Trial Outcomes & Findings for Temsirolimus With or Without Megestrol Acetate and Tamoxifen Citrate in Treating Patients With Advanced, Persistent, or Recurrent Endometrial Cancer (NCT NCT00729586)
NCT ID: NCT00729586
Last Updated: 2019-07-23
Results Overview
RECIST 1.0 defines complete response as the disappearance of all target lesions and non-target lesions and no evidence of new lesions documented by two disease assessments at least 4 weeks apart. Partial response is defined as at least a 30% decrease in the sum of longest dimensions (LD) of all target measurable lesions taking as reference the baseline sum of LD. There can be no unequivocal progression of non-target lesions and no new lesions. Documentation by two disease assessments at least 4 weeks apart is required. In the case where the ONLY target lesion is a solitary pelvic mass measured by physical exam, which is not radiographically measurable, a 50% decrease in the LD is required. These patients will have their response classified according to the definitions stated above. Complete and partial responses are included in the objective tumor response rate.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
73 participants
Primary outcome timeframe
Radiologic tumor evaluations at baseline and every 6 weeks for the first 24 weeks; then repeated every 12 weeks until disease progression. Repeat after treatment discontinuation if patient was taken off study for reasons other than progression.
Results posted on
2019-07-23
Participant Flow
Seventy-three patients were registered to this trial between 9/29/08 and 11/22/10. On 10/19/09 the trial was suspended and the combination arm was permanently closed to accrual because an excess of venous thromboses was noted. The single agent arm continued to the second stage of accrual on 5/24/2010.
Participant milestones
| Measure |
Arm 1: Temsirolimus
Temsirolimus IV 25 mg (flat dose) weekly
|
Arm 2: Megestrol Acetate+Tamoxifen+ Temsirolimus
Megestrol Acetate (MA) 80 mg bid for three weeks alternating with Tamoxifen (T) 20 mg bid for 3 weeks PLUS Temsirolimus IV 25 mg (flat dose) weekly
|
|---|---|---|
|
Overall Study
STARTED
|
51
|
22
|
|
Overall Study
COMPLETED
|
50
|
21
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
Arm 1: Temsirolimus
Temsirolimus IV 25 mg (flat dose) weekly
|
Arm 2: Megestrol Acetate+Tamoxifen+ Temsirolimus
Megestrol Acetate (MA) 80 mg bid for three weeks alternating with Tamoxifen (T) 20 mg bid for 3 weeks PLUS Temsirolimus IV 25 mg (flat dose) weekly
|
|---|---|---|
|
Overall Study
Ineligible
|
0
|
1
|
|
Overall Study
never treated
|
1
|
0
|
Baseline Characteristics
Temsirolimus With or Without Megestrol Acetate and Tamoxifen Citrate in Treating Patients With Advanced, Persistent, or Recurrent Endometrial Cancer
Baseline characteristics by cohort
| Measure |
Arm 1: Temsirolimus
n=50 Participants
Temsirolimus IV 25 mg (flat dose) weekly
|
Arm 2: Megestrol Acetate+Tamoxifen+ Temsirolimus
n=21 Participants
Megestrol Acetate (MA) 80 mg bid for three weeks alternating with Tamoxifen (T) 20 mg bid for 3 weeks PLUS Temsirolimus IV 25 mg (flat dose) weekly
|
Total
n=71 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
40-49 years
|
4 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Age, Customized
50-59 years
|
9 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Age, Customized
60-69 years
|
26 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Age, Customized
70-79 years
|
8 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Age, Customized
>=80 years
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
50 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
71 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
45 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
65 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Radiologic tumor evaluations at baseline and every 6 weeks for the first 24 weeks; then repeated every 12 weeks until disease progression. Repeat after treatment discontinuation if patient was taken off study for reasons other than progression.Population: Eligible and treated patients
RECIST 1.0 defines complete response as the disappearance of all target lesions and non-target lesions and no evidence of new lesions documented by two disease assessments at least 4 weeks apart. Partial response is defined as at least a 30% decrease in the sum of longest dimensions (LD) of all target measurable lesions taking as reference the baseline sum of LD. There can be no unequivocal progression of non-target lesions and no new lesions. Documentation by two disease assessments at least 4 weeks apart is required. In the case where the ONLY target lesion is a solitary pelvic mass measured by physical exam, which is not radiographically measurable, a 50% decrease in the LD is required. These patients will have their response classified according to the definitions stated above. Complete and partial responses are included in the objective tumor response rate.
