Trial Outcomes & Findings for Paclitaxel and Carboplatin or Bleomycin Sulfate, Etoposide Phosphate, and Cisplatin in Treating Patients With Advanced or Recurrent Sex Cord-Ovarian Stromal Tumors (NCT NCT01042522)
NCT ID: NCT01042522
Last Updated: 2022-01-25
Results Overview
The relationship of randomized treatment to progression free survival. The RECIST 1.1 criteria are used for disease progression. This is the criteria: progression is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progressions).
Recruitment status
UNKNOWN
Study phase
PHASE2
Target enrollment
63 participants
Primary outcome timeframe
From start of treatment to time of progression or death, whichever occurs first. Median follow-up time was 48 months.
Results posted on
2022-01-25
Participant Flow
Participant milestones
| Measure |
Arm I (Paclitaxel, Carboplatin)
Patients receive paclitaxel IV over 3 hours and carboplatin IV over 1 hour on day 1. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
Carboplatin: Given IV
Laboratory Biomarker Analysis: Correlative studies
Paclitaxel: Given IV
|
Arm II (Bleomycin Sulfate, Etoposide Phosphate, Cisplatin)
Patients receive bleomycin sulfate IV on day 1 and etoposide IV over 1 hour and cisplatin IV over 30 minutes on days 1-5. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
Bleomycin Sulfate: Given IV
Cisplatin: Given IV
Etoposide Phosphate: Given IV
Laboratory Biomarker Analysis: Correlative studies
|
|---|---|---|
|
Overall Study
STARTED
|
31
|
32
|
|
Overall Study
COMPLETED
|
23
|
26
|
|
Overall Study
NOT COMPLETED
|
8
|
6
|
Reasons for withdrawal
| Measure |
Arm I (Paclitaxel, Carboplatin)
Patients receive paclitaxel IV over 3 hours and carboplatin IV over 1 hour on day 1. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
Carboplatin: Given IV
Laboratory Biomarker Analysis: Correlative studies
Paclitaxel: Given IV
|
Arm II (Bleomycin Sulfate, Etoposide Phosphate, Cisplatin)
Patients receive bleomycin sulfate IV on day 1 and etoposide IV over 1 hour and cisplatin IV over 30 minutes on days 1-5. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
Bleomycin Sulfate: Given IV
Cisplatin: Given IV
Etoposide Phosphate: Given IV
Laboratory Biomarker Analysis: Correlative studies
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
2
|
|
Overall Study
Disease Progression
|
5
|
0
|
|
Overall Study
Death
|
1
|
0
|
|
Overall Study
Patient Refused
|
0
|
3
|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
Baseline Characteristics
Paclitaxel and Carboplatin or Bleomycin Sulfate, Etoposide Phosphate, and Cisplatin in Treating Patients With Advanced or Recurrent Sex Cord-Ovarian Stromal Tumors
Baseline characteristics by cohort
| Measure |
Arm I (Paclitaxel, Carboplatin)
n=31 Participants
Patients receive paclitaxel IV over 3 hours and carboplatin IV over 1 hour on day 1. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
Carboplatin: Given IV
Laboratory Biomarker Analysis: Correlative studies
Paclitaxel: Given IV
|
Arm II (Bleomycin Sulfate, Etoposide Phosphate, Cisplatin)
n=32 Participants
Patients receive bleomycin sulfate IV on day 1 and etoposide IV over 1 hour and cisplatin IV over 30 minutes on days 1-5. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
Bleomycin Sulfate: Given IV
Cisplatin: Given IV
Etoposide Phosphate: Given IV
Laboratory Biomarker Analysis: Correlative studies
|
Total
n=63 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
50.71 years
STANDARD_DEVIATION 12.51 • n=5 Participants
|
44.05 years
STANDARD_DEVIATION 13.86 • n=7 Participants
|
47.33 years
STANDARD_DEVIATION 13.53 • n=5 Participants
|
|
Age, Customized
20 - 29 years
|
2 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Age, Customized
30 - 39 years
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Age, Customized
40 - 49 years
|
13 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Age, Customized
50 - 59 years
|
6 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Age, Customized
>= 60 years
|
8 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
31 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
63 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
27 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 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
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 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
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
23 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
48 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
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Performance Status
0
|
21 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
|
Performance Status
1
|
9 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Performance Status
2
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Measurable Disease
Measurable Disease
|
11 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Measurable Disease
No Measurable Disease
|
20 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
Cell Type
Lipid Cell Tumor
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Cell Type
Granulosa Cell Tumor
|
28 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
55 Participants
n=5 Participants
|
|
Cell Type
Sex Cord Stromal Tumor, Unclassified
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Cell Type
Sertoli-leydig Cell Tumor
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From start of treatment to time of progression or death, whichever occurs first. Median follow-up time was 48 months.Population: Intent to Treat
The relationship of randomized treatment to progression free survival. The RECIST 1.1 criteria are used for disease progression. This is the criteria: progression is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progressions).
