Trial Outcomes & Findings for A Study of Glembatumumab Vedotin as Monotherapy or in Combination With Immunotherapies in Patients With Advanced Melanoma (NCT NCT02302339)
NCT ID: NCT02302339
Last Updated: 2019-09-06
Results Overview
ORR is defined as the percentage of patients who achieved best overall response of complete or partial response. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST version 1.1), Complete Response (CR) = disappearance of all target lesions and non-target lesions, Partial Response (PR), \>= 30% decrease in the sum of the longest diameter of target lesions with no progression in non-target lesions and no new lesions. ORR was the primary outcome for Cohorts 1-3 and a secondary outcome for Cohort 4.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
132 participants
Primary outcome timeframe
Every 6 to 9 weeks following treatment initiation until disease progression.
Results posted on
2019-09-06
Participant Flow
Participant milestones
| Measure |
Glembatumumab Vedotin
glembatumumab vedotin administered as an intravenous infusion on Day 1 of each 21 day cycle.
glembatumumab vedotin
|
Glembatumumab Vedotin and Varlilumab
glembatumumab vedotin administered as an intravenous infusion on Day 1 of each 21 day cycle. Varlilumab administered as an intravenous infusion on Day 1 of cycles 1, 2, 4, 6, 8 and 10.
glembatumumab vedotin and varlilumab
|
Glembatumumab Vedotin and PD-1 Targeted Checkpoint Inhibitor
glembatumumab vedotin administered as an intravenous infusion on Day 1 of each 21 day cycle. Nivolumab OR pembrolizumab administered according to institutional standard of care.
glembatumumab vedotin and PD-1 targeted checkpoint inhibitor (nivolumab OR pembrolizumab)
|
Glembatumumab Vedotin and CDX-301
glembatumumab vedotin administered as an intravenous infusion on Day 1 of each 21 day cycle. CDX-301 is injected once a day for five days before cycles 1 and 2.
glembatumumab vedotin and CDX-301
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
62
|
34
|
29
|
7
|
|
Overall Study
COMPLETED
|
61
|
32
|
28
|
7
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
1
|
0
|
Reasons for withdrawal
| Measure |
Glembatumumab Vedotin
glembatumumab vedotin administered as an intravenous infusion on Day 1 of each 21 day cycle.
glembatumumab vedotin
|
Glembatumumab Vedotin and Varlilumab
glembatumumab vedotin administered as an intravenous infusion on Day 1 of each 21 day cycle. Varlilumab administered as an intravenous infusion on Day 1 of cycles 1, 2, 4, 6, 8 and 10.
glembatumumab vedotin and varlilumab
|
Glembatumumab Vedotin and PD-1 Targeted Checkpoint Inhibitor
glembatumumab vedotin administered as an intravenous infusion on Day 1 of each 21 day cycle. Nivolumab OR pembrolizumab administered according to institutional standard of care.
glembatumumab vedotin and PD-1 targeted checkpoint inhibitor (nivolumab OR pembrolizumab)
|
Glembatumumab Vedotin and CDX-301
glembatumumab vedotin administered as an intravenous infusion on Day 1 of each 21 day cycle. CDX-301 is injected once a day for five days before cycles 1 and 2.
glembatumumab vedotin and CDX-301
|
|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
2
|
1
|
0
|
Baseline Characteristics
A Study of Glembatumumab Vedotin as Monotherapy or in Combination With Immunotherapies in Patients With Advanced Melanoma
Baseline characteristics by cohort
| Measure |
Glembatumumab Vedotin
n=62 Participants
glembatumumab vedotin administered as an intravenous infusion on Day 1 of each 21 day cycle.
glembatumumab vedotin
|
Glembatumumab Vedotin and Varlilumab
n=34 Participants
glembatumumab vedotin administered as an intravenous infusion on Day 1 of each 21 day cycle. Varlilumab administered as an intravenous infusion on Day 1 of cycles 1, 2, 4, 6, 8 and 10.
glembatumumab vedotin and varlilumab
|
Glembatumumab Vedotin and PD-1 Targeted Checkpoint Inhibitor
n=29 Participants
glembatumumab vedotin administered as an intravenous infusion on Day 1 of each 21 day cycle. Nivolumab OR pembrolizumab administered according to institutional standard of care.
glembatumumab vedotin and PD-1 targeted checkpoint inhibitor (nivolumab OR pembrolizumab)
|
Glembatumumab Vedotin and CDX-301
n=7 Participants
glembatumumab vedotin administered as an intravenous infusion on Day 1 of each 21 day cycle. CDX-301 is injected once a day for five days before cycles 1 and 2.
glembatumumab vedotin and CDX-301
|
Total
n=132 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
26 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
64 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
36 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
68 Participants
n=21 Participants
|
|
Sex: Female, Male
Female
|
28 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
57 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
34 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
75 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
57 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
123 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
White
|
61 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
126 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Every 6 to 9 weeks following treatment initiation until disease progression.Population: Response evaluable (at least one dose and a post treatment disease assessment)
ORR is defined as the percentage of patients who achieved best overall response of complete or partial response. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST version 1.1), Complete Response (CR) = disappearance of all target lesions and non-target lesions, Partial Response (PR), \>= 30% decrease in the sum of the longest diameter of target lesions with no progression in non-target lesions and no new lesions. ORR was the primary outcome for Cohorts 1-3 and a secondary outcome for Cohort 4.
Outcome measures
| Measure |
Glembatumumab Vedotin
n=62 Participants
glembatumumab vedotin administered as an intravenous infusion on Day 1 of each 21 day cycle.
glembatumumab vedotin
|
Glembatumumab Vedotin and Varlilumab
n=31 Participants
glembatumumab vedotin administered as an intravenous infusion on Day 1 of each 21 day cycle. Varlilumab administered as an intravenous infusion on Day 1 of cycles 1, 2, 4, 6, 8 and 10.
glembatumumab vedotin and varlilumab
|
Glembatumumab Vedotin and PD-1 Targeted Checkpoint Inhibitor
n=28 Participants
glembatumumab vedotin administered as an intravenous infusion on Day 1 of each 21 day cycle. Nivolumab OR pembrolizumab administered according to institutional standard of care.
glembatumumab vedotin and PD-1 targeted checkpoint inhibitor (nivolumab OR pembrolizumab)
|
Glembatumumab Vedotin and CDX-301
n=5 Participants
glembatumumab vedotin administered as an intravenous infusion on Day 1 of each 21 day cycle. CDX-301 is injected once a day for five days before cycles 1 and 2.
glembatumumab vedotin and CDX-301
|
|---|---|---|---|---|
|
Objective Response Rate (ORR)
|
7 Participants
|
1 Participants
|
4 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to 18 months following the screening visitThe percentage of patients experiencing one or more adverse events.
