Trial Outcomes & Findings for Gemcitabine Hydrochloride and Docetaxel With or Without Bevacizumab in Treating Patients With Advanced or Recurrent Uterine Leiomyosarcoma (NCT NCT01012297)
NCT ID: NCT01012297
Last Updated: 2020-09-02
Results Overview
Progression free survival (PFS) was defined as the number of months between study enrollment and documentation of disease progression (RECIST 1.1) or death from any cause. Patients still alive and disease free at the last followup were censored on the date of last CT Scan. Assessed with a log-rank test stratified by whether the patient had whole pelvic radiotherapy prior to starting the study treatment. The product-limit method will be used to estimate the cumulative distribution of PFS for the patients assigned to each treatment group.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
107 participants
Primary outcome timeframe
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months
Results posted on
2020-09-02
Participant Flow
Participant milestones
| Measure |
Arm I Gem+Doce+Placebo
Patients receive a placebo IV over 30-90 minutes on day 1, gemcitabine hydrochloride IV over 90 minutes on days 1 and 8, and docetaxel IV over 60 minutes on day 8. Patients also receive filgrastim subcutaneously (SC) on days 9-15 or pegfilgrastim SC on day 9 or 10.
Docetaxel: Given IV
Filgrastim: Given SC
Gemcitabine Hydrochloride: Given IV
Pegfilgrastim: Given SC
Placebo: Given IV
|
Arm II Gem+Doce+Bev
Patients receive bevacizumab IV over 30-90 minutes on day 1, gemcitabine hydrochloride IV over 90 minutes on days 1 and 8, and docetaxel IV over 60 minutes on day 8. Patients also receive filgrastim SC on days 9-15 or pegfilgrastim SC on day 9 or 10.
Bevacizumab: Given IV
Docetaxel: Given IV
Filgrastim: Given SC
Gemcitabine Hydrochloride: Given IV
Pegfilgrastim: Given SC
|
|---|---|---|
|
Overall Study
STARTED
|
54
|
53
|
|
Overall Study
COMPLETED
|
54
|
53
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Gemcitabine Hydrochloride and Docetaxel With or Without Bevacizumab in Treating Patients With Advanced or Recurrent Uterine Leiomyosarcoma
Baseline characteristics by cohort
| Measure |
Arm I Gem+Doce+Placebo
n=54 Participants
Patients receive a placebo IV over 30-90 minutes on day 1, gemcitabine hydrochloride IV over 90 minutes on days 1 and 8, and docetaxel IV over 60 minutes on day 8. Patients also receive filgrastim subcutaneously (SC) on days 9-15 or pegfilgrastim SC on day 9 or 10.
Docetaxel: Given IV
Filgrastim: Given SC
Gemcitabine Hydrochloride: Given IV
Pegfilgrastim: Given SC
Placebo: Given IV
|
Arm II Gem+Doce+Bev
n=53 Participants
Patients receive bevacizumab IV over 30-90 minutes on day 1, gemcitabine hydrochloride IV over 90 minutes on days 1 and 8, and docetaxel IV over 60 minutes on day 8. Patients also receive filgrastim SC on days 9-15 or pegfilgrastim SC on day 9 or 10.
Bevacizumab: Given IV
Docetaxel: Given IV
Filgrastim: Given SC
Gemcitabine Hydrochloride: Given IV
Pegfilgrastim: Given SC
|
Total
n=107 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
57.5 years
STANDARD_DEVIATION 8.1 • n=99 Participants
|
54.0 years
STANDARD_DEVIATION 8.7 • n=107 Participants
|
55.7 years
STANDARD_DEVIATION 8.6 • n=206 Participants
|
|
Age, Customized
Age Groups · 20-29 years
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Age, Customized
Age Groups · 30-39 years
|
0 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Age, Customized
Age Groups · 40-49 years
|
11 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
23 Participants
n=206 Participants
|
|
Age, Customized
Age Groups · 50-59 years
|
24 Participants
n=99 Participants
|
25 Participants
n=107 Participants
|
49 Participants
n=206 Participants
|
|
Age, Customized
Age Groups · 60-69 years
|
19 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
31 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
54 Participants
n=99 Participants
|
53 Participants
n=107 Participants
|
107 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
48 Participants
n=99 Participants
|
43 Participants
n=107 Participants
|
91 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
18 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
46 Participants
n=99 Participants
|
36 Participants
n=107 Participants
|
82 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Prior whole pelvic radiation
Yes
|
11 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
22 Participants
n=206 Participants
|
|
Prior whole pelvic radiation
No
|
43 Participants
n=99 Participants
|
42 Participants
n=107 Participants
|
85 Participants
n=206 Participants
|
|
Performance Status
0: Asymptomatic
|
38 Participants
n=99 Participants
|
41 Participants
n=107 Participants
|
79 Participants
n=206 Participants
|
|
Performance Status
1: Symptomatic, fully ambulatory
|
15 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
26 Participants
n=206 Participants
|
|
Performance Status
2: Symptomatic, in bed < 50% of time
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
FIGO Stage
1
|
20 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
31 Participants
n=206 Participants
|
|
FIGO Stage
2
|
4 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
FIGO Stage
3
|
3 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
FIGO Stage
4
|
22 Participants
n=99 Participants
|
30 Participants
n=107 Participants
|
52 Participants
n=206 Participants
|
|
FIGO Stage
unknown
|
5 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
|
Cell Type
Leiomyosarcoma
|
52 Participants
n=99 Participants
|
52 Participants
n=107 Participants
|
104 Participants
n=206 Participants
|
|
Cell Type
Sarcoma, Unsp.
