Trial Outcomes & Findings for Radiation Therapy, Gemcitabine Hydrochloride, and Cisplatin in Treating Patients With Locally Advanced Squamous Cell Cancer of the Vulva (NCT NCT01595061)
NCT ID: NCT01595061
Last Updated: 2021-12-29
Results Overview
Percentage of participants with complete pathologic response. Complete pathologic response is defined as negative local core biopsy or FNA specimens following primary chemo-radiation therapy.
Recruitment status
UNKNOWN
Study phase
PHASE2
Target enrollment
57 participants
Primary outcome timeframe
6 -8 weeks after completion of chemo-radiation
Results posted on
2021-12-29
Participant Flow
GOG-0279 was activated on 07/02/2012 and closed to accrual on February 20, 2020.
Participant milestones
| Measure |
GEM+CIS+IMRT
Gemcitabine 50 mg/m2 and Cisplatin 40mg/m2 administered weekly throughout IMRT radiation therapy. Gemcitabine will be infused prior to cisplatin and given over approximately 30 minutes while the cisplatin will be delivered over approximately 60 minutes.
|
|---|---|
|
Overall Study
STARTED
|
57
|
|
Overall Study
COMPLETED
|
53
|
|
Overall Study
NOT COMPLETED
|
4
|
Reasons for withdrawal
| Measure |
GEM+CIS+IMRT
Gemcitabine 50 mg/m2 and Cisplatin 40mg/m2 administered weekly throughout IMRT radiation therapy. Gemcitabine will be infused prior to cisplatin and given over approximately 30 minutes while the cisplatin will be delivered over approximately 60 minutes.
|
|---|---|
|
Overall Study
Never Treated
|
3
|
|
Overall Study
Inadequate Pathology
|
1
|
Baseline Characteristics
Radiation Therapy, Gemcitabine Hydrochloride, and Cisplatin in Treating Patients With Locally Advanced Squamous Cell Cancer of the Vulva
Baseline characteristics by cohort
| Measure |
GEM+CIS+IMRT
n=53 Participants
Gemcitabine 50 mg/m2 and Cisplatin 40mg/m2 administered weekly throughout IMRT radiation therapy. Gemcitabine will be infused prior to cisplatin and given over approximately 30 minutes while the cisplatin will be delivered over approximately 60 minutes.
|
|---|---|
|
Age, Customized
20 - 29 years
|
1 Participants
n=5 Participants
|
|
Age, Customized
30 - 39 years
|
0 Participants
n=5 Participants
|
|
Age, Customized
40 - 49 years
|
6 Participants
n=5 Participants
|
|
Age, Customized
50 - 59 years
|
23 Participants
n=5 Participants
|
|
Age, Customized
60 - 69 years
|
10 Participants
n=5 Participants
|
|
Age, Customized
70 - 79 years
|
8 Participants
n=5 Participants
|
|
Age, Customized
>= 80 years
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
53 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
52 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
50 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 -8 weeks after completion of chemo-radiationPopulation: Eligible and treated
Percentage of participants with complete pathologic response. Complete pathologic response is defined as negative local core biopsy or FNA specimens following primary chemo-radiation therapy.
Outcome measures
| Measure |
GEM+CIS+IMRT
n=53 Participants
Gemcitabine 50 mg/m2 and Cisplatin 40mg/m2 administered weekly throughout IMRT radiation therapy. Gemcitabine will be infused prior to cisplatin and given over approximately 30 minutes while the cisplatin will be delivered over approximately 60 minutes.
|
|---|---|
|
Complete Pathologic Response
|
73.6 percentage of participants
Interval 64.0 to 100.0
|
SECONDARY outcome
Timeframe: 6-8 weeks after completion of chemo-radiationPopulation: Eligible and Treated
Percentage of participants with complete clinical response. Complete clinical response is defined as no clinical/radiographic evidence of primary disease (vulva or groin) following primary chemo-radiation therapy.
Outcome measures
| Measure |
GEM+CIS+IMRT
n=53 Participants
Gemcitabine 50 mg/m2 and Cisplatin 40mg/m2 administered weekly throughout IMRT radiation therapy. Gemcitabine will be infused prior to cisplatin and given over approximately 30 minutes while the cisplatin will be delivered over approximately 60 minutes.
|
|---|---|
|
Complete Clinical Response
|
71.7 percentage of participants
Interval 60.0 to 82.0
|
SECONDARY outcome
Timeframe: During treatment period and up to 30 days after stopping the study treatment. The median for duration of study treatment was 2.1 months with a range from 1.2 months to 4.6 months.Population: Eligible and Treated
Number of participants with a maximum grade of 3 or higher during treatment period. Adverse events are graded and categorized using CTCAE v4.0.
Outcome measures
| Measure |
GEM+CIS+IMRT
n=53 Participants
Gemcitabine 50 mg/m2 and Cisplatin 40mg/m2 administered weekly throughout IMRT radiation therapy. Gemcitabine will be infused prior to cisplatin and given over approximately 30 minutes while the cisplatin will be delivered over approximately 60 minutes.
