Trial Outcomes & Findings for A Study of Durvalumab With or Without Tremelimumab in Endometrial Cancer (NCT NCT03015129)
NCT ID: NCT03015129
Last Updated: 2024-02-06
Results Overview
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) 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
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
80 participants
Primary outcome timeframe
Up to 72 months
Results posted on
2024-02-06
Participant Flow
Participant milestones
| Measure |
Durvalubmab
Patients will receive intravenous infusion of durvalumab 1500mg Fixed Dose every 4 weeks until patient develops a loss of clinical benefit or experiences unacceptable toxicities.
Durvalumab
|
Durvalubmab + Tremelimumab
Patients will receive 1500mg Flat Dose durvalubmab via intravenous infusion every 4 weeks for up to 4 cycles and 75mg tremelimumab via intravenous infusion every 4 weeks for up to 4 cycles, and then continue 1500mg Fixed Dose durvalumab every 4 weeks until patient develops a loss of clinical benefit or experiences unacceptable toxicities.
Durvalumab
Tremelimumab
|
|---|---|---|
|
Overall Study
STARTED
|
40
|
40
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
40
|
40
|
Reasons for withdrawal
| Measure |
Durvalubmab
Patients will receive intravenous infusion of durvalumab 1500mg Fixed Dose every 4 weeks until patient develops a loss of clinical benefit or experiences unacceptable toxicities.
Durvalumab
|
Durvalubmab + Tremelimumab
Patients will receive 1500mg Flat Dose durvalubmab via intravenous infusion every 4 weeks for up to 4 cycles and 75mg tremelimumab via intravenous infusion every 4 weeks for up to 4 cycles, and then continue 1500mg Fixed Dose durvalumab every 4 weeks until patient develops a loss of clinical benefit or experiences unacceptable toxicities.
Durvalumab
Tremelimumab
|
|---|---|---|
|
Overall Study
Death
|
2
|
2
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
|
Overall Study
Progression of disease
|
38
|
33
|
|
Overall Study
Adverse Event
|
0
|
4
|
Baseline Characteristics
A Study of Durvalumab With or Without Tremelimumab in Endometrial Cancer
Baseline characteristics by cohort
| Measure |
Durvalubmab
n=40 Participants
Patients will receive intravenous infusion of durvalumab 1500mg Fixed Dose every 4 weeks until patient develops a loss of clinical benefit or experiences unacceptable toxicities.
Durvalumab
|
Durvalubmab + Tremelimumab
n=40 Participants
Patients will receive 1500mg Flat Dose durvalubmab via intravenous infusion every 4 weeks for up to 4 cycles and 75mg tremelimumab via intravenous infusion every 4 weeks for up to 4 cycles, and then continue 1500mg Fixed Dose durvalumab every 4 weeks until patient develops a loss of clinical benefit or experiences unacceptable toxicities.
Durvalumab
Tremelimumab
|
Total
n=80 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
65 years
n=5 Participants
|
66 years
n=7 Participants
|
66 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
40 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
80 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
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
39 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
76 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 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
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
29 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
56 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
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
40 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
80 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 72 monthsPer Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) 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 |
Durvalubmab
n=40 Participants
Patients will receive intravenous infusion of durvalumab 1500mg Fixed Dose every 4 weeks until patient develops a loss of clinical benefit or experiences unacceptable toxicities.
Durvalumab
|
Durvalubmab + Tremelimumab
n=40 Participants
Patients will receive 1500mg Flat Dose durvalubmab via intravenous infusion every 4 weeks for up to 4 cycles and 75mg tremelimumab via intravenous infusion every 4 weeks for up to 4 cycles, and then continue 1500mg Fixed Dose durvalumab every 4 weeks until patient develops a loss of clinical benefit or experiences unacceptable toxicities.
Durvalumab
Tremelimumab
|
|---|---|---|
|
Treatment Efficacy Determined by Measuring the Overall Response Rate
|
5 Participants
|
4 Participants
|
Adverse Events
Durvalubmab
Serious events: 13 serious events
Other events: 39 other events
Deaths: 2 deaths
Durvalubmab + Tremelimumab
Serious events: 7 serious events
Other events: 38 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Durvalubmab
n=40 participants at risk
Patients will receive intravenous infusion of durvalumab 1500mg Fixed Dose every 4 weeks until patient develops a loss of clinical benefit or experiences unacceptable toxicities.
