of events 1 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
|
Gastrointestinal disorders
Fecal incontinence
|
0.00%
0/21 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
15.0%
3/20 • Number of events 3 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
14.3%
1/7 • Number of events 1 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
|
Gastrointestinal disorders
Flatulence
|
14.3%
3/21 • Number of events 3 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
0.00%
0/20 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
14.3%
1/7 • Number of events 1 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
0.00%
0/21 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
25.0%
5/20 • Number of events 5 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
14.3%
1/7 • Number of events 1 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
0.00%
0/21 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
0.00%
0/20 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
14.3%
1/7 • Number of events 1 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
|
Gastrointestinal disorders
Lower gastrointestinal hemorrhage
|
0.00%
0/21 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
0.00%
0/20 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
14.3%
1/7 • Number of events 1 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
|
Gastrointestinal disorders
Mucositis oral
|
28.6%
6/21 • Number of events 6 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
55.0%
11/20 • Number of events 13 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
28.6%
2/7 • Number of events 2 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
|
Gastrointestinal disorders
Nausea
|
61.9%
13/21 • Number of events 22 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
80.0%
16/20 • Number of events 24 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
100.0%
7/7 • Number of events 11 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
|
Gastrointestinal disorders
Oral hemorrhage
|
9.5%
2/21 • Number of events 2 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
15.0%
3/20 • Number of events 3 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
0.00%
0/7 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/21 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
20.0%
4/20 • Number of events 6 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
28.6%
2/7 • Number of events 2 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
0.00%
0/21 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
20.0%
4/20 • Number of events 4 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
0.00%
0/7 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
|
Gastrointestinal disorders
Rectal pain
|
0.00%
0/21 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
0.00%
0/20 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
14.3%
1/7 • Number of events 1 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
|
Gastrointestinal disorders
Vomiting
|
47.6%
10/21 • Number of events 13 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
50.0%
10/20 • Number of events 17 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
57.1%
4/7 • Number of events 7 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other:
|
23.8%
5/21 • Number of events 5 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
45.0%
9/20 • Number of events 20 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
71.4%
5/7 • Number of events 8 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
|
General disorders
Chills
|
52.4%
11/21 • Number of events 13 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
35.0%
7/20 • Number of events 8 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
57.1%
4/7 • Number of events 4 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
|
General disorders
Edema face
|
14.3%
3/21 • Number of events 3 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
10.0%
2/20 • Number of events 2 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
0.00%
0/7 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
|
General disorders
Edema limbs
|
57.1%
12/21 • Number of events 13 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
70.0%
14/20 • Number of events 21 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
57.1%
4/7 • Number of events 7 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
|
General disorders
Edema trunk
|
9.5%
2/21 • Number of events 2 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
0.00%
0/20 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
14.3%
1/7 • Number of events 1 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
|
General disorders
Facial pain
|
9.5%
2/21 • Number of events 2 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
0.00%
0/20 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
0.00%
0/7 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
|
General disorders
Fatigue
|
76.2%
16/21 • Number of events 25 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
85.0%
17/20 • Number of events 27 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
100.0%
7/7 • Number of events 10 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
|
General disorders
Fever
|
71.4%
15/21 • Number of events 20 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
70.0%
14/20 • Number of events 17 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
85.7%
6/7 • Number of events 7 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
|
General disorders
Gait disturbance
|
14.3%
3/21 • Number of events 3 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
0.00%
0/20 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
0.00%
0/7 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
|
General disorders
Hypothermia
|
9.5%
2/21 • Number of events 2 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
0.00%
0/20 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
0.00%
0/7 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
|
General disorders
Injection site reaction
|
9.5%
2/21 • Number of events 2 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
0.00%
0/20 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
0.00%
0/7 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
|
General disorders
Localized edema
|
9.5%
2/21 • Number of events 2 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
0.00%
0/20 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
0.00%
0/7 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
|
General disorders
Malaise
|
14.3%
3/21 • Number of events 3 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
0.00%
0/20 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
14.3%
1/7 • Number of events 1 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
|
General disorders
Non-cardiac chest pain
|
33.3%
7/21 • Number of events 8 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
35.0%
7/20 • Number of events 9 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
57.1%
4/7 • Number of events 4 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
|
General disorders
Pain
|
33.3%
7/21 • Number of events 9 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
55.0%
11/20 • Number of events 12 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
71.4%
5/7 • Number of events 9 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
|
General disorders
General disorders and administration site conditions - Other:
|
9.5%
2/21 • Number of events 2 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
0.00%
0/20 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
28.6%
2/7 • Number of events 2 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