Outcome measures
| Measure |
Arm I (Paclitaxel, Carboplatin)
n=31 Participants
Patients receive paclitaxel IV over 3 hours and carboplatin IV over 1 hour on day 1. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
Carboplatin: Given IV
Laboratory Biomarker Analysis: Correlative studies
Paclitaxel: Given IV
|
Arm II (Bleomycin Sulfate, Etoposide Phosphate, Cisplatin)
n=32 Participants
Patients receive bleomycin sulfate IV on day 1 and etoposide IV over 1 hour and cisplatin IV over 30 minutes on days 1-5. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
Bleomycin Sulfate: Given IV
Cisplatin: Given IV
Etoposide Phosphate: Given IV
Laboratory Biomarker Analysis: Correlative studies
|
|---|---|---|
|
Progression-free Survival (PFS)
|
27.7 months
Interval 11.2 to 41.0
|
19.7 months
Interval 10.4 to 52.7
|
SECONDARY outcome
Timeframe: Median followup time was 48 months.Population: Patients with at least one target lesion by RECIST 1.1 criteria and and at least one CT tumor assessment
Proportion of evaluable patients with complete or partial tumor response by RECIST 1.1 criteria. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. (ORR = CR + PR).
Outcome measures
| Measure |
Arm I (Paclitaxel, Carboplatin)
n=14 Participants
Patients receive paclitaxel IV over 3 hours and carboplatin IV over 1 hour on day 1. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
Carboplatin: Given IV
Laboratory Biomarker Analysis: Correlative studies
Paclitaxel: Given IV
|
Arm II (Bleomycin Sulfate, Etoposide Phosphate, Cisplatin)
n=13 Participants
Patients receive bleomycin sulfate IV on day 1 and etoposide IV over 1 hour and cisplatin IV over 30 minutes on days 1-5. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
Bleomycin Sulfate: Given IV
Cisplatin: Given IV
Etoposide Phosphate: Given IV
Laboratory Biomarker Analysis: Correlative studies
|
|---|---|---|
|
Tumor Response Rate
|
0.43 proportion of participants
Interval 0.21 to 0.67
|
0.54 proportion of participants
Interval 0.29 to 0.77
|
SECONDARY outcome
Timeframe: From start of treatment to time of death or the date of last contact, assessed up to 10 years. Median follow-up time was 48 months.Population: Intent to Treat
The relationship of treatment to overall survival will be assessed. The number of death events in the treatment arm is reported.