Outcome measures
| Measure |
Arm 1: Temsirolimus
n=50 Participants
Temsirolimus IV 25 mg (flat dose) weekly
|
Arm 2: Megestrol Acetate+Tamoxifen+ Temsirolimus
n=21 Participants
Megestrol Acetate (MA) 80 mg bid for three weeks alternating with Tamoxifen (T) 20 mg bid for 3 weeks PLUS Temsirolimus IV 25 mg (flat dose) weekly
|
|---|---|---|
|
Percentage of Participants With a Confirmed Objective Tumor Response Using RECIST Version 1.0
|
22 percentage of participants
Interval 11.0 to 52.0
|
14.3 percentage of participants
Interval 3.0 to 36.0
|
SECONDARY outcome
Timeframe: Every 6 weeks during treatment, then every 3 months for one year.Population: Eligible and treated patients
Overall survival is defined as the duration of time from study entry to time of death or the date of last contact.
Outcome measures
| Measure |
Arm 1: Temsirolimus
n=50 Participants
Temsirolimus IV 25 mg (flat dose) weekly
|
Arm 2: Megestrol Acetate+Tamoxifen+ Temsirolimus
n=21 Participants
Megestrol Acetate (MA) 80 mg bid for three weeks alternating with Tamoxifen (T) 20 mg bid for 3 weeks PLUS Temsirolimus IV 25 mg (flat dose) weekly
|
|---|---|---|
|
Duration of Overall Survival (OS)
|
13.3 months
Interval 9.8 to 20.7
|
9.6 months
Interval 6.4 to 16.3
|
SECONDARY outcome
Timeframe: Radiologic tumor evaluations at baseline and every six weeks for the first 24 weeks and then repeated every 12 weeks until disease progression. Repeat after treatment discontinuation if patient was taken off study for reasons other than progression.Population: Eligible and treated patients
Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions assessed radiographically and 50% increase if the only target lesion is a solitary pelvic mass measured by physical exam, or unequivocal progression of a non-target lesion, or the appearance of new lesions.
Outcome measures
| Measure |
Arm 1: Temsirolimus
n=50 Participants
Temsirolimus IV 25 mg (flat dose) weekly
|
Arm 2: Megestrol Acetate+Tamoxifen+ Temsirolimus
n=21 Participants
Megestrol Acetate (MA) 80 mg bid for three weeks alternating with Tamoxifen (T) 20 mg bid for 3 weeks PLUS Temsirolimus IV 25 mg (flat dose) weekly
|
|---|---|---|
|
Duration of Progression-free Survival (PFS)
|
5.6 months
Interval 4.0 to 8.2
|
4.2 months
Interval 1.5 to 6.2
|
SECONDARY outcome
Timeframe: Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment.Population: Eligible and treated patients
Number of participants with a maximum grade of 3 or higher during the treatment period.
Outcome measures
| Measure |
Arm 1: Temsirolimus
n=50 Participants
Temsirolimus IV 25 mg (flat dose) weekly
|
Arm 2: Megestrol Acetate+Tamoxifen+ Temsirolimus
n=21 Participants
Megestrol Acetate (MA) 80 mg bid for three weeks alternating with Tamoxifen (T) 20 mg bid for 3 weeks PLUS Temsirolimus IV 25 mg (flat dose) weekly
|
|---|---|---|
|
Incidence of Adverse Effects (Grade 3 or Higher) as Assessed by Common Terminology Criteria for Adverse Events Version 3.0
|
29 Participants
|
15 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: BaselinePopulation: Eligible and treated patients with primary tumor specimen
The levels of expression of the candidate markers measured prior to study treatment are tabulated. The expressions being tabulated include immunohistochemical expression of hormone receptors. The hormone receptors are estrogen receptor positive, progesterone receptors-A, progesterone receptor-B, PAKT Positive and PTEN Positive. The associations between the immunohistochemical expression of these biomarkers and between these biomarkers and treatment, outcome or clinical characteristics are reported for future investigation.
