Trial Outcomes & Findings for Carboplatin, Paclitaxel, and Bevacizumab With or Without Everolimus in Treating Patients With Metastatic Malignant Melanoma (NCT NCT00976573)
NCT ID: NCT00976573
Last Updated: 2017-04-04
Results Overview
The primary endpoint is progression-free survival (PFS) defined as the time from randomization to documentation of disease progression or death without documentation of progression. The distribution of PFS times will be estimated using the Kaplan-Meier method. Progression is defined using the RECIST Criteria as at least a 20% increase in the sum of diameters of target lesions taking as reference the smallest sum of diameters recorded on study (this includes the baseline sum if that is the smallest on study) or the appearance of one or more new lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm of target lesions, or the appearance of one or more new lesions, unequivocal progression of existing non-target lesions, although unequivocal progression should not normally trump target lesion status. It must be representative of overall disease status change, not a single lesion increase.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
149 participants
Primary outcome timeframe
Time from randomization to documentation of disease progression or death without documentation of progression;Up to 5 years
Results posted on
2017-04-04
Participant Flow
Participant milestones
| Measure |
Arm A (Bevacizumab, Paclitaxel, and Carboplatin)
Patients receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15, 80 mg/m\^2 paclitaxel IV over 60 minutes on days 1, 8, and 15, and AUC 5 carboplatin IV over 30 minutes on day 1. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Arm B (Bevacizumab, Paclitaxel, Carboplatin, and Everolimus)
Patients receive bevacizumab, paclitaxel, and carboplatin as in Arm I. Patients also receive 5 mg everolimus PO QD three times weekly (e.g. Monday, Wednesday, Friday). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Overall Study
STARTED
|
75
|
74
|
|
Overall Study
COMPLETED
|
71
|
71
|
|
Overall Study
NOT COMPLETED
|
4
|
3
|
Reasons for withdrawal
| Measure |
Arm A (Bevacizumab, Paclitaxel, and Carboplatin)
Patients receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15, 80 mg/m\^2 paclitaxel IV over 60 minutes on days 1, 8, and 15, and AUC 5 carboplatin IV over 30 minutes on day 1. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Arm B (Bevacizumab, Paclitaxel, Carboplatin, and Everolimus)
Patients receive bevacizumab, paclitaxel, and carboplatin as in Arm I. Patients also receive 5 mg everolimus PO QD three times weekly (e.g. Monday, Wednesday, Friday). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Overall Study
Ineligible
|
0
|
1
|
|
Overall Study
Cancel prior to receiving treatment
|
4
|
2
|
Baseline Characteristics
Carboplatin, Paclitaxel, and Bevacizumab With or Without Everolimus in Treating Patients With Metastatic Malignant Melanoma
Baseline characteristics by cohort
| Measure |
Arm A (Bevacizumab, Paclitaxel, and Carboplatin)
n=75 Participants
Patients receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15, 80 mg/m\^2 paclitaxel IV over 60 minutes on days 1, 8, and 15, and AUC 5 carboplatin IV over 30 minutes on day 1. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Arm B (Bevacizumab, Paclitaxel, Carboplatin, and Everolimus)
n=74 Participants
Patients receive bevacizumab, paclitaxel, and carboplatin as in Arm I. Patients also receive 5 mg everolimus PO QD three times weekly (e.g. Monday, Wednesday, Friday). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Total
n=149 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
59 years
n=99 Participants
|
58 years
n=107 Participants
|
59 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=99 Participants
|
33 Participants
n=107 Participants
|
54 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
54 Participants
n=99 Participants
|
41 Participants
n=107 Participants
|
95 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
75 participants
n=99 Participants
|
74 participants
n=107 Participants
|
149 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Time from randomization to documentation of disease progression or death without documentation of progression;Up to 5 yearsPopulation: Intent-to-treat analysis population: All participants enrolled are included in the primary analysis.
The primary endpoint is progression-free survival (PFS) defined as the time from randomization to documentation of disease progression or death without documentation of progression. The distribution of PFS times will be estimated using the Kaplan-Meier method. Progression is defined using the RECIST Criteria as at least a 20% increase in the sum of diameters of target lesions taking as reference the smallest sum of diameters recorded on study (this includes the baseline sum if that is the smallest on study) or the appearance of one or more new lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm of target lesions, or the appearance of one or more new lesions, unequivocal progression of existing non-target lesions, although unequivocal progression should not normally trump target lesion status. It must be representative of overall disease status change, not a single lesion increase.