|
|---|---|
|
Adverse Events (Grade 3 or Higher) During Treatment Period
Leukopenia
|
27 Participants
|
|
Adverse Events (Grade 3 or Higher) During Treatment Period
Thrombocytopenia
|
20 Participants
|
|
Adverse Events (Grade 3 or Higher) During Treatment Period
Neutropenia
|
20 Participants
|
|
Adverse Events (Grade 3 or Higher) During Treatment Period
Anemia
|
20 Participants
|
|
Adverse Events (Grade 3 or Higher) During Treatment Period
Other Investigations
|
7 Participants
|
|
Adverse Events (Grade 3 or Higher) During Treatment Period
Other blood and lymphatic disorders
|
8 Participants
|
|
Adverse Events (Grade 3 or Higher) During Treatment Period
Cardiac disorders
|
2 Participants
|
|
Adverse Events (Grade 3 or Higher) During Treatment Period
Gastrointestinal disorders
|
10 Participants
|
|
Adverse Events (Grade 3 or Higher) During Treatment Period
General disorders and administration site conditions
|
5 Participants
|
|
Adverse Events (Grade 3 or Higher) During Treatment Period
Infections and infestations
|
5 Participants
|
|
Adverse Events (Grade 3 or Higher) During Treatment Period
Injury, poisoning and procedural complications
|
20 Participants
|
|
Adverse Events (Grade 3 or Higher) During Treatment Period
Metabolism and nutrition disorders
|
19 Participants
|
|
Adverse Events (Grade 3 or Higher) During Treatment Period
Musculoskeletal and connective tissue disorders
|
2 Participants
|
|
Adverse Events (Grade 3 or Higher) During Treatment Period
Peripheral sensory neuropathy
|
1 Participants
|
|
Adverse Events (Grade 3 or Higher) During Treatment Period
Other nervous system disorders
|
2 Participants
|
|
Adverse Events (Grade 3 or Higher) During Treatment Period
Renal and urinary disorders
|
1 Participants
|
|
Adverse Events (Grade 3 or Higher) During Treatment Period
Reproductive system and breast disorders
|
7 Participants
|
|
Adverse Events (Grade 3 or Higher) During Treatment Period
Respiratory, thoracic and mediastinal disorders
|
1 Participants
|
|
Adverse Events (Grade 3 or Higher) During Treatment Period
Skin and subcutaneous tissue disorders
|
4 Participants
|
|
Adverse Events (Grade 3 or Higher) During Treatment Period
Surgical and medical procedures
|
1 Participants
|
|
Adverse Events (Grade 3 or Higher) During Treatment Period
Vascular disorders
|
5 Participants
|
SECONDARY outcome
Timeframe: From study entry to disease progression, death or date of last contact, whichever occurs first. The median for observed PFS was 26.2 month with a range from 1.5 months to 82.4 monthsPopulation: Eligible and treated
Estimate for probability of progression free survival by Kaplan-Meier method, where progression-free survival is defined as the period of time from study entry to time of disease progression, death or date of last contact, whichever occurs first. PFS is censored in patients who are alive and have not progressed. Progression is assessed by RECIST 1.1
Outcome measures
| Measure |
GEM+CIS+IMRT
n=53 Participants
Gemcitabine 50 mg/m2 and Cisplatin 40mg/m2 administered weekly throughout IMRT radiation therapy. Gemcitabine will be infused prior to cisplatin and given over approximately 30 minutes while the cisplatin will be delivered over approximately 60 minutes.
|
|---|---|
|
Progression-free Survival (PFS)
|
75 percentage of participants
Interval 63.0 to 83.0
|
Adverse Events
GEM+CIS+IMRT
Serious events: 24 serious events
Other events: 53 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
GEM+CIS+IMRT
n=53 participants at risk
Gemcitabine 50 mg/m2 and Cisplatin 40mg/m2 administered weekly throughout IMRT radiation therapy. Gemcitabine will be infused prior to cisplatin and given over approximately 30 minutes while the cisplatin will be delivered over approximately 60 minutes.
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
1.9%
1/53 • During treatment period and up to 30 days after stopping the study treatment. The median for duration of study treatment was 2.1 months with a range from 1.2 months to 4.6 months.
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
5.7%
3/53 • During treatment period and up to 30 days after stopping the study treatment. The median for duration of study treatment was 2.1 months with a range from 1.2 months to 4.6 months.
|
|
Cardiac disorders
Ventricular Tachycardia
|
1.9%
1/53 • During treatment period and up to 30 days after stopping the study treatment. The median for duration of study treatment was 2.1 months with a range from 1.2 months to 4.6 months.
|
|
Gastrointestinal disorders
Diarrhea
|
3.8%
2/53 • During treatment period and up to 30 days after stopping the study treatment. The median for duration of study treatment was 2.1 months with a range from 1.2 months to 4.6 months.
|
|
Gastrointestinal disorders
Gastrointestinal Pain
|
1.9%
1/53 • During treatment period and up to 30 days after stopping the study treatment. The median for duration of study treatment was 2.1 months with a range from 1.2 months to 4.6 months.
|
|
Gastrointestinal disorders
Nausea
|
3.8%
2/53 • During treatment period and up to 30 days after stopping the study treatment. The median for duration of study treatment was 2.1 months with a range from 1.2 months to 4.6 months.
|
|
General disorders
Sudden Death Nos
|
1.9%
1/53 • During treatment period and up to 30 days after stopping the study treatment. The median for duration of study treatment was 2.1 months with a range from 1.2 months to 4.6 months.
|
|
Infections and infestations
Skin Infection
|
1.9%
1/53 • During treatment period and up to 30 days after stopping the study treatment. The median for duration of study treatment was 2.1 months with a range from 1.2 months to 4.6 months.
|
|
Infections and infestations
Sepsis
|
1.9%
1/53 • During treatment period and up to 30 days after stopping the study treatment. The median for duration of study treatment was 2.1 months with a range from 1.2 months to 4.6 months.
|
|
Infections and infestations
Lung Infection
|
1.9%
1/53 • During treatment period and up to 30 days after stopping the study treatment. The median for duration of study treatment was 2.1 months with a range from 1.2 months to 4.6 months.
|
|
Injury, poisoning and procedural complications
Vascular Access Complication
|
1.9%
1/53 • During treatment period and up to 30 days after stopping the study treatment. The median for duration of study treatment was 2.1 months with a range from 1.2 months to 4.6 months.
|
|
Injury, poisoning and procedural complications
Fracture
|
1.9%
1/53 • During treatment period and up to 30 days after stopping the study treatment. The median for duration of study treatment was 2.1 months with a range from 1.2 months to 4.6 months.
