Trial Outcomes & Findings for Daily Oral Regorafenib for Chemotherapy-Refractory, Metastatic and Locally Advanced Angiosarcoma (NCT NCT02048722)
NCT ID: NCT02048722
Last Updated: 2022-04-25
Results Overview
The progression-free survival (PFS) at 4 months will be defined as the number of patients with progression absent at 4 months divided by the total number of evaluable study patients. This will be measured from start of treatment until time of progression or death, whichever occurs first and will be estimated using Kaplan-Meier methods and reported as a survival probability. Progression will be evaluated using the international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) v 1.1 Committee. Changes in only the largest diameter (unidimensional measurement) of the tumor lesions are used in RECIST v 1.1. Progression will be defined as: Progressive disease (PD): \> 20% increase in the sum diameters of target lesions, taking as reference the smallest sum diameters while on study. The sum diameters must also demonstrate an absolute increase of 5 mm. The appearance of one or more new lesions also qualifies as PD.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
31 participants
Primary outcome timeframe
At 4 months (of treatment)
Results posted on
2022-04-25
Participant Flow
The study was opened for enrollment March 12, 2014 with the first patient starting treatment June 13, 2014. A total of 31 patients were treated under the protocol. The study was permanently suspended to further enrollment August 5, 2019.
Participant milestones
| Measure |
Treatment (Regorafenib)
Patients receive regorafenib PO QD on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
regorafenib: Given PO
|
|---|---|
|
2 Cycles of Treatment
STARTED
|
31
|
|
2 Cycles of Treatment
Attempted 1st Cycle
|
31
|
|
2 Cycles of Treatment
Attempted 2nd Cycle
|
23
|
|
2 Cycles of Treatment
COMPLETED
|
23
|
|
2 Cycles of Treatment
NOT COMPLETED
|
8
|
|
Reached 1st Response/Continued Treatment
STARTED
|
23
|
|
Reached 1st Response/Continued Treatment
Assessed for First Response
|
23
|
|
Reached 1st Response/Continued Treatment
Went on to Cycle 3 and Beyond
|
13
|
|
Reached 1st Response/Continued Treatment
COMPLETED
|
13
|
|
Reached 1st Response/Continued Treatment
NOT COMPLETED
|
10
|
|
Follow up 5 Years or Cut of Timepoint
STARTED
|
31
|
|
Follow up 5 Years or Cut of Timepoint
COMPLETED
|
4
|
|
Follow up 5 Years or Cut of Timepoint
NOT COMPLETED
|
27
|
Reasons for withdrawal
| Measure |
Treatment (Regorafenib)
Patients receive regorafenib PO QD on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
regorafenib: Given PO
|
|---|---|
|
2 Cycles of Treatment
Adverse Event
|
2
|
|
2 Cycles of Treatment
Withdrawal by Subject
|
4
|
|
2 Cycles of Treatment
Progressive Disease
|
2
|
|
Reached 1st Response/Continued Treatment
Progressive Disease
|
10
|
|
Follow up 5 Years or Cut of Timepoint
Death
|
24
|
|
Follow up 5 Years or Cut of Timepoint
Withdrawal by Subject
|
3
|
Baseline Characteristics
Daily Oral Regorafenib for Chemotherapy-Refractory, Metastatic and Locally Advanced Angiosarcoma
Baseline characteristics by cohort
| Measure |
Treatment (Regorafenib)
n=31 Participants
Patients receive regorafenib PO QD on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
regorafenib: Given PO
|
|---|---|
|
Age, Customized
|
64.32 years
STANDARD_DEVIATION 14.58 • n=5 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
31 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
27 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
31 participants
n=5 Participants
|
|
Type of disease
Metastatic
|
21 Participants
n=5 Participants
|
|
Type of disease
Locally advanced/Unresectable
|
9 Participants
n=5 Participants
|
|
Type of disease
Not reported
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: At 4 months (of treatment)Population: 8 Patients were not included due to the following reasons: progressive disease, patient refused further treatment (withdrawal of consent for further treatment), toxicity. This was due to data having either missing time points or "cycle 1" or "Cycle 1: follow up" missing from the dataset at the time of the analysis.
The progression-free survival (PFS) at 4 months will be defined as the number of patients with progression absent at 4 months divided by the total number of evaluable study patients. This will be measured from start of treatment until time of progression or death, whichever occurs first and will be estimated using Kaplan-Meier methods and reported as a survival probability. Progression will be evaluated using the international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) v 1.1 Committee. Changes in only the largest diameter (unidimensional measurement) of the tumor lesions are used in RECIST v 1.1. Progression will be defined as: Progressive disease (PD): \> 20% increase in the sum diameters of target lesions, taking as reference the smallest sum diameters while on study. The sum diameters must also demonstrate an absolute increase of 5 mm. The appearance of one or more new lesions also qualifies as PD.
Outcome measures
| Measure |
Treatment (Regorafenib)
n=23 Participants
Patients receive regorafenib PO QD on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
regorafenib: Given PO
|
|---|---|
|
Progression-Free Survival (PFS) at 4 Months
|
52.17 percentage of patients alive
Interval 35.28 to 77.16
|
SECONDARY outcome
Timeframe: Assessed at 3 months and 6 monthsPopulation: 8 Patients were not included due to the following reasons: progressive disease, patient refused further treatment (withdrawal of consent for further treatment), toxicity. This was due to data having either missing time points or "cycle 1" or "Cycle 1: follow up" missing from the dataset at the time of the analysis.
The progression-free survival (PFS) at 3 and 6 months will be defined as the number of patients with progression absent at 3 months and 6 months divided by the total number of evaluable study patients. This will be measured from start of treatment until time of progression or death, whichever occurs first and will be estimated using Kaplan-Meier methods and reported as a survival probability. Progression will be evaluated using the international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) v 1.1 Committee. Changes in only the largest diameter (unidimensional measurement) of the tumor lesions are used in RECIST v 1.1. Progression will be defined as: Progressive disease (PD): \> 20% increase in the sum diameters of target lesions, taking as reference the smallest sum diameters while on study. The sum diameters must also demonstrate an absolute increase of 5 mm. The appearance of one or more new lesions also qualifies as PD.
Outcome measures
| Measure |
Treatment (Regorafenib)
n=23 Participants
Patients receive regorafenib PO QD on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
regorafenib: Given PO
|
|---|---|
|
Progression-Free Survival (PFS) at 3 and 6 Months
3 months
|
56.52 percentage patients alive
Interval 39.5 to 80.89
|
|
Progression-Free Survival (PFS) at 3 and 6 Months
6 months
|
47.83 percentage patients alive
Interval 31.21 to 73.29
|
SECONDARY outcome
Timeframe: The duration of time from start of treatment until time of progression, up to 5 yearsPopulation: 8 Patients were not included due to the following reasons: progressive disease, patient refused further treatment (withdrawal of consent for further treatment), toxicity. This was due to data having either missing time points or "cycle 1" or "Cycle 1: follow up" missing from the dataset at the time of the analysis.
The median progression-free rate (PFR) will be defined as the number of patients with progression absent divided by the total number of evaluable study patients. This will be measured from start of treatment until time of progression or death, whichever occurs first for up to 5 years and will be estimated using Kaplan-Meier methods. Progression will be evaluated using the international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) v 1.1 Committee. Changes in only the largest diameter (unidimensional measurement) of the tumor lesions are used in RECIST v 1.1. Progression will be defined as: Progressive disease (PD): \> 20% increase in the sum diameters of target lesions, taking as reference the smallest sum diameters while on study. The sum diameters must also demonstrate an absolute increase of 5 mm. The appearance of one or more new lesions also qualifies as PD.
Outcome measures
| Measure |
Treatment (Regorafenib)
n=23 Participants
Patients receive regorafenib PO QD on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
regorafenib: Given PO
|
|---|---|
|
Median Progression-free Survival (PFS)
|
5.49 months
Interval 1.84 to 9.53
|
SECONDARY outcome
Timeframe: From start of treatment up to 5 yearsPopulation: 8 Patients were not included due to the following reasons: progressive disease, patient refused further treatment (withdrawal of consent for further treatment), toxicity. This was due to data having either missing time points or "cycle 1" or "Cycle 1: follow up" missing from the dataset at the time of the analysis.
Overall survival will be defined as the time from start of treatment until death from any cause and will be estimated using Kaplan-Meier methods and reported as a survival probability. Patients that are alive at the time of data analysis will be censored at the date of known survival status.
Outcome measures
| Measure |
Treatment (Regorafenib)
n=23 Participants
Patients receive regorafenib PO QD on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
regorafenib: Given PO
|
|---|---|
|
Overall Survival
|
14.06 months
Interval 9.76 to 22.24
|
SECONDARY outcome
Timeframe: At baseline and after every 2 cycles, up to 12 cycles where one cycle is 28 daysPopulation: 8 Patients were not included due to the following reasons: progressive disease, patient refused further treatment (withdrawal of consent for further treatment), toxicity. This was due to data having either missing time points or "cycle 1" or "Cycle 1: follow up" missing from the dataset at the time of the analysis.
Imaging (such as a CT scan) will be done at baseline (within 4 weeks before the first dose) then after every 2 cycles while on treatment for tumor response evaluation. Response will be evaluated using the international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) v 1.1 Committee. Changes in only the largest diameter (unidimensional measurement) of the tumor lesions are used in RECIST v 1.1. Best response of each patient will be used and responses will be defined as the following: Complete response (CR): Disappearance of all target lesions Partial response (PR): \> 30% decrease in the baseline sum diameters of target lesions
Outcome measures
| Measure |
Treatment (Regorafenib)
n=23 Participants
Patients receive regorafenib PO QD on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
regorafenib: Given PO
|
|---|---|
|
Response Rate
Complete Response
|
2 participants
|
|
Response Rate
Partial Response
|
2 participants
|
SECONDARY outcome
Timeframe: At baseline and after every 2 cycles, up to 12 cycles where one cycle is 28 daysPopulation: 8 Patients were not included due to the following reasons: progressive disease, patient refused further treatment (withdrawal of consent for further treatment), toxicity. This was due to data having either missing time points or "cycle 1" or "Cycle 1: follow up" missing from the dataset at the time of the analysis.
Imaging will be used at baseline then after every 2 cycles while on treatment to measure tumor size and response to treatment, the data collected from all patients on study will be used to calculate the rate and duration of tumor control. Response will be evaluated using the international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) v 1.1 Committee. Changes in only the largest diameter (unidimensional measurement) of the tumor lesions are used in RECIST v 1.1. Response and stable disease will be defined as the following: Complete response (CR): Disappearance of all target lesions Partial response (PR): \> 30% decrease in the baseline sum diameters of target lesions Stable disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study
Outcome measures
| Measure |
Treatment (Regorafenib)
n=23 Participants
Patients receive regorafenib PO QD on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
regorafenib: Given PO
|
|---|---|
|
Rate of Tumor Control
Complete Response
|
2 patients
|
|
Rate of Tumor Control
Partial Response
|
2 patients
|
|
Rate of Tumor Control
Stable Disease
|
9 patients
|
SECONDARY outcome
Timeframe: From treatment initiation though 30 days post the last treatment for a max of 12 cycles where one cycle is 28 daysPopulation: At the time of data pull (12/02/2019) for this outcome measure two patients remained on treatment. Any subsequent AEs determined to be related to treatment for these patients is not included here.