Outcome measures
| Measure |
Arm 1: Temsirolimus
n=56 Participants
Temsirolimus IV 25 mg (flat dose) weekly
|
Arm 2: Megestrol Acetate+Tamoxifen+ Temsirolimus
Megestrol Acetate (MA) 80 mg bid for three weeks alternating with Tamoxifen (T) 20 mg bid for 3 weeks PLUS Temsirolimus IV 25 mg (flat dose) weekly
|
|---|---|---|
|
Number of Participants and Their Levels of Expression of the Candidate Markers
Estrogen Receptor Positive
|
20 participants
|
—
|
|
Number of Participants and Their Levels of Expression of the Candidate Markers
Progesterone Receptor Positive
|
30 participants
|
—
|
|
Number of Participants and Their Levels of Expression of the Candidate Markers
Progesterone Receptor B Positive
|
35 participants
|
—
|
|
Number of Participants and Their Levels of Expression of the Candidate Markers
PAKT Positive
|
11 participants
|
—
|
|
Number of Participants and Their Levels of Expression of the Candidate Markers
PTEN Positive
|
30 participants
|
—
|
Adverse Events
Arm 1: Temsirolimus
Serious events: 18 serious events
Other events: 50 other events
Deaths: 33 deaths
Arm 2: Megestrol Acetate+Tamoxifen+ Temsirolimus
Serious events: 13 serious events
Other events: 21 other events
Deaths: 16 deaths
Serious adverse events
| Measure |
Arm 1: Temsirolimus
n=50 participants at risk
Temsirolimus IV 25 mg (flat dose) weekly
|
Arm 2: Megestrol Acetate+Tamoxifen+ Temsirolimus
n=21 participants at risk
Megestrol Acetate (MA) 80 mg bid for three weeks alternating with Tamoxifen (T) 20 mg bid for 3 weeks PLUS Temsirolimus IV 25 mg (flat dose) weekly
|
|---|---|---|
|
Cardiac disorders
Cardiac Arrhythmia - Other
|
2.0%
1/50 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
0.00%
0/21 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
|
Cardiac disorders
Cardiac Ischemia/Infarction
|
0.00%
0/50 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
4.8%
1/21 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
|
General disorders
Fatigue
|
4.0%
2/50 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
0.00%
0/21 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
|
General disorders
Death No Ctcae Term - Disease Progression Nos
|
2.0%
1/50 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
9.5%
2/21 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
|
General disorders
Death No Ctcae Term - Sudden Death
|
0.00%
0/50 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
4.8%
1/21 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
|
Skin and subcutaneous tissue disorders
Ulceration
|
2.0%
1/50 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
0.00%
0/21 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
|
Gastrointestinal disorders
Obstruction, Gi - Small Bowel Nos
|
4.0%
2/50 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
0.00%
0/21 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
|
Gastrointestinal disorders
Colitis
|
2.0%
1/50 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
0.00%
0/21 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
|
Gastrointestinal disorders
Vomiting
|
4.0%
2/50 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
4.8%
1/21 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
|
Gastrointestinal disorders
Anorexia
|
2.0%
1/50 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
0.00%
0/21 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
|
Gastrointestinal disorders
Nausea
|
2.0%
1/50 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
0.00%
0/21 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Joint
|
2.0%
1/50 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
0.00%
0/21 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Skin(Cellulitis)
|
2.0%
1/50 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
0.00%
0/21 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Urinary Tract Nos
|
2.0%
1/50 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
0.00%
0/21 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Abdomen Nos
|
2.0%
1/50 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
0.00%
0/21 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
|
Blood and lymphatic system disorders
Edema: Limb
|
0.00%
0/50 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
4.8%
1/21 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
|
Metabolism and nutrition disorders
Creatinine
|
2.0%
1/50 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
0.00%
0/21 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
2.0%
1/50 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
0.00%
0/21 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
|
Metabolism and nutrition disorders
Hypokalemia
|
2.0%
1/50 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
9.5%
2/21 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
2.0%
1/50 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
0.00%
0/21 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
|
Musculoskeletal and connective tissue disorders
Muscle Weakness - Whole Body/Generalized
|
2.0%
1/50 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
0.00%
0/21 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
|
General disorders
Pain: Extremity-Limb
|
0.00%
0/50 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
4.8%
1/21 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
|
General disorders
Pain: Back
|
2.0%
1/50 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
0.00%
0/21 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
|
Respiratory, thoracic and mediastinal disorders
Dlco
|
2.0%
1/50 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
0.00%
0/21 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
2.0%
1/50 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
0.00%
0/21 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
|
Renal and urinary disorders
Obstruction, Gu - Ureter
|
2.0%
1/50 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
0.00%
0/21 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
|
Surgical and medical procedures
Intra-Op Injury: Other
|
2.0%
1/50 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
0.00%
0/21 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
|
Vascular disorders
Thrombosis/Embolism (Vascular Access-Related)
|
0.00%
0/50 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
4.8%
1/21 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
|
Vascular disorders
Thrombosis/Thrombus/Embolism
|
4.0%