Outcome measures
| Measure |
Glembatumumab Vedotin
n=7 Participants
glembatumumab vedotin administered as an intravenous infusion on Day 1 of each 21 day cycle.
glembatumumab vedotin
|
Glembatumumab Vedotin and Varlilumab
glembatumumab vedotin administered as an intravenous infusion on Day 1 of each 21 day cycle. Varlilumab administered as an intravenous infusion on Day 1 of cycles 1, 2, 4, 6, 8 and 10.
glembatumumab vedotin and varlilumab
|
Glembatumumab Vedotin and PD-1 Targeted Checkpoint Inhibitor
glembatumumab vedotin administered as an intravenous infusion on Day 1 of each 21 day cycle. Nivolumab OR pembrolizumab administered according to institutional standard of care.
glembatumumab vedotin and PD-1 targeted checkpoint inhibitor (nivolumab OR pembrolizumab)
|
Glembatumumab Vedotin and CDX-301
glembatumumab vedotin administered as an intravenous infusion on Day 1 of each 21 day cycle. CDX-301 is injected once a day for five days before cycles 1 and 2.
glembatumumab vedotin and CDX-301
|
|---|---|---|---|---|
|
Adverse Events of the Combination of Glembatumumab Vedotin and CDX-301 (in Cohort 4).
Vulvovaginal pain
|
1 Participants
|
—
|
—
|
—
|
|
Adverse Events of the Combination of Glembatumumab Vedotin and CDX-301 (in Cohort 4).
Epistaxis
|
1 Participants
|
—
|
—
|
—
|
|
Adverse Events of the Combination of Glembatumumab Vedotin and CDX-301 (in Cohort 4).
Hypertension
|
1 Participants
|
—
|
—
|
—
|
|
Adverse Events of the Combination of Glembatumumab Vedotin and CDX-301 (in Cohort 4).
Leukopenia
|
1 Participants
|
—
|
—
|
—
|
|
Adverse Events of the Combination of Glembatumumab Vedotin and CDX-301 (in Cohort 4).
Abdominal pain
|
1 Participants
|
—
|
—
|
—
|
|
Adverse Events of the Combination of Glembatumumab Vedotin and CDX-301 (in Cohort 4).
Constipation
|
2 Participants
|
—
|
—
|
—
|
|
Adverse Events of the Combination of Glembatumumab Vedotin and CDX-301 (in Cohort 4).
Dyspepsia
|
2 Participants
|
—
|
—
|
—
|
|
Adverse Events of the Combination of Glembatumumab Vedotin and CDX-301 (in Cohort 4).
Nausea
|
1 Participants
|
—
|
—
|
—
|
|
Adverse Events of the Combination of Glembatumumab Vedotin and CDX-301 (in Cohort 4).
Stomatitis
|
1 Participants
|
—
|
—
|
—
|
|
Adverse Events of the Combination of Glembatumumab Vedotin and CDX-301 (in Cohort 4).
Vomiting
|
1 Participants
|
—
|
—
|
—
|
|
Adverse Events of the Combination of Glembatumumab Vedotin and CDX-301 (in Cohort 4).
Fatigue
|
3 Participants
|
—
|
—
|
—
|
|
Adverse Events of the Combination of Glembatumumab Vedotin and CDX-301 (in Cohort 4).
Hepatic pain
|
1 Participants
|
—
|
—
|
—
|
|
Adverse Events of the Combination of Glembatumumab Vedotin and CDX-301 (in Cohort 4).
Mucosal infection
|
1 Participants
|
—
|
—
|
—
|
|
Adverse Events of the Combination of Glembatumumab Vedotin and CDX-301 (in Cohort 4).
Urinary tract infection
|
1 Participants
|
—
|
—
|
—
|
|
Adverse Events of the Combination of Glembatumumab Vedotin and CDX-301 (in Cohort 4).
Alanine aminotransferase increased
|
2 Participants
|
—
|
—
|
—
|
|
Adverse Events of the Combination of Glembatumumab Vedotin and CDX-301 (in Cohort 4).
Aspartate aminotransferase increased
|
3 Participants
|
—
|
—
|
—
|
|
Adverse Events of the Combination of Glembatumumab Vedotin and CDX-301 (in Cohort 4).
Blood alkaline phosphatase increased
|
1 Participants
|
—
|
—
|
—
|
|
Adverse Events of the Combination of Glembatumumab Vedotin and CDX-301 (in Cohort 4).
Neutrophil count decreased
|
1 Participants
|
—
|
—
|
—
|
|
Adverse Events of the Combination of Glembatumumab Vedotin and CDX-301 (in Cohort 4).
Platelet count decreased
|
1 Participants
|
—
|
—
|
—
|
|
Adverse Events of the Combination of Glembatumumab Vedotin and CDX-301 (in Cohort 4).
Weight decreased
|
1 Participants
|
—
|
—
|
—
|
|
Adverse Events of the Combination of Glembatumumab Vedotin and CDX-301 (in Cohort 4).
Decreased appetite
|
1 Participants
|
—
|
—
|
—
|
|
Adverse Events of the Combination of Glembatumumab Vedotin and CDX-301 (in Cohort 4).
Hyperglycemia
|
1 Participants
|
—
|
—
|
—
|
|
Adverse Events of the Combination of Glembatumumab Vedotin and CDX-301 (in Cohort 4).
Hyperuricemia
|
1 Participants
|
—
|
—
|
—
|
|
Adverse Events of the Combination of Glembatumumab Vedotin and CDX-301 (in Cohort 4).
Hypokalemia
|
1 Participants
|
—
|
—
|
—
|
|
Adverse Events of the Combination of Glembatumumab Vedotin and CDX-301 (in Cohort 4).
Myalgia
|
1 Participants
|
—
|
—
|
—
|
|
Adverse Events of the Combination of Glembatumumab Vedotin and CDX-301 (in Cohort 4).
Pain in extremity
|
1 Participants
|
—
|
—
|
—
|
|
Adverse Events of the Combination of Glembatumumab Vedotin and CDX-301 (in Cohort 4).
Peripheral sensory neuropathy
|
1 Participants
|
—
|
—
|
—
|
|
Adverse Events of the Combination of Glembatumumab Vedotin and CDX-301 (in Cohort 4).