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Cell Type
Carcinsarcoma
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Cell Type
Unknown
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 monthsPopulation: All randomized
Progression free survival (PFS) was defined as the number of months between study enrollment and documentation of disease progression (RECIST 1.1) or death from any cause. Patients still alive and disease free at the last followup were censored on the date of last CT Scan. Assessed with a log-rank test stratified by whether the patient had whole pelvic radiotherapy prior to starting the study treatment. The product-limit method will be used to estimate the cumulative distribution of PFS for the patients assigned to each treatment group.
Outcome measures
| Measure |
Arm I Gem+Doce+Placebo
n=54 Participants
Patients receive a placebo IV over 30-90 minutes on day 1, gemcitabine hydrochloride IV over 90 minutes on days 1 and 8, and docetaxel IV over 60 minutes on day 8. Patients also receive filgrastim subcutaneously (SC) on days 9-15 or pegfilgrastim SC on day 9 or 10.
Docetaxel: Given IV
Filgrastim: Given SC
Gemcitabine Hydrochloride: Given IV
Pegfilgrastim: Given SC
Placebo: Given IV
|
Arm II Gem+Doce+Bev
n=53 Participants
Patients receive bevacizumab IV over 30-90 minutes on day 1, gemcitabine hydrochloride IV over 90 minutes on days 1 and 8, and docetaxel IV over 60 minutes on day 8. Patients also receive filgrastim SC on days 9-15 or pegfilgrastim SC on day 9 or 10.
Bevacizumab: Given IV
Docetaxel: Given IV
Filgrastim: Given SC
Gemcitabine Hydrochloride: Given IV
Pegfilgrastim: Given SC
|
|---|---|---|
|
Progression-free Survival
|
6.2 months
Interval 2.9 to 9.9
|
4.2 months
Interval 3.1 to 8.4
|
SECONDARY outcome
Timeframe: Up to 5 yearsPopulation: All randomized
Overall survival (OS) was defined as the number of months between study enrollment and death from any cause. Patients still alive at the last followup were censored on the date of last CT Scan. The product-limit method will be used to estimate the cumulative distribution of overall survival times for the patients assigned to each treatment group.
Outcome measures
| Measure |
Arm I Gem+Doce+Placebo
n=54 Participants
Patients receive a placebo IV over 30-90 minutes on day 1, gemcitabine hydrochloride IV over 90 minutes on days 1 and 8, and docetaxel IV over 60 minutes on day 8. Patients also receive filgrastim subcutaneously (SC) on days 9-15 or pegfilgrastim SC on day 9 or 10.
Docetaxel: Given IV
Filgrastim: Given SC
Gemcitabine Hydrochloride: Given IV
Pegfilgrastim: Given SC
Placebo: Given IV
|
Arm II Gem+Doce+Bev
n=53 Participants
Patients receive bevacizumab IV over 30-90 minutes on day 1, gemcitabine hydrochloride IV over 90 minutes on days 1 and 8, and docetaxel IV over 60 minutes on day 8. Patients also receive filgrastim SC on days 9-15 or pegfilgrastim SC on day 9 or 10.
Bevacizumab: Given IV
Docetaxel: Given IV
Filgrastim: Given SC
Gemcitabine Hydrochloride: Given IV
Pegfilgrastim: Given SC
|
|---|---|---|
|
Overall Survival
|
26.9 months
Interval 15.9 to 32.1
|
23.3 months
Interval 16.6 to 27.3
|
SECONDARY outcome
Timeframe: Up to 5 yearsPopulation: All randomized.
Count of participants with Adverse events (AEs) that are CTCAE Grade 3 or worse. Please refer to the adverse event reporting for more detail.
Outcome measures
| Measure |
Arm I Gem+Doce+Placebo
n=54 Participants
Patients receive a placebo IV over 30-90 minutes on day 1, gemcitabine hydrochloride IV over 90 minutes on days 1 and 8, and docetaxel IV over 60 minutes on day 8. Patients also receive filgrastim subcutaneously (SC) on days 9-15 or pegfilgrastim SC on day 9 or 10.
Docetaxel: Given IV
Filgrastim: Given SC
Gemcitabine Hydrochloride: Given IV
Pegfilgrastim: Given SC
Placebo: Given IV
|
Arm II Gem+Doce+Bev
n=53 Participants
Patients receive bevacizumab IV over 30-90 minutes on day 1, gemcitabine hydrochloride IV over 90 minutes on days 1 and 8, and docetaxel IV over 60 minutes on day 8. Patients also receive filgrastim SC on days 9-15 or pegfilgrastim SC on day 9 or 10.
