Trial Outcomes & Findings for A Phase II, Single-Arm Study of RAD001 (Everolimus), Letrozole, and Metformin in Patients With Advanced or Recurrent Endometrial Carcinoma (NCT NCT01797523)
NCT ID: NCT01797523
Last Updated: 2026-07-30
Results Overview
The proportion of patients demonstrating a clinical benefit (CBR) complete response + partial response + stable disease rates) based on RECIST v1.1.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
62 participants
Primary outcome timeframe
93 months
Results posted on
2026-07-30
Participant Flow
Participant milestones
| Measure |
Rad-Let-Met
Everolimus 10 mg PO daily + Letrozole 2.5 mg PO daily + Metformin 500 mg PO twice daily on a 4 week schedule
|
|---|---|
|
Overall Study
STARTED
|
62
|
|
Overall Study
COMPLETED
|
54
|
|
Overall Study
NOT COMPLETED
|
8
|
Reasons for withdrawal
| Measure |
Rad-Let-Met
Everolimus 10 mg PO daily + Letrozole 2.5 mg PO daily + Metformin 500 mg PO twice daily on a 4 week schedule
|
|---|---|
|
Overall Study
Death
|
1
|
|
Overall Study
Physician Decision
|
1
|
|
Overall Study
Withdrawal by Subject
|
2
|
|
Overall Study
Rapid Progression
|
2
|
|
Overall Study
Diagnosis of other cancer
|
1
|
|
Overall Study
No measurable disease
|
1
|
Baseline Characteristics
A Phase II, Single-Arm Study of RAD001 (Everolimus), Letrozole, and Metformin in Patients With Advanced or Recurrent Endometrial Carcinoma
Baseline characteristics by cohort
| Measure |
Rad-Let-Met
n=62 Participants
Everolimus 10 mg PO daily + Letrozole 2.5 mg PO daily + Metformin 500 mg PO twice daily on a 4 week schedule
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=20 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
47 Participants
n=20 Participants
|
|
Age, Categorical
>=65 years
|
15 Participants
n=20 Participants
|
|
Sex: Female, Male
Female
|
62 Participants
n=20 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=20 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
11 Participants
n=20 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
40 Participants
n=20 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
11 Participants
n=20 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=20 Participants
|
|
Race (NIH/OMB)
White
|
52 Participants
n=20 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
8 Participants
n=20 Participants
|
|
Region of Enrollment
United States
|
62 participants
n=20 Participants
|
PRIMARY outcome
Timeframe: 93 monthsPopulation: 54 participants were evaluable
The proportion of patients demonstrating a clinical benefit (CBR) complete response + partial response + stable disease rates) based on RECIST v1.1.
Outcome measures
| Measure |
Rad-Let-Met
n=54 Participants
Everolimus 10 mg PO daily + Letrozole 2.5 mg PO daily + Metformin 500 mg PO twice daily on a 4 week schedule
|
|---|---|
|
Clinical Benefit (CBR) Complete Response + Partial Response + Stable Disease Rates) Based on RECIST v1.1.
CBR
|
27 Participants
|
|
Clinical Benefit (CBR) Complete Response + Partial Response + Stable Disease Rates) Based on RECIST v1.1.
PR
|
15 Participants
|
|
Clinical Benefit (CBR) Complete Response + Partial Response + Stable Disease Rates) Based on RECIST v1.1.
SD
|
12 Participants
|
SECONDARY outcome
Timeframe: 93 monthsPopulation: 54 participants were evaluable
Outcome measures
| Measure |
Rad-Let-Met
n=54 Participants
Everolimus 10 mg PO daily + Letrozole 2.5 mg PO daily + Metformin 500 mg PO twice daily on a 4 week schedule
|
|---|---|
|
Progression-Free Survival (PFS)
|
5.7 months
Interval 3.0 to 8.2
|
SECONDARY outcome
Timeframe: 93 monthsPopulation: 59 patients who had at least one dose of treatment and had a follow up evaluation for side effects
To determine the frequency and severity of toxicities associated with RAD001, letrozole, and metformin in this cohort of patients.