Overall worst grade related toxicity (number of patients) was collected from the start of treatment until 30 days post the last treatment where patients were treated until progressive disease or unacceptable toxicity or patient withdrawal of treatment. All Adverse events that were determined to be at least possibly related to treatment are reported. All adverse events will be graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The severity of an AE is graded as follows: Mild (grade 1): the event causes discomfort without disruption of normal daily activities. Moderate (grade 2): the event causes discomfort that affects normal daily activities. Severe (grade 3): the event makes the patient unable to perform normal daily activities or significantly affects his/her clinical status. Life-threatening (grade 4): the patient was at risk of death at the time of the event. Fatal (grade 5): the event caused death
Outcome measures
| Measure |
Treatment (Regorafenib)
n=31 Participants
Patients receive regorafenib PO QD on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
regorafenib: Given PO
|
|---|---|
|
Number of Grade 1, 2, 3, 4, and 5 Related Adverse Events Observed During Study Treatment (Defined by CTCAE v 4.0)
Renal and urinary disorders · Grade 3
|
0 Participants
|
|
Number of Grade 1, 2, 3, 4, and 5 Related Adverse Events Observed During Study Treatment (Defined by CTCAE v 4.0)
Blood and lymphatic system disorders · Grade 1
|
5 Participants
|
|
Number of Grade 1, 2, 3, 4, and 5 Related Adverse Events Observed During Study Treatment (Defined by CTCAE v 4.0)
Blood and lymphatic system disorders · Grade 2
|
3 Participants
|
|
Number of Grade 1, 2, 3, 4, and 5 Related Adverse Events Observed During Study Treatment (Defined by CTCAE v 4.0)
Blood and lymphatic system disorders · Grade 3
|
3 Participants
|
|
Number of Grade 1, 2, 3, 4, and 5 Related Adverse Events Observed During Study Treatment (Defined by CTCAE v 4.0)
Blood and lymphatic system disorders · Grade 4
|
0 Participants
|
|
Number of Grade 1, 2, 3, 4, and 5 Related Adverse Events Observed During Study Treatment (Defined by CTCAE v 4.0)
Blood and lymphatic system disorders · Number of patients who didn't experience any grade
|
20 Participants
|
|
Number of Grade 1, 2, 3, 4, and 5 Related Adverse Events Observed During Study Treatment (Defined by CTCAE v 4.0)
Endocrine disorders · Grade 1
|
1 Participants
|
|
Number of Grade 1, 2, 3, 4, and 5 Related Adverse Events Observed During Study Treatment (Defined by CTCAE v 4.0)
Endocrine disorders · Grade 2
|
0 Participants
|
|
Number of Grade 1, 2, 3, 4, and 5 Related Adverse Events Observed During Study Treatment (Defined by CTCAE v 4.0)
Endocrine disorders · Grade 3
|
0 Participants
|
|
Number of Grade 1, 2, 3, 4, and 5 Related Adverse Events Observed During Study Treatment (Defined by CTCAE v 4.0)
Endocrine disorders · Grade 4
|
0 Participants
|
|
Number of Grade 1, 2, 3, 4, and 5 Related Adverse Events Observed During Study Treatment (Defined by CTCAE v 4.0)
Endocrine disorders · Number of patients who didn't experience any grade
|
30 Participants
|
|
Number of Grade 1, 2, 3, 4, and 5 Related Adverse Events Observed During Study Treatment (Defined by CTCAE v 4.0)
Eye disorders · Grade 1
|
2 Participants
|
|
Number of Grade 1, 2, 3, 4, and 5 Related Adverse Events Observed During Study Treatment (Defined by CTCAE v 4.0)
Eye disorders · Grade 2
|
0 Participants
|
|
Number of Grade 1, 2, 3, 4, and 5 Related Adverse Events Observed During Study Treatment (Defined by CTCAE v 4.0)
Eye disorders · Grade 3
|
0 Participants
|
|
Number of Grade 1, 2, 3, 4, and 5 Related Adverse Events Observed During Study Treatment (Defined by CTCAE v 4.0)
Eye disorders · Grade 4
|
0 Participants
|
|
Number of Grade 1, 2, 3, 4, and 5 Related Adverse Events Observed During Study Treatment (Defined by CTCAE v 4.0)
Eye disorders · Number of patients who didn't experience any grade
|
29 Participants
|
|
Number of Grade 1, 2, 3, 4, and 5 Related Adverse Events Observed During Study Treatment (Defined by CTCAE v 4.0)
Gastrointestinal disorders · Grade 1
|
14 Participants
|
|
Number of Grade 1, 2, 3, 4, and 5 Related Adverse Events Observed During Study Treatment (Defined by CTCAE v 4.0)
Gastrointestinal disorders · Grade 2
|
9 Participants
|
|
Number of Grade 1, 2, 3, 4, and 5 Related Adverse Events Observed During Study Treatment (Defined by CTCAE v 4.0)
Gastrointestinal disorders · Grade 3
|
3 Participants
|
|
Number of Grade 1, 2, 3, 4, and 5 Related Adverse Events Observed During Study Treatment (Defined by CTCAE v 4.0)
Gastrointestinal disorders · Grade 4
|
0 Participants
|
|
Number of Grade 1, 2, 3, 4, and 5 Related Adverse Events Observed During Study Treatment (Defined by CTCAE v 4.0)
Gastrointestinal disorders · Number of patients who didn't experience any grade
|
5 Participants
|
|
Number of Grade 1, 2, 3, 4, and 5 Related Adverse Events Observed During Study Treatment (Defined by CTCAE v 4.0)
General disorders · Grade 1
|
11 Participants
|
|
Number of Grade 1, 2, 3, 4, and 5 Related Adverse Events Observed During Study Treatment (Defined by CTCAE v 4.0)
General disorders · Grade 2
|
8 Participants
|
|
Number of Grade 1, 2, 3, 4, and 5 Related Adverse Events Observed During Study Treatment (Defined by CTCAE v 4.0)
General disorders · Grade 3
|
4 Participants
|
|
Number of Grade 1, 2, 3, 4, and 5 Related Adverse Events Observed During Study Treatment (Defined by CTCAE v 4.0)
General disorders · Grade 4
|
0 Participants
|
|
Number of Grade 1, 2, 3, 4, and 5 Related Adverse Events Observed During Study Treatment (Defined by CTCAE v 4.0)
General disorders · Number of patients who didn't experience any grade
|
8 Participants
|
|
Number of Grade 1, 2, 3, 4, and 5 Related Adverse Events Observed During Study Treatment (Defined by CTCAE v 4.0)
Infections and infestations · Grade 1
|
1 Participants
|
|
Number of Grade 1, 2, 3, 4, and 5 Related Adverse Events Observed During Study Treatment (Defined by CTCAE v 4.0)
Infections and infestations · Grade 2
|
2 Participants
|
|
Number of Grade 1, 2, 3, 4, and 5 Related Adverse Events Observed During Study Treatment (Defined by CTCAE v 4.0)
Infections and infestations · Grade 3
|
0 Participants
|
|
Number of Grade 1, 2, 3, 4, and 5 Related Adverse Events Observed During Study Treatment (Defined by CTCAE v 4.0)
Infections and infestations · Grade 4
|
0 Participants
|
|
Number of Grade 1, 2, 3, 4, and 5 Related Adverse Events Observed During Study Treatment (Defined by CTCAE v 4.0)
Infections and infestations · Number of patients who didn't experience any grade
|
28 Participants
|
|
Number of Grade 1, 2, 3, 4, and 5 Related Adverse Events Observed During Study Treatment (Defined by CTCAE v 4.0)
Injury, poisoning and procedural complications · Grade 1
|
0 Participants
|
|
Number of Grade 1, 2, 3, 4, and 5 Related Adverse Events Observed During Study Treatment (Defined by CTCAE v 4.0)
Injury, poisoning and procedural complications · Grade 2
|
1 Participants
|
|
Number of Grade 1, 2, 3, 4, and 5 Related Adverse Events Observed During Study Treatment (Defined by CTCAE v 4.0)
Injury, poisoning and procedural complications · Grade 3
|
0 Participants
|
|
Number of Grade 1, 2, 3, 4, and 5 Related Adverse Events Observed During Study Treatment (Defined by CTCAE v 4.0)
Injury, poisoning and procedural complications · Grade 4
|
0 Participants
|
|
Number of Grade 1, 2, 3, 4, and 5 Related Adverse Events Observed During Study Treatment (Defined by CTCAE v 4.0)
Injury, poisoning and procedural complications · Number of patients who didn't experience any grade
|
30 Participants
|
|
Number of Grade 1, 2, 3, 4, and 5 Related Adverse Events Observed During Study Treatment (Defined by CTCAE v 4.0)
Metabolism and nutrition disorders · Grade 1
|
10 Participants
|
|
Number of Grade 1, 2, 3, 4, and 5 Related Adverse Events Observed During Study Treatment (Defined by CTCAE v 4.0)
Metabolism and nutrition disorders · Grade 2
|
4 Participants
|
|
Number of Grade 1, 2, 3, 4, and 5 Related Adverse Events Observed During Study Treatment (Defined by CTCAE v 4.0)
Metabolism and nutrition disorders · Grade 3
|
5 Participants
|
|
Number of Grade 1, 2, 3, 4, and 5 Related Adverse Events Observed During Study Treatment (Defined by CTCAE v 4.0)
Metabolism and nutrition disorders · Grade 4
|
0 Participants
|
|
Number of Grade 1, 2, 3, 4, and 5 Related Adverse Events Observed During Study Treatment (Defined by CTCAE v 4.0)
Metabolism and nutrition disorders · Number of patients who didn't experience any grade
|
12 Participants
|
|
Number of Grade 1, 2, 3, 4, and 5 Related Adverse Events Observed During Study Treatment (Defined by CTCAE v 4.0)
Investigations · Grade 1
|
14 Participants
|
|
Number of Grade 1, 2, 3, 4, and 5 Related Adverse Events Observed During Study Treatment (Defined by CTCAE v 4.0)
Investigations · Grade 2
|
2 Participants
|
|
Number of Grade 1, 2, 3, 4, and 5 Related Adverse Events Observed During Study Treatment (Defined by CTCAE v 4.0)
Investigations · Grade 3
|
3 Participants
|
|
Number of Grade 1, 2, 3, 4, and 5 Related Adverse Events Observed During Study Treatment (Defined by CTCAE v 4.0)
Investigations · Grade 4
|
1 Participants
|
|
Number of Grade 1, 2, 3, 4, and 5 Related Adverse Events Observed During Study Treatment (Defined by CTCAE v 4.0)
Investigations · Number of patients who didn't experience any grade
|
11 Participants
|
|
Number of Grade 1, 2, 3, 4, and 5 Related Adverse Events Observed During Study Treatment (Defined by CTCAE v 4.0)
musculoskeletal and connective tissue disorders · Grade 1
|
7 Participants
|
|
Number of Grade 1, 2, 3, 4, and 5 Related Adverse Events Observed During Study Treatment (Defined by CTCAE v 4.0)
musculoskeletal and connective tissue disorders · Grade 2
|
3 Participants
|
|
Number of Grade 1, 2, 3, 4, and 5 Related Adverse Events Observed During Study Treatment (Defined by CTCAE v 4.0)
musculoskeletal and connective tissue disorders · Grade 3
|
1 Participants
|
|
Number of Grade 1, 2, 3, 4, and 5 Related Adverse Events Observed During Study Treatment (Defined by CTCAE v 4.0)
musculoskeletal and connective tissue disorders · Grade 4
|
0 Participants
|
|
Number of Grade 1, 2, 3, 4, and 5 Related Adverse Events Observed During Study Treatment (Defined by CTCAE v 4.0)
musculoskeletal and connective tissue disorders · Number of patients who didn't experience any grade
|
20 Participants
|
|
Number of Grade 1, 2, 3, 4, and 5 Related Adverse Events Observed During Study Treatment (Defined by CTCAE v 4.0)
Neoplasms benign, malignant and unspecified · Grade 1
|
1 Participants
|
|
Number of Grade 1, 2, 3, 4, and 5 Related Adverse Events Observed During Study Treatment (Defined by CTCAE v 4.0)
Neoplasms benign, malignant and unspecified · Grade 2
|
0 Participants
|
|
Number of Grade 1, 2, 3, 4, and 5 Related Adverse Events Observed During Study Treatment (Defined by CTCAE v 4.0)
Neoplasms benign, malignant and unspecified · Grade 3
|
0 Participants
|
|
Number of Grade 1, 2, 3, 4, and 5 Related Adverse Events Observed During Study Treatment (Defined by CTCAE v 4.0)
Neoplasms benign, malignant and unspecified · Grade 4
|
0 Participants
|
|
Number of Grade 1, 2, 3, 4, and 5 Related Adverse Events Observed During Study Treatment (Defined by CTCAE v 4.0)
Neoplasms benign, malignant and unspecified · Number of patients who didn't experience any grade
|
30 Participants
|
|
Number of Grade 1, 2, 3, 4, and 5 Related Adverse Events Observed During Study Treatment (Defined by CTCAE v 4.0)
Nervous system disorders · Grade 1
|
11 Participants
|
|
Number of Grade 1, 2, 3, 4, and 5 Related Adverse Events Observed During Study Treatment (Defined by CTCAE v 4.0)
Nervous system disorders · Grade 2
|
2 Participants
|
|
Number of Grade 1, 2, 3, 4, and 5 Related Adverse Events Observed During Study Treatment (Defined by CTCAE v 4.0)
Nervous system disorders · Grade 3
|
1 Participants
|
|
Number of Grade 1, 2, 3, 4, and 5 Related Adverse Events Observed During Study Treatment (Defined by CTCAE v 4.0)
Nervous system disorders · Grade 4
|
0 Participants
|
|
Number of Grade 1, 2, 3, 4, and 5 Related Adverse Events Observed During Study Treatment (Defined by CTCAE v 4.0)
Nervous system disorders · Number of patients who didn't experience any grade
|
17 Participants
|
|
Number of Grade 1, 2, 3, 4, and 5 Related Adverse Events Observed During Study Treatment (Defined by CTCAE v 4.0)
Psychiatric disorders · Grade 1
|
3 Participants
|
|
Number of Grade 1, 2, 3, 4, and 5 Related Adverse Events Observed During Study Treatment (Defined by CTCAE v 4.0)
Psychiatric disorders · Grade 2
|
1 Participants
|
|
Number of Grade 1, 2, 3, 4, and 5 Related Adverse Events Observed During Study Treatment (Defined by CTCAE v 4.0)
Psychiatric disorders · Grade 3
|
2 Participants
|
|
Number of Grade 1, 2, 3, 4, and 5 Related Adverse Events Observed During Study Treatment (Defined by CTCAE v 4.0)
Psychiatric disorders · Grade 4
|
0 Participants
|
|
Number of Grade 1, 2, 3, 4, and 5 Related Adverse Events Observed During Study Treatment (Defined by CTCAE v 4.0)
Psychiatric disorders · Number of patients who didn't experience any grade
|
25 Participants
|
|
Number of Grade 1, 2, 3, 4, and 5 Related Adverse Events Observed During Study Treatment (Defined by CTCAE v 4.0)
Renal and urinary disorders · Grade 1
|
0 Participants
|
|
Number of Grade 1, 2, 3, 4, and 5 Related Adverse Events Observed During Study Treatment (Defined by CTCAE v 4.0)
Renal and urinary disorders · Grade 2
|
1 Participants
|
|
Number of Grade 1, 2, 3, 4, and 5 Related Adverse Events Observed During Study Treatment (Defined by CTCAE v 4.0)
Renal and urinary disorders · Grade 4
|
0 Participants
|
|
Number of Grade 1, 2, 3, 4, and 5 Related Adverse Events Observed During Study Treatment (Defined by CTCAE v 4.0)
Renal and urinary disorders · Number of patients who didn't experience any grade
|
30 Participants
|
|
Number of Grade 1, 2, 3, 4, and 5 Related Adverse Events Observed During Study Treatment (Defined by CTCAE v 4.0)
Respiratory, thoracic and mediastinal disorders · Grade 1
|
9 Participants
|
|
Number of Grade 1, 2, 3, 4, and 5 Related Adverse Events Observed During Study Treatment (Defined by CTCAE v 4.0)
Respiratory, thoracic and mediastinal disorders · Grade 2
|
1 Participants
|
|
Number of Grade 1, 2, 3, 4, and 5 Related Adverse Events Observed During Study Treatment (Defined by CTCAE v 4.0)
Respiratory, thoracic and mediastinal disorders · Grade 3
|
1 Participants
|
|
Number of Grade 1, 2, 3, 4, and 5 Related Adverse Events Observed During Study Treatment (Defined by CTCAE v 4.0)
Respiratory, thoracic and mediastinal disorders · Grade 4
|
0 Participants
|
|
Number of Grade 1, 2, 3, 4, and 5 Related Adverse Events Observed During Study Treatment (Defined by CTCAE v 4.0)
Respiratory, thoracic and mediastinal disorders · Number of patients who didn't experience any grade
|
20 Participants
|
|
Number of Grade 1, 2, 3, 4, and 5 Related Adverse Events Observed During Study Treatment (Defined by CTCAE v 4.0)
Skin and subcutaneous tissue disorders · Grade 1
|
14 Participants
|
|
Number of Grade 1, 2, 3, 4, and 5 Related Adverse Events Observed During Study Treatment (Defined by CTCAE v 4.0)
Skin and subcutaneous tissue disorders · Grade 2
|
6 Participants
|
|
Number of Grade 1, 2, 3, 4, and 5 Related Adverse Events Observed During Study Treatment (Defined by CTCAE v 4.0)
Skin and subcutaneous tissue disorders · Grade 3
|
1 Participants
|
|
Number of Grade 1, 2, 3, 4, and 5 Related Adverse Events Observed During Study Treatment (Defined by CTCAE v 4.0)
Skin and subcutaneous tissue disorders · Grade 4
|
0 Participants
|
|
Number of Grade 1, 2, 3, 4, and 5 Related Adverse Events Observed During Study Treatment (Defined by CTCAE v 4.0)
Skin and subcutaneous tissue disorders · Number of patients who didn't experience any grade
|
10 Participants
|
|
Number of Grade 1, 2, 3, 4, and 5 Related Adverse Events Observed During Study Treatment (Defined by CTCAE v 4.0)
Vascular disorders · Grade 1
|
3 Participants
|
|
Number of Grade 1, 2, 3, 4, and 5 Related Adverse Events Observed During Study Treatment (Defined by CTCAE v 4.0)
Vascular disorders · Grade 2
|
8 Participants
|
|
Number of Grade 1, 2, 3, 4, and 5 Related Adverse Events Observed During Study Treatment (Defined by CTCAE v 4.0)
Vascular disorders · Grade 3
|
4 Participants
|
|
Number of Grade 1, 2, 3, 4, and 5 Related Adverse Events Observed During Study Treatment (Defined by CTCAE v 4.0)
Vascular disorders · Grade 4
|
0 Participants
|
|
Number of Grade 1, 2, 3, 4, and 5 Related Adverse Events Observed During Study Treatment (Defined by CTCAE v 4.0)
Vascular disorders · Number of patients who didn't experience any grade
|
16 Participants
|
Adverse Events
Treatment (Regorafenib)
Serious events: 15 serious events
Other events: 31 other events
Deaths: 24 deaths
Serious adverse events
| Measure |
Treatment (Regorafenib)
n=31 participants at risk
Patients receive regorafenib PO QD on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
regorafenib: Given PO
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
3.2%
1/31 • Number of events 1 • Adverse events were collected for each patient from the initiation of treatment up until 30 days post last dose of treatment for a maximum of 12 cycles for any patient (where 1 Cycle = 28 days).