|
|
Investigations
Platelet Count Decreased
|
3.8%
2/53 • During treatment period and up to 30 days after stopping the study treatment. The median for duration of study treatment was 2.1 months with a range from 1.2 months to 4.6 months.
|
|
Investigations
Lymphocyte Count Decreased
|
1.9%
1/53 • During treatment period and up to 30 days after stopping the study treatment. The median for duration of study treatment was 2.1 months with a range from 1.2 months to 4.6 months.
|
|
Investigations
White Blood Cell Decreased
|
3.8%
2/53 • During treatment period and up to 30 days after stopping the study treatment. The median for duration of study treatment was 2.1 months with a range from 1.2 months to 4.6 months.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
3.8%
2/53 • During treatment period and up to 30 days after stopping the study treatment. The median for duration of study treatment was 2.1 months with a range from 1.2 months to 4.6 months.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
1.9%
1/53 • During treatment period and up to 30 days after stopping the study treatment. The median for duration of study treatment was 2.1 months with a range from 1.2 months to 4.6 months.
|
|
Metabolism and nutrition disorders
Dehydration
|
3.8%
2/53 • During treatment period and up to 30 days after stopping the study treatment. The median for duration of study treatment was 2.1 months with a range from 1.2 months to 4.6 months.
|
|
Musculoskeletal and connective tissue disorders
Muscle Weakness Lower Limb
|
1.9%
1/53 • During treatment period and up to 30 days after stopping the study treatment. The median for duration of study treatment was 2.1 months with a range from 1.2 months to 4.6 months.
|
|
Nervous system disorders
Seizure
|
1.9%
1/53 • During treatment period and up to 30 days after stopping the study treatment. The median for duration of study treatment was 2.1 months with a range from 1.2 months to 4.6 months.
|
|
Nervous system disorders
Dizziness
|
1.9%
1/53 • During treatment period and up to 30 days after stopping the study treatment. The median for duration of study treatment was 2.1 months with a range from 1.2 months to 4.6 months.
|
|
Reproductive system and breast disorders
Reproductive System And Breast Disorders - Other
|
1.9%
1/53 • During treatment period and up to 30 days after stopping the study treatment. The median for duration of study treatment was 2.1 months with a range from 1.2 months to 4.6 months.
|
Other adverse events
| Measure |
GEM+CIS+IMRT
n=53 participants at risk
Gemcitabine 50 mg/m2 and Cisplatin 40mg/m2 administered weekly throughout IMRT radiation therapy. Gemcitabine will be infused prior to cisplatin and given over approximately 30 minutes while the cisplatin will be delivered over approximately 60 minutes.
|
|---|---|
|
Blood and lymphatic system disorders
Blood And Lymphatic System Disorders - Other
|
17.0%
9/53 • During treatment period and up to 30 days after stopping the study treatment. The median for duration of study treatment was 2.1 months with a range from 1.2 months to 4.6 months.
|
|
Blood and lymphatic system disorders
Anemia
|
79.2%
42/53 • During treatment period and up to 30 days after stopping the study treatment. The median for duration of study treatment was 2.1 months with a range from 1.2 months to 4.6 months.
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
5.7%
3/53 • During treatment period and up to 30 days after stopping the study treatment. The median for duration of study treatment was 2.1 months with a range from 1.2 months to 4.6 months.
|
|
Cardiac disorders
Atrial Fibrillation
|
3.8%
2/53 • During treatment period and up to 30 days after stopping the study treatment. The median for duration of study treatment was 2.1 months with a range from 1.2 months to 4.6 months.
|
|
Cardiac disorders
Mobitz Type I
|
1.9%
1/53 • During treatment period and up to 30 days after stopping the study treatment. The median for duration of study treatment was 2.1 months with a range from 1.2 months to 4.6 months.
|
|
Cardiac disorders
Supraventricular Tachycardia
|
1.9%
1/53 • During treatment period and up to 30 days after stopping the study treatment. The median for duration of study treatment was 2.1 months with a range from 1.2 months to 4.6 months.
|
|
Cardiac disorders
Sinus Bradycardia
|
3.8%
2/53 • During treatment period and up to 30 days after stopping the study treatment. The median for duration of study treatment was 2.1 months with a range from 1.2 months to 4.6 months.
|
|
Cardiac disorders
Palpitations
|
5.7%
3/53 • During treatment period and up to 30 days after stopping the study treatment. The median for duration of study treatment was 2.1 months with a range from 1.2 months to 4.6 months.
|
|
Cardiac disorders
Sinus Tachycardia
|
9.4%
5/53 • During treatment period and up to 30 days after stopping the study treatment. The median for duration of study treatment was 2.1 months with a range from 1.2 months to 4.6 months.
|
|
Cardiac disorders
Chest Pain - Cardiac
|
1.9%
1/53 • During treatment period and up to 30 days after stopping the study treatment. The median for duration of study treatment was 2.1 months with a range from 1.2 months to 4.6 months.
|
|
Ear and labyrinth disorders
Tinnitus
|
7.5%
4/53 • During treatment period and up to 30 days after stopping the study treatment. The median for duration of study treatment was 2.1 months with a range from 1.2 months to 4.6 months.
|
|
Eye disorders
Blurred Vision
|
3.8%
2/53 • During treatment period and up to 30 days after stopping the study treatment. The median for duration of study treatment was 2.1 months with a range from 1.2 months to 4.6 months.
|
|
Eye disorders
Floaters
|
1.9%
1/53 • During treatment period and up to 30 days after stopping the study treatment. The median for duration of study treatment was 2.1 months with a range from 1.2 months to 4.6 months.
|
|
Gastrointestinal disorders
Enterocolitis
|
1.9%
1/53 • During treatment period and up to 30 days after stopping the study treatment. The median for duration of study treatment was 2.1 months with a range from 1.2 months to 4.6 months.