Outcome measures
| Measure |
Arm I (Paclitaxel, Carboplatin)
n=31 Participants
Patients receive paclitaxel IV over 3 hours and carboplatin IV over 1 hour on day 1. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
Carboplatin: Given IV
Laboratory Biomarker Analysis: Correlative studies
Paclitaxel: Given IV
|
Arm II (Bleomycin Sulfate, Etoposide Phosphate, Cisplatin)
n=32 Participants
Patients receive bleomycin sulfate IV on day 1 and etoposide IV over 1 hour and cisplatin IV over 30 minutes on days 1-5. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
Bleomycin Sulfate: Given IV
Cisplatin: Given IV
Etoposide Phosphate: Given IV
Laboratory Biomarker Analysis: Correlative studies
|
|---|---|---|
|
Overall Survival (OS)
|
5 Participants
|
8 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to up to 2 yearsPre-treatment levels of inhibin A and inhibin B will be examined in relation to OS and PFS in Cox proportional hazards models. Changes from baseline in inhibin levels will be compared between treatment groups using mixed effects models accounting for the longitudinal nature of the data. The repeated measures of inhibin will also be explored versus overall survival and PFS using time-dependent covariates in Cox proportional hazards models.
Outcome measures
Outcome data not reported
Adverse Events
Arm I (Paclitaxel, Carboplatin)
Serious events: 6 serious events
Other events: 31 other events
Deaths: 5 deaths
Arm II (Bleomycin Sulfate, Etoposide Phosphate, Cisplatin)
Serious events: 11 serious events
Other events: 29 other events
Deaths: 8 deaths
Serious adverse events
| Measure |
Arm I (Paclitaxel, Carboplatin)
n=31 participants at risk
Patients receive paclitaxel IV over 3 hours and carboplatin IV over 1 hour on day 1. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
Carboplatin: Given IV
Laboratory Biomarker Analysis: Correlative studies
Paclitaxel: Given IV
|
Arm II (Bleomycin Sulfate, Etoposide Phosphate, Cisplatin)
n=32 participants at risk
Patients receive bleomycin sulfate IV on day 1 and etoposide IV over 1 hour and cisplatin IV over 30 minutes on days 1-5. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
Bleomycin Sulfate: Given IV
Cisplatin: Given IV
Etoposide Phosphate: Given IV
Laboratory Biomarker Analysis: Correlative studies
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
3.2%
1/31 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
0.00%
0/32 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
0.00%
0/31 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
6.2%
2/32 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
|
Cardiac disorders
Sinus Bradycardia
|
0.00%
0/31 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
3.1%
1/32 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/31 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
3.1%
1/32 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
|
General disorders
Pain
|
3.2%
1/31 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
0.00%
0/32 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
|
General disorders
Death Nos
|
3.2%
1/31 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
0.00%
0/32 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
|
Investigations
Neutrophil Count Decreased
|
16.1%
5/31 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
21.9%
7/32 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/31 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
3.1%
1/32 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
|
Nervous system disorders
Syncope
|
0.00%
0/31 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
3.1%
1/32 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
|
Vascular disorders
Thromboembolic Event
|
0.00%
0/31 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
3.1%
1/32 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
Other adverse events
| Measure |
Arm I (Paclitaxel, Carboplatin)
n=31 participants at risk
Patients receive paclitaxel IV over 3 hours and carboplatin IV over 1 hour on day 1. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
Carboplatin: Given IV
Laboratory Biomarker Analysis: Correlative studies
Paclitaxel: Given IV
|
Arm II (Bleomycin Sulfate, Etoposide Phosphate, Cisplatin)
n=32 participants at risk
Patients receive bleomycin sulfate IV on day 1 and etoposide IV over 1 hour and cisplatin IV over 30 minutes on days 1-5. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
Bleomycin Sulfate: Given IV
Cisplatin: Given IV
Etoposide Phosphate: Given IV
Laboratory Biomarker Analysis: Correlative studies
|
|---|---|---|
|
Nervous system disorders
Extrapyramidal Disorder
|
0.00%
0/31 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
3.1%
1/32 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/31 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
6.2%
2/32 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
|
Blood and lymphatic system disorders
Blood And Lymphatic System Disorders - Other
|
9.7%
3/31 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
6.2%
2/32 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
|
Blood and lymphatic system disorders
Anemia
|
83.9%
26/31 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
81.2%
26/32 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
|
Cardiac disorders
Atrial Fibrillation
|
0.00%
0/31 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
3.1%
1/32 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
|
Cardiac disorders
Sinus Bradycardia
|
0.00%
0/31 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
3.1%
1/32 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
|
Cardiac disorders
Palpitations
|
3.2%
1/31 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
12.5%
4/32 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
|
Cardiac disorders
Cardiac Disorders - Other
|
3.2%
1/31 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
0.00%
0/32 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
|
Cardiac disorders
Sinus Tachycardia
|
3.2%
1/31 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
6.2%
2/32 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
|
Ear and labyrinth disorders
Tinnitus
|
9.7%
3/31 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
34.4%
11/32 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
|
Ear and labyrinth disorders