Due to data collection methods, some serious adverse event (SAEs) data maybe captured within the other adverse event data information. There are patients currently on treatment and these sections will be updated with complete information at the study completion. SAEs for any patients that were screenfails (i.e., signed consent but never started study treatment) have been removed from these results. These patients were not included in the participant flow and baseline characteristics section.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
3.2%
1/31 • Number of events 1 • Adverse events were collected for each patient from the initiation of treatment up until 30 days post last dose of treatment for a maximum of 12 cycles for any patient (where 1 Cycle = 28 days).
Due to data collection methods, some serious adverse event (SAEs) data maybe captured within the other adverse event data information. There are patients currently on treatment and these sections will be updated with complete information at the study completion. SAEs for any patients that were screenfails (i.e., signed consent but never started study treatment) have been removed from these results. These patients were not included in the participant flow and baseline characteristics section.
|
|
General disorders
Intractable pain
|
3.2%
1/31 • Number of events 1 • Adverse events were collected for each patient from the initiation of treatment up until 30 days post last dose of treatment for a maximum of 12 cycles for any patient (where 1 Cycle = 28 days).
Due to data collection methods, some serious adverse event (SAEs) data maybe captured within the other adverse event data information. There are patients currently on treatment and these sections will be updated with complete information at the study completion. SAEs for any patients that were screenfails (i.e., signed consent but never started study treatment) have been removed from these results. These patients were not included in the participant flow and baseline characteristics section.
|
|
Vascular disorders
Vascular Disorder
|
3.2%
1/31 • Number of events 1 • Adverse events were collected for each patient from the initiation of treatment up until 30 days post last dose of treatment for a maximum of 12 cycles for any patient (where 1 Cycle = 28 days).
Due to data collection methods, some serious adverse event (SAEs) data maybe captured within the other adverse event data information. There are patients currently on treatment and these sections will be updated with complete information at the study completion. SAEs for any patients that were screenfails (i.e., signed consent but never started study treatment) have been removed from these results. These patients were not included in the participant flow and baseline characteristics section.
|
|
Gastrointestinal disorders
Intra-abdominal hemorrhage
|
3.2%
1/31 • Number of events 1 • Adverse events were collected for each patient from the initiation of treatment up until 30 days post last dose of treatment for a maximum of 12 cycles for any patient (where 1 Cycle = 28 days).
Due to data collection methods, some serious adverse event (SAEs) data maybe captured within the other adverse event data information. There are patients currently on treatment and these sections will be updated with complete information at the study completion. SAEs for any patients that were screenfails (i.e., signed consent but never started study treatment) have been removed from these results. These patients were not included in the participant flow and baseline characteristics section.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
3.2%
1/31 • Number of events 1 • Adverse events were collected for each patient from the initiation of treatment up until 30 days post last dose of treatment for a maximum of 12 cycles for any patient (where 1 Cycle = 28 days).
Due to data collection methods, some serious adverse event (SAEs) data maybe captured within the other adverse event data information. There are patients currently on treatment and these sections will be updated with complete information at the study completion. SAEs for any patients that were screenfails (i.e., signed consent but never started study treatment) have been removed from these results. These patients were not included in the participant flow and baseline characteristics section.
|
|
General disorders
Fever
|
3.2%
1/31 • Number of events 1 • Adverse events were collected for each patient from the initiation of treatment up until 30 days post last dose of treatment for a maximum of 12 cycles for any patient (where 1 Cycle = 28 days).
Due to data collection methods, some serious adverse event (SAEs) data maybe captured within the other adverse event data information. There are patients currently on treatment and these sections will be updated with complete information at the study completion. SAEs for any patients that were screenfails (i.e., signed consent but never started study treatment) have been removed from these results. These patients were not included in the participant flow and baseline characteristics section.
|
|
Gastrointestinal disorders
Nausea
|
3.2%
1/31 • Number of events 1 • Adverse events were collected for each patient from the initiation of treatment up until 30 days post last dose of treatment for a maximum of 12 cycles for any patient (where 1 Cycle = 28 days).
Due to data collection methods, some serious adverse event (SAEs) data maybe captured within the other adverse event data information. There are patients currently on treatment and these sections will be updated with complete information at the study completion. SAEs for any patients that were screenfails (i.e., signed consent but never started study treatment) have been removed from these results. These patients were not included in the participant flow and baseline characteristics section.
|
|
Infections and infestations
Lung infection
|
3.2%
1/31 • Number of events 1 • Adverse events were collected for each patient from the initiation of treatment up until 30 days post last dose of treatment for a maximum of 12 cycles for any patient (where 1 Cycle = 28 days).
Due to data collection methods, some serious adverse event (SAEs) data maybe captured within the other adverse event data information. There are patients currently on treatment and these sections will be updated with complete information at the study completion. SAEs for any patients that were screenfails (i.e., signed consent but never started study treatment) have been removed from these results. These patients were not included in the participant flow and baseline characteristics section.
|
|
Nervous system disorders
Confusion
|
3.2%
1/31 • Number of events 1 • Adverse events were collected for each patient from the initiation of treatment up until 30 days post last dose of treatment for a maximum of 12 cycles for any patient (where 1 Cycle = 28 days).
Due to data collection methods, some serious adverse event (SAEs) data maybe captured within the other adverse event data information. There are patients currently on treatment and these sections will be updated with complete information at the study completion. SAEs for any patients that were screenfails (i.e., signed consent but never started study treatment) have been removed from these results. These patients were not included in the participant flow and baseline characteristics section.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
3.2%
1/31 • Number of events 1 • Adverse events were collected for each patient from the initiation of treatment up until 30 days post last dose of treatment for a maximum of 12 cycles for any patient (where 1 Cycle = 28 days).
Due to data collection methods, some serious adverse event (SAEs) data maybe captured within the other adverse event data information. There are patients currently on treatment and these sections will be updated with complete information at the study completion. SAEs for any patients that were screenfails (i.e., signed consent but never started study treatment) have been removed from these results. These patients were not included in the participant flow and baseline characteristics section.
|
|
Musculoskeletal and connective tissue disorders
Generalized weakness
|
3.2%
1/31 • Number of events 1 • Adverse events were collected for each patient from the initiation of treatment up until 30 days post last dose of treatment for a maximum of 12 cycles for any patient (where 1 Cycle = 28 days).
Due to data collection methods, some serious adverse event (SAEs) data maybe captured within the other adverse event data information. There are patients currently on treatment and these sections will be updated with complete information at the study completion. SAEs for any patients that were screenfails (i.e., signed consent but never started study treatment) have been removed from these results. These patients were not included in the participant flow and baseline characteristics section.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
3.2%
1/31 • Number of events 1 • Adverse events were collected for each patient from the initiation of treatment up until 30 days post last dose of treatment for a maximum of 12 cycles for any patient (where 1 Cycle = 28 days).
Due to data collection methods, some serious adverse event (SAEs) data maybe captured within the other adverse event data information. There are patients currently on treatment and these sections will be updated with complete information at the study completion. SAEs for any patients that were screenfails (i.e., signed consent but never started study treatment) have been removed from these results. These patients were not included in the participant flow and baseline characteristics section.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Disease progression
|
6.5%
2/31 • Number of events 2 • Adverse events were collected for each patient from the initiation of treatment up until 30 days post last dose of treatment for a maximum of 12 cycles for any patient (where 1 Cycle = 28 days).
Due to data collection methods, some serious adverse event (SAEs) data maybe captured within the other adverse event data information. There are patients currently on treatment and these sections will be updated with complete information at the study completion. SAEs for any patients that were screenfails (i.e., signed consent but never started study treatment) have been removed from these results. These patients were not included in the participant flow and baseline characteristics section.
|
|
General disorders
Neck pain
|
3.2%
1/31 • Number of events 1 • Adverse events were collected for each patient from the initiation of treatment up until 30 days post last dose of treatment for a maximum of 12 cycles for any patient (where 1 Cycle = 28 days).
Due to data collection methods, some serious adverse event (SAEs) data maybe captured within the other adverse event data information. There are patients currently on treatment and these sections will be updated with complete information at the study completion. SAEs for any patients that were screenfails (i.e., signed consent but never started study treatment) have been removed from these results. These patients were not included in the participant flow and baseline characteristics section.
|
|
Skin and subcutaneous tissue disorders
Skin ulceration
|
3.2%
1/31 • Number of events 1 • Adverse events were collected for each patient from the initiation of treatment up until 30 days post last dose of treatment for a maximum of 12 cycles for any patient (where 1 Cycle = 28 days).
Due to data collection methods, some serious adverse event (SAEs) data maybe captured within the other adverse event data information. There are patients currently on treatment and these sections will be updated with complete information at the study completion. SAEs for any patients that were screenfails (i.e., signed consent but never started study treatment) have been removed from these results. These patients were not included in the participant flow and baseline characteristics section.
|
|
Gastrointestinal disorders
Lower gastrointestinal hemorrhage
|
3.2%
1/31 • Number of events 1 • Adverse events were collected for each patient from the initiation of treatment up until 30 days post last dose of treatment for a maximum of 12 cycles for any patient (where 1 Cycle = 28 days).
Due to data collection methods, some serious adverse event (SAEs) data maybe captured within the other adverse event data information. There are patients currently on treatment and these sections will be updated with complete information at the study completion. SAEs for any patients that were screenfails (i.e., signed consent but never started study treatment) have been removed from these results. These patients were not included in the participant flow and baseline characteristics section.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor hemorrhage
|
3.2%
1/31 • Number of events 2 • Adverse events were collected for each patient from the initiation of treatment up until 30 days post last dose of treatment for a maximum of 12 cycles for any patient (where 1 Cycle = 28 days).
Due to data collection methods, some serious adverse event (SAEs) data maybe captured within the other adverse event data information. There are patients currently on treatment and these sections will be updated with complete information at the study completion. SAEs for any patients that were screenfails (i.e., signed consent but never started study treatment) have been removed from these results. These patients were not included in the participant flow and baseline characteristics section.
|
Other adverse events
| Measure |
Treatment (Regorafenib)
n=31 participants at risk
Patients receive regorafenib PO QD on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
regorafenib: Given PO
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
45.2%
14/31 • Adverse events were collected for each patient from the initiation of treatment up until 30 days post last dose of treatment for a maximum of 12 cycles for any patient (where 1 Cycle = 28 days).