|
|
Gastrointestinal disorders
Dysphagia
|
5.7%
3/53 • During treatment period and up to 30 days after stopping the study treatment. The median for duration of study treatment was 2.1 months with a range from 1.2 months to 4.6 months.
|
|
Gastrointestinal disorders
Dyspepsia
|
1.9%
1/53 • During treatment period and up to 30 days after stopping the study treatment. The median for duration of study treatment was 2.1 months with a range from 1.2 months to 4.6 months.
|
|
Gastrointestinal disorders
Constipation
|
37.7%
20/53 • During treatment period and up to 30 days after stopping the study treatment. The median for duration of study treatment was 2.1 months with a range from 1.2 months to 4.6 months.
|
|
Gastrointestinal disorders
Diarrhea
|
73.6%
39/53 • During treatment period and up to 30 days after stopping the study treatment. The median for duration of study treatment was 2.1 months with a range from 1.2 months to 4.6 months.
|
|
Gastrointestinal disorders
Vomiting
|
39.6%
21/53 • During treatment period and up to 30 days after stopping the study treatment. The median for duration of study treatment was 2.1 months with a range from 1.2 months to 4.6 months.
|
|
Gastrointestinal disorders
Bloating
|
3.8%
2/53 • During treatment period and up to 30 days after stopping the study treatment. The median for duration of study treatment was 2.1 months with a range from 1.2 months to 4.6 months.
|
|
Gastrointestinal disorders
Small Intestinal Obstruction
|
1.9%
1/53 • During treatment period and up to 30 days after stopping the study treatment. The median for duration of study treatment was 2.1 months with a range from 1.2 months to 4.6 months.
|
|
Gastrointestinal disorders
Anal Hemorrhage
|
1.9%
1/53 • During treatment period and up to 30 days after stopping the study treatment. The median for duration of study treatment was 2.1 months with a range from 1.2 months to 4.6 months.
|
|
Gastrointestinal disorders
Abdominal Pain
|
9.4%
5/53 • During treatment period and up to 30 days after stopping the study treatment. The median for duration of study treatment was 2.1 months with a range from 1.2 months to 4.6 months.
|
|
Gastrointestinal disorders
Proctitis
|
5.7%
3/53 • During treatment period and up to 30 days after stopping the study treatment. The median for duration of study treatment was 2.1 months with a range from 1.2 months to 4.6 months.
|
|
Gastrointestinal disorders
Mucositis Oral
|
3.8%
2/53 • During treatment period and up to 30 days after stopping the study treatment. The median for duration of study treatment was 2.1 months with a range from 1.2 months to 4.6 months.
|
|
Gastrointestinal disorders
Lower Gastrointestinal Hemorrhage
|
1.9%
1/53 • During treatment period and up to 30 days after stopping the study treatment. The median for duration of study treatment was 2.1 months with a range from 1.2 months to 4.6 months.
|
|
Gastrointestinal disorders
Gastrointestinal Disorders - Other
|
5.7%
3/53 • During treatment period and up to 30 days after stopping the study treatment. The median for duration of study treatment was 2.1 months with a range from 1.2 months to 4.6 months.
|
|
Gastrointestinal disorders
Anal Pain
|
5.7%
3/53 • During treatment period and up to 30 days after stopping the study treatment. The median for duration of study treatment was 2.1 months with a range from 1.2 months to 4.6 months.
|
|
Gastrointestinal disorders
Gingival Pain
|
1.9%
1/53 • During treatment period and up to 30 days after stopping the study treatment. The median for duration of study treatment was 2.1 months with a range from 1.2 months to 4.6 months.
|
|
Gastrointestinal disorders
Abdominal Distension
|
1.9%
1/53 • During treatment period and up to 30 days after stopping the study treatment. The median for duration of study treatment was 2.1 months with a range from 1.2 months to 4.6 months.
|
|
Gastrointestinal disorders
Nausea
|
71.7%
38/53 • During treatment period and up to 30 days after stopping the study treatment. The median for duration of study treatment was 2.1 months with a range from 1.2 months to 4.6 months.
|
|
Gastrointestinal disorders
Gastroesophageal Reflux Disease
|
1.9%
1/53 • During treatment period and up to 30 days after stopping the study treatment. The median for duration of study treatment was 2.1 months with a range from 1.2 months to 4.6 months.
|
|
Gastrointestinal disorders
Rectal Pain
|
3.8%
2/53 • During treatment period and up to 30 days after stopping the study treatment. The median for duration of study treatment was 2.1 months with a range from 1.2 months to 4.6 months.
|
|
Gastrointestinal disorders
Hemorrhoidal Hemorrhage
|
1.9%
1/53 • During treatment period and up to 30 days after stopping the study treatment. The median for duration of study treatment was 2.1 months with a range from 1.2 months to 4.6 months.
|
|
Gastrointestinal disorders
Hemorrhoids
|
7.5%
4/53 • During treatment period and up to 30 days after stopping the study treatment. The median for duration of study treatment was 2.1 months with a range from 1.2 months to 4.6 months.
|
|
Gastrointestinal disorders
Flatulence
|
1.9%
1/53 • During treatment period and up to 30 days after stopping the study treatment. The median for duration of study treatment was 2.1 months with a range from 1.2 months to 4.6 months.
|
|
General disorders
General Disorders And Administration Site Conditio
|
9.4%
5/53 • During treatment period and up to 30 days after stopping the study treatment. The median for duration of study treatment was 2.1 months with a range from 1.2 months to 4.6 months.
|
|
General disorders
Pain
|
17.0%
9/53 • During treatment period and up to 30 days after stopping the study treatment. The median for duration of study treatment was 2.1 months with a range from 1.2 months to 4.6 months.
|
|
General disorders
Malaise
|
3.8%
2/53 • During treatment period and up to 30 days after stopping the study treatment. The median for duration of study treatment was 2.1 months with a range from 1.2 months to 4.6 months.