Ear Pain
|
3.2%
1/31 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
3.1%
1/32 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
|
Endocrine disorders
Hypothyroidism
|
3.2%
1/31 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
3.1%
1/32 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/31 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
3.1%
1/32 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
|
Endocrine disorders
Endocrine Disorders - Other
|
0.00%
0/31 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
3.1%
1/32 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
|
Eye disorders
Eye Disorders - Other
|
6.5%
2/31 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
0.00%
0/32 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
|
Eye disorders
Watering Eyes
|
0.00%
0/31 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
3.1%
1/32 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
|
Eye disorders
Blurred Vision
|
9.7%
3/31 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
15.6%
5/32 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
|
Gastrointestinal disorders
Dyspepsia
|
6.5%
2/31 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
25.0%
8/32 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
|
Gastrointestinal disorders
Constipation
|
58.1%
18/31 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
34.4%
11/32 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
|
Gastrointestinal disorders
Diarrhea
|
22.6%
7/31 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
28.1%
9/32 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
|
Gastrointestinal disorders
Vomiting
|
29.0%
9/31 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
43.8%
14/32 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
|
Gastrointestinal disorders
Abdominal Pain
|
16.1%
5/31 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
34.4%
11/32 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
|
Gastrointestinal disorders
Mucositis Oral
|
9.7%
3/31 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
25.0%
8/32 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
|
Gastrointestinal disorders
Gastrointestinal Disorders - Other
|
0.00%
0/31 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
3.1%
1/32 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
|
Gastrointestinal disorders
Oral Pain
|
0.00%
0/31 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
6.2%
2/32 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
|
Gastrointestinal disorders
Nausea
|
71.0%
22/31 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
78.1%
25/32 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
|
Gastrointestinal disorders
Gastroesophageal Reflux Disease
|
6.5%
2/31 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
3.1%
1/32 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
|
Gastrointestinal disorders
Hemorrhoidal Hemorrhage
|
3.2%
1/31 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
0.00%
0/32 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
|
Gastrointestinal disorders
Hemorrhoids
|
3.2%
1/31 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
0.00%
0/32 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/31 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
3.1%
1/32 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
|
Gastrointestinal disorders
Esophageal Pain
|
0.00%
0/31 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
6.2%
2/32 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/31 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
3.1%
1/32 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
|
General disorders
General Disorders And Administration Site Conditions
|
0.00%
0/31 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
12.5%
4/32 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
|
General disorders
Pain
|
25.8%
8/31 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
12.5%
4/32 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
|
General disorders
Neck Edema
|
0.00%
0/31 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
3.1%
1/32 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
|
General disorders
Malaise
|
3.2%
1/31 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
3.1%
1/32 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
|
General disorders
Injection Site Reaction
|
3.2%
1/31 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
0.00%
0/32 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
|
General disorders
Flu Like Symptoms
|
3.2%
1/31 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
3.1%
1/32 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
|
General disorders
Non-Cardiac Chest Pain
|
3.2%
1/31 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
6.2%
2/32 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
|
General disorders
Edema Limbs
|
9.7%
3/31 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
21.9%
7/32 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
|
General disorders
Fatigue
|
74.2%
23/31 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
71.9%
23/32 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
|
General disorders
Fever
|
12.9%
4/31 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
12.5%
4/32 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
|
General disorders
Chills
|
3.2%
1/31 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
6.2%
2/32 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
|
General disorders
Infusion Related Reaction
|
6.5%
2/31 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
9.4%
3/32 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
|
Immune system disorders
Allergic Reaction
|
3.2%
1/31 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
3.1%
1/32 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
|
Infections and infestations
Wound Infection
|
0.00%
0/31 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
3.1%
1/32 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
|
Infections and infestations
Upper Respiratory Infection
|
3.2%
1/31 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
0.00%
0/32 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
|
Infections and infestations
Skin Infection
|
6.5%
2/31 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
0.00%