|
Infections and infestations
Catheter related infection
|
14.3%
3/21 • Number of events 3 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
30.0%
6/20 • Number of events 6 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
0.00%
0/7 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
|
Infections and infestations
Enterocolitis infectious
|
0.00%
0/21 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
0.00%
0/20 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
14.3%
1/7 • Number of events 1 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
|
Infections and infestations
Lung infection
|
23.8%
5/21 • Number of events 5 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
55.0%
11/20 • Number of events 11 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
28.6%
2/7 • Number of events 3 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
|
Infections and infestations
Mucosal infection
|
9.5%
2/21 • Number of events 2 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
0.00%
0/20 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
14.3%
1/7 • Number of events 1 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
|
Infections and infestations
Papulopustular rash
|
19.0%
4/21 • Number of events 4 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
0.00%
0/20 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
0.00%
0/7 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
|
Infections and infestations
Sinusitis
|
14.3%
3/21 • Number of events 3 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
0.00%
0/20 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
14.3%
1/7 • Number of events 1 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
|
Infections and infestations
Skin infection
|
0.00%
0/21 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
20.0%
4/20 • Number of events 4 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
0.00%
0/7 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
|
Infections and infestations
Urinary tract infection
|
9.5%
2/21 • Number of events 2 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
0.00%
0/20 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
0.00%
0/7 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
|
Infections and infestations
Infections and infestations - Other:
|
19.0%
4/21 • Number of events 5 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
30.0%
6/20 • Number of events 10 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
42.9%
3/7 • Number of events 3 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
|
Injury, poisoning and procedural complications
Bruising
|
19.0%
4/21 • Number of events 4 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
25.0%
5/20 • Number of events 7 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
0.00%
0/7 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/21 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
0.00%
0/20 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
14.3%
1/7 • Number of events 1 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
|
Injury, poisoning and procedural complications
Injury, poisoning and procedural complications - Other:
|
9.5%
2/21 • Number of events 2 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
0.00%
0/20 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
0.00%
0/7 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
|
Investigations
Activated partial thromboplastin time prolonged
|
38.1%
8/21 • Number of events 9 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
50.0%
10/20 • Number of events 13 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
85.7%
6/7 • Number of events 8 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
|
Investigations
Alanine aminotransferase increased
|
76.2%
16/21 • Number of events 20 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
70.0%
14/20 • Number of events 19 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
100.0%
7/7 • Number of events 9 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
|
Investigations
Alkaline phosphatase increased
|
47.6%
10/21 • Number of events 13 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
45.0%
9/20 • Number of events 12 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
57.1%
4/7 • Number of events 6 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
|
Investigations
Aspartate aminotransferase increased
|
85.7%
18/21 • Number of events 22 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
75.0%
15/20 • Number of events 21 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
100.0%
7/7 • Number of events 9 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
|
Investigations
Blood bilirubin increased
|
66.7%
14/21 • Number of events 16 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
75.0%
15/20 • Number of events 22 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
100.0%
7/7 • Number of events 8 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
|
Investigations
Cardiac troponin I increased
|
14.3%
3/21 • Number of events 3 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
25.0%
5/20 • Number of events 6 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
0.00%
0/7 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
|
Investigations
Creatinine increased
|
28.6%
6/21 • Number of events 6 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
0.00%
0/20 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
14.3%
1/7 • Number of events 1 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
|
Investigations
Ejection fraction decreased
|
14.3%
3/21 • Number of events 3 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
25.0%
5/20 • Number of events 6 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
14.3%
1/7 • Number of events 1 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
|
Investigations
Electrocardiogram QT corrected interval prolonged
|
14.3%
3/21 • Number of events 3 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
50.0%
10/20 • Number of events 12 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
57.1%
4/7 • Number of events 6 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
|
Investigations
GGT increased
|
0.00%
0/21 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
0.00%
0/20 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
14.3%
1/7 • Number of events 1 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
|
Investigations
Lymphocyte count decreased
|
19.0%
4/21 • Number of events 12 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
85.0%
17/20 • Number of events 22 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
85.7%
6/7 • Number of events 10 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
|
Investigations
Neutrophil count decreased
|
28.6%
6/21 • Number of events 12 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
85.0%
17/20 • Number of events 17 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
85.7%
6/7 • Number of events 9 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
|
Investigations
Platelet count decreased
|
23.8%
5/21 • Number of events 9 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
85.0%
17/20 • Number of events 18 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
85.7%
6/7 • Number of events 9 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
|
Investigations
Weight gain
|
23.8%
5/21 • Number of events 6 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
35.0%
7/20 • Number of events 9 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
71.4%
5/7 • Number of events 6 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