Bevacizumab: Given IV
Docetaxel: Given IV
Filgrastim: Given SC
Gemcitabine Hydrochloride: Given IV
Pegfilgrastim: Given SC
|
|---|---|---|
|
Frequency and Severity of Adverse Effects as Assessed by the CTCAE Version 4.0
|
36 Participants
|
46 Participants
|
SECONDARY outcome
Timeframe: Up to 5 yearsPopulation: All randomized
"Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Outcome measures
| Measure |
Arm I Gem+Doce+Placebo
n=54 Participants
Patients receive a placebo IV over 30-90 minutes on day 1, gemcitabine hydrochloride IV over 90 minutes on days 1 and 8, and docetaxel IV over 60 minutes on day 8. Patients also receive filgrastim subcutaneously (SC) on days 9-15 or pegfilgrastim SC on day 9 or 10.
Docetaxel: Given IV
Filgrastim: Given SC
Gemcitabine Hydrochloride: Given IV
Pegfilgrastim: Given SC
Placebo: Given IV
|
Arm II Gem+Doce+Bev
n=53 Participants
Patients receive bevacizumab IV over 30-90 minutes on day 1, gemcitabine hydrochloride IV over 90 minutes on days 1 and 8, and docetaxel IV over 60 minutes on day 8. Patients also receive filgrastim SC on days 9-15 or pegfilgrastim SC on day 9 or 10.
Bevacizumab: Given IV
Docetaxel: Given IV
Filgrastim: Given SC
Gemcitabine Hydrochloride: Given IV
Pegfilgrastim: Given SC
|
|---|---|---|
|
Objective Response Rate as Measured by RECIST 1.1 Criteria
|
31.5 percentage of participants
Interval 21.2 to 43.4
|
35.8 percentage of participants
Interval 24.9 to 48.0
|
Adverse Events
Arm I
Serious events: 17 serious events
Other events: 51 other events
Deaths: 0 deaths
Arm II
Serious events: 21 serious events
Other events: 51 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm I
n=54 participants at risk
Patients receive a placebo IV over 30-90 minutes on day 1, gemcitabine hydrochloride IV over 90 minutes on days 1 and 8, and docetaxel IV over 60 minutes on day 8. Patients also receive filgrastim subcutaneously (SC) on days 9-15 or pegfilgrastim SC on day 9 or 10.
Docetaxel: Given IV
Filgrastim: Given SC
Gemcitabine Hydrochloride: Given IV
Pegfilgrastim: Given SC
Placebo: Given IV
|
Arm II
n=53 participants at risk
Patients receive bevacizumab IV over 30-90 minutes on day 1, gemcitabine hydrochloride IV over 90 minutes on days 1 and 8, and docetaxel IV over 60 minutes on day 8. Patients also receive filgrastim SC on days 9-15 or pegfilgrastim SC on day 9 or 10.
Bevacizumab: Given IV
Docetaxel: Given IV
Filgrastim: Given SC
Gemcitabine Hydrochloride: Given IV
Pegfilgrastim: Given SC
|
|---|---|---|
|
Cardiac disorders
Pericardial Effusion
|
0.00%
0/54
|
1.9%
1/53
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/54
|
1.9%
1/53
|
|
Gastrointestinal disorders
Small Intestinal Obstruction
|
1.9%
1/54
|
3.8%
2/53
|
|
Gastrointestinal disorders
Abdominal Pain
|
1.9%
1/54
|
3.8%
2/53
|
|
General disorders
Fatigue
|
3.7%
2/54
|
0.00%
0/53
|
|
Immune system disorders
Anaphylaxis
|
0.00%
0/54
|
1.9%
1/53
|
|
Immune system disorders
Allergic Reaction
|
1.9%
1/54
|
0.00%
0/53
|
|
Infections and infestations
Infections And Infestations - Other
|
0.00%
0/54
|
3.8%
2/53
|
|
Infections and infestations
Soft Tissue Infection
|
1.9%
1/54
|
0.00%
0/53
|
|
Infections and infestations
Skin Infection
|
1.9%
1/54
|
0.00%
0/53
|
|
Infections and infestations
Sepsis
|
1.9%
1/54
|
0.00%
0/53
|
|
Infections and infestations
Lung Infection
|
5.6%
3/54
|
3.8%
2/53
|
|
Infections and infestations
Catheter Related Infection
|
1.9%
1/54
|
3.8%
2/53
|
|
Infections and infestations
Abdominal Infection
|
1.9%
1/54
|
0.00%
0/53
|
|
Injury, poisoning and procedural complications
Spinal Fracture
|
0.00%
0/54
|
1.9%
1/53
|
|
Injury, poisoning and procedural complications
Hip Fracture
|
1.9%
1/54
|
0.00%
0/53
|
|
Injury, poisoning and procedural complications
Fracture
|
1.9%
1/54
|
0.00%
0/53
|
|
Investigations
Platelet Count Decreased
|
1.9%
1/54
|
5.7%
3/53
|
|
Investigations
Lymphocyte Count Decreased
|
0.00%
0/54
|
1.9%
1/53
|
|
Investigations
Neutrophil Count Decreased
|
0.00%
0/54
|
1.9%
1/53
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
1.9%
1/54
|
0.00%
0/53
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
3.7%
2/54
|
1.9%
1/53
|
|
Metabolism and nutrition disorders
Dehydration
|
3.7%
2/54
|
1.9%
1/53
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
1.9%
1/54
|
0.00%
0/53
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/54
|
1.9%
1/53
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/54
|
1.9%
1/53
|
|
Vascular disorders
Thromboembolic Event
|
3.7%
2/54
|
5.7%
3/53
|
Other adverse events
| Measure |
Arm I
n=54 participants at risk
Patients receive a placebo IV over 30-90 minutes on day 1, gemcitabine hydrochloride IV over 90 minutes on days 1 and 8, and docetaxel IV over 60 minutes on day 8. Patients also receive filgrastim subcutaneously (SC) on days 9-15 or pegfilgrastim SC on day 9 or 10.