Anxiety
|
1 Participants
|
—
|
—
|
—
|
|
Adverse Events of the Combination of Glembatumumab Vedotin and CDX-301 (in Cohort 4).
Depression
|
1 Participants
|
—
|
—
|
—
|
|
Adverse Events of the Combination of Glembatumumab Vedotin and CDX-301 (in Cohort 4).
Vaginal hemorrhage
|
1 Participants
|
—
|
—
|
—
|
|
Adverse Events of the Combination of Glembatumumab Vedotin and CDX-301 (in Cohort 4).
Alopecia
|
3 Participants
|
—
|
—
|
—
|
|
Adverse Events of the Combination of Glembatumumab Vedotin and CDX-301 (in Cohort 4).
Rash erythematous
|
1 Participants
|
—
|
—
|
—
|
|
Adverse Events of the Combination of Glembatumumab Vedotin and CDX-301 (in Cohort 4).
Rash maculopapular
|
3 Participants
|
—
|
—
|
—
|
|
Adverse Events of the Combination of Glembatumumab Vedotin and CDX-301 (in Cohort 4).
Skin discoloration
|
1 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From start date of partial or complete response (whichever is achieved first) to first date that recurrent of progressive disease is objectively documented, assessed up to 18 months.Population: Number of patients analyzed are the number of patients who achieved an objective response per Cohort. The response was observed at the last measurement without further follow up due to study closure.
DOR is the number of months from the time criteria are first met for either CR or PR, until the first date that PD is objectively documented per RECIST 1.1.
Outcome measures
| Measure |
Glembatumumab Vedotin
n=7 Participants
glembatumumab vedotin administered as an intravenous infusion on Day 1 of each 21 day cycle.
glembatumumab vedotin
|
Glembatumumab Vedotin and Varlilumab
n=1 Participants
glembatumumab vedotin administered as an intravenous infusion on Day 1 of each 21 day cycle. Varlilumab administered as an intravenous infusion on Day 1 of cycles 1, 2, 4, 6, 8 and 10.
glembatumumab vedotin and varlilumab
|
Glembatumumab Vedotin and PD-1 Targeted Checkpoint Inhibitor
n=4 Participants
glembatumumab vedotin administered as an intravenous infusion on Day 1 of each 21 day cycle. Nivolumab OR pembrolizumab administered according to institutional standard of care.
glembatumumab vedotin and PD-1 targeted checkpoint inhibitor (nivolumab OR pembrolizumab)
|
Glembatumumab Vedotin and CDX-301
glembatumumab vedotin administered as an intravenous infusion on Day 1 of each 21 day cycle. CDX-301 is injected once a day for five days before cycles 1 and 2.
glembatumumab vedotin and CDX-301
|
|---|---|---|---|---|
|
Duration of Response (DOR)
|
6.0 months
Interval 4.1 to 27.5
|
2.2 months
With only 1 response achieved, it is not possible to calculate confidence intervals.
|
6.2 months
Interval 3.1 to 6.2
|
—
|
SECONDARY outcome
Timeframe: Evaluated every 6 to 9 weeks following treatment initiation until progression.Population: Response evaluable (at least one dose and a post treatment disease assessment). The analysis was not completed for the glembatumumab + CDX-301 cohort because sufficient data were not collected to perform the analysis.
PFS is defined as the time from randomization to the earlier of disease progression or death due to any cause. Disease progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or progression in a non-target lesion, or the appearance of new lesions.
Outcome measures
| Measure |
Glembatumumab Vedotin
n=62 Participants
glembatumumab vedotin administered as an intravenous infusion on Day 1 of each 21 day cycle.
glembatumumab vedotin
|
Glembatumumab Vedotin and Varlilumab
n=31 Participants
glembatumumab vedotin administered as an intravenous infusion on Day 1 of each 21 day cycle. Varlilumab administered as an intravenous infusion on Day 1 of cycles 1, 2, 4, 6, 8 and 10.
glembatumumab vedotin and varlilumab
|
Glembatumumab Vedotin and PD-1 Targeted Checkpoint Inhibitor
n=28 Participants
glembatumumab vedotin administered as an intravenous infusion on Day 1 of each 21 day cycle. Nivolumab OR pembrolizumab administered according to institutional standard of care.
glembatumumab vedotin and PD-1 targeted checkpoint inhibitor (nivolumab OR pembrolizumab)
|
Glembatumumab Vedotin and CDX-301
glembatumumab vedotin administered as an intravenous infusion on Day 1 of each 21 day cycle. CDX-301 is injected once a day for five days before cycles 1 and 2.
glembatumumab vedotin and CDX-301
|
|---|---|---|---|---|
|
Progression-free Survival (PFS)
|
4.4 months
Interval 2.6 to 5.4
|
2.6 months
Interval 1.4 to 2.9
|
4.1 months
Interval 2.7 to 6.9
|
—
|
SECONDARY outcome
Timeframe: During treatment and every 3 months from end of treatment through death or end of studyPopulation: Response evaluable (at least one dose and a post treatment disease assessment). The analysis was not completed for the glembatumumab + CDX-301 cohort or the glembatumumab vedotin and PD-1 targeted checkpoint inhibitor cohort because sufficient data were not collected to perform the analysis.
Overall Survival (OS) is defined as the number of months from randomization to the date of death due to any cause.
Outcome measures
| Measure |
Glembatumumab Vedotin
n=62 Participants
glembatumumab vedotin administered as an intravenous infusion on Day 1 of each 21 day cycle.
glembatumumab vedotin
|
Glembatumumab Vedotin and Varlilumab
n=31 Participants
glembatumumab vedotin administered as an intravenous infusion on Day 1 of each 21 day cycle. Varlilumab administered as an intravenous infusion on Day 1 of cycles 1, 2, 4, 6, 8 and 10.
glembatumumab vedotin and varlilumab
|
Glembatumumab Vedotin and PD-1 Targeted Checkpoint Inhibitor
glembatumumab vedotin administered as an intravenous infusion on Day 1 of each 21 day cycle. Nivolumab OR pembrolizumab administered according to institutional standard of care.
glembatumumab vedotin and PD-1 targeted checkpoint inhibitor (nivolumab OR pembrolizumab)
|
Glembatumumab Vedotin and CDX-301
glembatumumab vedotin administered as an intravenous infusion on Day 1 of each 21 day cycle. CDX-301 is injected once a day for five days before cycles 1 and 2.
glembatumumab vedotin and CDX-301
|
|---|---|---|---|---|
|
Overall Survival (OS)
|
8.8 months
Interval 5.9 to 11.7
|
6.6 months
Interval 3.2 to 8.6
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 18 months following the screening visitPopulation: Analysis not completed. gpNMB expression in tumor tissue was not done.