0/32 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
|
Infections and infestations
Sinusitis
|
9.7%
3/31 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
3.1%
1/32 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
|
Infections and infestations
Papulopustular Rash
|
3.2%
1/31 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
0.00%
0/32 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
|
Infections and infestations
Mucosal Infection
|
0.00%
0/31 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
6.2%
2/32 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
|
Infections and infestations
Lung Infection
|
3.2%
1/31 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
0.00%
0/32 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
|
Infections and infestations
Eye Infection
|
3.2%
1/31 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
0.00%
0/32 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
|
Infections and infestations
Vaginal Infection
|
6.5%
2/31 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
3.1%
1/32 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
|
Infections and infestations
Urinary Tract Infection
|
0.00%
0/31 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
9.4%
3/32 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
|
Infections and infestations
Catheter Related Infection
|
0.00%
0/31 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
3.1%
1/32 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
|
Infections and infestations
Bronchial Infection
|
0.00%
0/31 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
3.1%
1/32 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
|
Infections and infestations
Enterocolitis Infectious
|
0.00%
0/31 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
3.1%
1/32 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
|
Injury, poisoning and procedural complications
Vascular Access Complication
|
0.00%
0/31 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
3.1%
1/32 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
|
Nervous system disorders
Dysgeusia
|
6.5%
2/31 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
6.2%
2/32 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
|
Injury, poisoning and procedural complications
Fall
|
3.2%
1/31 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
3.1%
1/32 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
|
Injury, poisoning and procedural complications
Wound Complication
|
3.2%
1/31 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
0.00%
0/32 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
|
Injury, poisoning and procedural complications
Burn
|
0.00%
0/31 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
3.1%
1/32 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
|
Injury, poisoning and procedural complications
Bruising
|
3.2%
1/31 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
3.1%
1/32 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
|
Investigations
Investigations - Other
|
3.2%
1/31 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
6.2%
2/32 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
|
Investigations
Weight Loss
|
3.2%
1/31 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
6.2%
2/32 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
|
Investigations
Weight Gain
|
3.2%
1/31 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
12.5%
4/32 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
|
Investigations
Platelet Count Decreased
|
54.8%
17/31 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
46.9%
15/32 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
|
Investigations
Lymphocyte Count Decreased
|
0.00%
0/31 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
18.8%
6/32 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
|
Investigations
Ggt Increased
|
3.2%
1/31 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
0.00%
0/32 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
|
Investigations
Creatinine Increased
|
3.2%
1/31 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
3.1%
1/32 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
|
Investigations
Cholesterol High
|
0.00%
0/31 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
3.1%
1/32 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
|
Investigations
Neutrophil Count Decreased
|
83.9%
26/31 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
90.6%
29/32 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
|
Investigations
Carbon Monoxide Diffusing Capacity Decreased
|
0.00%
0/31 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
3.1%
1/32 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
|
Investigations
White Blood Cell Decreased
|
71.0%
22/31 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
84.4%
27/32 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
|
Investigations
Aspartate Aminotransferase Increased
|
12.9%
4/31 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
3.1%
1/32 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
|
Investigations
Alkaline Phosphatase Increased
|
9.7%
3/31 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
12.5%
4/32 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
|
Investigations
Alanine Aminotransferase Increased
|
6.5%
2/31 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
9.4%
3/32 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
0.00%
0/31 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
6.2%
2/32 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
|
Metabolism and nutrition disorders
Hyponatremia
|
9.7%
3/31 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
15.6%
5/32 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
|
Nervous system disorders
Syncope
|
3.2%
1/31 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
3.1%
1/32 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
22.6%
7/31 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
18.8%
6/32 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
|
Metabolism and nutrition disorders
Hypokalemia
|
3.2%
1/31 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
25.0%
8/32 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
0.00%
0/31 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
6.2%
2/32 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