Durvalumab
|
Durvalubmab + Tremelimumab
n=40 participants at risk
Patients will receive 1500mg Flat Dose durvalubmab via intravenous infusion every 4 weeks for up to 4 cycles and 75mg tremelimumab via intravenous infusion every 4 weeks for up to 4 cycles, and then continue 1500mg Fixed Dose durvalumab every 4 weeks until patient develops a loss of clinical benefit or experiences unacceptable toxicities.
Durvalumab
Tremelimumab
|
|---|---|---|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/40 • 1 year
|
2.5%
1/40 • 1 year
|
|
Investigations
Alanine aminotransferase increased
|
2.5%
1/40 • 1 year
|
2.5%
1/40 • 1 year
|
|
Investigations
Alkaline phosphatase increased
|
2.5%
1/40 • 1 year
|
2.5%
1/40 • 1 year
|
|
Gastrointestinal disorders
Ascites
|
2.5%
1/40 • 1 year
|
2.5%
1/40 • 1 year
|
|
Investigations
Aspartate aminotransferase increased
|
2.5%
1/40 • 1 year
|
5.0%
2/40 • 1 year
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/40 • 1 year
|
2.5%
1/40 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/40 • 1 year
|
2.5%
1/40 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/40 • 1 year
|
2.5%
1/40 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/40 • 1 year
|
5.0%
2/40 • 1 year
|
|
Nervous system disorders
Edema cerebral
|
0.00%
0/40 • 1 year
|
2.5%
1/40 • 1 year
|
|
General disorders
Fatigue
|
5.0%
2/40 • 1 year
|
5.0%
2/40 • 1 year
|
|
General disorders
Fever
|
7.5%
3/40 • 1 year
|
2.5%
1/40 • 1 year
|
|
Vascular disorders
Hematoma
|
0.00%
0/40 • 1 year
|
2.5%
1/40 • 1 year
|
|
General disorders
Hypercalcemia
|
0.00%
0/40 • 1 year
|
2.5%
1/40 • 1 year
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
0.00%
0/40 • 1 year
|
2.5%
1/40 • 1 year
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
0.00%
0/40 • 1 year
|
2.5%
1/40 • 1 year
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/40 • 1 year
|
2.5%
1/40 • 1 year
|
|
General disorders
Pain
|
0.00%
0/40 • 1 year
|
2.5%
1/40 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/40 • 1 year
|
2.5%
1/40 • 1 year
|
|
Nervous system disorders
Seizure
|
0.00%
0/40 • 1 year
|
2.5%
1/40 • 1 year
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.00%
0/40 • 1 year
|
2.5%
1/40 • 1 year
|
|
Nervous system disorders
Stroke
|
0.00%
0/40 • 1 year
|
2.5%
1/40 • 1 year
|
|
Gastrointestinal disorders
Abdominal Pain
|
15.0%
6/40 • 1 year
|
0.00%
0/40 • 1 year
|
|
Endocrine disorders
Adrenal insufficiency
|
2.5%
1/40 • 1 year
|
0.00%
0/40 • 1 year
|
|
Blood and lymphatic system disorders
Anemia
|
2.5%
1/40 • 1 year
|
0.00%
0/40 • 1 year
|
|
Investigations
Blood bilirubin increased
|
2.5%
1/40 • 1 year
|
0.00%
0/40 • 1 year
|
|
Gastrointestinal disorders
Colitis
|
2.5%
1/40 • 1 year
|
0.00%