To investigate if the anti-cancer activity of glembatumumab vedotin as monotherapy or in combination with immunotherapies in advanced melanoma is dependent upon the degree of gpNMB expression in tumor tissue.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Following at least one dose of study treatment through 28 days after last dose of glembatumumab vedotin, or 70 calendar days after last administration of varlilumab, CDX-301 or PD-1 targeted checkpoint inhibitor (whichever occurs latest)The percentage of patients experiencing one or more AEs will be summarized by relationship to study drug and severity.
Outcome measures
| Measure |
Glembatumumab Vedotin
n=62 Participants
glembatumumab vedotin administered as an intravenous infusion on Day 1 of each 21 day cycle.
glembatumumab vedotin
|
Glembatumumab Vedotin and Varlilumab
n=34 Participants
glembatumumab vedotin administered as an intravenous infusion on Day 1 of each 21 day cycle. Varlilumab administered as an intravenous infusion on Day 1 of cycles 1, 2, 4, 6, 8 and 10.
glembatumumab vedotin and varlilumab
|
Glembatumumab Vedotin and PD-1 Targeted Checkpoint Inhibitor
n=29 Participants
glembatumumab vedotin administered as an intravenous infusion on Day 1 of each 21 day cycle. Nivolumab OR pembrolizumab administered according to institutional standard of care.
glembatumumab vedotin and PD-1 targeted checkpoint inhibitor (nivolumab OR pembrolizumab)
|
Glembatumumab Vedotin and CDX-301
n=7 Participants
glembatumumab vedotin administered as an intravenous infusion on Day 1 of each 21 day cycle. CDX-301 is injected once a day for five days before cycles 1 and 2.
glembatumumab vedotin and CDX-301
|
|---|---|---|---|---|
|
Adverse Events
|
61 Participants
|
34 Participants
|
29 Participants
|
7 Participants
|
Adverse Events
Glembatumumab Vedotin
Serious events: 19 serious events
Other events: 61 other events
Deaths: 53 deaths
Glembatumumab Vedotin and Varlilumab
Serious events: 14 serious events
Other events: 34 other events
Deaths: 26 deaths
Glembatumumab Vedotin and PD-1 Targeted Checkpoint Inhibitor
Serious events: 14 serious events
Other events: 29 other events
Deaths: 8 deaths
Glembatumumab Vedotin and CDX-301
Serious events: 2 serious events
Other events: 7 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Glembatumumab Vedotin
n=62 participants at risk
glembatumumab vedotin administered as an intravenous infusion on Day 1 of each 21 day cycle.
glembatumumab vedotin
|
Glembatumumab Vedotin and Varlilumab
n=34 participants at risk
glembatumumab vedotin administered as an intravenous infusion on Day 1 of each 21 day cycle. Varlilumab administered as an intravenous infusion on Day 1 of cycles 1, 2, 4, 6, 8 and 10.
glembatumumab vedotin and varlilumab
|
Glembatumumab Vedotin and PD-1 Targeted Checkpoint Inhibitor
n=29 participants at risk
glembatumumab vedotin administered as an intravenous infusion on Day 1 of each 21 day cycle. Nivolumab OR pembrolizumab administered according to institutional standard of care.
glembatumumab vedotin and PD-1 targeted checkpoint inhibitor (nivolumab OR pembrolizumab)
|
Glembatumumab Vedotin and CDX-301
n=7 participants at risk
glembatumumab vedotin administered as an intravenous infusion on Day 1 of each 21 day cycle. CDX-301 is injected once a day for five days before cycles 1 and 2.
glembatumumab vedotin and CDX-301
|
|---|---|---|---|---|
|
Nervous system disorders
Intensive Care Unit Acquired Weakness
|
0.00%
0/62 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
2.9%
1/34 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
0.00%
0/29 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
0.00%
0/7 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
|
Psychiatric disorders
Confusional State
|
0.00%
0/62 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
2.9%
1/34 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
0.00%
0/29 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
0.00%
0/7 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
|
Blood and lymphatic system disorders
Anaemia
|
3.2%
2/62 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
2.9%
1/34 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
0.00%
0/29 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
0.00%
0/7 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
1.6%
1/62 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
0.00%
0/34 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
0.00%
0/29 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
0.00%
0/7 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
|
Blood and lymphatic system disorders
Neutropenia
|
4.8%
3/62 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
0.00%
0/34 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
3.4%
1/29 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
0.00%
0/7 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
|
Cardiac disorders
Acute Coronary Syndrome
|
0.00%
0/62 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
0.00%
0/34 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
3.4%
1/29 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
0.00%
0/7 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
|
Cardiac disorders
Angina Pectoris
|
1.6%
1/62 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
0.00%
0/34 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
0.00%
0/29 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
0.00%
0/7 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
|
Cardiac disorders
Atrial Fibrillation
|
0.00%
0/62 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
0.00%
0/34 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
3.4%
1/29 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
0.00%
0/7 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
|
Gastrointestinal disorders
Abdominal Pain
|
3.2%
2/62 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
0.00%
0/34 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
0.00%
0/29 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
14.3%
1/7 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/62 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
2.9%
1/34 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
3.4%
1/29 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
0.00%
0/7 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
|
Gastrointestinal disorders
Diarrhoea
|
1.6%
1/62 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
0.00%
0/34 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
0.00%
0/29 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
0.00%
0/7 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
|
Gastrointestinal disorders
Enteritis
|
1.6%
1/62 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
0.00%
0/34 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
0.00%
0/29 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
0.00%
0/7 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
|
Gastrointestinal disorders
Gastointestinal Haemorrhage
|
0.00%
0/62 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
2.9%
1/34 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
0.00%
0/29 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
0.00%
0/7 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
|
Gastrointestinal disorders
Nausea
|
1.6%
1/62 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
0.00%
0/34 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
0.00%
0/29 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
0.00%
0/7 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
|
Gastrointestinal disorders
Proctitis
|
0.00%
0/62 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
0.00%
0/34 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
3.4%
1/29 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
0.00%
0/7 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
|
Gastrointestinal disorders
Small Intestinal Obstruction
|
1.6%
1/62 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
2.9%
1/34 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
0.00%
0/29 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
0.00%
0/7 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
|
General disorders
Fatigue
|
0.00%
0/62 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
2.9%
1/34 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
0.00%
0/29 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
0.00%
0/7 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
|
General disorders
Infusion Site Extravasation
|
1.6%
1/62 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
0.00%
0/34 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
0.00%
0/29 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
0.00%
0/7 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
|
General disorders
Multiple Organ Dysfunction Syndrome
|
0.00%
0/62 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
0.00%
0/34 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
6.9%
2/29 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
0.00%
0/7 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
|
General disorders
Non-Cardiac Chest Pain
|
0.00%
0/62 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
0.00%
0/34 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
3.4%
1/29 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
0.00%
0/7 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
|
General disorders
Pain
|
1.6%
1/62 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
0.00%
0/34 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
0.00%
0/29 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
0.00%
0/7 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
|
General disorders
Pyrexia
|
1.6%
1/62 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
2.9%
1/34 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
0.00%
0/29 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
0.00%
0/7 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
|
Hepatobiliary disorders
Hepatic Failure
|
0.00%
0/62 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
0.00%
0/34 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
3.4%
1/29 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
0.00%
0/7 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/62 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
0.00%
0/34 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
3.4%
1/29 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
0.00%
0/7 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
|
Infections and infestations
Atypical Pneumonia
|
0.00%
0/62 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
0.00%
0/34 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
3.4%
1/29 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
0.00%
0/7 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
|
Infections and infestations
Cellulitis
|
1.6%
1/62 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
5.9%
2/34 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
0.00%
0/29 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
0.00%
0/7 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
|
Infections and infestations
Herpes Zoster
|