|
Investigations
Weight loss
|
19.0%
4/21 • Number of events 6 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
65.0%
13/20 • Number of events 20 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
57.1%
4/7 • Number of events 6 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
|
Investigations
White blood cell decreased
|
23.8%
5/21 • Number of events 13 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
85.0%
17/20 • Number of events 17 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
85.7%
6/7 • Number of events 10 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
|
Metabolism and nutrition disorders
Alkalosis
|
9.5%
2/21 • Number of events 2 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
30.0%
6/20 • Number of events 6 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
0.00%
0/7 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
|
Metabolism and nutrition disorders
Anorexia
|
76.2%
16/21 • Number of events 23 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
85.0%
17/20 • Number of events 25 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
85.7%
6/7 • Number of events 9 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
|
Metabolism and nutrition disorders
Dehydration
|
9.5%
2/21 • Number of events 2 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
0.00%
0/20 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
42.9%
3/7 • Number of events 3 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
100.0%
21/21 • Number of events 37 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
95.0%
19/20 • Number of events 36 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
100.0%
7/7 • Number of events 14 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
28.6%
6/21 • Number of events 7 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
30.0%
6/20 • Number of events 6 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
28.6%
2/7 • Number of events 3 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
|
Metabolism and nutrition disorders
Hypernatremia
|
9.5%
2/21 • Number of events 2 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
30.0%
6/20 • Number of events 6 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
0.00%
0/7 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
9.5%
2/21 • Number of events 2 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
0.00%
0/20 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
14.3%
1/7 • Number of events 1 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
0.00%
0/21 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
0.00%
0/20 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
14.3%
1/7 • Number of events 1 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
85.7%
18/21 • Number of events 30 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
100.0%
20/20 • Number of events 34 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
100.0%
7/7 • Number of events 12 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
66.7%
14/21 • Number of events 18 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
85.0%
17/20 • Number of events 20 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
85.7%
6/7 • Number of events 8 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
9.5%
2/21 • Number of events 2 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
30.0%
6/20 • Number of events 6 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
28.6%
2/7 • Number of events 2 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
85.7%
18/21 • Number of events 23 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
85.0%
17/20 • Number of events 27 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
100.0%
7/7 • Number of events 11 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
71.4%
15/21 • Number of events 25 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
90.0%
18/20 • Number of events 30 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
85.7%
6/7 • Number of events 11 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
47.6%
10/21 • Number of events 14 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
50.0%
10/20 • Number of events 12 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
85.7%
6/7 • Number of events 8 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
66.7%
14/21 • Number of events 16 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
75.0%
15/20 • Number of events 18 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
85.7%
6/7 • Number of events 10 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
9.5%
2/21 • Number of events 2 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
20.0%
4/20 • Number of events 5 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
28.6%
2/7 • Number of events 5 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
28.6%
6/21 • Number of events 6 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
35.0%
7/20 • Number of events 10 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
57.1%
4/7 • Number of events 4 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
19.0%
4/21 • Number of events 7 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
0.00%
0/20 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
0.00%
0/7 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
23.8%
5/21 • Number of events 5 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
0.00%
0/20 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
0.00%
0/7 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
38.1%
8/21 • Number of events 8 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
40.0%
8/20 • Number of events 10 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
57.1%
4/7 • Number of events 4 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/21 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
30.0%
6/20 • Number of events 6 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
28.6%
2/7 • Number of events 3 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
19.0%
4/21 • Number of events 5 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
0.00%
0/20 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
14.3%
1/7 • Number of events 2 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
33.3%
7/21 • Number of events 10 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
10.0%
2/20 • Number of events 2 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
85.7%
6/7 • Number of events 11 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other:
|
14.3%
3/21 • Number of events 4 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
0.00%
0/20 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
14.3%
1/7 • Number of events 1 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
|
Nervous system disorders
Ataxia
|
14.3%
3/21 • Number of events 3 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
0.00%
0/20 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
0.00%
0/7 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
|
Nervous system disorders
Cognitive disturbance
|
9.5%
2/21 • Number of events 2 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
0.00%
0/20 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
0.00%
0/7 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
|
Nervous system disorders
Dizziness
|
14.3%
3/21 • Number of events 4 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
30.0%
6/20 • Number of events 8 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
42.9%
3/7 • Number of events 3 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
|
Nervous system disorders
Dysarthria
|
9.5%