Docetaxel: Given IV
Filgrastim: Given SC
Gemcitabine Hydrochloride: Given IV
Pegfilgrastim: Given SC
Placebo: Given IV
|
Arm II
n=53 participants at risk
Patients receive bevacizumab IV over 30-90 minutes on day 1, gemcitabine hydrochloride IV over 90 minutes on days 1 and 8, and docetaxel IV over 60 minutes on day 8. Patients also receive filgrastim SC on days 9-15 or pegfilgrastim SC on day 9 or 10.
Bevacizumab: Given IV
Docetaxel: Given IV
Filgrastim: Given SC
Gemcitabine Hydrochloride: Given IV
Pegfilgrastim: Given SC
|
|---|---|---|
|
Blood and lymphatic system disorders
Thrombotic Thrombocytopenic Purpura
|
0.00%
0/54
|
1.9%
1/53
|
|
Blood and lymphatic system disorders
Blood And Lymphatic System Disorders - Other
|
1.9%
1/54
|
3.8%
2/53
|
|
Blood and lymphatic system disorders
Anemia
|
87.0%
47/54
|
90.6%
48/53
|
|
Cardiac disorders
Palpitations
|
3.7%
2/54
|
5.7%
3/53
|
|
Cardiac disorders
Pericardial Effusion
|
1.9%
1/54
|
1.9%
1/53
|
|
Cardiac disorders
Sinus Tachycardia
|
5.6%
3/54
|
9.4%
5/53
|
|
Cardiac disorders
Chest Pain - Cardiac
|
1.9%
1/54
|
0.00%
0/53
|
|
Ear and labyrinth disorders
Vertigo
|
1.9%
1/54
|
1.9%
1/53
|
|
Ear and labyrinth disorders
Tinnitus
|
3.7%
2/54
|
1.9%
1/53
|
|
Ear and labyrinth disorders
Hearing Impaired
|
0.00%
0/54
|
1.9%
1/53
|
|
Ear and labyrinth disorders
Ear Pain
|
1.9%
1/54
|
7.5%
4/53
|
|
Eye disorders
Eye Disorders - Other
|
1.9%
1/54
|
3.8%
2/53
|
|
Eye disorders
Watering Eyes
|
1.9%
1/54
|
17.0%
9/53
|
|
Eye disorders
Eye Pain
|
0.00%
0/54
|
1.9%
1/53
|
|
Eye disorders
Conjunctivitis
|
1.9%
1/54
|
1.9%
1/53
|
|
Eye disorders
Blurred Vision
|
11.1%
6/54
|
7.5%
4/53
|
|
Eye disorders
Dry Eye
|
1.9%
1/54
|
3.8%
2/53
|
|
Gastrointestinal disorders
Dysphagia
|
5.6%
3/54
|
5.7%
3/53
|
|
Gastrointestinal disorders
Dyspepsia
|
11.1%
6/54
|
5.7%
3/53
|
|
Gastrointestinal disorders
Dry Mouth
|
1.9%
1/54
|
9.4%
5/53
|
|
Gastrointestinal disorders
Colitis
|
1.9%
1/54
|
0.00%
0/53
|
|
Gastrointestinal disorders
Constipation
|
44.4%
24/54
|
49.1%
26/53
|
|
Gastrointestinal disorders
Diarrhea
|
35.2%
19/54
|
41.5%
22/53
|
|
Gastrointestinal disorders
Vomiting
|
25.9%
14/54
|
30.2%
16/53
|
|
Gastrointestinal disorders
Bloating
|
1.9%
1/54
|
5.7%
3/53
|
|
Gastrointestinal disorders
Stomach Pain
|
1.9%
1/54
|
1.9%
1/53
|
|
Gastrointestinal disorders
Small Intestinal Obstruction
|
0.00%
0/54
|
3.8%
2/53
|
|
Gastrointestinal disorders
Anal Hemorrhage
|
1.9%
1/54
|
3.8%
2/53
|
|
Gastrointestinal disorders
Rectal Fistula
|
0.00%
0/54
|
1.9%
1/53
|
|
Gastrointestinal disorders
Rectal Mucositis
|
1.9%
1/54
|
0.00%
0/53
|
|
Gastrointestinal disorders
Abdominal Pain
|
29.6%
16/54
|
28.3%
15/53
|
|
Gastrointestinal disorders
Rectal Hemorrhage
|
9.3%
5/54
|
3.8%
2/53
|
|
Gastrointestinal disorders
Oral Dysesthesia
|
3.7%
2/54
|
1.9%
1/53
|
|
Gastrointestinal disorders
Mucositis Oral
|
25.9%
14/54
|
28.3%
15/53
|
|
Gastrointestinal disorders
Gastrointestinal Disorders - Other
|
1.9%
1/54
|
5.7%
3/53
|
|
Gastrointestinal disorders
Oral Hemorrhage
|
0.00%
0/54
|
7.5%
4/53
|
|
Gastrointestinal disorders
Gastrointestinal Pain
|
1.9%
1/54
|
1.9%
1/53
|
|
Gastrointestinal disorders
Gingival Pain
|
1.9%
1/54
|
1.9%
1/53
|
|
Gastrointestinal disorders
Oral Pain
|
3.7%
2/54
|
5.7%
3/53
|
|
Gastrointestinal disorders
Abdominal Distension
|
9.3%
5/54
|
1.9%
1/53
|
|
Gastrointestinal disorders
Nausea
|
64.8%
35/54
|
54.7%
29/53
|
|
Gastrointestinal disorders
Gastroesophageal Reflux Disease
|
3.7%
2/54
|
11.3%