0/40 • 1 year
|
|
Gastrointestinal disorders
Colonic perforation
|
2.5%
1/40 • 1 year
|
0.00%
0/40 • 1 year
|
|
Psychiatric disorders
Confusion
|
2.5%
1/40 • 1 year
|
0.00%
0/40 • 1 year
|
|
Gastrointestinal disorders
Constipation
|
2.5%
1/40 • 1 year
|
0.00%
0/40 • 1 year
|
|
Investigations
CPK increased
|
2.5%
1/40 • 1 year
|
0.00%
0/40 • 1 year
|
|
Investigations
Creatinine increased
|
2.5%
1/40 • 1 year
|
0.00%
0/40 • 1 year
|
|
Gastrointestinal disorders
Diarrhea
|
15.0%
6/40 • 1 year
|
0.00%
0/40 • 1 year
|
|
Nervous system disorders
Dizziness
|
2.5%
1/40 • 1 year
|
0.00%
0/40 • 1 year
|
|
Nervous system disorders
Dysarthria
|
2.5%
1/40 • 1 year
|
0.00%
0/40 • 1 year
|
|
Endocrine disorders
Hypothyroidism
|
2.5%
1/40 • 1 year
|
0.00%
0/40 • 1 year
|
|
Cardiac disorders
Left ventricular systolic dysfunction
|
2.5%
1/40 • 1 year
|
0.00%
0/40 • 1 year
|
|
Nervous system disorders
Lethargy
|
2.5%
1/40 • 1 year
|
0.00%
0/40 • 1 year
|
|
Nervous system disorders
Muscle weakness left-sided
|
2.5%
1/40 • 1 year
|
0.00%
0/40 • 1 year
|
|
Cardiac disorders
Myocarditis
|
2.5%
1/40 • 1 year
|
0.00%
0/40 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
2.5%
1/40 • 1 year
|
0.00%
0/40 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
2.5%
1/40 • 1 year
|
0.00%
0/40 • 1 year
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
2.5%
1/40 • 1 year
|
0.00%
0/40 • 1 year
|
|
Gastrointestinal disorders
Rectal pain
|
2.5%
1/40 • 1 year
|
0.00%
0/40 • 1 year
|
|
Renal and urinary disorders
Renal and urinary disorders - Other, specify
|
5.0%
2/40 • 1 year
|
0.00%
0/40 • 1 year
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
5.0%
2/40 • 1 year
|
0.00%
0/40 • 1 year
|
|
Vascular disorders
Thromboembolic event
|
2.5%
1/40 • 1 year
|
0.00%
0/40 • 1 year
|
|
Reproductive system and breast disorders
Vaginal hemorrhage
|
2.5%
1/40 • 1 year
|
0.00%
0/40 • 1 year
|
|
Gastrointestinal disorders
Vomiting
|
2.5%
1/40 • 1 year
|
0.00%
0/40 • 1 year
|
|
Investigations
Weight Loss
|
2.5%
1/40 • 1 year
|
0.00%
0/40 • 1 year
|
Other adverse events
| Measure |
Durvalubmab
n=40 participants at risk
Patients will receive intravenous infusion of durvalumab 1500mg Fixed Dose every 4 weeks until patient develops a loss of clinical benefit or experiences unacceptable toxicities.
Durvalumab
|
Durvalubmab + Tremelimumab
n=40 participants at risk
Patients will receive 1500mg Flat Dose durvalubmab via intravenous infusion every 4 weeks for up to 4 cycles and 75mg tremelimumab via intravenous infusion every 4 weeks for up to 4 cycles, and then continue 1500mg Fixed Dose durvalumab every 4 weeks until patient develops a loss of clinical benefit or experiences unacceptable toxicities.