2/50 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
23.8%
5/21 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
Other adverse events
| Measure |
Arm 1: Temsirolimus
n=50 participants at risk
Temsirolimus IV 25 mg (flat dose) weekly
|
Arm 2: Megestrol Acetate+Tamoxifen+ Temsirolimus
n=21 participants at risk
Megestrol Acetate (MA) 80 mg bid for three weeks alternating with Tamoxifen (T) 20 mg bid for 3 weeks PLUS Temsirolimus IV 25 mg (flat dose) weekly
|
|---|---|---|
|
Immune system disorders
Allergic Reaction/Hypersensitivity
|
2.0%
1/50 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
4.8%
1/21 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
|
Immune system disorders
Rhinitis
|
4.0%
2/50 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
14.3%
3/21 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
|
Ear and labyrinth disorders
Auditory/Ear - Other
|
0.00%
0/50 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
4.8%
1/21 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
|
Ear and labyrinth disorders
Tinnitus
|
2.0%
1/50 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
0.00%
0/21 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
|
Blood and lymphatic system disorders
Neutrophils
|
30.0%
15/50 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
19.0%
4/21 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
|
Blood and lymphatic system disorders
Platelets
|
30.0%
15/50 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
52.4%
11/21 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
|
Blood and lymphatic system disorders
Blood/Bone Marrow - Other
|
4.0%
2/50 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
0.00%
0/21 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
|
Blood and lymphatic system disorders
Leukocytes
|
54.0%
27/50 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
33.3%
7/21 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
|
Blood and lymphatic system disorders
Lymphopenia
|
4.0%
2/50 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
4.8%
1/21 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
|
Blood and lymphatic system disorders
Hemoglobin
|
78.0%
39/50 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
95.2%
20/21 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
|
Cardiac disorders
S/N Arrhythmia: Atrial Fibrillation
|
0.00%
0/50 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
4.8%
1/21 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
|
Cardiac disorders
Palpitations
|
0.00%
0/50 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
4.8%
1/21 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
|
Cardiac disorders
Cardiac Arrhythmia - Other
|
2.0%
1/50 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
0.00%
0/21 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
|
Cardiac disorders
S/N Arrhythmia: Sinus Tachycardia
|
0.00%
0/50 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
4.8%
1/21 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
|
Cardiac disorders
Cardiac Ischemia/Infarction
|
0.00%
0/50 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
4.8%
1/21 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
|
Cardiac disorders
Hypertension
|
4.0%
2/50 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
0.00%
0/21 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
|
Cardiac disorders
Lt Ventricular Systolic Dysfunction
|
0.00%
0/50 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
4.8%
1/21 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
|
Cardiac disorders
Hypotension
|
0.00%
0/50 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
4.8%
1/21 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
|
Vascular disorders
Inr
|
0.00%
0/50 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
4.8%
1/21 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
|
Vascular disorders
Ptt
|
2.0%
1/50 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
0.00%
0/21 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
|
General disorders
Constitutional Symptoms - Other
|
0.00%
0/50 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
4.8%
1/21 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
|
General disorders
Sweating
|
2.0%
1/50 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
4.8%
1/21 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
|
General disorders
Weight Gain
|
0.00%
0/50 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
9.5%
2/21 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
|
General disorders
Fever
|
14.0%
7/50 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
14.3%
3/21 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
|
General disorders
Weight Loss
|
16.0%
8/50 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
9.5%
2/21 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
|
General disorders
Rigors/Chills
|
2.0%
1/50 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
9.5%
2/21 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
|
General disorders
Fatigue
|
76.0%
38/50 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
85.7%
18/21 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
|
General disorders
Insomnia
|
8.0%
4/50 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
33.3%
7/21 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
|
General disorders
Death No Ctcae Term - Disease Progression Nos
|
2.0%
1/50 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
9.5%
2/21 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
|
General disorders
Death No Ctcae Term - Sudden Death
|
0.00%
0/50 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
4.8%
1/21 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
|
Skin and subcutaneous tissue disorders
Nail Changes
|
12.0%
6/50 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
9.5%
2/21 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
|
Skin and subcutaneous tissue disorders
Hair Loss/Alopecia (Scalp Or Body)
|
6.0%
3/50 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
14.3%
3/21 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
|
Skin and subcutaneous tissue disorders
Induration
|
0.00%
0/50 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
4.8%
1/21 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
|
Skin and subcutaneous tissue disorders
Cheilitis
|
2.0%
1/50 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
4.8%