Outcome measures
| Measure |
Rad-Let-Met
n=59 Participants
Everolimus 10 mg PO daily + Letrozole 2.5 mg PO daily + Metformin 500 mg PO twice daily on a 4 week schedule
|
|---|---|
|
Percentage of Participants With Toxicities Associated With RAD001, Letrozole, and Metformin
Fatigue
|
6 percentage of participants
|
|
Percentage of Participants With Toxicities Associated With RAD001, Letrozole, and Metformin
Hyponatremia
|
7 percentage of participants
|
|
Percentage of Participants With Toxicities Associated With RAD001, Letrozole, and Metformin
Anemia (Grade 2)
|
85 percentage of participants
|
|
Percentage of Participants With Toxicities Associated With RAD001, Letrozole, and Metformin
Anemia (Grade 3)
|
24 percentage of participants
|
|
Percentage of Participants With Toxicities Associated With RAD001, Letrozole, and Metformin
Hypertriglyceridemia
|
15 percentage of participants
|
|
Percentage of Participants With Toxicities Associated With RAD001, Letrozole, and Metformin
Hyperglycemia
|
9 percentage of participants
|
|
Percentage of Participants With Toxicities Associated With RAD001, Letrozole, and Metformin
Thrombocytopenia
|
6 percentage of participants
|
SECONDARY outcome
Timeframe: 93 monthsPopulation: There were 9 patients who had mutational analysis on their primary tumor in addition to the research biopsy performed as part of the study.
Outcome measures
| Measure |
Rad-Let-Met
n=62 Participants
Everolimus 10 mg PO daily + Letrozole 2.5 mg PO daily + Metformin 500 mg PO twice daily on a 4 week schedule
|
|---|---|
|
Number of Mutations Detected in Women With Endometrial Cancer
|
2 mutations detected
Interval 1.0 to 4.0
|
Adverse Events
Rad-Let-Met
Serious events: 6 serious events
Other events: 60 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Rad-Let-Met
n=62 participants at risk
Everolimus 10 mg PO daily + Letrozole 2.5 mg PO daily + Metformin 500 mg PO twice daily on a 4 week schedule
|
|---|---|
|
General disorders
Decreased performance status
|
1.6%
1/62 • Number of events 1 • 93 months from October 2013 until July 2021
One participant expired unrelated to the clinical trial treatment
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
1.6%
1/62 • Number of events 1 • 93 months from October 2013 until July 2021
One participant expired unrelated to the clinical trial treatment
|
|
Gastrointestinal disorders
Vomiting
|
1.6%
1/62 • Number of events 1 • 93 months from October 2013 until July 2021
One participant expired unrelated to the clinical trial treatment
|
|
Metabolism and nutrition disorders
Hypokalemia
|
1.6%
1/62 • Number of events 1 • 93 months from October 2013 until July 2021
One participant expired unrelated to the clinical trial treatment
|
|
Metabolism and nutrition disorders
Hyponatremia
|
3.2%
2/62 • Number of events 2 • 93 months from October 2013 until July 2021
One participant expired unrelated to the clinical trial treatment
|
|
Infections and infestations
Infection
|
1.6%
1/62 • Number of events 1 • 93 months from October 2013 until July 2021
One participant expired unrelated to the clinical trial treatment
|
|
Gastrointestinal disorders
Nausea
|
1.6%
1/62 • Number of events 1 • 93 months from October 2013 until July 2021
One participant expired unrelated to the clinical trial treatment
|
|
Blood and lymphatic system disorders
Anemia
|
3.2%
2/62 • Number of events 2 • 93 months from October 2013 until July 2021
One participant expired unrelated to the clinical trial treatment
|
|
Metabolism and nutrition disorders
Dehydration
|
1.6%
1/62 • Number of events 1 • 93 months from October 2013 until July 2021
One participant expired unrelated to the clinical trial treatment
|
|
Gastrointestinal disorders
Diarrhea
|
1.6%
1/62 • Number of events 1 • 93 months from October 2013 until July 2021
One participant expired unrelated to the clinical trial treatment
|
|
General disorders
Fatigue
|
1.6%
1/62 • Number of events 1 • 93 months from October 2013 until July 2021
One participant expired unrelated to the clinical trial treatment
|
Other adverse events
| Measure |
Rad-Let-Met
n=62 participants at risk
Everolimus 10 mg PO daily + Letrozole 2.5 mg PO daily + Metformin 500 mg PO twice daily on a 4 week schedule
|
|---|---|
|
Infections and infestations
Infections and infestations - other, sinus infection
|
1.6%
1/62 • Number of events 1 • 93 months from October 2013 until July 2021
One participant expired unrelated to the clinical trial treatment
|
|
Infections and infestations
Infections and infestations - other, cold