0.00%
0/62 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
2.9%
1/34 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
0.00%
0/29 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
0.00%
0/7 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
|
Infections and infestations
Pneumonia
|
1.6%
1/62 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
0.00%
0/34 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
3.4%
1/29 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
0.00%
0/7 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
|
Infections and infestations
Sepsis
|
0.00%
0/62 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
2.9%
1/34 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
13.8%
4/29 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
0.00%
0/7 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
|
Infections and infestations
Septic Shock
|
1.6%
1/62 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
5.9%
2/34 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
0.00%
0/29 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
0.00%
0/7 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
|
Infections and infestations
Skin Infection
|
1.6%
1/62 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
0.00%
0/34 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
0.00%
0/29 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
0.00%
0/7 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
|
Injury, poisoning and procedural complications
Subdural Haematoma
|
1.6%
1/62 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
0.00%
0/34 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
0.00%
0/29 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
0.00%
0/7 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
|
Investigations
Neutrophil Count Decreased
|
1.6%
1/62 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
0.00%
0/34 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
0.00%
0/29 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
14.3%
1/7 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
|
Investigations
White Blood Cell Count Decreased
|
1.6%
1/62 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
0.00%
0/34 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
0.00%
0/29 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
0.00%
0/7 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
|
Metabolism and nutrition disorders
Dehydration
|
4.8%
3/62 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
0.00%
0/34 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
3.4%
1/29 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
0.00%
0/7 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
|
Metabolism and nutrition disorders
Diabetic Ketoacidosis
|
0.00%
0/62 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
2.9%
1/34 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
0.00%
0/29 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
0.00%
0/7 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
4.8%
3/62 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
0.00%
0/34 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
3.4%
1/29 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
0.00%
0/7 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
|
Metabolism and nutrition disorders
Tumour Lysis Syndrome
|
0.00%
0/62 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
0.00%
0/34 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
3.4%
1/29 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
0.00%
0/7 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.00%
0/62 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
2.9%
1/34 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
0.00%
0/29 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
0.00%
0/7 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/62 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
0.00%
0/34 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
0.00%
0/29 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
14.3%
1/7 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer Pain
|
0.00%
0/62 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
0.00%
0/34 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
3.4%
1/29 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
0.00%
0/7 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant Pleural Effusion
|
0.00%
0/62 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
2.9%
1/34 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
0.00%
0/29 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
0.00%
0/7 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour Haemorrhage
|
0.00%
0/62 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
2.9%
1/34 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
0.00%
0/29 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
0.00%
0/7 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
|
Renal and urinary disorders
Acute Kidney Injury
|
0.00%
0/62 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
0.00%
0/34 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
6.9%
2/29 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
0.00%
0/7 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
|
Renal and urinary disorders
Renal Failure
|
0.00%
0/62 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
2.9%
1/34 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
0.00%
0/29 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
0.00%
0/7 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
|
Renal and urinary disorders
Urinary Retention
|
1.6%
1/62 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
0.00%
0/34 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
0.00%
0/29 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
0.00%
0/7 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
|
Reproductive system and breast disorders
Vaginal Haemorrhage
|
0.00%
0/62 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
0.00%
0/34 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
0.00%
0/29 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
14.3%
1/7 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
|
Respiratory, thoracic and mediastinal disorders
Acute Respiratory Failure
|
0.00%
0/62 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
2.9%
1/34 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
3.4%
1/29 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
0.00%
0/7 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.6%
1/62 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
0.00%
0/34 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
0.00%
0/29 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
0.00%
0/7 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
1.6%
1/62 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
0.00%
0/34 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
0.00%
0/29 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
0.00%
0/7 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/62 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
0.00%
0/34 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
3.4%
1/29 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
0.00%
0/7 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
1.6%
1/62 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
0.00%
0/34 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
0.00%
0/29 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
0.00%
0/7 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic Pain
|
0.00%
0/62 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
2.9%
1/34 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
0.00%
0/29 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
0.00%
0/7 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/62 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
0.00%
0/34 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
3.4%
1/29 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
0.00%
0/7 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
1.6%
1/62 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
0.00%
0/34 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
0.00%
0/29 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
0.00%
0/7 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Acidosis
|
0.00%
0/62 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
2.9%
1/34 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
0.00%
0/29 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
0.00%
0/7 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
0.00%
0/62 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
2.9%
1/34 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
0.00%
0/29 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
0.00%
0/7 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
|
Skin and subcutaneous tissue disorders
Rash Macular
|
1.6%
1/62 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
0.00%
0/34 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
0.00%
0/29 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
0.00%
0/7 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
|
Skin and subcutaneous tissue disorders
Rash Maculo-Papular
|
0.00%
0/62 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
2.9%
1/34 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
3.4%
1/29 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
0.00%
0/7 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
|
Skin and subcutaneous tissue disorders
Rash Pruritic
|
1.6%
1/62 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
0.00%
0/34 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
0.00%
0/29 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
0.00%
0/7 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
|
Skin and subcutaneous tissue disorders
Toxic Epidermal Necrolysis
|
0.00%
0/62 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
2.9%
1/34 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
0.00%
0/29 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
0.00%
0/7 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
|
Vascular disorders
Deep Vein Thrombosis
|
0.00%
0/62 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
2.9%
1/34 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
0.00%
0/29 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
0.00%
0/7 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
|
Vascular disorders
Embolism
|
1.6%
1/62 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
0.00%
0/34 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
3.4%
1/29 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
0.00%
0/7 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
|
Vascular disorders
Hypotension
|
0.00%
0/62 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
0.00%
0/34 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
3.4%
1/29 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
0.00%
0/7 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
Other adverse events
| Measure |
Glembatumumab Vedotin
n=62 participants at risk
glembatumumab vedotin administered as an intravenous infusion on Day 1 of each 21 day cycle.