Due to data collection methods, some serious adverse event (SAEs) data maybe captured within the other adverse event data information. There are patients currently on treatment and these sections will be updated with complete information at the study completion. SAEs for any patients that were screenfails (i.e., signed consent but never started study treatment) have been removed from these results. These patients were not included in the participant flow and baseline characteristics section.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
3.2%
1/31 • Adverse events were collected for each patient from the initiation of treatment up until 30 days post last dose of treatment for a maximum of 12 cycles for any patient (where 1 Cycle = 28 days).
Due to data collection methods, some serious adverse event (SAEs) data maybe captured within the other adverse event data information. There are patients currently on treatment and these sections will be updated with complete information at the study completion. SAEs for any patients that were screenfails (i.e., signed consent but never started study treatment) have been removed from these results. These patients were not included in the participant flow and baseline characteristics section.
|
|
Cardiac disorders
Cardiac disorders - Other, specify
|
6.5%
2/31 • Adverse events were collected for each patient from the initiation of treatment up until 30 days post last dose of treatment for a maximum of 12 cycles for any patient (where 1 Cycle = 28 days).
Due to data collection methods, some serious adverse event (SAEs) data maybe captured within the other adverse event data information. There are patients currently on treatment and these sections will be updated with complete information at the study completion. SAEs for any patients that were screenfails (i.e., signed consent but never started study treatment) have been removed from these results. These patients were not included in the participant flow and baseline characteristics section.
|
|
Cardiac disorders
Chest pain - cardiac
|
3.2%
1/31 • Adverse events were collected for each patient from the initiation of treatment up until 30 days post last dose of treatment for a maximum of 12 cycles for any patient (where 1 Cycle = 28 days).
Due to data collection methods, some serious adverse event (SAEs) data maybe captured within the other adverse event data information. There are patients currently on treatment and these sections will be updated with complete information at the study completion. SAEs for any patients that were screenfails (i.e., signed consent but never started study treatment) have been removed from these results. These patients were not included in the participant flow and baseline characteristics section.
|
|
Cardiac disorders
Myocardial infarction
|
3.2%
1/31 • Adverse events were collected for each patient from the initiation of treatment up until 30 days post last dose of treatment for a maximum of 12 cycles for any patient (where 1 Cycle = 28 days).
Due to data collection methods, some serious adverse event (SAEs) data maybe captured within the other adverse event data information. There are patients currently on treatment and these sections will be updated with complete information at the study completion. SAEs for any patients that were screenfails (i.e., signed consent but never started study treatment) have been removed from these results. These patients were not included in the participant flow and baseline characteristics section.
|
|
Cardiac disorders
Sinus tachycardia
|
3.2%
1/31 • Adverse events were collected for each patient from the initiation of treatment up until 30 days post last dose of treatment for a maximum of 12 cycles for any patient (where 1 Cycle = 28 days).
Due to data collection methods, some serious adverse event (SAEs) data maybe captured within the other adverse event data information. There are patients currently on treatment and these sections will be updated with complete information at the study completion. SAEs for any patients that were screenfails (i.e., signed consent but never started study treatment) have been removed from these results. These patients were not included in the participant flow and baseline characteristics section.
|
|
Ear and labyrinth disorders
Ear and labyrinth disorders - Other, specify
|
3.2%
1/31 • Adverse events were collected for each patient from the initiation of treatment up until 30 days post last dose of treatment for a maximum of 12 cycles for any patient (where 1 Cycle = 28 days).
Due to data collection methods, some serious adverse event (SAEs) data maybe captured within the other adverse event data information. There are patients currently on treatment and these sections will be updated with complete information at the study completion. SAEs for any patients that were screenfails (i.e., signed consent but never started study treatment) have been removed from these results. These patients were not included in the participant flow and baseline characteristics section.
|
|
Ear and labyrinth disorders
Ear pain
|
3.2%
1/31 • Adverse events were collected for each patient from the initiation of treatment up until 30 days post last dose of treatment for a maximum of 12 cycles for any patient (where 1 Cycle = 28 days).
Due to data collection methods, some serious adverse event (SAEs) data maybe captured within the other adverse event data information. There are patients currently on treatment and these sections will be updated with complete information at the study completion. SAEs for any patients that were screenfails (i.e., signed consent but never started study treatment) have been removed from these results. These patients were not included in the participant flow and baseline characteristics section.
|
|
Ear and labyrinth disorders
Tinnitus
|
3.2%
1/31 • Adverse events were collected for each patient from the initiation of treatment up until 30 days post last dose of treatment for a maximum of 12 cycles for any patient (where 1 Cycle = 28 days).
Due to data collection methods, some serious adverse event (SAEs) data maybe captured within the other adverse event data information. There are patients currently on treatment and these sections will be updated with complete information at the study completion. SAEs for any patients that were screenfails (i.e., signed consent but never started study treatment) have been removed from these results. These patients were not included in the participant flow and baseline characteristics section.
|
|
Endocrine disorders
Hypothyroidism
|
3.2%
1/31 • Adverse events were collected for each patient from the initiation of treatment up until 30 days post last dose of treatment for a maximum of 12 cycles for any patient (where 1 Cycle = 28 days).
Due to data collection methods, some serious adverse event (SAEs) data maybe captured within the other adverse event data information. There are patients currently on treatment and these sections will be updated with complete information at the study completion. SAEs for any patients that were screenfails (i.e., signed consent but never started study treatment) have been removed from these results. These patients were not included in the participant flow and baseline characteristics section.
|
|
Eye disorders
Blurred vision
|
3.2%
1/31 • Adverse events were collected for each patient from the initiation of treatment up until 30 days post last dose of treatment for a maximum of 12 cycles for any patient (where 1 Cycle = 28 days).
Due to data collection methods, some serious adverse event (SAEs) data maybe captured within the other adverse event data information. There are patients currently on treatment and these sections will be updated with complete information at the study completion. SAEs for any patients that were screenfails (i.e., signed consent but never started study treatment) have been removed from these results. These patients were not included in the participant flow and baseline characteristics section.
|
|
Eye disorders
Eye disorders - Other, specify
|
3.2%
1/31 • Adverse events were collected for each patient from the initiation of treatment up until 30 days post last dose of treatment for a maximum of 12 cycles for any patient (where 1 Cycle = 28 days).
Due to data collection methods, some serious adverse event (SAEs) data maybe captured within the other adverse event data information. There are patients currently on treatment and these sections will be updated with complete information at the study completion. SAEs for any patients that were screenfails (i.e., signed consent but never started study treatment) have been removed from these results. These patients were not included in the participant flow and baseline characteristics section.
|
|
Gastrointestinal disorders
Abdominal pain
|
19.4%
6/31 • Adverse events were collected for each patient from the initiation of treatment up until 30 days post last dose of treatment for a maximum of 12 cycles for any patient (where 1 Cycle = 28 days).
Due to data collection methods, some serious adverse event (SAEs) data maybe captured within the other adverse event data information. There are patients currently on treatment and these sections will be updated with complete information at the study completion. SAEs for any patients that were screenfails (i.e., signed consent but never started study treatment) have been removed from these results. These patients were not included in the participant flow and baseline characteristics section.
|
|
Gastrointestinal disorders
Ascites
|
3.2%
1/31 • Adverse events were collected for each patient from the initiation of treatment up until 30 days post last dose of treatment for a maximum of 12 cycles for any patient (where 1 Cycle = 28 days).
Due to data collection methods, some serious adverse event (SAEs) data maybe captured within the other adverse event data information. There are patients currently on treatment and these sections will be updated with complete information at the study completion. SAEs for any patients that were screenfails (i.e., signed consent but never started study treatment) have been removed from these results. These patients were not included in the participant flow and baseline characteristics section.
|
|
Gastrointestinal disorders
Constipation
|
38.7%
12/31 • Adverse events were collected for each patient from the initiation of treatment up until 30 days post last dose of treatment for a maximum of 12 cycles for any patient (where 1 Cycle = 28 days).
Due to data collection methods, some serious adverse event (SAEs) data maybe captured within the other adverse event data information. There are patients currently on treatment and these sections will be updated with complete information at the study completion. SAEs for any patients that were screenfails (i.e., signed consent but never started study treatment) have been removed from these results. These patients were not included in the participant flow and baseline characteristics section.
|
|
Gastrointestinal disorders
Diarrhea
|
51.6%
16/31 • Adverse events were collected for each patient from the initiation of treatment up until 30 days post last dose of treatment for a maximum of 12 cycles for any patient (where 1 Cycle = 28 days).
Due to data collection methods, some serious adverse event (SAEs) data maybe captured within the other adverse event data information. There are patients currently on treatment and these sections will be updated with complete information at the study completion. SAEs for any patients that were screenfails (i.e., signed consent but never started study treatment) have been removed from these results. These patients were not included in the participant flow and baseline characteristics section.
|
|
Gastrointestinal disorders
Dry mouth
|
25.8%
8/31 • Adverse events were collected for each patient from the initiation of treatment up until 30 days post last dose of treatment for a maximum of 12 cycles for any patient (where 1 Cycle = 28 days).
Due to data collection methods, some serious adverse event (SAEs) data maybe captured within the other adverse event data information. There are patients currently on treatment and these sections will be updated with complete information at the study completion. SAEs for any patients that were screenfails (i.e., signed consent but never started study treatment) have been removed from these results. These patients were not included in the participant flow and baseline characteristics section.
|
|
Gastrointestinal disorders
Dysphagia
|
3.2%
1/31 • Adverse events were collected for each patient from the initiation of treatment up until 30 days post last dose of treatment for a maximum of 12 cycles for any patient (where 1 Cycle = 28 days).
Due to data collection methods, some serious adverse event (SAEs) data maybe captured within the other adverse event data information. There are patients currently on treatment and these sections will be updated with complete information at the study completion. SAEs for any patients that were screenfails (i.e., signed consent but never started study treatment) have been removed from these results. These patients were not included in the participant flow and baseline characteristics section.
|
|
Gastrointestinal disorders
Flatulence
|
6.5%
2/31 • Adverse events were collected for each patient from the initiation of treatment up until 30 days post last dose of treatment for a maximum of 12 cycles for any patient (where 1 Cycle = 28 days).
Due to data collection methods, some serious adverse event (SAEs) data maybe captured within the other adverse event data information. There are patients currently on treatment and these sections will be updated with complete information at the study completion. SAEs for any patients that were screenfails (i.e., signed consent but never started study treatment) have been removed from these results. These patients were not included in the participant flow and baseline characteristics section.
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify
|
6.5%
2/31 • Adverse events were collected for each patient from the initiation of treatment up until 30 days post last dose of treatment for a maximum of 12 cycles for any patient (where 1 Cycle = 28 days).
Due to data collection methods, some serious adverse event (SAEs) data maybe captured within the other adverse event data information. There are patients currently on treatment and these sections will be updated with complete information at the study completion. SAEs for any patients that were screenfails (i.e., signed consent but never started study treatment) have been removed from these results. These patients were not included in the participant flow and baseline characteristics section.
|
|
Gastrointestinal disorders
Hemorrhoids
|
3.2%
1/31 • Adverse events were collected for each patient from the initiation of treatment up until 30 days post last dose of treatment for a maximum of 12 cycles for any patient (where 1 Cycle = 28 days).
Due to data collection methods, some serious adverse event (SAEs) data maybe captured within the other adverse event data information. There are patients currently on treatment and these sections will be updated with complete information at the study completion. SAEs for any patients that were screenfails (i.e., signed consent but never started study treatment) have been removed from these results. These patients were not included in the participant flow and baseline characteristics section.
|
|
Gastrointestinal disorders
Ileus
|
3.2%
1/31 • Adverse events were collected for each patient from the initiation of treatment up until 30 days post last dose of treatment for a maximum of 12 cycles for any patient (where 1 Cycle = 28 days).
Due to data collection methods, some serious adverse event (SAEs) data maybe captured within the other adverse event data information. There are patients currently on treatment and these sections will be updated with complete information at the study completion. SAEs for any patients that were screenfails (i.e., signed consent but never started study treatment) have been removed from these results. These patients were not included in the participant flow and baseline characteristics section.
|
|
Gastrointestinal disorders
Intra-abdominal hemorrhage
|
3.2%
1/31 • Adverse events were collected for each patient from the initiation of treatment up until 30 days post last dose of treatment for a maximum of 12 cycles for any patient (where 1 Cycle = 28 days).
Due to data collection methods, some serious adverse event (SAEs) data maybe captured within the other adverse event data information. There are patients currently on treatment and these sections will be updated with complete information at the study completion. SAEs for any patients that were screenfails (i.e., signed consent but never started study treatment) have been removed from these results. These patients were not included in the participant flow and baseline characteristics section.
|
|
Gastrointestinal disorders
Lower gastrointestinal hemorrhage
|
3.2%
1/31 • Adverse events were collected for each patient from the initiation of treatment up until 30 days post last dose of treatment for a maximum of 12 cycles for any patient (where 1 Cycle = 28 days).
Due to data collection methods, some serious adverse event (SAEs) data maybe captured within the other adverse event data information. There are patients currently on treatment and these sections will be updated with complete information at the study completion. SAEs for any patients that were screenfails (i.e., signed consent but never started study treatment) have been removed from these results. These patients were not included in the participant flow and baseline characteristics section.
|
|
Gastrointestinal disorders
Mucositis oral
|
35.5%
11/31 • Adverse events were collected for each patient from the initiation of treatment up until 30 days post last dose of treatment for a maximum of 12 cycles for any patient (where 1 Cycle = 28 days).
Due to data collection methods, some serious adverse event (SAEs) data maybe captured within the other adverse event data information. There are patients currently on treatment and these sections will be updated with complete information at the study completion. SAEs for any patients that were screenfails (i.e., signed consent but never started study treatment) have been removed from these results. These patients were not included in the participant flow and baseline characteristics section.
|
|
Gastrointestinal disorders
Nausea
|
51.6%
16/31 • Adverse events were collected for each patient from the initiation of treatment up until 30 days post last dose of treatment for a maximum of 12 cycles for any patient (where 1 Cycle = 28 days).