1/21 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
|
Skin and subcutaneous tissue disorders
Wound Complication, Non-Infectious
|
2.0%
1/50 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
0.00%
0/21 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
|
Skin and subcutaneous tissue disorders
Acne
|
4.0%
2/50 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
14.3%
3/21 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
|
Skin and subcutaneous tissue disorders
Rash
|
54.0%
27/50 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
33.3%
7/21 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
8.0%
4/50 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
14.3%
3/21 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
20.0%
10/50 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
14.3%
3/21 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
|
Skin and subcutaneous tissue disorders
Burn
|
2.0%
1/50 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
0.00%
0/21 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
|
Skin and subcutaneous tissue disorders
Flushing
|
4.0%
2/50 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
4.8%
1/21 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin - Other
|
2.0%
1/50 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
23.8%
5/21 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
|
Skin and subcutaneous tissue disorders
Ulceration
|
6.0%
3/50 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
9.5%
2/21 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
|
Endocrine disorders
Hot Flashes
|
4.0%
2/50 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
19.0%
4/21 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
|
Gastrointestinal disorders
Heartburn
|
2.0%
1/50 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
9.5%
2/21 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
|
Gastrointestinal disorders
Mucositis (Functional/Sympt) - Trachea
|
0.00%
0/50 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
4.8%
1/21 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
|
Gastrointestinal disorders
Ascites
|
4.0%
2/50 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
4.8%
1/21 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
|
Gastrointestinal disorders
Leak, Gi - Rectum
|
2.0%
1/50 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
0.00%
0/21 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
|
Gastrointestinal disorders
Dysphagia
|
2.0%
1/50 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
0.00%
0/21 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
|
Gastrointestinal disorders
Distention
|
6.0%
3/50 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
4.8%
1/21 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
|
Gastrointestinal disorders
Taste Alteration
|
20.0%
10/50 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
19.0%
4/21 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
|
Gastrointestinal disorders
Dry Mouth
|
4.0%
2/50 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
9.5%
2/21 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
|
Gastrointestinal disorders
Mucositis (Functional/Sympt) - Oral Cavity
|
14.0%
7/50 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
33.3%
7/21 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
|
Gastrointestinal disorders
Obstruction, Gi - Small Bowel Nos
|
6.0%
3/50 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
0.00%
0/21 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
|
Gastrointestinal disorders
Colitis
|
2.0%
1/50 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
0.00%
0/21 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
|
Gastrointestinal disorders
Mucositis (Clinical Exam) - Oral Cavity
|
20.0%
10/50 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
19.0%
4/21 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
|
Gastrointestinal disorders
Mucositis (Clinical Exam) - Anus
|
0.00%
0/50 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
4.8%
1/21 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
|
Gastrointestinal disorders
Vomiting
|
26.0%
13/50 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
19.0%
4/21 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
|
Gastrointestinal disorders
Anorexia
|
36.0%
18/50 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
19.0%
4/21 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
|
Gastrointestinal disorders
Dehydration
|
4.0%
2/50 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
4.8%
1/21 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
|
Gastrointestinal disorders
Constipation
|
30.0%
15/50 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
23.8%
5/21 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
|
Gastrointestinal disorders
Nausea
|
46.0%
23/50 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
14.3%
3/21 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
|
Gastrointestinal disorders
Diarrhea
|
32.0%
16/50 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
38.1%
8/21 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
|
Vascular disorders
Hemorrhage, Gu - Vagina
|
10.0%
5/50 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
0.00%
0/21 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
|
Vascular disorders
Hemorrhage, Gi - Varices (Rectal)
|
2.0%
1/50 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
0.00%
0/21 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
|
Vascular disorders
Hemorrhage, Gi - Upper Gi Nos
|
0.00%
0/50 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
4.8%
1/21 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
|
Vascular disorders
Hemorrhage/Pulmonary - Nose
|
6.0%
3/50 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
23.8%
5/21 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
|
Vascular disorders
Hemorrhage, Gu - Ureter
|
2.0%
1/50 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
0.00%
0/21 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
|
Vascular disorders
Petechiae
|
0.00%
0/50 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
4.8%
1/21 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
|
Vascular disorders
Hemorrhage/Bleeding - Other
|
4.0%
2/50 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
4.8%
1/21 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Upper Airway Nos
|
0.00%