Durvalumab
Tremelimumab
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/40 • 1 year
|
5.0%
2/40 • 1 year
|
|
Gastrointestinal disorders
Abdominal pain
|
62.5%
25/40 • 1 year
|
30.0%
12/40 • 1 year
|
|
Endocrine disorders
Adrenal insufficiency
|
5.0%
2/40 • 1 year
|
0.00%
0/40 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
0.00%
0/40 • 1 year
|
5.0%
2/40 • 1 year
|
|
Gastrointestinal disorders
Anal pain
|
7.5%
3/40 • 1 year
|
0.00%
0/40 • 1 year
|
|
Blood and lymphatic system disorders
Anemia
|
5.0%
2/40 • 1 year
|
0.00%
0/40 • 1 year
|
|
Metabolism and nutrition disorders
Anorexia
|
30.0%
12/40 • 1 year
|
12.5%
5/40 • 1 year
|
|
Psychiatric disorders
Anxiety
|
10.0%
4/40 • 1 year
|
7.5%
3/40 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
12.5%
5/40 • 1 year
|
27.5%
11/40 • 1 year
|
|
Gastrointestinal disorders
Ascites
|
5.0%
2/40 • 1 year
|
10.0%
4/40 • 1 year
|
|
Investigations
Aspartate aminotransferase increased
|
2.5%
1/40 • 1 year
|
5.0%
2/40 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
15.0%
6/40 • 1 year
|
17.5%
7/40 • 1 year
|
|
Infections and infestations
Bladder infection
|
10.0%
4/40 • 1 year
|
17.5%
7/40 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/40 • 1 year
|
5.0%
2/40 • 1 year
|
|
Gastrointestinal disorders
Colitis
|
7.5%
3/40 • 1 year
|
0.00%
0/40 • 1 year
|
|
Psychiatric disorders
Confusion
|
5.0%
2/40 • 1 year
|
2.5%
1/40 • 1 year
|
|
Gastrointestinal disorders
Constipation
|
30.0%
12/40 • 1 year
|
20.0%
8/40 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
15.0%
6/40 • 1 year
|
7.5%
3/40 • 1 year
|
|
Investigations
Creatinine Increased
|
0.00%
0/40 • 1 year
|
5.0%
2/40 • 1 year
|
|
Gastrointestinal disorders
Diarrhea
|
55.0%
22/40 • 1 year
|
25.0%
10/40 • 1 year
|
|
Nervous system disorders
Dizziness
|
10.0%
4/40 • 1 year
|
22.5%
9/40 • 1 year
|
|
Gastrointestinal disorders
Dry mouth
|
7.5%
3/40 • 1 year
|
5.0%
2/40 • 1 year
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
7.5%
3/40 • 1 year
|
7.5%
3/40 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
20.0%
8/40 • 1 year
|
25.0%
10/40 • 1 year
|
|
General disorders
Edema limbs
|
7.5%
3/40 • 1 year
|
5.0%
2/40 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/40 • 1 year
|
5.0%
2/40 • 1 year
|
|
Injury, poisoning and procedural complications
Fall
|
2.5%
1/40 • 1 year
|
7.5%
3/40 • 1 year
|
|
General disorders
Fatigue
|
65.0%
26/40 • 1 year
|
50.0%
20/40 • 1 year
|
|
General disorders
Fever
|
7.5%
3/40 • 1 year
|
15.0%
6/40 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/40 • 1 year
|
5.0%
2/40 • 1 year
|
|
Gastrointestinal disorders
Flatulence
|
7.5%
3/40 • 1 year
|
0.00%
0/40 • 1 year
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
5.0%
2/40 • 1 year
|
7.5%
3/40 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
2.5%
1/40 • 1 year
|
5.0%
2/40 • 1 year
|
|
Infections and infestations
Gum infection
|
0.00%
0/40 • 1 year
|
20.0%
8/40 • 1 year
|
|
Nervous system disorders
Headache
|
7.5%
3/40 • 1 year
|
0.00%
0/40 • 1 year
|
|
Vascular disorders
Hematoma
|
0.00%
0/40 • 1 year
|
5.0%
2/40 • 1 year
|
|
Vascular disorders
Hot flashes
|
7.5%
3/40 • 1 year
|
0.00%
0/40 • 1 year
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
2.5%
1/40 • 1 year
|
5.0%
2/40 • 1 year
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
2.5%
1/40 • 1 year
|
5.0%
2/40 • 1 year
|
|
Vascular disorders
Hypertension
|
35.0%
14/40 • 1 year
|
7.5%
3/40 • 1 year
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