Due to data collection methods, some serious adverse event (SAEs) data maybe captured within the other adverse event data information. There are patients currently on treatment and these sections will be updated with complete information at the study completion. SAEs for any patients that were screenfails (i.e., signed consent but never started study treatment) have been removed from these results. These patients were not included in the participant flow and baseline characteristics section.
|
|
Gastrointestinal disorders
Oral dysesthesia
|
9.7%
3/31 • Adverse events were collected for each patient from the initiation of treatment up until 30 days post last dose of treatment for a maximum of 12 cycles for any patient (where 1 Cycle = 28 days).
Due to data collection methods, some serious adverse event (SAEs) data maybe captured within the other adverse event data information. There are patients currently on treatment and these sections will be updated with complete information at the study completion. SAEs for any patients that were screenfails (i.e., signed consent but never started study treatment) have been removed from these results. These patients were not included in the participant flow and baseline characteristics section.
|
|
Gastrointestinal disorders
Stomach pain
|
6.5%
2/31 • Adverse events were collected for each patient from the initiation of treatment up until 30 days post last dose of treatment for a maximum of 12 cycles for any patient (where 1 Cycle = 28 days).
Due to data collection methods, some serious adverse event (SAEs) data maybe captured within the other adverse event data information. There are patients currently on treatment and these sections will be updated with complete information at the study completion. SAEs for any patients that were screenfails (i.e., signed consent but never started study treatment) have been removed from these results. These patients were not included in the participant flow and baseline characteristics section.
|
|
Gastrointestinal disorders
Vomiting
|
35.5%
11/31 • Adverse events were collected for each patient from the initiation of treatment up until 30 days post last dose of treatment for a maximum of 12 cycles for any patient (where 1 Cycle = 28 days).
Due to data collection methods, some serious adverse event (SAEs) data maybe captured within the other adverse event data information. There are patients currently on treatment and these sections will be updated with complete information at the study completion. SAEs for any patients that were screenfails (i.e., signed consent but never started study treatment) have been removed from these results. These patients were not included in the participant flow and baseline characteristics section.
|
|
General disorders
Chills
|
6.5%
2/31 • Adverse events were collected for each patient from the initiation of treatment up until 30 days post last dose of treatment for a maximum of 12 cycles for any patient (where 1 Cycle = 28 days).
Due to data collection methods, some serious adverse event (SAEs) data maybe captured within the other adverse event data information. There are patients currently on treatment and these sections will be updated with complete information at the study completion. SAEs for any patients that were screenfails (i.e., signed consent but never started study treatment) have been removed from these results. These patients were not included in the participant flow and baseline characteristics section.
|
|
General disorders
Edema face
|
6.5%
2/31 • Adverse events were collected for each patient from the initiation of treatment up until 30 days post last dose of treatment for a maximum of 12 cycles for any patient (where 1 Cycle = 28 days).
Due to data collection methods, some serious adverse event (SAEs) data maybe captured within the other adverse event data information. There are patients currently on treatment and these sections will be updated with complete information at the study completion. SAEs for any patients that were screenfails (i.e., signed consent but never started study treatment) have been removed from these results. These patients were not included in the participant flow and baseline characteristics section.
|
|
General disorders
Edema limbs
|
12.9%
4/31 • Adverse events were collected for each patient from the initiation of treatment up until 30 days post last dose of treatment for a maximum of 12 cycles for any patient (where 1 Cycle = 28 days).
Due to data collection methods, some serious adverse event (SAEs) data maybe captured within the other adverse event data information. There are patients currently on treatment and these sections will be updated with complete information at the study completion. SAEs for any patients that were screenfails (i.e., signed consent but never started study treatment) have been removed from these results. These patients were not included in the participant flow and baseline characteristics section.
|
|
General disorders
Fatigue
|
74.2%
23/31 • Adverse events were collected for each patient from the initiation of treatment up until 30 days post last dose of treatment for a maximum of 12 cycles for any patient (where 1 Cycle = 28 days).
Due to data collection methods, some serious adverse event (SAEs) data maybe captured within the other adverse event data information. There are patients currently on treatment and these sections will be updated with complete information at the study completion. SAEs for any patients that were screenfails (i.e., signed consent but never started study treatment) have been removed from these results. These patients were not included in the participant flow and baseline characteristics section.
|
|
General disorders
Fever
|
19.4%
6/31 • Adverse events were collected for each patient from the initiation of treatment up until 30 days post last dose of treatment for a maximum of 12 cycles for any patient (where 1 Cycle = 28 days).
Due to data collection methods, some serious adverse event (SAEs) data maybe captured within the other adverse event data information. There are patients currently on treatment and these sections will be updated with complete information at the study completion. SAEs for any patients that were screenfails (i.e., signed consent but never started study treatment) have been removed from these results. These patients were not included in the participant flow and baseline characteristics section.
|
|
General disorders
Gait disturbance
|
16.1%
5/31 • Adverse events were collected for each patient from the initiation of treatment up until 30 days post last dose of treatment for a maximum of 12 cycles for any patient (where 1 Cycle = 28 days).
Due to data collection methods, some serious adverse event (SAEs) data maybe captured within the other adverse event data information. There are patients currently on treatment and these sections will be updated with complete information at the study completion. SAEs for any patients that were screenfails (i.e., signed consent but never started study treatment) have been removed from these results. These patients were not included in the participant flow and baseline characteristics section.
|
|
General disorders
General disorders and administration site conditions - Other, specify
|
6.5%
2/31 • Adverse events were collected for each patient from the initiation of treatment up until 30 days post last dose of treatment for a maximum of 12 cycles for any patient (where 1 Cycle = 28 days).
Due to data collection methods, some serious adverse event (SAEs) data maybe captured within the other adverse event data information. There are patients currently on treatment and these sections will be updated with complete information at the study completion. SAEs for any patients that were screenfails (i.e., signed consent but never started study treatment) have been removed from these results. These patients were not included in the participant flow and baseline characteristics section.
|
|
General disorders
Malaise
|
3.2%
1/31 • Adverse events were collected for each patient from the initiation of treatment up until 30 days post last dose of treatment for a maximum of 12 cycles for any patient (where 1 Cycle = 28 days).
Due to data collection methods, some serious adverse event (SAEs) data maybe captured within the other adverse event data information. There are patients currently on treatment and these sections will be updated with complete information at the study completion. SAEs for any patients that were screenfails (i.e., signed consent but never started study treatment) have been removed from these results. These patients were not included in the participant flow and baseline characteristics section.
|
|
General disorders
Non-cardiac chest pain
|
3.2%
1/31 • Adverse events were collected for each patient from the initiation of treatment up until 30 days post last dose of treatment for a maximum of 12 cycles for any patient (where 1 Cycle = 28 days).
Due to data collection methods, some serious adverse event (SAEs) data maybe captured within the other adverse event data information. There are patients currently on treatment and these sections will be updated with complete information at the study completion. SAEs for any patients that were screenfails (i.e., signed consent but never started study treatment) have been removed from these results. These patients were not included in the participant flow and baseline characteristics section.
|
|
General disorders
Pain
|
25.8%
8/31 • Adverse events were collected for each patient from the initiation of treatment up until 30 days post last dose of treatment for a maximum of 12 cycles for any patient (where 1 Cycle = 28 days).
Due to data collection methods, some serious adverse event (SAEs) data maybe captured within the other adverse event data information. There are patients currently on treatment and these sections will be updated with complete information at the study completion. SAEs for any patients that were screenfails (i.e., signed consent but never started study treatment) have been removed from these results. These patients were not included in the participant flow and baseline characteristics section.
|
|
Infections and infestations
Gum infection
|
3.2%
1/31 • Adverse events were collected for each patient from the initiation of treatment up until 30 days post last dose of treatment for a maximum of 12 cycles for any patient (where 1 Cycle = 28 days).
Due to data collection methods, some serious adverse event (SAEs) data maybe captured within the other adverse event data information. There are patients currently on treatment and these sections will be updated with complete information at the study completion. SAEs for any patients that were screenfails (i.e., signed consent but never started study treatment) have been removed from these results. These patients were not included in the participant flow and baseline characteristics section.
|
|
Infections and infestations
Lung infection
|
3.2%
1/31 • Adverse events were collected for each patient from the initiation of treatment up until 30 days post last dose of treatment for a maximum of 12 cycles for any patient (where 1 Cycle = 28 days).
Due to data collection methods, some serious adverse event (SAEs) data maybe captured within the other adverse event data information. There are patients currently on treatment and these sections will be updated with complete information at the study completion. SAEs for any patients that were screenfails (i.e., signed consent but never started study treatment) have been removed from these results. These patients were not included in the participant flow and baseline characteristics section.
|
|
Infections and infestations
Otitis externa
|
3.2%
1/31 • Adverse events were collected for each patient from the initiation of treatment up until 30 days post last dose of treatment for a maximum of 12 cycles for any patient (where 1 Cycle = 28 days).
Due to data collection methods, some serious adverse event (SAEs) data maybe captured within the other adverse event data information. There are patients currently on treatment and these sections will be updated with complete information at the study completion. SAEs for any patients that were screenfails (i.e., signed consent but never started study treatment) have been removed from these results. These patients were not included in the participant flow and baseline characteristics section.
|
|
Infections and infestations
Otitis media
|
3.2%
1/31 • Adverse events were collected for each patient from the initiation of treatment up until 30 days post last dose of treatment for a maximum of 12 cycles for any patient (where 1 Cycle = 28 days).
Due to data collection methods, some serious adverse event (SAEs) data maybe captured within the other adverse event data information. There are patients currently on treatment and these sections will be updated with complete information at the study completion. SAEs for any patients that were screenfails (i.e., signed consent but never started study treatment) have been removed from these results. These patients were not included in the participant flow and baseline characteristics section.
|
|
Infections and infestations
Peripheral nerve infection
|
3.2%
1/31 • Adverse events were collected for each patient from the initiation of treatment up until 30 days post last dose of treatment for a maximum of 12 cycles for any patient (where 1 Cycle = 28 days).
Due to data collection methods, some serious adverse event (SAEs) data maybe captured within the other adverse event data information. There are patients currently on treatment and these sections will be updated with complete information at the study completion. SAEs for any patients that were screenfails (i.e., signed consent but never started study treatment) have been removed from these results. These patients were not included in the participant flow and baseline characteristics section.
|
|
Infections and infestations
Tooth infection
|
3.2%
1/31 • Adverse events were collected for each patient from the initiation of treatment up until 30 days post last dose of treatment for a maximum of 12 cycles for any patient (where 1 Cycle = 28 days).
Due to data collection methods, some serious adverse event (SAEs) data maybe captured within the other adverse event data information. There are patients currently on treatment and these sections will be updated with complete information at the study completion. SAEs for any patients that were screenfails (i.e., signed consent but never started study treatment) have been removed from these results. These patients were not included in the participant flow and baseline characteristics section.
|
|
Infections and infestations
Upper respiratory infection
|
6.5%
2/31 • Adverse events were collected for each patient from the initiation of treatment up until 30 days post last dose of treatment for a maximum of 12 cycles for any patient (where 1 Cycle = 28 days).
Due to data collection methods, some serious adverse event (SAEs) data maybe captured within the other adverse event data information. There are patients currently on treatment and these sections will be updated with complete information at the study completion. SAEs for any patients that were screenfails (i.e., signed consent but never started study treatment) have been removed from these results. These patients were not included in the participant flow and baseline characteristics section.
|
|
Infections and infestations
Urinary tract infection
|
3.2%
1/31 • Adverse events were collected for each patient from the initiation of treatment up until 30 days post last dose of treatment for a maximum of 12 cycles for any patient (where 1 Cycle = 28 days).
Due to data collection methods, some serious adverse event (SAEs) data maybe captured within the other adverse event data information. There are patients currently on treatment and these sections will be updated with complete information at the study completion. SAEs for any patients that were screenfails (i.e., signed consent but never started study treatment) have been removed from these results. These patients were not included in the participant flow and baseline characteristics section.
|
|
Injury, poisoning and procedural complications
Fall
|
3.2%
1/31 • Adverse events were collected for each patient from the initiation of treatment up until 30 days post last dose of treatment for a maximum of 12 cycles for any patient (where 1 Cycle = 28 days).
Due to data collection methods, some serious adverse event (SAEs) data maybe captured within the other adverse event data information. There are patients currently on treatment and these sections will be updated with complete information at the study completion. SAEs for any patients that were screenfails (i.e., signed consent but never started study treatment) have been removed from these results. These patients were not included in the participant flow and baseline characteristics section.
|
|
Injury, poisoning and procedural complications
Fracture
|
9.7%
3/31 • Adverse events were collected for each patient from the initiation of treatment up until 30 days post last dose of treatment for a maximum of 12 cycles for any patient (where 1 Cycle = 28 days).
Due to data collection methods, some serious adverse event (SAEs) data maybe captured within the other adverse event data information. There are patients currently on treatment and these sections will be updated with complete information at the study completion. SAEs for any patients that were screenfails (i.e., signed consent but never started study treatment) have been removed from these results. These patients were not included in the participant flow and baseline characteristics section.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
3.2%
1/31 • Adverse events were collected for each patient from the initiation of treatment up until 30 days post last dose of treatment for a maximum of 12 cycles for any patient (where 1 Cycle = 28 days).
Due to data collection methods, some serious adverse event (SAEs) data maybe captured within the other adverse event data information. There are patients currently on treatment and these sections will be updated with complete information at the study completion. SAEs for any patients that were screenfails (i.e., signed consent but never started study treatment) have been removed from these results. These patients were not included in the participant flow and baseline characteristics section.
|
|
Investigations
Activated partial thromboplastin time prolonged
|
6.5%
2/31 • Adverse events were collected for each patient from the initiation of treatment up until 30 days post last dose of treatment for a maximum of 12 cycles for any patient (where 1 Cycle = 28 days).