0/50 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
4.8%
1/21 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Paranasal
|
0.00%
0/50 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
4.8%
1/21 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Lung(Pneumonia)
|
0.00%
0/50 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
4.8%
1/21 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Eye Nos
|
2.0%
1/50 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
0.00%
0/21 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Soft Tissue Nos
|
0.00%
0/50 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
4.8%
1/21 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Joint
|
2.0%
1/50 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
0.00%
0/21 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Blood
|
2.0%
1/50 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
0.00%
0/21 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Small Bowel Nos
|
2.0%
1/50 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
0.00%
0/21 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Oral Cavity-Gums
|
0.00%
0/50 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
4.8%
1/21 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Skin(Cellulitis)
|
2.0%
1/50 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
4.8%
1/21 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
|
Infections and infestations
Inf Unknown Anc: Lung (Pneumonia)
|
2.0%
1/50 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
0.00%
0/21 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Urinary Tract Nos
|
2.0%
1/50 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
0.00%
0/21 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Abdomen Nos
|
2.0%
1/50 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
0.00%
0/21 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Ungual (Nails)
|
2.0%
1/50 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
0.00%
0/21 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
|
Infections and infestations
Infection - Other
|
4.0%
2/50 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
0.00%
0/21 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
|
Infections and infestations
Colitis, Infectious (Eg.C. Difficile)
|
2.0%
1/50 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
0.00%
0/21 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Nerve-Peripheral
|
2.0%
1/50 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
0.00%
0/21 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Bronchus
|
0.00%
0/50 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
4.8%
1/21 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Mucosa
|
0.00%
0/50 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
4.8%
1/21 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
|
Infections and infestations
Inf Unknown Anc: Upper Airway Nos
|
2.0%
1/50 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
0.00%
0/21 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Sinus
|
0.00%
0/50 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
4.8%
1/21 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
|
Infections and infestations
Inf Unknown Anc: Urinary Tract Nos
|
0.00%
0/50 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
4.8%
1/21 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
|
Infections and infestations
Inf Unknown Anc: Skin (Cellulitis)
|
0.00%
0/50 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
4.8%
1/21 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Kidney
|
2.0%
1/50 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
0.00%
0/21 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
|
Blood and lymphatic system disorders
Lymphedema-Related Fibrosis
|
0.00%
0/50 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
4.8%
1/21 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
|
Blood and lymphatic system disorders
Edema: Trunk/Genital
|
0.00%
0/50 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
4.8%
1/21 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
|
Blood and lymphatic system disorders
Edema: Limb
|
32.0%
16/50 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
47.6%
10/21 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
|
Blood and lymphatic system disorders
Edema: Head And Neck
|
4.0%
2/50 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
14.3%
3/21 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
|
Metabolism and nutrition disorders
Ast
|
10.0%
5/50 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
4.8%
1/21 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
|
Metabolism and nutrition disorders
Gfr
|
0.00%
0/50 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
4.8%
1/21 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
|
Metabolism and nutrition disorders
Metabolic/Laboratory - Other
|
2.0%
1/50 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
9.5%
2/21 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
|
Metabolism and nutrition disorders
Cholesterol,serum High
|
38.0%
19/50 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
33.3%
7/21 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
|
Metabolism and nutrition disorders
Creatinine
|
18.0%
9/50 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
19.0%
4/21 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
14.0%
7/50 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
28.6%
6/21 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
|
Metabolism and nutrition disorders
Alt
|
8.0%
4/50 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
4.8%
1/21 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
|
Metabolism and nutrition disorders
Alkaline Phosphatase
|
14.0%
7/50 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
4.8%
1/21 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
0.00%
0/50 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
4.8%
1/21 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
2.0%
1/50 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
0.00%
0/21 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
|
Metabolism and nutrition disorders
Hyponatremia
|
12.0%
6/50 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
19.0%
4/21 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
40.0%
20/50 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
33.3%
7/21 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