|
1.6%
1/62 • Number of events 1 • 93 months from October 2013 until July 2021
One participant expired unrelated to the clinical trial treatment
|
|
Infections and infestations
Infections and infestations - other, shingles
|
1.6%
1/62 • Number of events 1 • 93 months from October 2013 until July 2021
One participant expired unrelated to the clinical trial treatment
|
|
Psychiatric disorders
Insomnia
|
1.6%
1/62 • Number of events 1 • 93 months from October 2013 until July 2021
One participant expired unrelated to the clinical trial treatment
|
|
Investigations
Investigations - Other, elevated BUN
|
4.8%
3/62 • Number of events 5 • 93 months from October 2013 until July 2021
One participant expired unrelated to the clinical trial treatment
|
|
Investigations
Investigations - Other, elevated carbon dioxide
|
1.6%
1/62 • Number of events 1 • 93 months from October 2013 until July 2021
One participant expired unrelated to the clinical trial treatment
|
|
Investigations
Investigations - Other, elevated chloride
|
1.6%
1/62 • Number of events 1 • 93 months from October 2013 until July 2021
One participant expired unrelated to the clinical trial treatment
|
|
Investigations
Investigations - Other, decreased chloride
|
1.6%
1/62 • Number of events 1 • 93 months from October 2013 until July 2021
One participant expired unrelated to the clinical trial treatment
|
|
Investigations
Investigations - Other, decreased creatinine
|
1.6%
1/62 • Number of events 1 • 93 months from October 2013 until July 2021
One participant expired unrelated to the clinical trial treatment
|
|
Investigations
Investigations - Other, elevated LDL
|
3.2%
2/62 • Number of events 2 • 93 months from October 2013 until July 2021
One participant expired unrelated to the clinical trial treatment
|
|
Investigations
Investigations - Other, elevated bilirubin
|
1.6%
1/62 • Number of events 1 • 93 months from October 2013 until July 2021
One participant expired unrelated to the clinical trial treatment
|
|
Nervous system disorders
Memory impairment
|
8.1%
5/62 • Number of events 5 • 93 months from October 2013 until July 2021
One participant expired unrelated to the clinical trial treatment
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders - Other, elevated phosphorous
|
1.6%
1/62 • Number of events 1 • 93 months from October 2013 until July 2021
One participant expired unrelated to the clinical trial treatment
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders - Other, triglycerides increased
|
1.6%
1/62 • Number of events 1 • 93 months from October 2013 until July 2021
One participant expired unrelated to the clinical trial treatment
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders - Other, hypochloremia
|
1.6%
1/62 • Number of events 1 • 93 months from October 2013 until July 2021
One participant expired unrelated to the clinical trial treatment
|
|
Gastrointestinal disorders
Mucositis oral
|
35.5%
22/62 • Number of events 50 • 93 months from October 2013 until July 2021
One participant expired unrelated to the clinical trial treatment
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
1.6%
1/62 • Number of events 1 • 93 months from October 2013 until July 2021
One participant expired unrelated to the clinical trial treatment
|
|
Skin and subcutaneous tissue disorders
Nail discoloration
|
1.6%
1/62 • Number of events 1 • 93 months from October 2013 until July 2021
One participant expired unrelated to the clinical trial treatment
|
|
Skin and subcutaneous tissue disorders
Nail loss
|
3.2%
2/62 • Number of events 2 • 93 months from October 2013 until July 2021
One participant expired unrelated to the clinical trial treatment
|
|
Skin and subcutaneous tissue disorders
Nail ridging
|
1.6%
1/62 • Number of events 1 • 93 months from October 2013 until July 2021
One participant expired unrelated to the clinical trial treatment
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
3.2%
2/62 • Number of events 2 • 93 months from October 2013 until July 2021
One participant expired unrelated to the clinical trial treatment
|
|
Gastrointestinal disorders
Nausea
|
38.7%
24/62 • Number of events 35 • 93 months from October 2013 until July 2021
One participant expired unrelated to the clinical trial treatment
|
|
Nervous system disorders
Nervous system disorders - Other, unsteadiness
|
1.6%
1/62 • Number of events 1 • 93 months from October 2013 until July 2021
One participant expired unrelated to the clinical trial treatment
|
|
Investigations