9.7%
3/31 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
15.6%
5/32 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
6.5%
2/31 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
9.4%
3/32 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
0.00%
0/31 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
3.1%
1/32 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
|
Metabolism and nutrition disorders
Hypernatremia
|
3.2%
1/31 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
3.1%
1/32 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
3.2%
1/31 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
3.1%
1/32 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
3.2%
1/31 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
6.2%
2/32 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
16.1%
5/31 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
12.5%
4/32 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
0.00%
0/31 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
6.2%
2/32 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
|
Metabolism and nutrition disorders
Dehydration
|
6.5%
2/31 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
3.1%
1/32 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
|
Metabolism and nutrition disorders
Anorexia
|
32.3%
10/31 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
18.8%
6/32 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
|
Musculoskeletal and connective tissue disorders
Pain In Extremity
|
12.9%
4/31 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
3.1%
1/32 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
25.8%
8/31 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
9.4%
3/32 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
|
Musculoskeletal and connective tissue disorders
Muscle Weakness Lower Limb
|
3.2%
1/31 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
0.00%
0/32 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
|
Musculoskeletal and connective tissue disorders
Generalized Muscle Weakness
|
9.7%
3/31 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
9.4%
3/32 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
|
Musculoskeletal and connective tissue disorders
Flank Pain
|
0.00%
0/31 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
6.2%
2/32 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
|
Musculoskeletal and connective tissue disorders
Bone Pain
|
19.4%
6/31 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
3.1%
1/32 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
12.9%
4/31 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
15.6%
5/32 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
3.2%
1/31 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
0.00%
0/32 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
22.6%
7/31 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
15.6%
5/32 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal And Connective Tissue Disorder - Other
|
0.00%
0/31 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
6.2%
2/32 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
|
Nervous system disorders
Tremor
|
3.2%
1/31 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
3.1%
1/32 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
|
Nervous system disorders
Presyncope
|
0.00%
0/31 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
3.1%
1/32 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
|
Nervous system disorders
Peripheral Sensory Neuropathy
|
61.3%
19/31 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
40.6%
13/32 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
|
Nervous system disorders
Peripheral Motor Neuropathy
|
3.2%
1/31 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
3.1%
1/32 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
|
Nervous system disorders
Paresthesia
|
3.2%
1/31 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
0.00%
0/32 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
|
Nervous system disorders
Memory Impairment
|
9.7%
3/31 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
0.00%
0/32 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
|
Nervous system disorders
Headache
|
22.6%
7/31 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
37.5%
12/32 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
|
Nervous system disorders
Dizziness
|
9.7%
3/31 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
18.8%
6/32 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
|
Nervous system disorders
Cognitive Disturbance
|
0.00%
0/31 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
3.1%
1/32 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
|
Psychiatric disorders
Restlessness
|
3.2%
1/31 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
0.00%
0/32 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
|
Psychiatric disorders
Insomnia
|
25.8%
8/31 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
18.8%
6/32 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
|
Psychiatric disorders
Depression
|
12.9%
4/31 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
21.9%
7/32 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
|
Psychiatric disorders
Confusion
|
3.2%
1/31 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
3.1%
1/32 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
|
Psychiatric disorders
Anxiety
|
16.1%
5/31 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
18.8%
6/32 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
|
Renal and urinary disorders
Urinary Urgency
|
0.00%
0/31 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
3.1%
1/32 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
|
Renal and urinary disorders
Urinary Incontinence
|
3.2%
1/31 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
3.1%
1/32 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
|
Renal and urinary disorders
Urinary Tract Pain
|
3.2%
1/31 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
12.5%
4/32 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
|
Renal and urinary disorders
Urinary Frequency
|
6.5%
2/31 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
3.1%
1/32 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/31 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
3.1%