Outcome measures
| Measure |
Arm A (Bevacizumab, Paclitaxel, and Carboplatin)
n=75 Participants
Patients receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15, 80 mg/m\^2 paclitaxel IV over 60 minutes on days 1, 8, and 15, and AUC 5 carboplatin IV over 30 minutes on day 1. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Arm B (Bevacizumab, Paclitaxel, Carboplatin, and Everolimus)
n=74 Participants
Patients receive bevacizumab, paclitaxel, and carboplatin as in Arm I. Patients also receive 5 mg everolimus PO QD three times weekly (e.g. Monday, Wednesday, Friday). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Progression-free Survival
|
5.6 months
Interval 4.7 to 8.3
|
5.1 months
Interval 3.9 to 6.7
|
SECONDARY outcome
Timeframe: Up to 5 yearsPopulation: Participants who completed the study (specified in the Participant Flow) are included.
For this secondary endpoint, toxicity is defined as a grade 3 or higher adverse events that is classified as either possibly, probably, or definitely related to study treatment. The assignment of attribution to study treatment and grade (or degree of severity) of the adverse event are classified using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The percentage of participants reporting a grade 3 or higher toxicity is reported. For a list of all reported adverse events, please refer to the Adverse Events Section below.
Outcome measures
| Measure |
Arm A (Bevacizumab, Paclitaxel, and Carboplatin)
n=71 Participants
Patients receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15, 80 mg/m\^2 paclitaxel IV over 60 minutes on days 1, 8, and 15, and AUC 5 carboplatin IV over 30 minutes on day 1. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Arm B (Bevacizumab, Paclitaxel, Carboplatin, and Everolimus)
n=71 Participants
Patients receive bevacizumab, paclitaxel, and carboplatin as in Arm I. Patients also receive 5 mg everolimus PO QD three times weekly (e.g. Monday, Wednesday, Friday). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Toxicity
Neutropenia
|
35 percentage of participants
|
58 percentage of participants
|
|
Toxicity
Leukopenia
|
17 percentage of participants
|
24 percentage of participants
|
|
Toxicity
Fatigue
|
11 percentage of participants
|
17 percentage of participants
|
SECONDARY outcome
Timeframe: Up to 5 yearsPopulation: Intent-to-treat analysis population: All participants enrolled are included.
Confirmed Tumor Response: A confirmed tumor response is defined to be a CR or PR (by the RECIST criteria) noted as the objective status on 2 consecutive evaluations at least 8 weeks apart. The proportion of tumor responses will be estimated by the number of confirmed tumor responses divided by the total number of evaluable patients. A ninety percent confidence interval for the true proportion of confirmed tumor responses will be calculated assuming that the number of confirmed tumor responses follows a binomial distribution.
Outcome measures
| Measure |
Arm A (Bevacizumab, Paclitaxel, and Carboplatin)
n=75 Participants
Patients receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15, 80 mg/m\^2 paclitaxel IV over 60 minutes on days 1, 8, and 15, and AUC 5 carboplatin IV over 30 minutes on day 1. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Arm B (Bevacizumab, Paclitaxel, Carboplatin, and Everolimus)
n=74 Participants
Patients receive bevacizumab, paclitaxel, and carboplatin as in Arm I. Patients also receive 5 mg everolimus PO QD three times weekly (e.g. Monday, Wednesday, Friday). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Confirmed Tumor Response Rate (Complete Response [CR] or Partial Response [PR]) According to Response Evaluation Criteria in Solid Tumors (RECIST) Criteria
|
13 percentage of patients
Interval 6.0 to 22.7
|
23 percentage of patients
Interval 13.5 to 34.0
|
SECONDARY outcome
Timeframe: up to 5 yearsPopulation: Intent-to-treat analysis population: All participants enrolled are included.
Overall survival time is defined as the time from registration to death due to any cause. The distribution of survival times will be estimated using the method of Kaplan-Meier.