|
|
General disorders
Localized Edema
|
5.7%
3/53 • During treatment period and up to 30 days after stopping the study treatment. The median for duration of study treatment was 2.1 months with a range from 1.2 months to 4.6 months.
|
|
General disorders
Non-Cardiac Chest Pain
|
3.8%
2/53 • During treatment period and up to 30 days after stopping the study treatment. The median for duration of study treatment was 2.1 months with a range from 1.2 months to 4.6 months.
|
|
General disorders
Edema Limbs
|
22.6%
12/53 • During treatment period and up to 30 days after stopping the study treatment. The median for duration of study treatment was 2.1 months with a range from 1.2 months to 4.6 months.
|
|
General disorders
Fatigue
|
79.2%
42/53 • During treatment period and up to 30 days after stopping the study treatment. The median for duration of study treatment was 2.1 months with a range from 1.2 months to 4.6 months.
|
|
General disorders
Fever
|
11.3%
6/53 • During treatment period and up to 30 days after stopping the study treatment. The median for duration of study treatment was 2.1 months with a range from 1.2 months to 4.6 months.
|
|
General disorders
Chills
|
3.8%
2/53 • During treatment period and up to 30 days after stopping the study treatment. The median for duration of study treatment was 2.1 months with a range from 1.2 months to 4.6 months.
|
|
Immune system disorders
Allergic Reaction
|
1.9%
1/53 • During treatment period and up to 30 days after stopping the study treatment. The median for duration of study treatment was 2.1 months with a range from 1.2 months to 4.6 months.
|
|
Infections and infestations
Infections And Infestations - Other
|
9.4%
5/53 • During treatment period and up to 30 days after stopping the study treatment. The median for duration of study treatment was 2.1 months with a range from 1.2 months to 4.6 months.
|
|
Infections and infestations
Vulval Infection
|
3.8%
2/53 • During treatment period and up to 30 days after stopping the study treatment. The median for duration of study treatment was 2.1 months with a range from 1.2 months to 4.6 months.
|
|
Infections and infestations
Skin Infection
|
3.8%
2/53 • During treatment period and up to 30 days after stopping the study treatment. The median for duration of study treatment was 2.1 months with a range from 1.2 months to 4.6 months.
|
|
Infections and infestations
Sinusitis
|
1.9%
1/53 • During treatment period and up to 30 days after stopping the study treatment. The median for duration of study treatment was 2.1 months with a range from 1.2 months to 4.6 months.
|
|
Infections and infestations
Sepsis
|
1.9%
1/53 • During treatment period and up to 30 days after stopping the study treatment. The median for duration of study treatment was 2.1 months with a range from 1.2 months to 4.6 months.
|
|
Infections and infestations
Hepatitis Viral
|
1.9%
1/53 • During treatment period and up to 30 days after stopping the study treatment. The median for duration of study treatment was 2.1 months with a range from 1.2 months to 4.6 months.
|
|
Infections and infestations
Vaginal Infection
|
7.5%
4/53 • During treatment period and up to 30 days after stopping the study treatment. The median for duration of study treatment was 2.1 months with a range from 1.2 months to 4.6 months.
|
|
Infections and infestations
Urinary Tract Infection
|
24.5%
13/53 • During treatment period and up to 30 days after stopping the study treatment. The median for duration of study treatment was 2.1 months with a range from 1.2 months to 4.6 months.
|
|
Injury, poisoning and procedural complications
Vascular Access Complication
|
1.9%
1/53 • During treatment period and up to 30 days after stopping the study treatment. The median for duration of study treatment was 2.1 months with a range from 1.2 months to 4.6 months.
|
|
Injury, poisoning and procedural complications
Fall
|
1.9%
1/53 • During treatment period and up to 30 days after stopping the study treatment. The median for duration of study treatment was 2.1 months with a range from 1.2 months to 4.6 months.
|
|
Injury, poisoning and procedural complications
Dermatitis Radiation
|
66.0%
35/53 • During treatment period and up to 30 days after stopping the study treatment. The median for duration of study treatment was 2.1 months with a range from 1.2 months to 4.6 months.
|
|
Injury, poisoning and procedural complications
Burn
|
1.9%
1/53 • During treatment period and up to 30 days after stopping the study treatment. The median for duration of study treatment was 2.1 months with a range from 1.2 months to 4.6 months.
|
|
Injury, poisoning and procedural complications
Bruising
|
1.9%
1/53 • During treatment period and up to 30 days after stopping the study treatment. The median for duration of study treatment was 2.1 months with a range from 1.2 months to 4.6 months.
|
|
Investigations
Investigations - Other
|
3.8%
2/53 • During treatment period and up to 30 days after stopping the study treatment. The median for duration of study treatment was 2.1 months with a range from 1.2 months to 4.6 months.
|
|
Investigations
Weight Loss
|
9.4%
5/53 • During treatment period and up to 30 days after stopping the study treatment. The median for duration of study treatment was 2.1 months with a range from 1.2 months to 4.6 months.
|
|
Investigations
Platelet Count Decreased
|
71.7%
38/53 • During treatment period and up to 30 days after stopping the study treatment. The median for duration of study treatment was 2.1 months with a range from 1.2 months to 4.6 months.
|
|
Investigations
Lymphocyte Count Decreased
|
13.2%
7/53 • During treatment period and up to 30 days after stopping the study treatment. The median for duration of study treatment was 2.1 months with a range from 1.2 months to 4.6 months.
|
|
Investigations
Creatinine Increased
|
15.1%
8/53 • During treatment period and up to 30 days after stopping the study treatment. The median for duration of study treatment was 2.1 months with a range from 1.2 months to 4.6 months.
|
|
Investigations
Neutrophil Count Decreased
|
58.5%
31/53 • During treatment period and up to 30 days after stopping the study treatment. The median for duration of study treatment was 2.1 months with a range from 1.2 months to 4.6 months.