Neutrophil count decreased
|
14.5%
9/62 • Number of events 20 • 93 months from October 2013 until July 2021
One participant expired unrelated to the clinical trial treatment
|
|
General disorders
Pain
|
6.5%
4/62 • Number of events 4 • 93 months from October 2013 until July 2021
One participant expired unrelated to the clinical trial treatment
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
1.6%
1/62 • Number of events 3 • 93 months from October 2013 until July 2021
One participant expired unrelated to the clinical trial treatment
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
1.6%
1/62 • Number of events 1 • 93 months from October 2013 until July 2021
One participant expired unrelated to the clinical trial treatment
|
|
Cardiac disorders
Palpitations
|
3.2%
2/62 • Number of events 2 • 93 months from October 2013 until July 2021
One participant expired unrelated to the clinical trial treatment
|
|
Nervous system disorders
Paresthesia
|
4.8%
3/62 • Number of events 4 • 93 months from October 2013 until July 2021
One participant expired unrelated to the clinical trial treatment
|
|
Reproductive system and breast disorders
Pelvic pain
|
1.6%
1/62 • Number of events 1 • 93 months from October 2013 until July 2021
One participant expired unrelated to the clinical trial treatment
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
1.6%
1/62 • Number of events 2 • 93 months from October 2013 until July 2021
One participant expired unrelated to the clinical trial treatment
|
|
Infections and infestations
Pharyngitis
|
1.6%
1/62 • Number of events 2 • 93 months from October 2013 until July 2021
One participant expired unrelated to the clinical trial treatment
|
|
Investigations
Platelet count decreased
|
35.5%
22/62 • Number of events 32 • 93 months from October 2013 until July 2021
One participant expired unrelated to the clinical trial treatment
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
9.7%
6/62 • Number of events 9 • 93 months from October 2013 until July 2021
One participant expired unrelated to the clinical trial treatment
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
1.6%
1/62 • Number of events 1 • 93 months from October 2013 until July 2021
One participant expired unrelated to the clinical trial treatment
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
1.6%
1/62 • Number of events 1 • 93 months from October 2013 until July 2021
One participant expired unrelated to the clinical trial treatment
|
|
Renal and urinary disorders
Proteinuria
|
1.6%
1/62 • Number of events 1 • 93 months from October 2013 until July 2021
One participant expired unrelated to the clinical trial treatment
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
3.2%
2/62 • Number of events 2 • 93 months from October 2013 until July 2021
One participant expired unrelated to the clinical trial treatment
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
4.8%
3/62 • Number of events 5 • 93 months from October 2013 until July 2021
One participant expired unrelated to the clinical trial treatment
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
3.2%
2/62 • Number of events 2 • 93 months from October 2013 until July 2021
One participant expired unrelated to the clinical trial treatment
|
|
Skin and subcutaneous tissue disorders
Rash pustular
|
1.6%
1/62 • Number of events 1 • 93 months from October 2013 until July 2021
One participant expired unrelated to the clinical trial treatment
|
|
Renal and urinary disorders
Renal and urinary disorders - Other, elevated BUN
|
3.2%
2/62 • Number of events 2 • 93 months from October 2013 until July 2021
One participant expired unrelated to the clinical trial treatment
|
|
Renal and urinary disorders
Renal and urinary disorders - Other, lowered GFR
|
3.2%
2/62 • Number of events 5 • 93 months from October 2013 until July 2021
One participant expired unrelated to the clinical trial treatment
|
|
Renal and urinary disorders
Renal and urinary disorders - Other, decreased creatinine
|
1.6%
1/62 • Number of events 2 • 93 months from October 2013 until July 2021
One participant expired unrelated to the clinical trial treatment
|
|
Reproductive system and breast disorders
Reproductive system - Other, labial mucositis
|
1.6%
1/62 • Number of events 1 • 93 months from October 2013 until July 2021
One participant expired unrelated to the clinical trial treatment
|
|
Reproductive system and breast disorders
Reproductive system - Other, vulvar blisters
|
1.6%