Outcome measures
| Measure |
Arm A (Bevacizumab, Paclitaxel, and Carboplatin)
n=75 Participants
Patients receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15, 80 mg/m\^2 paclitaxel IV over 60 minutes on days 1, 8, and 15, and AUC 5 carboplatin IV over 30 minutes on day 1. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Arm B (Bevacizumab, Paclitaxel, Carboplatin, and Everolimus)
n=74 Participants
Patients receive bevacizumab, paclitaxel, and carboplatin as in Arm I. Patients also receive 5 mg everolimus PO QD three times weekly (e.g. Monday, Wednesday, Friday). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Overall Survival Time
|
14.5 months
Interval 11.5 to 21.8
|
10.8 months
Interval 9.1 to 14.3
|
Adverse Events
Arm A (Bevacizumab, Paclitaxel, and Carboplatin)
Serious events: 12 serious events
Other events: 71 other events
Deaths: 0 deaths
Arm B (Bevacizumab, Paclitaxel, Carboplatin, and Everolimus)
Serious events: 18 serious events
Other events: 71 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm A (Bevacizumab, Paclitaxel, and Carboplatin)
n=71 participants at risk
Patients receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15, 80 mg/m\^2 paclitaxel IV over 60 minutes on days 1, 8, and 15, and AUC 5 carboplatin IV over 30 minutes on day 1. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Arm B (Bevacizumab, Paclitaxel, Carboplatin, and Everolimus)
n=71 participants at risk
Patients receive bevacizumab, paclitaxel, and carboplatin as in Arm I. Patients also receive 5 mg everolimus PO QD three times weekly (e.g. Monday, Wednesday, Friday). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/71 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
1.4%
1/71 • Number of events 1 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
|
Gastrointestinal disorders
Abdominal pain
|
1.4%
1/71 • Number of events 1 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
1.4%
1/71 • Number of events 1 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/71 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
1.4%
1/71 • Number of events 1 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
|
Gastrointestinal disorders
Gastric perforation
|
1.4%
1/71 • Number of events 1 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
0.00%
0/71 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
|
Gastrointestinal disorders
Jejunal perforation
|
0.00%
0/71 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
1.4%
1/71 • Number of events 1 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
|
Gastrointestinal disorders
Nausea
|
1.4%
1/71 • Number of events 1 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
2.8%
2/71 • Number of events 2 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
|
Gastrointestinal disorders
Vomiting
|
1.4%
1/71 • Number of events 2 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
1.4%
1/71 • Number of events 1 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
|
General disorders
Death NOS
|
0.00%
0/71 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
1.4%
1/71 • Number of events 1 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
|
General disorders
Fatigue
|
2.8%
2/71 • Number of events 2 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
1.4%
1/71 • Number of events 1 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
|
General disorders
Fever
|
0.00%
0/71 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
1.4%
1/71 • Number of events 1 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
|
General disorders
Flu like symptoms
|
1.4%
1/71 • Number of events 1 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
0.00%
0/71 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/71 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
1.4%
1/71 • Number of events 1 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
|
Immune system disorders
Allergic reaction
|
0.00%
0/71 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
1.4%
1/71 • Number of events 1 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
|
Immune system disorders
Anaphylaxis
|
1.4%
1/71 • Number of events 1 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
0.00%
0/71 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
|
Infections and infestations
Sepsis
|
0.00%
0/71 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
2.8%
2/71 • Number of events 2 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/71 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
2.8%
2/71 • Number of events 2 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
|
Infections and infestations
Wound infection
|
0.00%
0/71 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
1.4%
1/71 • Number of events 1 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
1.4%
1/71 • Number of events 1 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
0.00%
0/71 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
|
Investigations
Lymphocyte count decreased
|
1.4%
1/71 • Number of events 1 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
0.00%
0/71 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
|
Investigations
Neutrophil count decreased
|
5.6%
4/71 • Number of events 4 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
7.0%
5/71 • Number of events 5 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
|
Investigations
Platelet count decreased
|
2.8%
2/71 • Number of events 2 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
2.8%
2/71 • Number of events 2 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
|
Investigations
White blood cell decreased
|
2.8%
2/71 • Number of events 2 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
1.4%
1/71 • Number of events 1 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/71 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
1.4%
1/71 • Number of events 1 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
0.00%
0/71 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
2.8%
2/71 • Number of events 2 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/71 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
1.4%
1/71 • Number of events 1 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
0.00%
0/71 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
1.4%
1/71 • Number of events 1 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.4%
1/71 • Number of events 1 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
0.00%
0/71 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
0.00%
0/71 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