|
|
Investigations
Blood Bilirubin Increased
|
1.9%
1/53 • During treatment period and up to 30 days after stopping the study treatment. The median for duration of study treatment was 2.1 months with a range from 1.2 months to 4.6 months.
|
|
Investigations
White Blood Cell Decreased
|
77.4%
41/53 • During treatment period and up to 30 days after stopping the study treatment. The median for duration of study treatment was 2.1 months with a range from 1.2 months to 4.6 months.
|
|
Investigations
Aspartate Aminotransferase Increased
|
5.7%
3/53 • During treatment period and up to 30 days after stopping the study treatment. The median for duration of study treatment was 2.1 months with a range from 1.2 months to 4.6 months.
|
|
Investigations
Alkaline Phosphatase Increased
|
11.3%
6/53 • During treatment period and up to 30 days after stopping the study treatment. The median for duration of study treatment was 2.1 months with a range from 1.2 months to 4.6 months.
|
|
Investigations
Alanine Aminotransferase Increased
|
7.5%
4/53 • During treatment period and up to 30 days after stopping the study treatment. The median for duration of study treatment was 2.1 months with a range from 1.2 months to 4.6 months.
|
|
Metabolism and nutrition disorders
Metabolism And Nutrition Disorders - Other
|
1.9%
1/53 • During treatment period and up to 30 days after stopping the study treatment. The median for duration of study treatment was 2.1 months with a range from 1.2 months to 4.6 months.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
7.5%
4/53 • During treatment period and up to 30 days after stopping the study treatment. The median for duration of study treatment was 2.1 months with a range from 1.2 months to 4.6 months.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
28.3%
15/53 • During treatment period and up to 30 days after stopping the study treatment. The median for duration of study treatment was 2.1 months with a range from 1.2 months to 4.6 months.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
47.2%
25/53 • During treatment period and up to 30 days after stopping the study treatment. The median for duration of study treatment was 2.1 months with a range from 1.2 months to 4.6 months.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
35.8%
19/53 • During treatment period and up to 30 days after stopping the study treatment. The median for duration of study treatment was 2.1 months with a range from 1.2 months to 4.6 months.
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
1.9%
1/53 • During treatment period and up to 30 days after stopping the study treatment. The median for duration of study treatment was 2.1 months with a range from 1.2 months to 4.6 months.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
24.5%
13/53 • During treatment period and up to 30 days after stopping the study treatment. The median for duration of study treatment was 2.1 months with a range from 1.2 months to 4.6 months.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
34.0%
18/53 • During treatment period and up to 30 days after stopping the study treatment. The median for duration of study treatment was 2.1 months with a range from 1.2 months to 4.6 months.
|
|
Metabolism and nutrition disorders
Hypernatremia
|
1.9%
1/53 • During treatment period and up to 30 days after stopping the study treatment. The median for duration of study treatment was 2.1 months with a range from 1.2 months to 4.6 months.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
7.5%
4/53 • During treatment period and up to 30 days after stopping the study treatment. The median for duration of study treatment was 2.1 months with a range from 1.2 months to 4.6 months.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
24.5%
13/53 • During treatment period and up to 30 days after stopping the study treatment. The median for duration of study treatment was 2.1 months with a range from 1.2 months to 4.6 months.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
1.9%
1/53 • During treatment period and up to 30 days after stopping the study treatment. The median for duration of study treatment was 2.1 months with a range from 1.2 months to 4.6 months.
|
|
Metabolism and nutrition disorders
Dehydration
|
13.2%
7/53 • During treatment period and up to 30 days after stopping the study treatment. The median for duration of study treatment was 2.1 months with a range from 1.2 months to 4.6 months.
|
|
Metabolism and nutrition disorders
Anorexia
|
32.1%
17/53 • During treatment period and up to 30 days after stopping the study treatment. The median for duration of study treatment was 2.1 months with a range from 1.2 months to 4.6 months.
|
|
Musculoskeletal and connective tissue disorders
Pain In Extremity
|
11.3%
6/53 • During treatment period and up to 30 days after stopping the study treatment. The median for duration of study treatment was 2.1 months with a range from 1.2 months to 4.6 months.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
5.7%
3/53 • During treatment period and up to 30 days after stopping the study treatment. The median for duration of study treatment was 2.1 months with a range from 1.2 months to 4.6 months.
|
|
Musculoskeletal and connective tissue disorders
Muscle Weakness Lower Limb
|
3.8%
2/53 • During treatment period and up to 30 days after stopping the study treatment. The median for duration of study treatment was 2.1 months with a range from 1.2 months to 4.6 months.
|
|
Musculoskeletal and connective tissue disorders
Generalized Muscle Weakness
|
9.4%
5/53 • During treatment period and up to 30 days after stopping the study treatment. The median for duration of study treatment was 2.1 months with a range from 1.2 months to 4.6 months.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
5.7%
3/53 • During treatment period and up to 30 days after stopping the study treatment. The median for duration of study treatment was 2.1 months with a range from 1.2 months to 4.6 months.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.7%
3/53 • During treatment period and up to 30 days after stopping the study treatment. The median for duration of study treatment was 2.1 months with a range from 1.2 months to 4.6 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor Pain
|
5.7%
3/53 • During treatment period and up to 30 days after stopping the study treatment. The median for duration of study treatment was 2.1 months with a range from 1.2 months to 4.6 months.
|
|
Nervous system disorders
Seizure
|
1.9%
1/53 • During treatment period and up to 30 days after stopping the study treatment. The median for duration of study treatment was 2.1 months with a range from 1.2 months to 4.6 months.
|
|
Nervous system disorders
Presyncope
|
1.9%
1/53 • During treatment period and up to 30 days after stopping the study treatment. The median for duration of study treatment was 2.1 months with a range from 1.2 months to 4.6 months.