glembatumumab vedotin
|
Glembatumumab Vedotin and Varlilumab
n=34 participants at risk
glembatumumab vedotin administered as an intravenous infusion on Day 1 of each 21 day cycle. Varlilumab administered as an intravenous infusion on Day 1 of cycles 1, 2, 4, 6, 8 and 10.
glembatumumab vedotin and varlilumab
|
Glembatumumab Vedotin and PD-1 Targeted Checkpoint Inhibitor
n=29 participants at risk
glembatumumab vedotin administered as an intravenous infusion on Day 1 of each 21 day cycle. Nivolumab OR pembrolizumab administered according to institutional standard of care.
glembatumumab vedotin and PD-1 targeted checkpoint inhibitor (nivolumab OR pembrolizumab)
|
Glembatumumab Vedotin and CDX-301
n=7 participants at risk
glembatumumab vedotin administered as an intravenous infusion on Day 1 of each 21 day cycle. CDX-301 is injected once a day for five days before cycles 1 and 2.
glembatumumab vedotin and CDX-301
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
24.2%
15/62 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
38.2%
13/34 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
13.8%
4/29 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
0.00%
0/7 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
|
Blood and lymphatic system disorders
Leukopenia
|
1.6%
1/62 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
2.9%
1/34 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
3.4%
1/29 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
14.3%
1/7 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/62 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
5.9%
2/34 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
0.00%
0/29 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
0.00%
0/7 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
|
Blood and lymphatic system disorders
Neutropenia
|
11.3%
7/62 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
11.8%
4/34 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
24.1%
7/29 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
0.00%
0/7 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
|
Cardiac disorders
Atrial Fibrilation
|
0.00%
0/62 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
0.00%
0/34 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
6.9%
2/29 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
0.00%
0/7 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
|
Cardiac disorders
Palpitations
|
6.5%
4/62 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
0.00%
0/34 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
0.00%
0/29 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
0.00%
0/7 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
|
Cardiac disorders
Sinus Tachycardia
|
1.6%
1/62 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
5.9%
2/34 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
3.4%
1/29 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
0.00%
0/7 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
|
Cardiac disorders
Supraventricular Tachycardia
|
0.00%
0/62 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
0.00%
0/34 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
6.9%
2/29 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
0.00%
0/7 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/62 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
0.00%
0/34 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
6.9%
2/29 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
0.00%
0/7 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
|
Eye disorders
Vision Blurred
|
4.8%
3/62 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
2.9%
1/34 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
6.9%
2/29 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
0.00%
0/7 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
|
Gastrointestinal disorders
Abdominal Distension
|
3.2%
2/62 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
0.00%
0/34 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
6.9%
2/29 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
0.00%
0/7 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
|
Gastrointestinal disorders
Abdominal Pain
|
17.7%
11/62 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
17.6%
6/34 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
24.1%
7/29 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
14.3%
1/7 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
4.8%
3/62 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
0.00%
0/34 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
6.9%
2/29 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
0.00%
0/7 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
|
Gastrointestinal disorders
Constipation
|
22.6%
14/62 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
38.2%
13/34 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
37.9%
11/29 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
28.6%
2/7 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
|
Gastrointestinal disorders
Diarrhoea
|
30.6%
19/62 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
44.1%
15/34 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
48.3%
14/29 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
0.00%
0/7 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
|
Gastrointestinal disorders
Dry Mouth
|
9.7%
6/62 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
2.9%
1/34 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
10.3%
3/29 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
0.00%
0/7 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
|
Gastrointestinal disorders
Dyspepsia
|
4.8%
3/62 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
8.8%
3/34 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
10.3%
3/29 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
28.6%
2/7 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
|
Gastrointestinal disorders
Flatulence
|
1.6%
1/62 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
5.9%
2/34 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
6.9%
2/29 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
0.00%
0/7 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
|
Gastrointestinal disorders
Gastrooesophageal Reflux Disease
|
6.5%
4/62 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
2.9%
1/34 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
6.9%
2/29 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
0.00%
0/7 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
|
Gastrointestinal disorders
Haemorrhoids
|
1.6%
1/62 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
5.9%
2/34 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
0.00%
0/29 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
0.00%
0/7 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
|
Gastrointestinal disorders
Ileus
|
1.6%
1/62 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
0.00%
0/34 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
6.9%
2/29 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
0.00%
0/7 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
|
Gastrointestinal disorders
Nausea
|
37.1%
23/62 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
35.3%
12/34 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
55.2%
16/29 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
14.3%
1/7 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/62 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
0.00%
0/34 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
6.9%
2/29 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
0.00%
0/7 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
|
Gastrointestinal disorders
Stomatits
|
11.3%
7/62 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
5.9%
2/34 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
20.7%
6/29 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
14.3%
1/7 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
|
Gastrointestinal disorders
Vomiting
|
19.4%
12/62 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
29.4%
10/34 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
27.6%
8/29 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
14.3%
1/7 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
|
General disorders
Asthenia
|
6.5%
4/62 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
5.9%
2/34 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
6.9%
2/29 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
0.00%
0/7 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
|
General disorders
Chills
|
4.8%
3/62 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
5.9%
2/34 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
24.1%
7/29 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
0.00%
0/7 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
|
General disorders
Fatigue
|
41.9%
26/62 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
64.7%
22/34 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
37.9%
11/29 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
42.9%
3/7 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
|
General disorders
Influenza Like Illness
|
4.8%
3/62 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
5.9%
2/34 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
0.00%
0/29 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
0.00%
0/7 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
|
General disorders
Malaise
|
0.00%
0/62 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
0.00%
0/34 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
6.9%
2/29 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
0.00%
0/7 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
|
General disorders
Non-Cardiac Chest pain
|
3.2%
2/62 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
5.9%
2/34 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
6.9%
2/29 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
0.00%
0/7 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
|
General disorders
Oedema Peripheral
|
14.5%
9/62 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
8.8%
3/34 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
10.3%
3/29 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
0.00%
0/7 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
|
General disorders
Pain
|
6.5%
4/62 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
11.8%
4/34 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
3.4%
1/29 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
0.00%
0/7 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
|
General disorders
Pyrexia
|
9.7%
6/62 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
20.6%
7/34 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
20.7%
6/29 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
0.00%
0/7 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
|
Hepatobiliary disorders
Hepatic Pain
|
1.6%
1/62 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
2.9%
1/34 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
3.4%
1/29 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
14.3%
1/7 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
|
Infections and infestations
Candida Infection
|
3.2%
2/62 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
5.9%
2/34 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
13.8%
4/29 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
0.00%
0/7 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
|
Infections and infestations
Eye Infection
|
0.00%
0/62 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
0.00%
0/34 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
6.9%
2/29 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
0.00%
0/7 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
|