2.8%
2/71 • Number of events 2 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/71 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
1.4%
1/71 • Number of events 1 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify
|
1.4%
1/71 • Number of events 1 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
1.4%
1/71 • Number of events 1 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/71 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
1.4%
1/71 • Number of events 1 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
|
Nervous system disorders
Dysarthria
|
0.00%
0/71 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
1.4%
1/71 • Number of events 1 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
|
Nervous system disorders
Headache
|
2.8%
2/71 • Number of events 3 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
0.00%
0/71 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
|
Nervous system disorders
Intracranial hemorrhage
|
1.4%
1/71 • Number of events 1 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
1.4%
1/71 • Number of events 1 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
|
Nervous system disorders
Seizure
|
1.4%
1/71 • Number of events 1 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
1.4%
1/71 • Number of events 1 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
|
Nervous system disorders
Stroke
|
0.00%
0/71 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
1.4%
1/71 • Number of events 2 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/71 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
2.8%
2/71 • Number of events 2 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/71 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
1.4%
1/71 • Number of events 1 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
|
Respiratory, thoracic and mediastinal disorders
Voice alteration
|
1.4%
1/71 • Number of events 1 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
0.00%
0/71 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify
|
1.4%
1/71 • Number of events 1 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
0.00%
0/71 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
|
Skin and subcutaneous tissue disorders
Skin ulceration
|
1.4%
1/71 • Number of events 1 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
0.00%
0/71 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
|
Vascular disorders
Hematoma
|
0.00%
0/71 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
1.4%
1/71 • Number of events 1 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
|
Vascular disorders
Hypertension
|
1.4%
1/71 • Number of events 1 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
1.4%
1/71 • Number of events 1 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
|
Vascular disorders
Lymphedema
|
0.00%
0/71 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
1.4%
1/71 • Number of events 1 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
|
Vascular disorders
Thromboembolic event
|
1.4%
1/71 • Number of events 1 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
2.8%
2/71 • Number of events 2 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
Other adverse events
| Measure |
Arm A (Bevacizumab, Paclitaxel, and Carboplatin)
n=71 participants at risk
Patients receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15, 80 mg/m\^2 paclitaxel IV over 60 minutes on days 1, 8, and 15, and AUC 5 carboplatin IV over 30 minutes on day 1. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
Arm B (Bevacizumab, Paclitaxel, Carboplatin, and Everolimus)
n=71 participants at risk
Patients receive bevacizumab, paclitaxel, and carboplatin as in Arm I. Patients also receive 5 mg everolimus PO QD three times weekly (e.g. Monday, Wednesday, Friday). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|---|
|
Metabolism and nutrition disorders
Anorexia
|
11.3%
8/71 • Number of events 14 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
18.3%
13/71 • Number of events 23 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
|
Investigations
Weight gain
|
1.4%
1/71 • Number of events 12 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
2.8%
2/71 • Number of events 2 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
|
Investigations
Weight loss
|
2.8%
2/71 • Number of events 3 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
7.0%
5/71 • Number of events 23 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
|
Investigations
White blood cell decreased
|
76.1%
54/71 • Number of events 217 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
77.5%
55/71 • Number of events 215 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
|
Blood and lymphatic system disorders
Anemia
|
88.7%
63/71 • Number of events 357 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
83.1%
59/71 • Number of events 332 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/71 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
2.8%
2/71 • Number of events 2 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/71 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
1.4%
1/71 • Number of events 1 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
|
Cardiac disorders
Atrial fibrillation
|
1.4%
1/71 • Number of events 1 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
1.4%
1/71 • Number of events 1 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
|
Cardiac disorders
Cardiac arrest
|
1.4%
1/71 • Number of events 1 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
0.00%
0/71 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
|
Cardiac disorders
Heart failure
|
0.00%
0/71 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
1.4%
1/71 • Number of events 1 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
|
Cardiac disorders
Left ventricular systolic dysfunction
|
0.00%
0/71 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
1.4%
1/71 • Number of events 1 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/71 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
1.4%
1/71 • Number of events 1 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
|
Cardiac disorders
Pericardial effusion
|
1.4%
1/71 • Number of events 1 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
0.00%
0/71 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
|
Cardiac disorders
Sinus tachycardia
|
1.4%
1/71 • Number of events 1 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
1.4%
1/71 • Number of events 1 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
|