2/21 • Number of events 2 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
0.00%
0/20 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
0.00%
0/7 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
|
Nervous system disorders
Dysgeusia
|
42.9%
9/21 • Number of events 9 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
55.0%
11/20 • Number of events 15 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
28.6%
2/7 • Number of events 3 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
|
Nervous system disorders
Encephalopathy
|
9.5%
2/21 • Number of events 2 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
10.0%
2/20 • Number of events 2 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
0.00%
0/7 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
|
Nervous system disorders
Headache
|
42.9%
9/21 • Number of events 11 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
65.0%
13/20 • Number of events 16 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
71.4%
5/7 • Number of events 8 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
|
Nervous system disorders
Lethargy
|
19.0%
4/21 • Number of events 4 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
10.0%
2/20 • Number of events 2 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
28.6%
2/7 • Number of events 2 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
|
Nervous system disorders
Movements involuntary
|
9.5%
2/21 • Number of events 2 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
0.00%
0/20 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
0.00%
0/7 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
19.0%
4/21 • Number of events 4 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
0.00%
0/20 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
28.6%
2/7 • Number of events 2 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
|
Nervous system disorders
Somnolence
|
19.0%
4/21 • Number of events 4 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
30.0%
6/20 • Number of events 6 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
42.9%
3/7 • Number of events 3 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
|
Nervous system disorders
Syncope
|
0.00%
0/21 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
10.0%
2/20 • Number of events 2 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
14.3%
1/7 • Number of events 1 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
|
Nervous system disorders
Tremor
|
0.00%
0/21 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
15.0%
3/20 • Number of events 5 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
0.00%
0/7 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
|
Nervous system disorders
Nervous system disorders - Other:
|
19.0%
4/21 • Number of events 8 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
10.0%
2/20 • Number of events 2 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
28.6%
2/7 • Number of events 3 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
|
Psychiatric disorders
Agitation
|
19.0%
4/21 • Number of events 4 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
10.0%
2/20 • Number of events 2 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
14.3%
1/7 • Number of events 1 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
|
Psychiatric disorders
Anxiety
|
38.1%
8/21 • Number of events 8 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
50.0%
10/20 • Number of events 12 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
71.4%
5/7 • Number of events 6 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
|
Psychiatric disorders
Confusion
|
28.6%
6/21 • Number of events 6 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
35.0%
7/20 • Number of events 7 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
42.9%
3/7 • Number of events 4 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
|
Psychiatric disorders
Delirium
|
28.6%
6/21 • Number of events 6 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
15.0%
3/20 • Number of events 3 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
0.00%
0/7 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
|
Psychiatric disorders
Depression
|
33.3%
7/21 • Number of events 9 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
15.0%
3/20 • Number of events 4 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
28.6%
2/7 • Number of events 3 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
|
Psychiatric disorders
Hallucinations
|
19.0%
4/21 • Number of events 4 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
10.0%
2/20 • Number of events 2 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
14.3%
1/7 • Number of events 1 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
|
Psychiatric disorders
Insomnia
|
23.8%
5/21 • Number of events 7 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
30.0%
6/20 • Number of events 7 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
0.00%
0/7 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
|
Renal and urinary disorders
Acute kidney injury
|
23.8%
5/21 • Number of events 5 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
10.0%
2/20 • Number of events 2 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
14.3%
1/7 • Number of events 1 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
|
Renal and urinary disorders
Chronic kidney disease
|
23.8%
5/21 • Number of events 6 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
55.0%
11/20 • Number of events 14 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
42.9%
3/7 • Number of events 5 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
|
Renal and urinary disorders
Hematuria
|
28.6%
6/21 • Number of events 6 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
10.0%
2/20 • Number of events 2 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
14.3%
1/7 • Number of events 1 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
|
Renal and urinary disorders
Proteinuria
|
19.0%
4/21 • Number of events 4 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
25.0%
5/20 • Number of events 5 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
28.6%
2/7 • Number of events 2 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
|
Renal and urinary disorders
Urinary frequency
|
23.8%
5/21 • Number of events 5 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
0.00%
0/20 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
14.3%
1/7 • Number of events 1 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
|
Renal and urinary disorders
Urinary incontinence
|
9.5%
2/21 • Number of events 2 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
0.00%
0/20 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
14.3%
1/7 • Number of events 1 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/21 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
10.0%
2/20 • Number of events 3 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
14.3%
1/7 • Number of events 1 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
|
Renal and urinary disorders
Urinary tract pain
|
9.5%
2/21 • Number of events 2 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
25.0%
5/20 • Number of events 5 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
14.3%
1/7 • Number of events 1 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
|
Renal and urinary disorders
Renal and urinary disorders - Other:
|
14.3%
3/21 • Number of events 6 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
10.0%
2/20 • Number of events 3 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
14.3%
1/7 • Number of events 1 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