Due to data collection methods, some serious adverse event (SAEs) data maybe captured within the other adverse event data information. There are patients currently on treatment and these sections will be updated with complete information at the study completion. SAEs for any patients that were screenfails (i.e., signed consent but never started study treatment) have been removed from these results. These patients were not included in the participant flow and baseline characteristics section.
|
|
Investigations
Alanine aminotransferase increased
|
19.4%
6/31 • Adverse events were collected for each patient from the initiation of treatment up until 30 days post last dose of treatment for a maximum of 12 cycles for any patient (where 1 Cycle = 28 days).
Due to data collection methods, some serious adverse event (SAEs) data maybe captured within the other adverse event data information. There are patients currently on treatment and these sections will be updated with complete information at the study completion. SAEs for any patients that were screenfails (i.e., signed consent but never started study treatment) have been removed from these results. These patients were not included in the participant flow and baseline characteristics section.
|
|
Investigations
Alkaline phosphatase increased
|
22.6%
7/31 • Adverse events were collected for each patient from the initiation of treatment up until 30 days post last dose of treatment for a maximum of 12 cycles for any patient (where 1 Cycle = 28 days).
Due to data collection methods, some serious adverse event (SAEs) data maybe captured within the other adverse event data information. There are patients currently on treatment and these sections will be updated with complete information at the study completion. SAEs for any patients that were screenfails (i.e., signed consent but never started study treatment) have been removed from these results. These patients were not included in the participant flow and baseline characteristics section.
|
|
Investigations
Aspartate aminotransferase increased
|
22.6%
7/31 • Adverse events were collected for each patient from the initiation of treatment up until 30 days post last dose of treatment for a maximum of 12 cycles for any patient (where 1 Cycle = 28 days).
Due to data collection methods, some serious adverse event (SAEs) data maybe captured within the other adverse event data information. There are patients currently on treatment and these sections will be updated with complete information at the study completion. SAEs for any patients that were screenfails (i.e., signed consent but never started study treatment) have been removed from these results. These patients were not included in the participant flow and baseline characteristics section.
|
|
Investigations
Blood bilirubin increased
|
29.0%
9/31 • Adverse events were collected for each patient from the initiation of treatment up until 30 days post last dose of treatment for a maximum of 12 cycles for any patient (where 1 Cycle = 28 days).
Due to data collection methods, some serious adverse event (SAEs) data maybe captured within the other adverse event data information. There are patients currently on treatment and these sections will be updated with complete information at the study completion. SAEs for any patients that were screenfails (i.e., signed consent but never started study treatment) have been removed from these results. These patients were not included in the participant flow and baseline characteristics section.
|
|
Investigations
Cholesterol high
|
3.2%
1/31 • Adverse events were collected for each patient from the initiation of treatment up until 30 days post last dose of treatment for a maximum of 12 cycles for any patient (where 1 Cycle = 28 days).
Due to data collection methods, some serious adverse event (SAEs) data maybe captured within the other adverse event data information. There are patients currently on treatment and these sections will be updated with complete information at the study completion. SAEs for any patients that were screenfails (i.e., signed consent but never started study treatment) have been removed from these results. These patients were not included in the participant flow and baseline characteristics section.
|
|
Investigations
Creatinine increased
|
22.6%
7/31 • Adverse events were collected for each patient from the initiation of treatment up until 30 days post last dose of treatment for a maximum of 12 cycles for any patient (where 1 Cycle = 28 days).
Due to data collection methods, some serious adverse event (SAEs) data maybe captured within the other adverse event data information. There are patients currently on treatment and these sections will be updated with complete information at the study completion. SAEs for any patients that were screenfails (i.e., signed consent but never started study treatment) have been removed from these results. These patients were not included in the participant flow and baseline characteristics section.
|
|
Investigations
INR increased
|
16.1%
5/31 • Adverse events were collected for each patient from the initiation of treatment up until 30 days post last dose of treatment for a maximum of 12 cycles for any patient (where 1 Cycle = 28 days).
Due to data collection methods, some serious adverse event (SAEs) data maybe captured within the other adverse event data information. There are patients currently on treatment and these sections will be updated with complete information at the study completion. SAEs for any patients that were screenfails (i.e., signed consent but never started study treatment) have been removed from these results. These patients were not included in the participant flow and baseline characteristics section.
|
|
Investigations
Investigations - Other, specify
|
6.5%
2/31 • Adverse events were collected for each patient from the initiation of treatment up until 30 days post last dose of treatment for a maximum of 12 cycles for any patient (where 1 Cycle = 28 days).
Due to data collection methods, some serious adverse event (SAEs) data maybe captured within the other adverse event data information. There are patients currently on treatment and these sections will be updated with complete information at the study completion. SAEs for any patients that were screenfails (i.e., signed consent but never started study treatment) have been removed from these results. These patients were not included in the participant flow and baseline characteristics section.
|
|
Investigations
Lipase increased
|
9.7%
3/31 • Adverse events were collected for each patient from the initiation of treatment up until 30 days post last dose of treatment for a maximum of 12 cycles for any patient (where 1 Cycle = 28 days).
Due to data collection methods, some serious adverse event (SAEs) data maybe captured within the other adverse event data information. There are patients currently on treatment and these sections will be updated with complete information at the study completion. SAEs for any patients that were screenfails (i.e., signed consent but never started study treatment) have been removed from these results. These patients were not included in the participant flow and baseline characteristics section.
|
|
Investigations
Lymphocyte count decreased
|
51.6%
16/31 • Adverse events were collected for each patient from the initiation of treatment up until 30 days post last dose of treatment for a maximum of 12 cycles for any patient (where 1 Cycle = 28 days).
Due to data collection methods, some serious adverse event (SAEs) data maybe captured within the other adverse event data information. There are patients currently on treatment and these sections will be updated with complete information at the study completion. SAEs for any patients that were screenfails (i.e., signed consent but never started study treatment) have been removed from these results. These patients were not included in the participant flow and baseline characteristics section.
|
|
Investigations
Neutrophil count decreased
|
3.2%
1/31 • Adverse events were collected for each patient from the initiation of treatment up until 30 days post last dose of treatment for a maximum of 12 cycles for any patient (where 1 Cycle = 28 days).
Due to data collection methods, some serious adverse event (SAEs) data maybe captured within the other adverse event data information. There are patients currently on treatment and these sections will be updated with complete information at the study completion. SAEs for any patients that were screenfails (i.e., signed consent but never started study treatment) have been removed from these results. These patients were not included in the participant flow and baseline characteristics section.
|
|
Investigations
Platelet count decreased
|
35.5%
11/31 • Adverse events were collected for each patient from the initiation of treatment up until 30 days post last dose of treatment for a maximum of 12 cycles for any patient (where 1 Cycle = 28 days).
Due to data collection methods, some serious adverse event (SAEs) data maybe captured within the other adverse event data information. There are patients currently on treatment and these sections will be updated with complete information at the study completion. SAEs for any patients that were screenfails (i.e., signed consent but never started study treatment) have been removed from these results. These patients were not included in the participant flow and baseline characteristics section.
|
|
Investigations
Serum amylase increased
|
3.2%
1/31 • Adverse events were collected for each patient from the initiation of treatment up until 30 days post last dose of treatment for a maximum of 12 cycles for any patient (where 1 Cycle = 28 days).
Due to data collection methods, some serious adverse event (SAEs) data maybe captured within the other adverse event data information. There are patients currently on treatment and these sections will be updated with complete information at the study completion. SAEs for any patients that were screenfails (i.e., signed consent but never started study treatment) have been removed from these results. These patients were not included in the participant flow and baseline characteristics section.
|
|
Investigations
Weight loss
|
19.4%
6/31 • Adverse events were collected for each patient from the initiation of treatment up until 30 days post last dose of treatment for a maximum of 12 cycles for any patient (where 1 Cycle = 28 days).
Due to data collection methods, some serious adverse event (SAEs) data maybe captured within the other adverse event data information. There are patients currently on treatment and these sections will be updated with complete information at the study completion. SAEs for any patients that were screenfails (i.e., signed consent but never started study treatment) have been removed from these results. These patients were not included in the participant flow and baseline characteristics section.
|
|
Investigations
White blood cell decreased
|
3.2%
1/31 • Adverse events were collected for each patient from the initiation of treatment up until 30 days post last dose of treatment for a maximum of 12 cycles for any patient (where 1 Cycle = 28 days).
Due to data collection methods, some serious adverse event (SAEs) data maybe captured within the other adverse event data information. There are patients currently on treatment and these sections will be updated with complete information at the study completion. SAEs for any patients that were screenfails (i.e., signed consent but never started study treatment) have been removed from these results. These patients were not included in the participant flow and baseline characteristics section.
|
|
Metabolism and nutrition disorders
Anorexia
|
41.9%
13/31 • Adverse events were collected for each patient from the initiation of treatment up until 30 days post last dose of treatment for a maximum of 12 cycles for any patient (where 1 Cycle = 28 days).
Due to data collection methods, some serious adverse event (SAEs) data maybe captured within the other adverse event data information. There are patients currently on treatment and these sections will be updated with complete information at the study completion. SAEs for any patients that were screenfails (i.e., signed consent but never started study treatment) have been removed from these results. These patients were not included in the participant flow and baseline characteristics section.
|
|
Metabolism and nutrition disorders
Dehydration
|
3.2%
1/31 • Adverse events were collected for each patient from the initiation of treatment up until 30 days post last dose of treatment for a maximum of 12 cycles for any patient (where 1 Cycle = 28 days).
Due to data collection methods, some serious adverse event (SAEs) data maybe captured within the other adverse event data information. There are patients currently on treatment and these sections will be updated with complete information at the study completion. SAEs for any patients that were screenfails (i.e., signed consent but never started study treatment) have been removed from these results. These patients were not included in the participant flow and baseline characteristics section.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
19.4%
6/31 • Adverse events were collected for each patient from the initiation of treatment up until 30 days post last dose of treatment for a maximum of 12 cycles for any patient (where 1 Cycle = 28 days).
Due to data collection methods, some serious adverse event (SAEs) data maybe captured within the other adverse event data information. There are patients currently on treatment and these sections will be updated with complete information at the study completion. SAEs for any patients that were screenfails (i.e., signed consent but never started study treatment) have been removed from these results. These patients were not included in the participant flow and baseline characteristics section.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
12.9%
4/31 • Adverse events were collected for each patient from the initiation of treatment up until 30 days post last dose of treatment for a maximum of 12 cycles for any patient (where 1 Cycle = 28 days).
Due to data collection methods, some serious adverse event (SAEs) data maybe captured within the other adverse event data information. There are patients currently on treatment and these sections will be updated with complete information at the study completion. SAEs for any patients that were screenfails (i.e., signed consent but never started study treatment) have been removed from these results. These patients were not included in the participant flow and baseline characteristics section.
|
|
Metabolism and nutrition disorders
Hypernatremia
|
3.2%
1/31 • Adverse events were collected for each patient from the initiation of treatment up until 30 days post last dose of treatment for a maximum of 12 cycles for any patient (where 1 Cycle = 28 days).
Due to data collection methods, some serious adverse event (SAEs) data maybe captured within the other adverse event data information. There are patients currently on treatment and these sections will be updated with complete information at the study completion. SAEs for any patients that were screenfails (i.e., signed consent but never started study treatment) have been removed from these results. These patients were not included in the participant flow and baseline characteristics section.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
51.6%
16/31 • Adverse events were collected for each patient from the initiation of treatment up until 30 days post last dose of treatment for a maximum of 12 cycles for any patient (where 1 Cycle = 28 days).
Due to data collection methods, some serious adverse event (SAEs) data maybe captured within the other adverse event data information. There are patients currently on treatment and these sections will be updated with complete information at the study completion. SAEs for any patients that were screenfails (i.e., signed consent but never started study treatment) have been removed from these results. These patients were not included in the participant flow and baseline characteristics section.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
41.9%
13/31 • Adverse events were collected for each patient from the initiation of treatment up until 30 days post last dose of treatment for a maximum of 12 cycles for any patient (where 1 Cycle = 28 days).
Due to data collection methods, some serious adverse event (SAEs) data maybe captured within the other adverse event data information. There are patients currently on treatment and these sections will be updated with complete information at the study completion. SAEs for any patients that were screenfails (i.e., signed consent but never started study treatment) have been removed from these results. These patients were not included in the participant flow and baseline characteristics section.
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
3.2%
1/31 • Adverse events were collected for each patient from the initiation of treatment up until 30 days post last dose of treatment for a maximum of 12 cycles for any patient (where 1 Cycle = 28 days).
Due to data collection methods, some serious adverse event (SAEs) data maybe captured within the other adverse event data information. There are patients currently on treatment and these sections will be updated with complete information at the study completion. SAEs for any patients that were screenfails (i.e., signed consent but never started study treatment) have been removed from these results. These patients were not included in the participant flow and baseline characteristics section.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
25.8%
8/31 • Adverse events were collected for each patient from the initiation of treatment up until 30 days post last dose of treatment for a maximum of 12 cycles for any patient (where 1 Cycle = 28 days).
Due to data collection methods, some serious adverse event (SAEs) data maybe captured within the other adverse event data information. There are patients currently on treatment and these sections will be updated with complete information at the study completion. SAEs for any patients that were screenfails (i.e., signed consent but never started study treatment) have been removed from these results. These patients were not included in the participant flow and baseline characteristics section.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
16.1%
5/31 • Adverse events were collected for each patient from the initiation of treatment up until 30 days post last dose of treatment for a maximum of 12 cycles for any patient (where 1 Cycle = 28 days).