|
Metabolism and nutrition disorders
Bicarbonate, Serum-Low
|
2.0%
1/50 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
0.00%
0/21 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
|
Metabolism and nutrition disorders
Hypernatremia
|
4.0%
2/50 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
0.00%
0/21 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
16.0%
8/50 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
14.3%
3/21 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
4.0%
2/50 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
0.00%
0/21 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
18.0%
9/50 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
14.3%
3/21 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
|
Metabolism and nutrition disorders
Hypokalemia
|
20.0%
10/50 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
19.0%
4/21 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
4.0%
2/50 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
9.5%
2/21 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
2.0%
1/50 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
0.00%
0/21 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
6.0%
3/50 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
14.3%
3/21 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal/St: Other
|
2.0%
1/50 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
4.8%
1/21 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
|
Musculoskeletal and connective tissue disorders
Fracture
|
2.0%
1/50 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
4.8%
1/21 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
|
Musculoskeletal and connective tissue disorders
Extremity-Upper (Function)
|
4.0%
2/50 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
0.00%
0/21 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
2.0%
1/50 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
0.00%
0/21 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
|
Musculoskeletal and connective tissue disorders
Muscle Weakness - Whole Body/Generalized
|
6.0%
3/50 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
9.5%
2/21 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
|
Nervous system disorders
Syncope
|
2.0%
1/50 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
0.00%
0/21 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
|
Nervous system disorders
Psychosis
|
0.00%
0/50 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
4.8%
1/21 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
|
Nervous system disorders
Mood Alteration - Depression
|
4.0%
2/50 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
4.8%
1/21 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
|
Nervous system disorders
Mood Alteration - Anxiety
|
8.0%
4/50 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
4.8%
1/21 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
|
Nervous system disorders
Mood Alteration - Agitation
|
0.00%
0/50 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
4.8%
1/21 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
|
Nervous system disorders
Tremor
|
0.00%
0/50 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
9.5%
2/21 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
|
Nervous system disorders
Speech Impairment
|
2.0%
1/50 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
0.00%
0/21 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
|
Nervous system disorders
Irritability
|
0.00%
0/50 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
4.8%
1/21 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
|
Nervous system disorders
Confusion
|
4.0%
2/50 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
0.00%
0/21 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
|
Nervous system disorders
Memory Impairment
|
2.0%
1/50 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
0.00%
0/21 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
|
Nervous system disorders
Dizziness
|
6.0%
3/50 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
19.0%
4/21 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
|
Nervous system disorders
Neuropathy-Sensory
|
14.0%
7/50 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
4.8%
1/21 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
|
Eye disorders
Ocular/Visual - Other
|
2.0%
1/50 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
0.00%
0/21 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
|
Eye disorders
Watery Eye
|
2.0%
1/50 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
0.00%
0/21 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
|
Eye disorders
Dry Eye
|
2.0%
1/50 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
0.00%
0/21 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
|
General disorders
Pain - Other
|
4.0%
2/50 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
19.0%
4/21 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
|
General disorders
Pain: Urethra
|
0.00%
0/50 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
4.8%
1/21 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
|
General disorders
Pain: Breast
|
0.00%
0/50 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
4.8%
1/21 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
|
General disorders
Pain: Chest /Thorax Nos
|
2.0%
1/50 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
4.8%
1/21 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
|
General disorders
Pain: Chest Wall
|
2.0%
1/50 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
4.8%
1/21 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
|
General disorders
Pain: Throat/Pharynx/Larynx
|
4.0%
2/50 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
4.8%
1/21 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
|
General disorders
Pain: Head/Headache
|
16.0%
8/50 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
19.0%
4/21 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
|
General disorders
Pain: Neck
|
0.00%
0/50 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
4.8%
1/21 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
|
General disorders
Pain: Extremity-Limb
|
12.0%
6/50 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
14.3%
3/21 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
|
General disorders
Pain: Buttock
|
2.0%
1/50 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