|
Reproductive system and breast disorders
Menorrhagia
|
9.5%
2/21 • Number of events 2 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
0.00%
0/20 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
0.00%
0/7 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
|
Reproductive system and breast disorders
Reproductive system and breast disorders - Other:
|
0.00%
0/21 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
0.00%
0/20 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
14.3%
1/7 • Number of events 1 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
0.00%
0/21 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
10.0%
2/20 • Number of events 2 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
14.3%
1/7 • Number of events 1 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.00%
0/21 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
0.00%
0/20 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
14.3%
1/7 • Number of events 1 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
42.9%
9/21 • Number of events 9 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
40.0%
8/20 • Number of events 9 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
57.1%
4/7 • Number of events 6 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
42.9%
9/21 • Number of events 9 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
60.0%
12/20 • Number of events 18 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
42.9%
3/7 • Number of events 3 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
19.0%
4/21 • Number of events 4 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
30.0%
6/20 • Number of events 6 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
14.3%
1/7 • Number of events 1 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
9.5%
2/21 • Number of events 2 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
20.0%
4/20 • Number of events 5 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
14.3%
1/7 • Number of events 1 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
9.5%
2/21 • Number of events 3 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
10.0%
2/20 • Number of events 3 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
14.3%
1/7 • Number of events 1 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
14.3%
3/21 • Number of events 3 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
40.0%
8/20 • Number of events 8 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
42.9%
3/7 • Number of events 3 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
9.5%
2/21 • Number of events 2 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
0.00%
0/20 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
0.00%
0/7 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
9.5%
2/21 • Number of events 3 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
10.0%
2/20 • Number of events 2 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
0.00%
0/7 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
14.3%
3/21 • Number of events 3 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
15.0%
3/20 • Number of events 3 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
28.6%
2/7 • Number of events 2 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary edema
|
23.8%
5/21 • Number of events 5 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
20.0%
4/20 • Number of events 4 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
0.00%
0/7 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
33.3%
7/21 • Number of events 10 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
35.0%
7/20 • Number of events 7 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
42.9%
3/7 • Number of events 4 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/21 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
35.0%
7/20 • Number of events 9 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
14.3%
1/7 • Number of events 1 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other:
|
19.0%
4/21 • Number of events 5 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
25.0%
5/20 • Number of events 9 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
14.3%
1/7 • Number of events 1 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
9.5%
2/21 • Number of events 2 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
0.00%
0/20 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
0.00%
0/7 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/21 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
15.0%
3/20 • Number of events 3 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
0.00%
0/7 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
19.0%
4/21 • Number of events 7 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
45.0%
9/20 • Number of events 11 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
28.6%
2/7 • Number of events 2 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
|
Skin and subcutaneous tissue disorders
Purpura
|
0.00%
0/21 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
15.0%
3/20 • Number of events 3 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
0.00%
0/7 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
9.5%
2/21 • Number of events 2 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
0.00%
0/20 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
0.00%
0/7 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
19.0%
4/21 • Number of events 5 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
45.0%
9/20 • Number of events 12 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
28.6%
2/7 • Number of events 3 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other:
|
19.0%
4/21 • Number of events 8 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
60.0%
12/20 • Number of events 22 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
85.7%
6/7 • Number of events 10 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
|
Vascular disorders
Hot flashes
|
28.6%
6/21 • Number of events 6 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
0.00%
0/20 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
0.00%
0/7 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
|
Vascular disorders
Hypertension
|
38.1%
8/21 • Number of events 8 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
25.0%
5/20 • Number of events 6 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
28.6%
2/7 • Number of events 2 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
|
Vascular disorders
Hypotension
|
23.8%
5/21 • Number of events 6 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
25.0%
5/20 • Number of events 7 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
57.1%
4/7 • Number of events 6 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
|
Vascular disorders
Superficial thrombophlebitis
|
0.00%
0/21 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
0.00%
0/20 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
14.3%
1/7 • Number of events 1 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps
|
9.5%
2/21 • Number of events 2 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
0.00%
0/20 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
0.00%
0/7 • Adverse Events were collected while patients were on treatment, which ranged from 15 days to 187 days (up to 6 months)
Serious adverse events include all unexpected grade 4 and all grade 5 adverse events.
|
Additional Information
Principal Investigator
Wake Forest Baptist Comprehensive Cancer Center
Phone: 336-716-7970
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place