|
|
Nervous system disorders
Peripheral Sensory Neuropathy
|
13.2%
7/53 • During treatment period and up to 30 days after stopping the study treatment. The median for duration of study treatment was 2.1 months with a range from 1.2 months to 4.6 months.
|
|
Nervous system disorders
Paresthesia
|
1.9%
1/53 • During treatment period and up to 30 days after stopping the study treatment. The median for duration of study treatment was 2.1 months with a range from 1.2 months to 4.6 months.
|
|
Nervous system disorders
Headache
|
18.9%
10/53 • During treatment period and up to 30 days after stopping the study treatment. The median for duration of study treatment was 2.1 months with a range from 1.2 months to 4.6 months.
|
|
Nervous system disorders
Dysgeusia
|
9.4%
5/53 • During treatment period and up to 30 days after stopping the study treatment. The median for duration of study treatment was 2.1 months with a range from 1.2 months to 4.6 months.
|
|
Nervous system disorders
Dizziness
|
7.5%
4/53 • During treatment period and up to 30 days after stopping the study treatment. The median for duration of study treatment was 2.1 months with a range from 1.2 months to 4.6 months.
|
|
Nervous system disorders
Cognitive Disturbance
|
1.9%
1/53 • During treatment period and up to 30 days after stopping the study treatment. The median for duration of study treatment was 2.1 months with a range from 1.2 months to 4.6 months.
|
|
Psychiatric disorders
Insomnia
|
13.2%
7/53 • During treatment period and up to 30 days after stopping the study treatment. The median for duration of study treatment was 2.1 months with a range from 1.2 months to 4.6 months.
|
|
Psychiatric disorders
Depression
|
11.3%
6/53 • During treatment period and up to 30 days after stopping the study treatment. The median for duration of study treatment was 2.1 months with a range from 1.2 months to 4.6 months.
|
|
Psychiatric disorders
Delirium
|
1.9%
1/53 • During treatment period and up to 30 days after stopping the study treatment. The median for duration of study treatment was 2.1 months with a range from 1.2 months to 4.6 months.
|
|
Psychiatric disorders
Confusion
|
1.9%
1/53 • During treatment period and up to 30 days after stopping the study treatment. The median for duration of study treatment was 2.1 months with a range from 1.2 months to 4.6 months.
|
|
Psychiatric disorders
Anxiety
|
3.8%
2/53 • During treatment period and up to 30 days after stopping the study treatment. The median for duration of study treatment was 2.1 months with a range from 1.2 months to 4.6 months.
|
|
Psychiatric disorders
Agitation
|
1.9%
1/53 • During treatment period and up to 30 days after stopping the study treatment. The median for duration of study treatment was 2.1 months with a range from 1.2 months to 4.6 months.
|
|
Renal and urinary disorders
Urine Discoloration
|
1.9%
1/53 • During treatment period and up to 30 days after stopping the study treatment. The median for duration of study treatment was 2.1 months with a range from 1.2 months to 4.6 months.
|
|
Renal and urinary disorders
Urinary Urgency
|
9.4%
5/53 • During treatment period and up to 30 days after stopping the study treatment. The median for duration of study treatment was 2.1 months with a range from 1.2 months to 4.6 months.
|
|
Renal and urinary disorders
Urinary Tract Obstruction
|
3.8%
2/53 • During treatment period and up to 30 days after stopping the study treatment. The median for duration of study treatment was 2.1 months with a range from 1.2 months to 4.6 months.
|
|
Renal and urinary disorders
Urinary Retention
|
5.7%
3/53 • During treatment period and up to 30 days after stopping the study treatment. The median for duration of study treatment was 2.1 months with a range from 1.2 months to 4.6 months.
|
|
Renal and urinary disorders
Urinary Incontinence
|
13.2%
7/53 • During treatment period and up to 30 days after stopping the study treatment. The median for duration of study treatment was 2.1 months with a range from 1.2 months to 4.6 months.
|
|
Renal and urinary disorders
Urinary Tract Pain
|
22.6%
12/53 • During treatment period and up to 30 days after stopping the study treatment. The median for duration of study treatment was 2.1 months with a range from 1.2 months to 4.6 months.
|
|
Renal and urinary disorders
Urinary Frequency
|
28.3%
15/53 • During treatment period and up to 30 days after stopping the study treatment. The median for duration of study treatment was 2.1 months with a range from 1.2 months to 4.6 months.
|
|
Renal and urinary disorders
Proteinuria
|
1.9%
1/53 • During treatment period and up to 30 days after stopping the study treatment. The median for duration of study treatment was 2.1 months with a range from 1.2 months to 4.6 months.
|
|
Renal and urinary disorders
Hematuria
|
7.5%
4/53 • During treatment period and up to 30 days after stopping the study treatment. The median for duration of study treatment was 2.1 months with a range from 1.2 months to 4.6 months.
|
|
Renal and urinary disorders
Cystitis Noninfective
|
3.8%
2/53 • During treatment period and up to 30 days after stopping the study treatment. The median for duration of study treatment was 2.1 months with a range from 1.2 months to 4.6 months.
|
|
Renal and urinary disorders
Chronic Kidney Disease
|
1.9%
1/53 • During treatment period and up to 30 days after stopping the study treatment. The median for duration of study treatment was 2.1 months with a range from 1.2 months to 4.6 months.
|
|
Renal and urinary disorders
Bladder Spasm
|
5.7%
3/53 • During treatment period and up to 30 days after stopping the study treatment. The median for duration of study treatment was 2.1 months with a range from 1.2 months to 4.6 months.
|
|
Reproductive system and breast disorders
Vaginal Pain
|
20.8%
11/53 • During treatment period and up to 30 days after stopping the study treatment. The median for duration of study treatment was 2.1 months with a range from 1.2 months to 4.6 months.