0.00%
0/21 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
|
General disorders
Pain: Back
|
18.0%
9/50 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
9.5%
2/21 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
|
General disorders
Pain: Joint
|
8.0%
4/50 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
14.3%
3/21 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
|
General disorders
Pain: Kidney
|
2.0%
1/50 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
0.00%
0/21 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
|
General disorders
Pain: Bladder
|
2.0%
1/50 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
0.00%
0/21 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
|
General disorders
Pain: Pain Nos
|
2.0%
1/50 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
9.5%
2/21 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
|
General disorders
Pain: Stomach
|
2.0%
1/50 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
4.8%
1/21 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
|
General disorders
Pain: Oral Cavity
|
4.0%
2/50 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
0.00%
0/21 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
|
General disorders
Pain: Dental/Teeth/Peridontal
|
0.00%
0/50 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
4.8%
1/21 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
|
General disorders
Pain: Abdominal Pain Nos
|
24.0%
12/50 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
28.6%
6/21 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
|
General disorders
Pain: Muscle
|
8.0%
4/50 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
9.5%
2/21 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary: Other
|
10.0%
5/50 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
4.8%
1/21 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
|
Respiratory, thoracic and mediastinal disorders
Nasal/Paranasal Reactions
|
4.0%
2/50 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
9.5%
2/21 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.00%
0/50 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
9.5%
2/21 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
|
Respiratory, thoracic and mediastinal disorders
Voice Changes
|
0.00%
0/50 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
4.8%
1/21 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
2.0%
1/50 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
0.00%
0/21 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
|
Respiratory, thoracic and mediastinal disorders
Fev1
|
2.0%
1/50 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
0.00%
0/21 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
26.0%
13/50 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
23.8%
5/21 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
|
Respiratory, thoracic and mediastinal disorders
Dlco
|
2.0%
1/50 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
0.00%
0/21 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
10.0%
5/50 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
14.3%
3/21 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
4.0%
2/50 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
4.8%
1/21 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
28.0%
14/50 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
61.9%
13/21 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
|
Renal and urinary disorders
Renal/Genitourinary - Other
|
2.0%
1/50 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
0.00%
0/21 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
|
Renal and urinary disorders
Stricture, Anastomotic, Gu - Ureter
|
0.00%
0/50 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
4.8%
1/21 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
|
Renal and urinary disorders
Cystitis
|
2.0%
1/50 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
0.00%
0/21 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
|
Renal and urinary disorders
Obstruction, Gu - Ureter
|
2.0%
1/50 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
0.00%
0/21 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
|
Renal and urinary disorders
Incontinence, Urinary
|
2.0%
1/50 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
4.8%
1/21 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
|
Renal and urinary disorders
Renal Failure
|
0.00%
0/50 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
4.8%
1/21 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
|
Renal and urinary disorders
Urinary Frequency
|
2.0%
1/50 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
9.5%
2/21 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
|
Reproductive system and breast disorders
Breast
|
2.0%
1/50 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
0.00%
0/21 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
|
Reproductive system and breast disorders
Vaginal Dryness
|
2.0%
1/50 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
0.00%
0/21 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
|
Reproductive system and breast disorders
Sexual/Reproductive Function: Other
|
2.0%
1/50 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
0.00%
0/21 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
|
General disorders
Flu-Like Syndrome
|
0.00%
0/50 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
4.8%
1/21 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
|
Vascular disorders
Artery Injury - Extremity-Lower
|
0.00%
0/50 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
4.8%
1/21 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
|
Vascular disorders
Thrombosis/Embolism (Vascular Access-Related)
|
0.00%
0/50 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
4.8%
1/21 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
|
Vascular disorders
Thrombosis/Thrombus/Embolism
|
6.0%
3/50 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
23.8%
5/21 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
|
Vascular disorders
Phlebitis
|
0.00%
0/50 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
4.8%
1/21 • Assessed every 6 weeks while on treatment, 30 days after the last cycle of treatment, and up to 1 year in follow-up
|
Additional Information
Angela Kuras on behalf of Virginia Filiaci
NRG Oncology
Phone: 716-845-5702
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60