6/53
|
|
Gastrointestinal disorders
Rectal Pain
|
0.00%
0/54
|
1.9%
1/53
|
|
Gastrointestinal disorders
Esophagitis
|
1.9%
1/54
|
0.00%
0/53
|
|
Gastrointestinal disorders
Hemorrhoidal Hemorrhage
|
5.6%
3/54
|
5.7%
3/53
|
|
Gastrointestinal disorders
Hemorrhoids
|
1.9%
1/54
|
1.9%
1/53
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/54
|
1.9%
1/53
|
|
Gastrointestinal disorders
Toothache
|
1.9%
1/54
|
0.00%
0/53
|
|
Gastrointestinal disorders
Esophageal Pain
|
1.9%
1/54
|
1.9%
1/53
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/54
|
1.9%
1/53
|
|
General disorders
General Disorders And Administration Site Conditio
|
3.7%
2/54
|
0.00%
0/53
|
|
General disorders
Pain
|
24.1%
13/54
|
17.0%
9/53
|
|
General disorders
Localized Edema
|
0.00%
0/54
|
1.9%
1/53
|
|
General disorders
Injection Site Reaction
|
3.7%
2/54
|
3.8%
2/53
|
|
General disorders
Infusion Site Extravasation
|
1.9%
1/54
|
0.00%
0/53
|
|
General disorders
Flu Like Symptoms
|
3.7%
2/54
|
3.8%
2/53
|
|
General disorders
Edema Trunk
|
3.7%
2/54
|
0.00%
0/53
|
|
General disorders
Non-Cardiac Chest Pain
|
7.4%
4/54
|
5.7%
3/53
|
|
General disorders
Edema Limbs
|
42.6%
23/54
|
22.6%
12/53
|
|
General disorders
Edema Face
|
7.4%
4/54
|
5.7%
3/53
|
|
General disorders
Fatigue
|
83.3%
45/54
|
79.2%
42/53
|
|
General disorders
Fever
|
31.5%
17/54
|
35.8%
19/53
|
|
General disorders
Chills
|
5.6%
3/54
|
5.7%
3/53
|
|
General disorders
Infusion Related Reaction
|
3.7%
2/54
|
1.9%
1/53
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/54
|
1.9%
1/53
|
|
Immune system disorders
Allergic Reaction
|
13.0%
7/54
|
1.9%
1/53
|
|
Immune system disorders
Cytokine Release Syndrome
|
1.9%
1/54
|
0.00%
0/53
|
|
Infections and infestations
Infections And Infestations - Other
|
3.7%
2/54
|
1.9%
1/53
|
|
Infections and infestations
Upper Respiratory Infection
|
3.7%
2/54
|
1.9%
1/53
|
|
Infections and infestations
Tooth Infection
|
1.9%
1/54
|
5.7%
3/53
|
|
Infections and infestations
Skin Infection
|
3.7%
2/54
|
0.00%
0/53
|
|
Infections and infestations
Sinusitis
|
3.7%
2/54
|
1.9%
1/53
|
|
Infections and infestations
Papulopustular Rash
|
1.9%
1/54
|
0.00%
0/53
|
|
Infections and infestations
Nail Infection
|
1.9%
1/54
|
5.7%
3/53
|
|
Infections and infestations
Mucosal Infection
|
5.6%
3/54
|
1.9%
1/53
|
|
Infections and infestations
Pelvic Infection
|
0.00%
0/54
|
1.9%
1/53
|
|
Infections and infestations
Lung Infection
|
3.7%
2/54
|
3.8%
2/53
|
|
Infections and infestations
Eye Infection
|
0.00%
0/54
|
1.9%
1/53
|
|
Infections and infestations
Device Related Infection
|
3.7%
2/54
|
1.9%
1/53
|
|
Infections and infestations
Vaginal Infection
|
1.9%
1/54
|
0.00%
0/53
|
|
Infections and infestations
Urinary Tract Infection
|
14.8%
8/54
|
13.2%
7/53
|
|
Infections and infestations
Catheter Related Infection
|
0.00%
0/54
|
3.8%
2/53
|
|
Infections and infestations
Bronchial Infection
|
1.9%
1/54
|
0.00%
0/53
|
|
Infections and infestations
Enterocolitis Infectious
|
1.9%
1/54
|
0.00%
0/53
|
|
Infections and infestations
Bladder Infection
|
0.00%
0/54
|
1.9%
1/53
|
|
Infections and infestations
Lip Infection
|
1.9%
1/54
|
0.00%
0/53
|
|
Infections and infestations
Anorectal Infection
|
0.00%
0/54
|
1.9%
1/53
|
|
Injury, poisoning and procedural complications
Injury, Poisoning And Procedural Complications - O
|
1.9%
1/54
|
0.00%
0/53
|
|
Injury, poisoning and procedural complications
Vascular Access Complication
|
0.00%
0/54
|
1.9%
1/53
|
|
Injury, poisoning and procedural complications