1/32 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
|
Renal and urinary disorders
Cystitis Noninfective
|
0.00%
0/31 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
3.1%
1/32 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
|
Renal and urinary disorders
Acute Kidney Injury
|
0.00%
0/31 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
6.2%
2/32 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
|
Reproductive system and breast disorders
Vaginal Hemorrhage
|
3.2%
1/31 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
9.4%
3/32 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
|
Reproductive system and breast disorders
Vaginal Dryness
|
0.00%
0/31 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
3.1%
1/32 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
|
Reproductive system and breast disorders
Pelvic Pain
|
6.5%
2/31 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
0.00%
0/32 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
|
Reproductive system and breast disorders
Vaginal Discharge
|
9.7%
3/31 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
3.1%
1/32 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
|
Reproductive system and breast disorders
Dyspareunia
|
0.00%
0/31 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
3.1%
1/32 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, Thoracic And Mediastinal Disorders - Other
|
3.2%
1/31 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
3.1%
1/32 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
|
Respiratory, thoracic and mediastinal disorders
Sore Throat
|
3.2%
1/31 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
3.1%
1/32 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
0.00%
0/31 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
3.1%
1/32 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal Drip
|
3.2%
1/31 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
3.1%
1/32 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
0.00%
0/31 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
3.1%
1/32 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
16.1%
5/31 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
6.2%
2/32 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic Pain
|
0.00%
0/31 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
3.1%
1/32 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal Inflammation
|
3.2%
1/31 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
0.00%
0/32 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
0.00%
0/31 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
3.1%
1/32 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
3.2%
1/31 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
0.00%
0/32 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
3.2%
1/31 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
0.00%
0/32 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
22.6%
7/31 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
28.1%
9/32 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
25.8%
8/31 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
15.6%
5/32 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
|
Respiratory, thoracic and mediastinal disorders
Allergic Rhinitis
|
0.00%
0/31 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
6.2%
2/32 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
|
Skin and subcutaneous tissue disorders
Skin And Subcutaneous Tissue Disorders - Other
|
6.5%
2/31 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
0.00%
0/32 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
|
Skin and subcutaneous tissue disorders
Skin Hyperpigmentation
|
0.00%
0/31 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
9.4%
3/32 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
|
Skin and subcutaneous tissue disorders
Scalp Pain
|
3.2%
1/31 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
3.1%
1/32 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
|
Skin and subcutaneous tissue disorders
Rash Acneiform
|
3.2%
1/31 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
6.2%
2/32 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
3.2%
1/31 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
6.2%
2/32 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
|
Skin and subcutaneous tissue disorders
Rash Maculo-Papular
|
3.2%
1/31 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
9.4%
3/32 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
|
Skin and subcutaneous tissue disorders
Nail Discoloration
|
0.00%
0/31 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
6.2%
2/32 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
3.2%
1/31 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
6.2%
2/32 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
80.6%
25/31 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
59.4%
19/32 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
|
Vascular disorders
Thromboembolic Event
|
0.00%
0/31 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
6.2%
2/32 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
|
Vascular disorders
Phlebitis
|
3.2%
1/31 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
0.00%
0/32 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
|
Vascular disorders
Hypotension
|
9.7%
3/31 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
0.00%
0/32 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
|
Vascular disorders
Hypertension
|
19.4%
6/31 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
15.6%
5/32 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
|
Vascular disorders
Hot Flashes
|
25.8%
8/31 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
18.8%
6/32 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
|
Vascular disorders
Hematoma
|
3.2%
1/31 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
0.00%
0/32 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
|
Vascular disorders
Flushing
|
9.7%
3/31 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
0.00%
0/32 • The adverse events were assessed during the treatment period and up to 100 days after stopping study treatment (an average of 33 months).
|
Additional Information
Christopher Purdy on behalf of Austin Miller PhD
NRG Oncology
Phone: (716) 845-1300
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60