Endocrine disorders
Adrenal insufficiency
|
0.00%
0/71 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
1.4%
1/71 • Number of events 1 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/71 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
1.4%
1/71 • Number of events 1 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
|
Eye disorders
Blurred vision
|
1.4%
1/71 • Number of events 1 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
2.8%
2/71 • Number of events 2 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
|
Eye disorders
Dry eye
|
1.4%
1/71 • Number of events 1 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
0.00%
0/71 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
|
Eye disorders
Eye disorders - Other, specify
|
0.00%
0/71 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
1.4%
1/71 • Number of events 1 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
|
Gastrointestinal disorders
Abdominal pain
|
33.8%
24/71 • Number of events 51 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
33.8%
24/71 • Number of events 47 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
|
Gastrointestinal disorders
Bloating
|
0.00%
0/71 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
1.4%
1/71 • Number of events 1 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
|
Gastrointestinal disorders
Constipation
|
12.7%
9/71 • Number of events 11 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
7.0%
5/71 • Number of events 7 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
|
Gastrointestinal disorders
Diarrhea
|
9.9%
7/71 • Number of events 12 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
14.1%
10/71 • Number of events 16 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
|
Gastrointestinal disorders
Duodenal ulcer
|
1.4%
1/71 • Number of events 1 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
0.00%
0/71 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
|
Gastrointestinal disorders
Dyspepsia
|
5.6%
4/71 • Number of events 4 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
2.8%
2/71 • Number of events 6 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
|
Gastrointestinal disorders
Dysphagia
|
1.4%
1/71 • Number of events 1 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
2.8%
2/71 • Number of events 2 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/71 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
1.4%
1/71 • Number of events 1 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
|
Gastrointestinal disorders
Gastric hemorrhage
|
1.4%
1/71 • Number of events 1 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
0.00%
0/71 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
|
Gastrointestinal disorders
Hemorrhoids
|
1.4%
1/71 • Number of events 1 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
2.8%
2/71 • Number of events 3 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
|
Gastrointestinal disorders
Ileus
|
1.4%
1/71 • Number of events 1 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
0.00%
0/71 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
|
Gastrointestinal disorders
Mucositis oral
|
4.2%
3/71 • Number of events 11 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
11.3%
8/71 • Number of events 11 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
|
Gastrointestinal disorders
Nausea
|
56.3%
40/71 • Number of events 152 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
64.8%
46/71 • Number of events 129 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/71 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
1.4%
1/71 • Number of events 2 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
|
Gastrointestinal disorders
Toothache
|
1.4%
1/71 • Number of events 1 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
1.4%
1/71 • Number of events 1 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
|
Gastrointestinal disorders
Vomiting
|
31.0%
22/71 • Number of events 46 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
35.2%
25/71 • Number of events 52 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
|
General disorders
Death NOS
|
1.4%
1/71 • Number of events 1 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
1.4%
1/71 • Number of events 1 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
|
General disorders
Edema limbs
|
1.4%
1/71 • Number of events 1 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
1.4%
1/71 • Number of events 1 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
|
General disorders
Fatigue
|
95.8%
68/71 • Number of events 408 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
94.4%
67/71 • Number of events 352 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
|
General disorders
Fever
|
19.7%
14/71 • Number of events 19 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
21.1%
15/71 • Number of events 16 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
|
General disorders
Infusion related reaction
|
2.8%
2/71 • Number of events 7 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
0.00%
0/71 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
|
General disorders
Infusion site extravasation
|
0.00%
0/71 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
2.8%
2/71 • Number of events 2 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
|
General disorders
Non-cardiac chest pain
|
1.4%
1/71 • Number of events 1 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
0.00%
0/71 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
|
General disorders
Pain
|
0.00%
0/71 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
1.4%
1/71 • Number of events 1 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
|
Immune system disorders
Allergic reaction
|
14.1%
10/71 • Number of events 14 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
9.9%
7/71 • Number of events 8 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
|
Immune system disorders
Anaphylaxis
|
0.00%
0/71 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
1.4%
1/71 • Number of events 1 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
|
Infections and infestations
Anorectal infection
|
0.00%
0/71 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
1.4%
1/71 • Number of events 1 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
|
Infections and infestations
Bladder infection
|
1.4%
1/71 • Number of events 1 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
0.00%
0/71 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
|
Infections and infestations
Catheter related infection