Tracheostomy Site Bleeding
|
1.9%
1/54
|
0.00%
0/53
|
|
Injury, poisoning and procedural complications
Fall
|
1.9%
1/54
|
0.00%
0/53
|
|
Injury, poisoning and procedural complications
Bruising
|
3.7%
2/54
|
7.5%
4/53
|
|
Injury, poisoning and procedural complications
Ankle Fracture
|
1.9%
1/54
|
0.00%
0/53
|
|
Investigations
Investigations - Other
|
3.7%
2/54
|
0.00%
0/53
|
|
Investigations
Weight Loss
|
7.4%
4/54
|
11.3%
6/53
|
|
Investigations
Weight Gain
|
7.4%
4/54
|
9.4%
5/53
|
|
Investigations
Platelet Count Decreased
|
72.2%
39/54
|
84.9%
45/53
|
|
Investigations
Lymphocyte Count Decreased
|
3.7%
2/54
|
9.4%
5/53
|
|
Investigations
Inr Increased
|
3.7%
2/54
|
0.00%
0/53
|
|
Investigations
Creatinine Increased
|
3.7%
2/54
|
5.7%
3/53
|
|
Investigations
Neutrophil Count Decreased
|
48.1%
26/54
|
47.2%
25/53
|
|
Investigations
Blood Bilirubin Increased
|
3.7%
2/54
|
1.9%
1/53
|
|
Investigations
White Blood Cell Decreased
|
51.9%
28/54
|
62.3%
33/53
|
|
Investigations
Aspartate Aminotransferase Increased
|
16.7%
9/54
|
18.9%
10/53
|
|
Investigations
Alkaline Phosphatase Increased
|
29.6%
16/54
|
32.1%
17/53
|
|
Investigations
Alanine Aminotransferase Increased
|
25.9%
14/54
|
18.9%
10/53
|
|
Investigations
Activated Partial Thromboplastin Time Prolonged
|
3.7%
2/54
|
1.9%
1/53
|
|
Metabolism and nutrition disorders
Metabolism And Nutrition Disorders - Other
|
3.7%
2/54
|
1.9%
1/53
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
1.9%
1/54
|
3.8%
2/53
|
|
Metabolism and nutrition disorders
Hyponatremia
|
14.8%
8/54
|
9.4%
5/53
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
11.1%
6/54
|
7.5%
4/53
|
|
Metabolism and nutrition disorders
Hypokalemia
|
14.8%
8/54
|
15.1%
8/53
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
1.9%
1/54
|
1.9%
1/53
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
22.2%
12/54
|
15.1%
8/53
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
25.9%
14/54
|
17.0%
9/53
|
|
Metabolism and nutrition disorders
Hypernatremia
|
1.9%
1/54
|
1.9%
1/53
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
3.7%
2/54
|
1.9%
1/53
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
3.7%
2/54
|
5.7%
3/53
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
25.9%
14/54
|
13.2%
7/53
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
0.00%
0/54
|
9.4%
5/53
|
|
Metabolism and nutrition disorders
Dehydration
|
5.6%
3/54
|
3.8%
2/53
|
|
Metabolism and nutrition disorders
Anorexia
|
38.9%
21/54
|
35.8%
19/53
|
|
Musculoskeletal and connective tissue disorders
Pain In Extremity
|
24.1%
13/54
|
22.6%
12/53
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
3.7%
2/54
|
1.9%
1/53
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
20.4%
11/54
|
37.7%
20/53
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Deformity
|
0.00%
0/54
|
1.9%
1/53
|
|
Musculoskeletal and connective tissue disorders
Muscle Weakness Upper Limb
|
0.00%
0/54
|
1.9%
1/53
|
|
Musculoskeletal and connective tissue disorders
Muscle Weakness Lower Limb
|
3.7%
2/54
|
3.8%
2/53
|
|
Musculoskeletal and connective tissue disorders
Joint Range Of Motion Decreased
|
0.00%
0/54
|
1.9%
1/53
|
|
Musculoskeletal and connective tissue disorders
Generalized Muscle Weakness
|
9.3%
5/54
|
5.7%
3/53
|
|
Musculoskeletal and connective tissue disorders
Flank Pain
|
3.7%
2/54
|
0.00%
0/53
|
|
Musculoskeletal and connective tissue disorders
Chest Wall Pain
|
1.9%
1/54
|
7.5%
4/53
|
|
Musculoskeletal and connective tissue disorders