|
|
Reproductive system and breast disorders
Vaginal Hemorrhage
|
13.2%
7/53 • During treatment period and up to 30 days after stopping the study treatment. The median for duration of study treatment was 2.1 months with a range from 1.2 months to 4.6 months.
|
|
Reproductive system and breast disorders
Perineal Pain
|
15.1%
8/53 • During treatment period and up to 30 days after stopping the study treatment. The median for duration of study treatment was 2.1 months with a range from 1.2 months to 4.6 months.
|
|
Reproductive system and breast disorders
Pelvic Pain
|
9.4%
5/53 • During treatment period and up to 30 days after stopping the study treatment. The median for duration of study treatment was 2.1 months with a range from 1.2 months to 4.6 months.
|
|
Reproductive system and breast disorders
Vaginal Discharge
|
17.0%
9/53 • During treatment period and up to 30 days after stopping the study treatment. The median for duration of study treatment was 2.1 months with a range from 1.2 months to 4.6 months.
|
|
Reproductive system and breast disorders
Vaginal Inflammation
|
1.9%
1/53 • During treatment period and up to 30 days after stopping the study treatment. The median for duration of study treatment was 2.1 months with a range from 1.2 months to 4.6 months.
|
|
Reproductive system and breast disorders
Genital Edema
|
1.9%
1/53 • During treatment period and up to 30 days after stopping the study treatment. The median for duration of study treatment was 2.1 months with a range from 1.2 months to 4.6 months.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
1.9%
1/53 • During treatment period and up to 30 days after stopping the study treatment. The median for duration of study treatment was 2.1 months with a range from 1.2 months to 4.6 months.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
17.0%
9/53 • During treatment period and up to 30 days after stopping the study treatment. The median for duration of study treatment was 2.1 months with a range from 1.2 months to 4.6 months.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.7%
3/53 • During treatment period and up to 30 days after stopping the study treatment. The median for duration of study treatment was 2.1 months with a range from 1.2 months to 4.6 months.
|
|
Skin and subcutaneous tissue disorders
Skin And Subcutaneous Tissue Disorders - Other
|
11.3%
6/53 • During treatment period and up to 30 days after stopping the study treatment. The median for duration of study treatment was 2.1 months with a range from 1.2 months to 4.6 months.
|
|
Skin and subcutaneous tissue disorders
Skin Ulceration
|
5.7%
3/53 • During treatment period and up to 30 days after stopping the study treatment. The median for duration of study treatment was 2.1 months with a range from 1.2 months to 4.6 months.
|
|
Skin and subcutaneous tissue disorders
Rash Acneiform
|
3.8%
2/53 • During treatment period and up to 30 days after stopping the study treatment. The median for duration of study treatment was 2.1 months with a range from 1.2 months to 4.6 months.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
11.3%
6/53 • During treatment period and up to 30 days after stopping the study treatment. The median for duration of study treatment was 2.1 months with a range from 1.2 months to 4.6 months.
|
|
Skin and subcutaneous tissue disorders
Pain Of Skin
|
9.4%
5/53 • During treatment period and up to 30 days after stopping the study treatment. The median for duration of study treatment was 2.1 months with a range from 1.2 months to 4.6 months.
|
|
Skin and subcutaneous tissue disorders
Rash Maculo-Papular
|
5.7%
3/53 • During treatment period and up to 30 days after stopping the study treatment. The median for duration of study treatment was 2.1 months with a range from 1.2 months to 4.6 months.
|
|
Skin and subcutaneous tissue disorders
Nail Loss
|
1.9%
1/53 • During treatment period and up to 30 days after stopping the study treatment. The median for duration of study treatment was 2.1 months with a range from 1.2 months to 4.6 months.
|
|
Skin and subcutaneous tissue disorders
Erythroderma
|
1.9%
1/53 • During treatment period and up to 30 days after stopping the study treatment. The median for duration of study treatment was 2.1 months with a range from 1.2 months to 4.6 months.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
11.3%
6/53 • During treatment period and up to 30 days after stopping the study treatment. The median for duration of study treatment was 2.1 months with a range from 1.2 months to 4.6 months.
|
|
Surgical and medical procedures
Surgical And Medical Procedures - Other
|
1.9%
1/53 • During treatment period and up to 30 days after stopping the study treatment. The median for duration of study treatment was 2.1 months with a range from 1.2 months to 4.6 months.
|
|
Vascular disorders
Thromboembolic Event
|
11.3%
6/53 • During treatment period and up to 30 days after stopping the study treatment. The median for duration of study treatment was 2.1 months with a range from 1.2 months to 4.6 months.
|
|
Vascular disorders
Superficial Thrombophlebitis
|
3.8%
2/53 • During treatment period and up to 30 days after stopping the study treatment. The median for duration of study treatment was 2.1 months with a range from 1.2 months to 4.6 months.
|
|
Vascular disorders
Lymphedema
|
1.9%
1/53 • During treatment period and up to 30 days after stopping the study treatment. The median for duration of study treatment was 2.1 months with a range from 1.2 months to 4.6 months.
|
|
Vascular disorders
Hypotension
|
1.9%
1/53 • During treatment period and up to 30 days after stopping the study treatment. The median for duration of study treatment was 2.1 months with a range from 1.2 months to 4.6 months.
|
|
Vascular disorders
Hypertension
|
15.1%
8/53 • During treatment period and up to 30 days after stopping the study treatment. The median for duration of study treatment was 2.1 months with a range from 1.2 months to 4.6 months.
|
|
Vascular disorders
Hot Flashes
|
5.7%
3/53 • During treatment period and up to 30 days after stopping the study treatment. The median for duration of study treatment was 2.1 months with a range from 1.2 months to 4.6 months.
|
|
Musculoskeletal and connective tissue disorders
Flank Pain
|
1.9%
1/53 • During treatment period and up to 30 days after stopping the study treatment. The median for duration of study treatment was 2.1 months with a range from 1.2 months to 4.6 months.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60