1/62 • Number of events 1 • 93 months from October 2013 until July 2021
One participant expired unrelated to the clinical trial treatment
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory disorders - Other, mucositis, nares
|
1.6%
1/62 • Number of events 1 • 93 months from October 2013 until July 2021
One participant expired unrelated to the clinical trial treatment
|
|
Gastrointestinal disorders
Dyspepsia
|
1.6%
1/62 • Number of events 1 • 93 months from October 2013 until July 2021
One participant expired unrelated to the clinical trial treatment
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
19.4%
12/62 • Number of events 16 • 93 months from October 2013 until July 2021
One participant expired unrelated to the clinical trial treatment
|
|
General disorders
Edema - limbs
|
9.7%
6/62 • Number of events 9 • 93 months from October 2013 until July 2021
One participant expired unrelated to the clinical trial treatment
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
4.8%
3/62 • Number of events 4 • 93 months from October 2013 until July 2021
One participant expired unrelated to the clinical trial treatment
|
|
Eye disorders
Eye disorder - tunnel vision
|
1.6%
1/62 • Number of events 1 • 93 months from October 2013 until July 2021
One participant expired unrelated to the clinical trial treatment
|
|
Eye disorders
Eye disorder - change in vision
|
1.6%
1/62 • Number of events 1 • 93 months from October 2013 until July 2021
One participant expired unrelated to the clinical trial treatment
|
|
Eye disorders
Eye disorder - lump and swelling on eyelid
|
1.6%
1/62 • Number of events 1 • 93 months from October 2013 until July 2021
One participant expired unrelated to the clinical trial treatment
|
|
Eye disorders
Eye disorder - dark spot in vision
|
1.6%
1/62 • Number of events 1 • 93 months from October 2013 until July 2021
One participant expired unrelated to the clinical trial treatment
|
|
General disorders
Fatigue
|
45.2%
28/62 • Number of events 46 • 93 months from October 2013 until July 2021
One participant expired unrelated to the clinical trial treatment
|
|
General disorders
Fever
|
6.5%
4/62 • Number of events 4 • 93 months from October 2013 until July 2021
One participant expired unrelated to the clinical trial treatment
|
|
Gastrointestinal disorders
Flatulence
|
1.6%
1/62 • Number of events 1 • 93 months from October 2013 until July 2021
One participant expired unrelated to the clinical trial treatment
|
|
General disorders
Flu like symptoms
|
6.5%
4/62 • Number of events 13 • 93 months from October 2013 until July 2021
One participant expired unrelated to the clinical trial treatment
|
|
General disorders
Gait disturbance
|
1.6%
1/62 • Number of events 1 • 93 months from October 2013 until July 2021
One participant expired unrelated to the clinical trial treatment
|
|
Gastrointestinal disorders
Gastric fistula
|
1.6%
1/62 • Number of events 1 • 93 months from October 2013 until July 2021
One participant expired unrelated to the clinical trial treatment
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
1.6%
1/62 • Number of events 1 • 93 months from October 2013 until July 2021
One participant expired unrelated to the clinical trial treatment
|
|
Gastrointestinal disorders
Gastrointestinal disorders - heartburn
|
1.6%
1/62 • Number of events 1 • 93 months from October 2013 until July 2021
One participant expired unrelated to the clinical trial treatment
|
|
Gastrointestinal disorders
Gastrointestinal disorders - blister on tongue
|
1.6%
1/62 • Number of events 1 • 93 months from October 2013 until July 2021
One participant expired unrelated to the clinical trial treatment
|
|
Gastrointestinal disorders
Gastrointestinal disorders - mouth ulcers
|
8.1%
5/62 • Number of events 6 • 93 months from October 2013 until July 2021
One participant expired unrelated to the clinical trial treatment
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
1.6%
1/62 • Number of events 1 • 93 months from October 2013 until July 2021
One participant expired unrelated to the clinical trial treatment
|
|
General disorders
Night sweats
|
1.6%
1/62 • Number of events 1 • 93 months from October 2013 until July 2021
One participant expired unrelated to the clinical trial treatment
|
|
General disorders
Sore fingernails & toes
|
1.6%
1/62 • Number of events 1 • 93 months from October 2013 until July 2021
One participant expired unrelated to the clinical trial treatment
|
|
Nervous system disorders
Headache
|
9.7%
6/62 • Number of events 6 • 93 months from October 2013 until July 2021