Infections and infestations
Mucosal Infection
|
0.00%
0/62 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
0.00%
0/34 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
3.4%
1/29 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
14.3%
1/7 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
|
Infections and infestations
Oral Candidiasis
|
3.2%
2/62 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
17.6%
6/34 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
6.9%
2/29 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
0.00%
0/7 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
3.2%
2/62 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
5.9%
2/34 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
3.4%
1/29 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
0.00%
0/7 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
|
Infections and infestations
Urinary Tract Infection
|
4.8%
3/62 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
5.9%
2/34 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
3.4%
1/29 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
14.3%
1/7 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
|
Injury, poisoning and procedural complications
Fall
|
1.6%
1/62 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
5.9%
2/34 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
3.4%
1/29 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
0.00%
0/7 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
|
Injury, poisoning and procedural complications
Procedural Site Reaction
|
0.00%
0/62 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
0.00%
0/34 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
6.9%
2/29 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
0.00%
0/7 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
|
Injury, poisoning and procedural complications
Wound
|
0.00%
0/62 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
5.9%
2/34 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
3.4%
1/29 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
0.00%
0/7 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
|
Investigations
Alanine Aminotransferase Increased
|
4.8%
3/62 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
14.7%
5/34 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
20.7%
6/29 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
28.6%
2/7 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
|
Investigations
Aspartate Aminotransferase Increased
|
12.9%
8/62 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
11.8%
4/34 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
24.1%
7/29 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
42.9%
3/7 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
|
Investigations
Blood Alkaline Phosphatase Increased
|
1.6%
1/62 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
5.9%
2/34 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
3.4%
1/29 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
14.3%
1/7 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
|
Investigations
Blood Creatinine Increased
|
8.1%
5/62 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
0.00%
0/34 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
3.4%
1/29 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
0.00%
0/7 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
|
Investigations
Lymphocyte Count Decreased
|
6.5%
4/62 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
2.9%
1/34 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
3.4%
1/29 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
0.00%
0/7 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
|
Investigations
Neutrophil Count Decreased
|
22.6%
14/62 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
14.7%
5/34 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
27.6%
8/29 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
14.3%
1/7 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
|
Investigations
Platelet Count Decreased
|
1.6%
1/62 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
0.00%
0/34 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
3.4%
1/29 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
14.3%
1/7 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
|
Investigations
Weight Decreased
|
16.1%
10/62 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
17.6%
6/34 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
24.1%
7/29 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
14.3%
1/7 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
|
Investigations
White Blood Cell Count Decreased
|
12.9%
8/62 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
11.8%
4/34 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
24.1%
7/29 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
0.00%
0/7 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
|
Metabolism and nutrition disorders
Cachexia
|
0.00%
0/62 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
5.9%
2/34 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
0.00%
0/29 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
0.00%
0/7 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
37.1%
23/62 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
38.2%
13/34 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
37.9%
11/29 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
14.3%
1/7 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
|
Metabolism and nutrition disorders
Dehydration
|
14.5%
9/62 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
20.6%
7/34 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
20.7%
6/29 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
0.00%
0/7 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
|
Metabolism and nutrition disorders
Hyperglaecemia
|
8.1%
5/62 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
11.8%
4/34 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
10.3%
3/29 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
14.3%
1/7 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
8.1%
5/62 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
2.9%
1/34 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
3.4%
1/29 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
0.00%
0/7 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.00%
0/62 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
0.00%
0/34 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
0.00%
0/29 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
14.3%
1/7 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
11.3%
7/62 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
2.9%
1/34 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
3.4%
1/29 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
0.00%
0/7 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
8.1%
5/62 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
2.9%
1/34 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
6.9%
2/29 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
0.00%
0/7 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
16.1%
10/62 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
8.8%
3/34 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
10.3%
3/29 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
14.3%
1/7 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
8.1%
5/62 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
2.9%
1/34 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
6.9%
2/29 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
0.00%
0/7 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
17.7%
11/62 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
14.7%
5/34 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
6.9%
2/29 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
0.00%
0/7 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
4.8%
3/62 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
0.00%
0/34 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
10.3%
3/29 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
0.00%
0/7 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
|
Metabolism and nutrition disorders
Malnutrition
|
1.6%
1/62 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
5.9%
2/34 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
3.4%
1/29 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
0.00%
0/7 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
21.0%
13/62 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
11.8%
4/34 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
27.6%
8/29 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
0.00%
0/7 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
14.5%
9/62 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
2.9%
1/34 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
10.3%
3/29 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
0.00%
0/7 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
|
Musculoskeletal and connective tissue disorders
Flank Pain
|
0.00%
0/62 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
0.00%
0/34 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
6.9%
2/29 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
0.00%
0/7 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasma
|
3.2%
2/62 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
2.9%
1/34 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
6.9%
2/29 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
0.00%
0/7 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
|
Musculoskeletal and connective tissue disorders
Muscular Weakness
|
12.9%
8/62 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
0.00%
0/34 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
10.3%
3/29 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
0.00%
0/7 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Chest Pain
|
4.8%
3/62 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
2.9%
1/34 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
6.9%
2/29 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
0.00%
0/7 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
|
Musculoskeletal and connective tissue disorders
Muskuloskeletal Pain
|
6.5%
4/62 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
2.9%
1/34 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
3.4%
1/29 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
0.00%
0/7 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
9.7%
6/62 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
8.8%
3/34 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
13.8%
4/29 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
14.3%
1/7 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
8.1%
5/62 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
5.9%
2/34 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
24.1%
7/29 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
14.3%
1/7 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
|
Nervous system disorders
Carpal Tunnel Syndrome
|
0.00%
0/62 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
5.9%
2/34 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
0.00%
0/29 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
0.00%
0/7 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
|
Nervous system disorders
Dizziness
|
9.7%
6/62 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
5.9%
2/34 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
10.3%
3/29 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
0.00%
0/7 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
|
Nervous system disorders
Dysgeusia
|
9.7%
6/62 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
5.9%
2/34 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
24.1%
7/29 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
0.00%