Buttock Pain
|
0.00%
0/54
|
3.8%
2/53
|
|
Musculoskeletal and connective tissue disorders
Bone Pain
|
24.1%
13/54
|
20.8%
11/53
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
16.7%
9/54
|
17.0%
9/53
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
1.9%
1/54
|
0.00%
0/53
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
18.5%
10/54
|
17.0%
9/53
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal And Connective Tissue Disorder -
|
1.9%
1/54
|
1.9%
1/53
|
|
Nervous system disorders
Tremor
|
1.9%
1/54
|
0.00%
0/53
|
|
Nervous system disorders
Spasticity
|
0.00%
0/54
|
1.9%
1/53
|
|
Nervous system disorders
Seizure
|
1.9%
1/54
|
0.00%
0/53
|
|
Nervous system disorders
Peripheral Sensory Neuropathy
|
38.9%
21/54
|
35.8%
19/53
|
|
Nervous system disorders
Peripheral Motor Neuropathy
|
5.6%
3/54
|
5.7%
3/53
|
|
Nervous system disorders
Paresthesia
|
3.7%
2/54
|
5.7%
3/53
|
|
Nervous system disorders
Memory Impairment
|
1.9%
1/54
|
0.00%
0/53
|
|
Nervous system disorders
Lethargy
|
1.9%
1/54
|
0.00%
0/53
|
|
Nervous system disorders
Headache
|
31.5%
17/54
|
26.4%
14/53
|
|
Nervous system disorders
Dysgeusia
|
11.1%
6/54
|
15.1%
8/53
|
|
Nervous system disorders
Sinus Pain
|
0.00%
0/54
|
1.9%
1/53
|
|
Nervous system disorders
Syncope
|
1.9%
1/54
|
0.00%
0/53
|
|
Nervous system disorders
Dizziness
|
16.7%
9/54
|
13.2%
7/53
|
|
Nervous system disorders
Ataxia
|
1.9%
1/54
|
1.9%
1/53
|
|
Psychiatric disorders
Restlessness
|
0.00%
0/54
|
1.9%
1/53
|
|
Psychiatric disorders
Insomnia
|
20.4%
11/54
|
18.9%
10/53
|
|
Psychiatric disorders
Depression
|
9.3%
5/54
|
13.2%
7/53
|
|
Psychiatric disorders
Anxiety
|
18.5%
10/54
|
17.0%
9/53
|
|
Renal and urinary disorders
Renal And Urinary Disorders - Other
|
3.7%
2/54
|
0.00%
0/53
|
|
Renal and urinary disorders
Urinary Retention
|
3.7%
2/54
|
0.00%
0/53
|
|
Renal and urinary disorders
Urinary Incontinence
|
0.00%
0/54
|
7.5%
4/53
|
|
Renal and urinary disorders
Urinary Tract Pain
|
3.7%
2/54
|
1.9%
1/53
|
|
Renal and urinary disorders
Urinary Frequency
|
0.00%
0/54
|
3.8%
2/53
|
|
Renal and urinary disorders
Proteinuria
|
3.7%
2/54
|
1.9%
1/53
|
|
Renal and urinary disorders
Hemoglobinuria
|
1.9%
1/54
|
0.00%
0/53
|
|
Renal and urinary disorders
Hematuria
|
3.7%
2/54
|
3.8%
2/53
|
|
Renal and urinary disorders
Cystitis Noninfective
|
1.9%
1/54
|
0.00%
0/53
|
|
Renal and urinary disorders
Bladder Spasm
|
0.00%
0/54
|
1.9%
1/53
|
|
Reproductive system and breast disorders
Reproductive System And Breast Disorders - Other
|
0.00%
0/54
|
1.9%
1/53
|
|
Reproductive system and breast disorders
Vaginal Pain
|
0.00%
0/54
|
1.9%
1/53
|
|
Reproductive system and breast disorders
Vaginal Hemorrhage
|
0.00%
0/54
|
1.9%
1/53
|
|
Reproductive system and breast disorders
Pelvic Pain
|
3.7%
2/54
|
1.9%
1/53
|
|
Reproductive system and breast disorders
Vaginal Discharge
|
0.00%
0/54
|
5.7%
3/53
|
|
Reproductive system and breast disorders
Breast Pain
|
1.9%
1/54
|
0.00%
0/53
|
|
Respiratory, thoracic and mediastinal disorders
Sore Throat
|
11.1%
6/54
|
17.0%
9/53
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
0.00%
0/54
|
3.8%
2/53
|
|
Respiratory, thoracic and mediastinal disorders
Sinus Disorder
|
0.00%
0/54
|
3.8%
2/53
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal Drip
|
1.9%
1/54
|
7.5%
4/53
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/54
|
1.9%
1/53
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
3.7%
2/54
|
0.00%
0/53
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