Due to data collection methods, some serious adverse event (SAEs) data maybe captured within the other adverse event data information. There are patients currently on treatment and these sections will be updated with complete information at the study completion. SAEs for any patients that were screenfails (i.e., signed consent but never started study treatment) have been removed from these results. These patients were not included in the participant flow and baseline characteristics section.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
32.3%
10/31 • Adverse events were collected for each patient from the initiation of treatment up until 30 days post last dose of treatment for a maximum of 12 cycles for any patient (where 1 Cycle = 28 days).
Due to data collection methods, some serious adverse event (SAEs) data maybe captured within the other adverse event data information. There are patients currently on treatment and these sections will be updated with complete information at the study completion. SAEs for any patients that were screenfails (i.e., signed consent but never started study treatment) have been removed from these results. These patients were not included in the participant flow and baseline characteristics section.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
3.2%
1/31 • Adverse events were collected for each patient from the initiation of treatment up until 30 days post last dose of treatment for a maximum of 12 cycles for any patient (where 1 Cycle = 28 days).
Due to data collection methods, some serious adverse event (SAEs) data maybe captured within the other adverse event data information. There are patients currently on treatment and these sections will be updated with complete information at the study completion. SAEs for any patients that were screenfails (i.e., signed consent but never started study treatment) have been removed from these results. These patients were not included in the participant flow and baseline characteristics section.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
12.9%
4/31 • Adverse events were collected for each patient from the initiation of treatment up until 30 days post last dose of treatment for a maximum of 12 cycles for any patient (where 1 Cycle = 28 days).
Due to data collection methods, some serious adverse event (SAEs) data maybe captured within the other adverse event data information. There are patients currently on treatment and these sections will be updated with complete information at the study completion. SAEs for any patients that were screenfails (i.e., signed consent but never started study treatment) have been removed from these results. These patients were not included in the participant flow and baseline characteristics section.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
22.6%
7/31 • Adverse events were collected for each patient from the initiation of treatment up until 30 days post last dose of treatment for a maximum of 12 cycles for any patient (where 1 Cycle = 28 days).
Due to data collection methods, some serious adverse event (SAEs) data maybe captured within the other adverse event data information. There are patients currently on treatment and these sections will be updated with complete information at the study completion. SAEs for any patients that were screenfails (i.e., signed consent but never started study treatment) have been removed from these results. These patients were not included in the participant flow and baseline characteristics section.
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
3.2%
1/31 • Adverse events were collected for each patient from the initiation of treatment up until 30 days post last dose of treatment for a maximum of 12 cycles for any patient (where 1 Cycle = 28 days).
Due to data collection methods, some serious adverse event (SAEs) data maybe captured within the other adverse event data information. There are patients currently on treatment and these sections will be updated with complete information at the study completion. SAEs for any patients that were screenfails (i.e., signed consent but never started study treatment) have been removed from these results. These patients were not included in the participant flow and baseline characteristics section.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
3.2%
1/31 • Adverse events were collected for each patient from the initiation of treatment up until 30 days post last dose of treatment for a maximum of 12 cycles for any patient (where 1 Cycle = 28 days).
Due to data collection methods, some serious adverse event (SAEs) data maybe captured within the other adverse event data information. There are patients currently on treatment and these sections will be updated with complete information at the study completion. SAEs for any patients that were screenfails (i.e., signed consent but never started study treatment) have been removed from these results. These patients were not included in the participant flow and baseline characteristics section.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
16.1%
5/31 • Adverse events were collected for each patient from the initiation of treatment up until 30 days post last dose of treatment for a maximum of 12 cycles for any patient (where 1 Cycle = 28 days).
Due to data collection methods, some serious adverse event (SAEs) data maybe captured within the other adverse event data information. There are patients currently on treatment and these sections will be updated with complete information at the study completion. SAEs for any patients that were screenfails (i.e., signed consent but never started study treatment) have been removed from these results. These patients were not included in the participant flow and baseline characteristics section.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
3.2%
1/31 • Adverse events were collected for each patient from the initiation of treatment up until 30 days post last dose of treatment for a maximum of 12 cycles for any patient (where 1 Cycle = 28 days).
Due to data collection methods, some serious adverse event (SAEs) data maybe captured within the other adverse event data information. There are patients currently on treatment and these sections will be updated with complete information at the study completion. SAEs for any patients that were screenfails (i.e., signed consent but never started study treatment) have been removed from these results. These patients were not included in the participant flow and baseline characteristics section.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, specify
|
6.5%
2/31 • Adverse events were collected for each patient from the initiation of treatment up until 30 days post last dose of treatment for a maximum of 12 cycles for any patient (where 1 Cycle = 28 days).
Due to data collection methods, some serious adverse event (SAEs) data maybe captured within the other adverse event data information. There are patients currently on treatment and these sections will be updated with complete information at the study completion. SAEs for any patients that were screenfails (i.e., signed consent but never started study treatment) have been removed from these results. These patients were not included in the participant flow and baseline characteristics section.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
12.9%
4/31 • Adverse events were collected for each patient from the initiation of treatment up until 30 days post last dose of treatment for a maximum of 12 cycles for any patient (where 1 Cycle = 28 days).
Due to data collection methods, some serious adverse event (SAEs) data maybe captured within the other adverse event data information. There are patients currently on treatment and these sections will be updated with complete information at the study completion. SAEs for any patients that were screenfails (i.e., signed consent but never started study treatment) have been removed from these results. These patients were not included in the participant flow and baseline characteristics section.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
9.7%
3/31 • Adverse events were collected for each patient from the initiation of treatment up until 30 days post last dose of treatment for a maximum of 12 cycles for any patient (where 1 Cycle = 28 days).
Due to data collection methods, some serious adverse event (SAEs) data maybe captured within the other adverse event data information. There are patients currently on treatment and these sections will be updated with complete information at the study completion. SAEs for any patients that were screenfails (i.e., signed consent but never started study treatment) have been removed from these results. These patients were not included in the participant flow and baseline characteristics section.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
25.8%
8/31 • Adverse events were collected for each patient from the initiation of treatment up until 30 days post last dose of treatment for a maximum of 12 cycles for any patient (where 1 Cycle = 28 days).
Due to data collection methods, some serious adverse event (SAEs) data maybe captured within the other adverse event data information. There are patients currently on treatment and these sections will be updated with complete information at the study completion. SAEs for any patients that were screenfails (i.e., signed consent but never started study treatment) have been removed from these results. These patients were not included in the participant flow and baseline characteristics section.
|
|
Musculoskeletal and connective tissue disorders
Trismus
|
3.2%
1/31 • Adverse events were collected for each patient from the initiation of treatment up until 30 days post last dose of treatment for a maximum of 12 cycles for any patient (where 1 Cycle = 28 days).
Due to data collection methods, some serious adverse event (SAEs) data maybe captured within the other adverse event data information. There are patients currently on treatment and these sections will be updated with complete information at the study completion. SAEs for any patients that were screenfails (i.e., signed consent but never started study treatment) have been removed from these results. These patients were not included in the participant flow and baseline characteristics section.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify
|
6.5%
2/31 • Adverse events were collected for each patient from the initiation of treatment up until 30 days post last dose of treatment for a maximum of 12 cycles for any patient (where 1 Cycle = 28 days).
Due to data collection methods, some serious adverse event (SAEs) data maybe captured within the other adverse event data information. There are patients currently on treatment and these sections will be updated with complete information at the study completion. SAEs for any patients that were screenfails (i.e., signed consent but never started study treatment) have been removed from these results. These patients were not included in the participant flow and baseline characteristics section.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor pain
|
6.5%
2/31 • Adverse events were collected for each patient from the initiation of treatment up until 30 days post last dose of treatment for a maximum of 12 cycles for any patient (where 1 Cycle = 28 days).
Due to data collection methods, some serious adverse event (SAEs) data maybe captured within the other adverse event data information. There are patients currently on treatment and these sections will be updated with complete information at the study completion. SAEs for any patients that were screenfails (i.e., signed consent but never started study treatment) have been removed from these results. These patients were not included in the participant flow and baseline characteristics section.
|
|
Nervous system disorders
Ataxia
|
6.5%
2/31 • Adverse events were collected for each patient from the initiation of treatment up until 30 days post last dose of treatment for a maximum of 12 cycles for any patient (where 1 Cycle = 28 days).
Due to data collection methods, some serious adverse event (SAEs) data maybe captured within the other adverse event data information. There are patients currently on treatment and these sections will be updated with complete information at the study completion. SAEs for any patients that were screenfails (i.e., signed consent but never started study treatment) have been removed from these results. These patients were not included in the participant flow and baseline characteristics section.
|
|
Nervous system disorders
Dizziness
|
19.4%
6/31 • Adverse events were collected for each patient from the initiation of treatment up until 30 days post last dose of treatment for a maximum of 12 cycles for any patient (where 1 Cycle = 28 days).
Due to data collection methods, some serious adverse event (SAEs) data maybe captured within the other adverse event data information. There are patients currently on treatment and these sections will be updated with complete information at the study completion. SAEs for any patients that were screenfails (i.e., signed consent but never started study treatment) have been removed from these results. These patients were not included in the participant flow and baseline characteristics section.
|
|
Nervous system disorders
Dysgeusia
|
9.7%
3/31 • Adverse events were collected for each patient from the initiation of treatment up until 30 days post last dose of treatment for a maximum of 12 cycles for any patient (where 1 Cycle = 28 days).
Due to data collection methods, some serious adverse event (SAEs) data maybe captured within the other adverse event data information. There are patients currently on treatment and these sections will be updated with complete information at the study completion. SAEs for any patients that were screenfails (i.e., signed consent but never started study treatment) have been removed from these results. These patients were not included in the participant flow and baseline characteristics section.
|
|
Nervous system disorders
Headache
|
29.0%
9/31 • Adverse events were collected for each patient from the initiation of treatment up until 30 days post last dose of treatment for a maximum of 12 cycles for any patient (where 1 Cycle = 28 days).
Due to data collection methods, some serious adverse event (SAEs) data maybe captured within the other adverse event data information. There are patients currently on treatment and these sections will be updated with complete information at the study completion. SAEs for any patients that were screenfails (i.e., signed consent but never started study treatment) have been removed from these results. These patients were not included in the participant flow and baseline characteristics section.
|
|
Nervous system disorders
Movements involuntary
|
3.2%
1/31 • Adverse events were collected for each patient from the initiation of treatment up until 30 days post last dose of treatment for a maximum of 12 cycles for any patient (where 1 Cycle = 28 days).
Due to data collection methods, some serious adverse event (SAEs) data maybe captured within the other adverse event data information. There are patients currently on treatment and these sections will be updated with complete information at the study completion. SAEs for any patients that were screenfails (i.e., signed consent but never started study treatment) have been removed from these results. These patients were not included in the participant flow and baseline characteristics section.
|
|
Nervous system disorders
Paresthesia
|
6.5%
2/31 • Adverse events were collected for each patient from the initiation of treatment up until 30 days post last dose of treatment for a maximum of 12 cycles for any patient (where 1 Cycle = 28 days).
Due to data collection methods, some serious adverse event (SAEs) data maybe captured within the other adverse event data information. There are patients currently on treatment and these sections will be updated with complete information at the study completion. SAEs for any patients that were screenfails (i.e., signed consent but never started study treatment) have been removed from these results. These patients were not included in the participant flow and baseline characteristics section.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
19.4%
6/31 • Adverse events were collected for each patient from the initiation of treatment up until 30 days post last dose of treatment for a maximum of 12 cycles for any patient (where 1 Cycle = 28 days).
Due to data collection methods, some serious adverse event (SAEs) data maybe captured within the other adverse event data information. There are patients currently on treatment and these sections will be updated with complete information at the study completion. SAEs for any patients that were screenfails (i.e., signed consent but never started study treatment) have been removed from these results. These patients were not included in the participant flow and baseline characteristics section.
|
|
Nervous system disorders
Syncope
|
3.2%
1/31 • Adverse events were collected for each patient from the initiation of treatment up until 30 days post last dose of treatment for a maximum of 12 cycles for any patient (where 1 Cycle = 28 days).
Due to data collection methods, some serious adverse event (SAEs) data maybe captured within the other adverse event data information. There are patients currently on treatment and these sections will be updated with complete information at the study completion. SAEs for any patients that were screenfails (i.e., signed consent but never started study treatment) have been removed from these results. These patients were not included in the participant flow and baseline characteristics section.
|
|
Psychiatric disorders
Anxiety
|
6.5%
2/31 • Adverse events were collected for each patient from the initiation of treatment up until 30 days post last dose of treatment for a maximum of 12 cycles for any patient (where 1 Cycle = 28 days).
Due to data collection methods, some serious adverse event (SAEs) data maybe captured within the other adverse event data information. There are patients currently on treatment and these sections will be updated with complete information at the study completion. SAEs for any patients that were screenfails (i.e., signed consent but never started study treatment) have been removed from these results. These patients were not included in the participant flow and baseline characteristics section.
|
|
Psychiatric disorders
Confusion
|
9.7%
3/31 • Adverse events were collected for each patient from the initiation of treatment up until 30 days post last dose of treatment for a maximum of 12 cycles for any patient (where 1 Cycle = 28 days).
Due to data collection methods, some serious adverse event (SAEs) data maybe captured within the other adverse event data information. There are patients currently on treatment and these sections will be updated with complete information at the study completion. SAEs for any patients that were screenfails (i.e., signed consent but never started study treatment) have been removed from these results. These patients were not included in the participant flow and baseline characteristics section.
|
|
Psychiatric disorders
Insomnia
|
25.8%
8/31 • Adverse events were collected for each patient from the initiation of treatment up until 30 days post last dose of treatment for a maximum of 12 cycles for any patient (where 1 Cycle = 28 days).