0/7 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/62 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
5.9%
2/34 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
6.9%
2/29 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
0.00%
0/7 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
|
Nervous system disorders
Headache
|
14.5%
9/62 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
14.7%
5/34 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
17.2%
5/29 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
0.00%
0/7 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
|
Nervous system disorders
Paraesthesia
|
6.5%
4/62 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
2.9%
1/34 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
6.9%
2/29 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
0.00%
0/7 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
|
Nervous system disorders
Peripheral Sensory Neuropathy
|
43.5%
27/62 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
23.5%
8/34 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
34.5%
10/29 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
14.3%
1/7 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
|
Nervous system disorders
Seizure
|
0.00%
0/62 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
5.9%
2/34 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
3.4%
1/29 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
0.00%
0/7 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
|
Psychiatric disorders
Anxiety
|
3.2%
2/62 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
5.9%
2/34 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
17.2%
5/29 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
14.3%
1/7 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
|
Psychiatric disorders
Confusional State
|
1.6%
1/62 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
11.8%
4/34 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
3.4%
1/29 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
0.00%
0/7 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
|
Psychiatric disorders
Depression
|
4.8%
3/62 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
0.00%
0/34 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
0.00%
0/29 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
14.3%
1/7 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
|
Psychiatric disorders
Insomnia
|
17.7%
11/62 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
8.8%
3/34 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
24.1%
7/29 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
0.00%
0/7 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
|
Psychiatric disorders
Restlessness
|
0.00%
0/62 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
0.00%
0/34 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
6.9%
2/29 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
0.00%
0/7 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
|
Renal and urinary disorders
Acute Kidney Injury
|
4.8%
3/62 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
8.8%
3/34 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
3.4%
1/29 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
0.00%
0/7 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
|
Renal and urinary disorders
Micronutrition Urgency
|
0.00%
0/62 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
0.00%
0/34 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
6.9%
2/29 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
0.00%
0/7 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
|
Renal and urinary disorders
Urinary Retention
|
1.6%
1/62 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
5.9%
2/34 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
0.00%
0/29 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
0.00%
0/7 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
|
Reproductive system and breast disorders
Vaginal Hemorrhage
|
0.00%
0/62 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
0.00%
0/34 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
0.00%
0/29 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
14.3%
1/7 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
|
Reproductive system and breast disorders
Vuvlovaginal Pain
|
0.00%
0/62 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
0.00%
0/34 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
0.00%
0/29 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
14.3%
1/7 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
8.1%
5/62 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
11.8%
4/34 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
10.3%
3/29 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
0.00%
0/7 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
8.1%
5/62 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
0.00%
0/34 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
10.3%
3/29 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
0.00%
0/7 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
11.3%
7/62 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
14.7%
5/34 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
17.2%
5/29 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
0.00%
0/7 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
4.8%
3/62 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
2.9%
1/34 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
10.3%
3/29 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
14.3%
1/7 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
4.8%
3/62 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
2.9%
1/34 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
10.3%
3/29 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
0.00%
0/7 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
3.2%
2/62 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
5.9%
2/34 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
17.2%
5/29 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
0.00%
0/7 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
48.4%
30/62 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
44.1%
15/34 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
51.7%
15/29 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
42.9%
3/7 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
|
Skin and subcutaneous tissue disorders
Decubitus Ulcer
|
0.00%
0/62 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
5.9%
2/34 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
0.00%
0/29 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
0.00%
0/7 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
1.6%
1/62 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
5.9%
2/34 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
3.4%
1/29 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
0.00%
0/7 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
8.1%
5/62 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
5.9%
2/34 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
3.4%
1/29 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
0.00%
0/7 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
|
Skin and subcutaneous tissue disorders
Night Sweats
|
0.00%
0/62 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
2.9%
1/34 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
6.9%
2/29 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
0.00%
0/7 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
24.2%
15/62 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
29.4%
10/34 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
44.8%
13/29 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
0.00%
0/7 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
|
Skin and subcutaneous tissue disorders
Pruritis Generalised
|
3.2%
2/62 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
23.5%
8/34 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
10.3%
3/29 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
0.00%
0/7 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
|
Skin and subcutaneous tissue disorders
Rash
|
14.5%
9/62 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
11.8%
4/34 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
13.8%
4/29 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
0.00%
0/7 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
|
Skin and subcutaneous tissue disorders
Rash Erythaemous
|
3.2%
2/62 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
0.00%
0/34 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
6.9%
2/29 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
14.3%
1/7 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
|
Skin and subcutaneous tissue disorders
Rash Generalised
|
9.7%
6/62 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
8.8%
3/34 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
20.7%
6/29 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
0.00%
0/7 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
|
Skin and subcutaneous tissue disorders
Rash Mascular
|
6.5%
4/62 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
2.9%
1/34 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
0.00%
0/29 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
0.00%
0/7 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
|
Skin and subcutaneous tissue disorders
Rash Maculo-Papular
|
17.7%
11/62 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
38.2%
13/34 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
37.9%
11/29 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
42.9%
3/7 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
|
Skin and subcutaneous tissue disorders
Rash Pruritic
|
4.8%
3/62 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
5.9%
2/34 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
3.4%
1/29 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
0.00%
0/7 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
|
Skin and subcutaneous tissue disorders
Skin Discolouration
|
0.00%
0/62 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
0.00%
0/34 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
0.00%
0/29 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
14.3%
1/7 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
|
Skin and subcutaneous tissue disorders
Skin Hyperpigmentation
|
3.2%
2/62 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
5.9%
2/34 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
0.00%
0/29 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
0.00%
0/7 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
|
Skin and subcutaneous tissue disorders
Vitiligo
|
4.8%
3/62 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
0.00%
0/34 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
6.9%
2/29 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
0.00%
0/7 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
|
Vascular disorders
Hypertension
|
3.2%
2/62 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
2.9%
1/34 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
0.00%
0/29 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
14.3%
1/7 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
|
Vascular disorders
Hypotension
|
11.3%
7/62 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
2.9%
1/34 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
6.9%
2/29 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
0.00%
0/7 • Adverse Events were recorded from the time the patient has taken at least one dose of study treatment through (whichever occurs first) either: a) 28 - 70 calendar days after the last administration of study drug depending on the cohort; or b) initiation of alternate anticancer therapy.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place