3.7%
2/54
|
1.9%
1/53
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal Hemorrhage
|
0.00%
0/54
|
1.9%
1/53
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
11.1%
6/54
|
15.1%
8/53
|
|
Respiratory, thoracic and mediastinal disorders
Productive Cough
|
0.00%
0/54
|
5.7%
3/53
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal Inflammation
|
0.00%
0/54
|
1.9%
1/53
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/54
|
1.9%
1/53
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
0.00%
0/54
|
11.3%
6/53
|
|
Respiratory, thoracic and mediastinal disorders
Sleep Apnea
|
1.9%
1/54
|
0.00%
0/53
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
22.2%
12/54
|
47.2%
25/53
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
51.9%
28/54
|
43.4%
23/53
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
25.9%
14/54
|
37.7%
20/53
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.00%
0/54
|
1.9%
1/53
|
|
Respiratory, thoracic and mediastinal disorders
Bronchopulmonary Hemorrhage
|
0.00%
0/54
|
1.9%
1/53
|
|
Respiratory, thoracic and mediastinal disorders
Allergic Rhinitis
|
7.4%
4/54
|
9.4%
5/53
|
|
Skin and subcutaneous tissue disorders
Skin And Subcutaneous Tissue Disorders - Other
|
9.3%
5/54
|
7.5%
4/53
|
|
Skin and subcutaneous tissue disorders
Skin Ulceration
|
0.00%
0/54
|
1.9%
1/53
|
|
Skin and subcutaneous tissue disorders
Skin Hyperpigmentation
|
0.00%
0/54
|
9.4%
5/53
|
|
Skin and subcutaneous tissue disorders
Rash Acneiform
|
9.3%
5/54
|
13.2%
7/53
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/54
|
7.5%
4/53
|
|
Skin and subcutaneous tissue disorders
Periorbital Edema
|
0.00%
0/54
|
3.8%
2/53
|
|
Skin and subcutaneous tissue disorders
Palmar-Plantar Erythrodysesthesia Syndrome
|
1.9%
1/54
|
3.8%
2/53
|
|
Skin and subcutaneous tissue disorders
Pain Of Skin
|
1.9%
1/54
|
3.8%
2/53
|
|
Skin and subcutaneous tissue disorders
Rash Maculo-Papular
|
14.8%
8/54
|
9.4%
5/53
|
|
Skin and subcutaneous tissue disorders
Nail Ridging
|
1.9%
1/54
|
1.9%
1/53
|
|
Skin and subcutaneous tissue disorders
Nail Loss
|
5.6%
3/54
|
5.7%
3/53
|
|
Skin and subcutaneous tissue disorders
Nail Discoloration
|
3.7%
2/54
|
11.3%
6/53
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/54
|
5.7%
3/53
|
|
Skin and subcutaneous tissue disorders
Erythroderma
|
0.00%
0/54
|
1.9%
1/53
|
|
Skin and subcutaneous tissue disorders
Erythema Multiforme
|
1.9%
1/54
|
1.9%
1/53
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
0.00%
0/54
|
13.2%
7/53
|
|
Skin and subcutaneous tissue disorders
Body Odor
|
1.9%
1/54
|
0.00%
0/53
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
66.7%
36/54
|
64.2%
34/53
|
|
Vascular disorders
Vascular Disorders - Other
|
0.00%
0/54
|
1.9%
1/53
|
|
Vascular disorders
Thromboembolic Event
|
11.1%
6/54
|
7.5%
4/53
|
|
Vascular disorders
Superficial Thrombophlebitis
|
0.00%
0/54
|
1.9%
1/53
|
|
Vascular disorders
Lymphedema
|
0.00%
0/54
|
7.5%
4/53
|
|
Vascular disorders
Hypotension
|
1.9%
1/54
|
1.9%
1/53
|
|
Vascular disorders
Hypertension
|
18.5%
10/54
|
22.6%
12/53
|
|
Vascular disorders
Hot Flashes
|
3.7%
2/54
|
13.2%
7/53
|
|
Vascular disorders
Hematoma
|
1.9%
1/54
|
1.9%
1/53
|
|
Vascular disorders
Flushing
|
1.9%
1/54
|
3.8%
2/53
|
Additional Information
Angela M. Kuras, Associate Director of Administration and Operations
NRG Oncology Statistics and Data Management Center - Buffalo
Phone: (716) 845-5702
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60