|
2.8%
2/71 • Number of events 3 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
0.00%
0/71 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
|
Infections and infestations
Device related infection
|
0.00%
0/71 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
1.4%
1/71 • Number of events 1 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
|
Infections and infestations
Infections and infestations - Other, specify
|
1.4%
1/71 • Number of events 1 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
1.4%
1/71 • Number of events 1 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
|
Infections and infestations
Lip infection
|
1.4%
1/71 • Number of events 1 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
1.4%
1/71 • Number of events 1 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
|
Infections and infestations
Lung infection
|
1.4%
1/71 • Number of events 1 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
0.00%
0/71 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
|
Infections and infestations
Peripheral nerve infection
|
0.00%
0/71 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
1.4%
1/71 • Number of events 1 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
|
Infections and infestations
Rash pustular
|
0.00%
0/71 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
1.4%
1/71 • Number of events 1 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
|
Infections and infestations
Sepsis
|
1.4%
1/71 • Number of events 1 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
4.2%
3/71 • Number of events 3 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
|
Infections and infestations
Sinusitis
|
1.4%
1/71 • Number of events 3 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
2.8%
2/71 • Number of events 6 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
|
Infections and infestations
Skin infection
|
2.8%
2/71 • Number of events 2 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
7.0%
5/71 • Number of events 7 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
|
Infections and infestations
Soft tissue infection
|
1.4%
1/71 • Number of events 2 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
0.00%
0/71 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
|
Infections and infestations
Tooth infection
|
1.4%
1/71 • Number of events 1 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
1.4%
1/71 • Number of events 1 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
|
Infections and infestations
Upper respiratory infection
|
1.4%
1/71 • Number of events 3 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
4.2%
3/71 • Number of events 4 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
|
Infections and infestations
Urinary tract infection
|
1.4%
1/71 • Number of events 3 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
2.8%
2/71 • Number of events 2 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
|
Infections and infestations
Vulval infection
|
0.00%
0/71 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
1.4%
1/71 • Number of events 2 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
|
Infections and infestations
Wound infection
|
2.8%
2/71 • Number of events 2 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
1.4%
1/71 • Number of events 1 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
|
Injury, poisoning and procedural complications
Injury, poisoning and procedural complications - Other, specify
|
1.4%
1/71 • Number of events 1 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
0.00%
0/71 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
1.4%
1/71 • Number of events 4 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
4.2%
3/71 • Number of events 9 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/71 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
4.2%
3/71 • Number of events 3 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
|
Investigations
Alkaline phosphatase increased
|
0.00%
0/71 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
4.2%
3/71 • Number of events 4 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/71 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
4.2%
3/71 • Number of events 3 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/71 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
1.4%
1/71 • Number of events 1 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
|
Investigations
CD4 lymphocytes decreased
|
2.8%
2/71 • Number of events 2 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
1.4%
1/71 • Number of events 2 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
|
Investigations
Cholesterol high
|
0.00%
0/71 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
8.5%
6/71 • Number of events 13 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
|
Investigations
Creatinine increased
|
2.8%
2/71 • Number of events 3 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
2.8%
2/71 • Number of events 2 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
|
Investigations
Investigations - Other, specify
|
1.4%
1/71 • Number of events 2 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
0.00%
0/71 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
|
Investigations
Lipase increased
|
0.00%
0/71 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
1.4%
1/71 • Number of events 1 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
|
Investigations
Lymphocyte count decreased
|
7.0%
5/71 • Number of events 14 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
9.9%
7/71 • Number of events 13 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
|
Investigations
Lymphocyte count increased
|
1.4%
1/71 • Number of events 1 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
1.4%
1/71 • Number of events 1 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
|
Investigations
Neutrophil count decreased
|
69.0%
49/71 • Number of events 177 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
83.1%
59/71 • Number of events 209 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
|
Investigations
Platelet count decreased
|
66.2%
47/71 • Number of events 177 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
70.4%
50/71 • Number of events 196 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
|
Metabolism and nutrition disorders
Dehydration
|
9.9%
7/71 • Number of events 8 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
5.6%
4/71 • Number of events 4 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
1.4%