5.0%
2/40 • 1 year
|
0.00%
0/40 • 1 year
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/40 • 1 year
|
10.0%
4/40 • 1 year
|
|
Renal and urinary disorders
Increased Urinary Frequency
|
15.0%
6/40 • 1 year
|
0.00%
0/40 • 1 year
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/40 • 1 year
|
7.5%
3/40 • 1 year
|
|
Vascular disorders
Lymphedema
|
5.0%
2/40 • 1 year
|
0.00%
0/40 • 1 year
|
|
Nervous system disorders
Memory impairment
|
5.0%
2/40 • 1 year
|
0.00%
0/40 • 1 year
|
|
Gastrointestinal disorders
Mucositis oral
|
5.0%
2/40 • 1 year
|
10.0%
4/40 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
7.5%
3/40 • 1 year
|
22.5%
9/40 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
10.0%
4/40 • 1 year
|
10.0%
4/40 • 1 year
|
|
Gastrointestinal disorders
Nausea
|
27.5%
11/40 • 1 year
|
37.5%
15/40 • 1 year
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/40 • 1 year
|
5.0%
2/40 • 1 year
|
|
General disorders
Pain
|
42.5%
17/40 • 1 year
|
20.0%
8/40 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
2.5%
1/40 • 1 year
|
10.0%
4/40 • 1 year
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
2.5%
1/40 • 1 year
|
7.5%
3/40 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
2.5%
1/40 • 1 year
|
7.5%
3/40 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
5.0%
2/40 • 1 year
|
0.00%
0/40 • 1 year
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
27.5%
11/40 • 1 year
|
27.5%
11/40 • 1 year
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
5.0%
2/40 • 1 year
|
0.00%
0/40 • 1 year
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
17.5%
7/40 • 1 year
|
15.0%
6/40 • 1 year
|
|
Cardiac disorders
Sinus bradycardia
|
5.0%
2/40 • 1 year
|
0.00%
0/40 • 1 year
|
|
Infections and infestations
Sinusitis
|
0.00%
0/40 • 1 year
|
5.0%
2/40 • 1 year
|
|
Infections and infestations
Skin infection
|
2.5%
1/40 • 1 year
|
5.0%
2/40 • 1 year
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
7.5%
3/40 • 1 year
|
0.00%
0/40 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
0.00%
0/40 • 1 year
|
5.0%
2/40 • 1 year
|
|
Vascular disorders
Thromboembolic event
|
7.5%
3/40 • 1 year
|
10.0%
4/40 • 1 year
|
|
Infections and infestations
Upper respiratory infection
|
5.0%
2/40 • 1 year
|
5.0%
2/40 • 1 year
|
|
Renal and urinary disorders
Urinary frequency
|
7.5%
3/40 • 1 year
|
5.0%
2/40 • 1 year
|
|
Renal and urinary disorders
Urinary hesitancy
|
0.00%
0/40 • 1 year
|
10.0%
4/40 • 1 year
|
|
Infections and infestations
Urinary tract infection
|
20.0%
8/40 • 1 year
|
10.0%
4/40 • 1 year
|
|
Renal and urinary disorders
Urinary tract pain
|
7.5%
3/40 • 1 year
|
17.5%
7/40 • 1 year
|
|
Renal and urinary disorders
Urinary urgency
|
5.0%
2/40 • 1 year
|
2.5%
1/40 • 1 year
|
|
Reproductive system and breast disorders
Vaginal discharge
|
10.0%
4/40 • 1 year
|
2.5%
1/40 • 1 year
|
|
Reproductive system and breast disorders
Vaginal hemorrhage
|
5.0%
2/40 • 1 year
|
7.5%
3/40 • 1 year
|
|
Reproductive system and breast disorders
Vaginal yeast
|
0.00%
0/40 • 1 year
|
5.0%
2/40 • 1 year
|
|
Gastrointestinal disorders
Vomiting
|
25.0%
10/40 • 1 year
|
15.0%
6/40 • 1 year
|
|
Investigations
Weight gain
|
15.0%
6/40 • 1 year
|
12.5%
5/40 • 1 year
|
|
Investigations
Weight loss
|
40.0%
16/40 • 1 year
|
0.00%
0/40 • 1 year
|
Additional Information
Dr. Vicky Makker, MD
Memorial Sloan Kettering Cancer Center
Phone: 646-888-4224
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place