Due to data collection methods, some serious adverse event (SAEs) data maybe captured within the other adverse event data information. There are patients currently on treatment and these sections will be updated with complete information at the study completion. SAEs for any patients that were screenfails (i.e., signed consent but never started study treatment) have been removed from these results. These patients were not included in the participant flow and baseline characteristics section.
|
|
Renal and urinary disorders
Acute kidney injury
|
3.2%
1/31 • Adverse events were collected for each patient from the initiation of treatment up until 30 days post last dose of treatment for a maximum of 12 cycles for any patient (where 1 Cycle = 28 days).
Due to data collection methods, some serious adverse event (SAEs) data maybe captured within the other adverse event data information. There are patients currently on treatment and these sections will be updated with complete information at the study completion. SAEs for any patients that were screenfails (i.e., signed consent but never started study treatment) have been removed from these results. These patients were not included in the participant flow and baseline characteristics section.
|
|
Renal and urinary disorders
Urinary frequency
|
3.2%
1/31 • Adverse events were collected for each patient from the initiation of treatment up until 30 days post last dose of treatment for a maximum of 12 cycles for any patient (where 1 Cycle = 28 days).
Due to data collection methods, some serious adverse event (SAEs) data maybe captured within the other adverse event data information. There are patients currently on treatment and these sections will be updated with complete information at the study completion. SAEs for any patients that were screenfails (i.e., signed consent but never started study treatment) have been removed from these results. These patients were not included in the participant flow and baseline characteristics section.
|
|
Renal and urinary disorders
Urinary incontinence
|
3.2%
1/31 • Adverse events were collected for each patient from the initiation of treatment up until 30 days post last dose of treatment for a maximum of 12 cycles for any patient (where 1 Cycle = 28 days).
Due to data collection methods, some serious adverse event (SAEs) data maybe captured within the other adverse event data information. There are patients currently on treatment and these sections will be updated with complete information at the study completion. SAEs for any patients that were screenfails (i.e., signed consent but never started study treatment) have been removed from these results. These patients were not included in the participant flow and baseline characteristics section.
|
|
Renal and urinary disorders
Urinary retention
|
3.2%
1/31 • Adverse events were collected for each patient from the initiation of treatment up until 30 days post last dose of treatment for a maximum of 12 cycles for any patient (where 1 Cycle = 28 days).
Due to data collection methods, some serious adverse event (SAEs) data maybe captured within the other adverse event data information. There are patients currently on treatment and these sections will be updated with complete information at the study completion. SAEs for any patients that were screenfails (i.e., signed consent but never started study treatment) have been removed from these results. These patients were not included in the participant flow and baseline characteristics section.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
19.4%
6/31 • Adverse events were collected for each patient from the initiation of treatment up until 30 days post last dose of treatment for a maximum of 12 cycles for any patient (where 1 Cycle = 28 days).
Due to data collection methods, some serious adverse event (SAEs) data maybe captured within the other adverse event data information. There are patients currently on treatment and these sections will be updated with complete information at the study completion. SAEs for any patients that were screenfails (i.e., signed consent but never started study treatment) have been removed from these results. These patients were not included in the participant flow and baseline characteristics section.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
29.0%
9/31 • Adverse events were collected for each patient from the initiation of treatment up until 30 days post last dose of treatment for a maximum of 12 cycles for any patient (where 1 Cycle = 28 days).
Due to data collection methods, some serious adverse event (SAEs) data maybe captured within the other adverse event data information. There are patients currently on treatment and these sections will be updated with complete information at the study completion. SAEs for any patients that were screenfails (i.e., signed consent but never started study treatment) have been removed from these results. These patients were not included in the participant flow and baseline characteristics section.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
9.7%
3/31 • Adverse events were collected for each patient from the initiation of treatment up until 30 days post last dose of treatment for a maximum of 12 cycles for any patient (where 1 Cycle = 28 days).
Due to data collection methods, some serious adverse event (SAEs) data maybe captured within the other adverse event data information. There are patients currently on treatment and these sections will be updated with complete information at the study completion. SAEs for any patients that were screenfails (i.e., signed consent but never started study treatment) have been removed from these results. These patients were not included in the participant flow and baseline characteristics section.
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
19.4%
6/31 • Adverse events were collected for each patient from the initiation of treatment up until 30 days post last dose of treatment for a maximum of 12 cycles for any patient (where 1 Cycle = 28 days).
Due to data collection methods, some serious adverse event (SAEs) data maybe captured within the other adverse event data information. There are patients currently on treatment and these sections will be updated with complete information at the study completion. SAEs for any patients that were screenfails (i.e., signed consent but never started study treatment) have been removed from these results. These patients were not included in the participant flow and baseline characteristics section.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal mucositis
|
3.2%
1/31 • Adverse events were collected for each patient from the initiation of treatment up until 30 days post last dose of treatment for a maximum of 12 cycles for any patient (where 1 Cycle = 28 days).
Due to data collection methods, some serious adverse event (SAEs) data maybe captured within the other adverse event data information. There are patients currently on treatment and these sections will be updated with complete information at the study completion. SAEs for any patients that were screenfails (i.e., signed consent but never started study treatment) have been removed from these results. These patients were not included in the participant flow and baseline characteristics section.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
3.2%
1/31 • Adverse events were collected for each patient from the initiation of treatment up until 30 days post last dose of treatment for a maximum of 12 cycles for any patient (where 1 Cycle = 28 days).
Due to data collection methods, some serious adverse event (SAEs) data maybe captured within the other adverse event data information. There are patients currently on treatment and these sections will be updated with complete information at the study completion. SAEs for any patients that were screenfails (i.e., signed consent but never started study treatment) have been removed from these results. These patients were not included in the participant flow and baseline characteristics section.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
3.2%
1/31 • Adverse events were collected for each patient from the initiation of treatment up until 30 days post last dose of treatment for a maximum of 12 cycles for any patient (where 1 Cycle = 28 days).
Due to data collection methods, some serious adverse event (SAEs) data maybe captured within the other adverse event data information. There are patients currently on treatment and these sections will be updated with complete information at the study completion. SAEs for any patients that were screenfails (i.e., signed consent but never started study treatment) have been removed from these results. These patients were not included in the participant flow and baseline characteristics section.
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
3.2%
1/31 • Adverse events were collected for each patient from the initiation of treatment up until 30 days post last dose of treatment for a maximum of 12 cycles for any patient (where 1 Cycle = 28 days).
Due to data collection methods, some serious adverse event (SAEs) data maybe captured within the other adverse event data information. There are patients currently on treatment and these sections will be updated with complete information at the study completion. SAEs for any patients that were screenfails (i.e., signed consent but never started study treatment) have been removed from these results. These patients were not included in the participant flow and baseline characteristics section.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, specify
|
3.2%
1/31 • Adverse events were collected for each patient from the initiation of treatment up until 30 days post last dose of treatment for a maximum of 12 cycles for any patient (where 1 Cycle = 28 days).
Due to data collection methods, some serious adverse event (SAEs) data maybe captured within the other adverse event data information. There are patients currently on treatment and these sections will be updated with complete information at the study completion. SAEs for any patients that were screenfails (i.e., signed consent but never started study treatment) have been removed from these results. These patients were not included in the participant flow and baseline characteristics section.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
9.7%
3/31 • Adverse events were collected for each patient from the initiation of treatment up until 30 days post last dose of treatment for a maximum of 12 cycles for any patient (where 1 Cycle = 28 days).
Due to data collection methods, some serious adverse event (SAEs) data maybe captured within the other adverse event data information. There are patients currently on treatment and these sections will be updated with complete information at the study completion. SAEs for any patients that were screenfails (i.e., signed consent but never started study treatment) have been removed from these results. These patients were not included in the participant flow and baseline characteristics section.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
9.7%
3/31 • Adverse events were collected for each patient from the initiation of treatment up until 30 days post last dose of treatment for a maximum of 12 cycles for any patient (where 1 Cycle = 28 days).
Due to data collection methods, some serious adverse event (SAEs) data maybe captured within the other adverse event data information. There are patients currently on treatment and these sections will be updated with complete information at the study completion. SAEs for any patients that were screenfails (i.e., signed consent but never started study treatment) have been removed from these results. These patients were not included in the participant flow and baseline characteristics section.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
3.2%
1/31 • Adverse events were collected for each patient from the initiation of treatment up until 30 days post last dose of treatment for a maximum of 12 cycles for any patient (where 1 Cycle = 28 days).
Due to data collection methods, some serious adverse event (SAEs) data maybe captured within the other adverse event data information. There are patients currently on treatment and these sections will be updated with complete information at the study completion. SAEs for any patients that were screenfails (i.e., signed consent but never started study treatment) have been removed from these results. These patients were not included in the participant flow and baseline characteristics section.
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
6.5%
2/31 • Adverse events were collected for each patient from the initiation of treatment up until 30 days post last dose of treatment for a maximum of 12 cycles for any patient (where 1 Cycle = 28 days).
Due to data collection methods, some serious adverse event (SAEs) data maybe captured within the other adverse event data information. There are patients currently on treatment and these sections will be updated with complete information at the study completion. SAEs for any patients that were screenfails (i.e., signed consent but never started study treatment) have been removed from these results. These patients were not included in the participant flow and baseline characteristics section.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysesthesia syndrome
|
38.7%
12/31 • Adverse events were collected for each patient from the initiation of treatment up until 30 days post last dose of treatment for a maximum of 12 cycles for any patient (where 1 Cycle = 28 days).
Due to data collection methods, some serious adverse event (SAEs) data maybe captured within the other adverse event data information. There are patients currently on treatment and these sections will be updated with complete information at the study completion. SAEs for any patients that were screenfails (i.e., signed consent but never started study treatment) have been removed from these results. These patients were not included in the participant flow and baseline characteristics section.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
3.2%
1/31 • Adverse events were collected for each patient from the initiation of treatment up until 30 days post last dose of treatment for a maximum of 12 cycles for any patient (where 1 Cycle = 28 days).
Due to data collection methods, some serious adverse event (SAEs) data maybe captured within the other adverse event data information. There are patients currently on treatment and these sections will be updated with complete information at the study completion. SAEs for any patients that were screenfails (i.e., signed consent but never started study treatment) have been removed from these results. These patients were not included in the participant flow and baseline characteristics section.
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
9.7%
3/31 • Adverse events were collected for each patient from the initiation of treatment up until 30 days post last dose of treatment for a maximum of 12 cycles for any patient (where 1 Cycle = 28 days).
Due to data collection methods, some serious adverse event (SAEs) data maybe captured within the other adverse event data information. There are patients currently on treatment and these sections will be updated with complete information at the study completion. SAEs for any patients that were screenfails (i.e., signed consent but never started study treatment) have been removed from these results. These patients were not included in the participant flow and baseline characteristics section.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
22.6%
7/31 • Adverse events were collected for each patient from the initiation of treatment up until 30 days post last dose of treatment for a maximum of 12 cycles for any patient (where 1 Cycle = 28 days).
Due to data collection methods, some serious adverse event (SAEs) data maybe captured within the other adverse event data information. There are patients currently on treatment and these sections will be updated with complete information at the study completion. SAEs for any patients that were screenfails (i.e., signed consent but never started study treatment) have been removed from these results. These patients were not included in the participant flow and baseline characteristics section.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify
|
29.0%
9/31 • Adverse events were collected for each patient from the initiation of treatment up until 30 days post last dose of treatment for a maximum of 12 cycles for any patient (where 1 Cycle = 28 days).
Due to data collection methods, some serious adverse event (SAEs) data maybe captured within the other adverse event data information. There are patients currently on treatment and these sections will be updated with complete information at the study completion. SAEs for any patients that were screenfails (i.e., signed consent but never started study treatment) have been removed from these results. These patients were not included in the participant flow and baseline characteristics section.
|
|
Skin and subcutaneous tissue disorders
Skin ulceration
|
6.5%
2/31 • Adverse events were collected for each patient from the initiation of treatment up until 30 days post last dose of treatment for a maximum of 12 cycles for any patient (where 1 Cycle = 28 days).
Due to data collection methods, some serious adverse event (SAEs) data maybe captured within the other adverse event data information. There are patients currently on treatment and these sections will be updated with complete information at the study completion. SAEs for any patients that were screenfails (i.e., signed consent but never started study treatment) have been removed from these results. These patients were not included in the participant flow and baseline characteristics section.
|
|
Vascular disorders
Hypertension
|
54.8%
17/31 • Adverse events were collected for each patient from the initiation of treatment up until 30 days post last dose of treatment for a maximum of 12 cycles for any patient (where 1 Cycle = 28 days).
Due to data collection methods, some serious adverse event (SAEs) data maybe captured within the other adverse event data information. There are patients currently on treatment and these sections will be updated with complete information at the study completion. SAEs for any patients that were screenfails (i.e., signed consent but never started study treatment) have been removed from these results. These patients were not included in the participant flow and baseline characteristics section.
|
|
Vascular disorders
Hypotension
|
12.9%
4/31 • Adverse events were collected for each patient from the initiation of treatment up until 30 days post last dose of treatment for a maximum of 12 cycles for any patient (where 1 Cycle = 28 days).
Due to data collection methods, some serious adverse event (SAEs) data maybe captured within the other adverse event data information. There are patients currently on treatment and these sections will be updated with complete information at the study completion. SAEs for any patients that were screenfails (i.e., signed consent but never started study treatment) have been removed from these results. These patients were not included in the participant flow and baseline characteristics section.
|
|
Vascular disorders
Vascular disorders - Other, specify
|
3.2%
1/31 • Adverse events were collected for each patient from the initiation of treatment up until 30 days post last dose of treatment for a maximum of 12 cycles for any patient (where 1 Cycle = 28 days).
Due to data collection methods, some serious adverse event (SAEs) data maybe captured within the other adverse event data information. There are patients currently on treatment and these sections will be updated with complete information at the study completion. SAEs for any patients that were screenfails (i.e., signed consent but never started study treatment) have been removed from these results. These patients were not included in the participant flow and baseline characteristics section.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place