1/71 • Number of events 1 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
4.2%
3/71 • Number of events 3 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
0.00%
0/71 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
1.4%
1/71 • Number of events 1 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
1.4%
1/71 • Number of events 1 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
15.5%
11/71 • Number of events 34 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
0.00%
0/71 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
1.4%
1/71 • Number of events 1 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
0.00%
0/71 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
8.5%
6/71 • Number of events 6 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
0.00%
0/71 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
4.2%
3/71 • Number of events 7 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
0.00%
0/71 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
1.4%
1/71 • Number of events 1 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/71 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
1.4%
1/71 • Number of events 2 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
1.4%
1/71 • Number of events 3 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
0.00%
0/71 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
5.6%
4/71 • Number of events 7 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
2.8%
2/71 • Number of events 2 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
4.2%
3/71 • Number of events 5 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
2.8%
2/71 • Number of events 11 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
26.8%
19/71 • Number of events 41 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
33.8%
24/71 • Number of events 60 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.6%
4/71 • Number of events 4 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
2.8%
2/71 • Number of events 2 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/71 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
1.4%
1/71 • Number of events 1 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
1.4%
1/71 • Number of events 1 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
0.00%
0/71 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
4.2%
3/71 • Number of events 3 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
7.0%
5/71 • Number of events 6 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
1.4%
1/71 • Number of events 1 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
1.4%
1/71 • Number of events 1 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, specify
|
0.00%
0/71 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
1.4%
1/71 • Number of events 1 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
19.7%
14/71 • Number of events 28 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
35.2%
25/71 • Number of events 66 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
2.8%
2/71 • Number of events 6 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
1.4%
1/71 • Number of events 1 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor pain
|
2.8%
2/71 • Number of events 3 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
0.00%
0/71 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
|
Nervous system disorders
Cognitive disturbance
|
2.8%
2/71 • Number of events 2 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
1.4%
1/71 • Number of events 1 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
|
Nervous system disorders
Dizziness
|
1.4%
1/71 • Number of events 1 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
2.8%
2/71 • Number of events 2 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
|
Nervous system disorders
Dysesthesia
|
0.00%
0/71 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
1.4%
1/71 • Number of events 1 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
|
Nervous system disorders
Dysgeusia
|
4.2%
3/71 • Number of events 7 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
9.9%
7/71 • Number of events 12 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
|
Nervous system disorders
Headache
|
1.4%
1/71 • Number of events 3 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
4.2%
3/71 • Number of events 3 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
|
Nervous system disorders
Hypersomnia
|
1.4%
1/71 • Number of events 1 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
0.00%
0/71 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
|
Nervous system disorders
Intracranial hemorrhage
|
1.4%
1/71 • Number of events 1 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
1.4%
1/71 • Number of events 1 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
|
Nervous system disorders
Memory impairment
|
1.4%
1/71 • Number of events 1 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
0.00%
0/71 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
|
Nervous system disorders
Olfactory nerve disorder
|
0.00%
0/71 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
1.4%
1/71 • Number of events 1 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
|
Nervous system disorders
Paresthesia
|
1.4%
1/71 • Number of events 9 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
0.00%
0/71 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
|
Nervous system disorders
Peripheral motor neuropathy
|
2.8%
2/71 • Number of events 2 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
0.00%
0/71 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
50.7%
36/71 • Number of events 190 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
40.8%
29/71 • Number of events 159 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/71 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
1.4%
1/71 • Number of events 1 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
|
Nervous system disorders
Seizure
|
0.00%
0/71 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
1.4%
1/71 • Number of events 1 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
|
Psychiatric disorders
Anxiety
|
2.8%
2/71 • Number of events 2 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
1.4%
1/71 • Number of events 1 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
|
Psychiatric disorders
Confusion
|
1.4%
1/71 • Number of events 1 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
0.00%
0/71 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
|
Psychiatric disorders
Depression
|
1.4%
1/71 • Number of events 1 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
1.4%
1/71 • Number of events 1 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
|
Psychiatric disorders
Insomnia
|
4.2%
3/71 • Number of events 4 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
2.8%
2/71 • Number of events 6 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
|
Renal and urinary disorders
Acute kidney injury
|
1.4%
1/71 • Number of events 1 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
0.00%
0/71 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
|
Renal and urinary disorders
Hematuria
|
0.00%
0/71 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
1.4%
1/71 • Number of events 1 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
|
Renal and urinary disorders
Proteinuria
|
19.7%
14/71 • Number of events 24 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
19.7%
14/71 • Number of events 31 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
|
Renal and urinary disorders
Renal and urinary disorders - Other, specify
|
0.00%
0/71 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
1.4%
1/71 • Number of events 1 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.00%
0/71 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
1.4%
1/71 • Number of events 1 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
|
Reproductive system and breast disorders
Irregular menstruation
|
0.00%
0/71 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
1.4%
1/71 • Number of events 1 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchopulmonary hemorrhage
|
1.4%
1/71 • Number of events 2 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
0.00%
0/71 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
11.3%
8/71 • Number of events 28 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
2.8%
2/71 • Number of events 2 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
4.2%
3/71 • Number of events 3 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
1.4%
1/71 • Number of events 3 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/71 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
1.4%
1/71 • Number of events 2 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/71 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
1.4%
1/71 • Number of events 1 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary edema
|
1.4%
1/71 • Number of events 1 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
0.00%
0/71 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/71 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
1.4%
1/71 • Number of events 1 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, specify
|
0.00%
0/71 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
1.4%
1/71 • Number of events 2 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus disorder
|
0.00%
0/71 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
1.4%
1/71 • Number of events 1 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
1.4%
1/71 • Number of events 1 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
1.4%
1/71 • Number of events 2 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
18.3%
13/71 • Number of events 32 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
29.6%
21/71 • Number of events 73 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
|
Skin and subcutaneous tissue disorders
Bullous dermatitis
|
0.00%
0/71 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
1.4%
1/71 • Number of events 1 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/71 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
2.8%
2/71 • Number of events 3 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
2.8%
2/71 • Number of events 3 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
0.00%
0/71 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
|
Skin and subcutaneous tissue disorders
Nail loss
|
1.4%
1/71 • Number of events 2 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
0.00%
0/71 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/71 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
1.4%
1/71 • Number of events 1 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
1.4%
1/71 • Number of events 1 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
0.00%
0/71 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/71 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
4.2%
3/71 • Number of events 3 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
|
Skin and subcutaneous tissue disorders
Skin ulceration
|
1.4%
1/71 • Number of events 4 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
1.4%
1/71 • Number of events 1 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
|
Vascular disorders
Flushing
|
0.00%
0/71 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
1.4%
1/71 • Number of events 1 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
|
Vascular disorders
Hot flashes
|
0.00%
0/71 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
1.4%
1/71 • Number of events 1 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
|
Vascular disorders
Hypertension
|
54.9%
39/71 • Number of events 190 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
52.1%
37/71 • Number of events 205 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
|
Vascular disorders
Hypotension
|
1.4%
1/71 • Number of events 1 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
7.0%
5/71 • Number of events 5 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
|
Vascular disorders
Peripheral ischemia
|
1.4%
1/71 • Number of events 2 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
0.00%
0/71 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
|
Vascular disorders
Thromboembolic event
|
5.6%
4/71 • Number of events 5 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
7.0%
5/71 • Number of events 9 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
|
Vascular disorders
Vascular disorders - Other, specify
|
0.00%
0/71 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
1.4%
1/71 • Number of events 3 • Adverse events are assessed less than or equal to 14 days prior to registration, prior to each cycle of treatment, at discontinuation of study treatment, and during observation 28-42 days after discontinuation of study treatment; Up to 5 years.
The CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. All graded adverse events are reported. Patients who completed the study (as specified in the Participant Flow) and had adverse events assessed are included below.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place