One participant expired unrelated to the clinical trial treatment
|
|
Renal and urinary disorders
Hemoglobinuria
|
1.6%
1/62 • Number of events 1 • 93 months from October 2013 until July 2021
One participant expired unrelated to the clinical trial treatment
|
|
Gastrointestinal disorders
Hemorrhoidal hemorrhage
|
1.6%
1/62 • Number of events 1 • 93 months from October 2013 until July 2021
One participant expired unrelated to the clinical trial treatment
|
|
Vascular disorders
Hot flashes
|
1.6%
1/62 • Number of events 1 • 93 months from October 2013 until July 2021
One participant expired unrelated to the clinical trial treatment
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
3.2%
2/62 • Number of events 2 • 93 months from October 2013 until July 2021
One participant expired unrelated to the clinical trial treatment
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
35.5%
22/62 • Number of events 41 • 93 months from October 2013 until July 2021
One participant expired unrelated to the clinical trial treatment
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
6.5%
4/62 • Number of events 4 • 93 months from October 2013 until July 2021
One participant expired unrelated to the clinical trial treatment
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
1.6%
1/62 • Number of events 1 • 93 months from October 2013 until July 2021
One participant expired unrelated to the clinical trial treatment
|
|
Vascular disorders
Hypertension
|
9.7%
6/62 • Number of events 11 • 93 months from October 2013 until July 2021
One participant expired unrelated to the clinical trial treatment
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
45.2%
28/62 • Number of events 58 • 93 months from October 2013 until July 2021
One participant expired unrelated to the clinical trial treatment
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
3.2%
2/62 • Number of events 2 • 93 months from October 2013 until July 2021
One participant expired unrelated to the clinical trial treatment
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
1.6%
1/62 • Number of events 1 • 93 months from October 2013 until July 2021
One participant expired unrelated to the clinical trial treatment
|
|
Metabolism and nutrition disorders
Hypokalemia
|
11.3%
7/62 • Number of events 8 • 93 months from October 2013 until July 2021
One participant expired unrelated to the clinical trial treatment
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
25.8%
16/62 • Number of events 24 • 93 months from October 2013 until July 2021
One participant expired unrelated to the clinical trial treatment
|
|
Metabolism and nutrition disorders
Hyponatremia
|
4.8%
3/62 • Number of events 6 • 93 months from October 2013 until July 2021
One participant expired unrelated to the clinical trial treatment
|
|
Vascular disorders
Hypotension
|
1.6%
1/62 • Number of events 2 • 93 months from October 2013 until July 2021
One participant expired unrelated to the clinical trial treatment
|
|
Infections and infestations
Infections and infestations - other, cellulitis
|
1.6%
1/62 • Number of events 1 • 93 months from October 2013 until July 2021
One participant expired unrelated to the clinical trial treatment
|
|
Gastrointestinal disorders
Abdominal pain
|
9.7%
6/62 • Number of events 7 • 93 months from October 2013 until July 2021
One participant expired unrelated to the clinical trial treatment
|
|
Investigations
Alanine aminotransferase increased
|
40.3%
25/62 • Number of events 38 • 93 months from October 2013 until July 2021
One participant expired unrelated to the clinical trial treatment
|
|
Investigations
Alkaline phosphatase increased
|
9.7%
6/62 • Number of events 7 • 93 months from October 2013 until July 2021
One participant expired unrelated to the clinical trial treatment
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
1.6%
1/62 • Number of events 1 • 93 months from October 2013 until July 2021
One participant expired unrelated to the clinical trial treatment
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
4.8%
3/62 • Number of events 3 • 93 months from October 2013 until July 2021
One participant expired unrelated to the clinical trial treatment
|
|
Blood and lymphatic system disorders
Anemia
|
53.2%
33/62 • Number of events 66 • 93 months from October 2013 until July 2021
One participant expired unrelated to the clinical trial treatment
|
|
Metabolism and nutrition disorders
Anorexia
|
19.4%
12/62 • Number of events 16 • 93 months from October 2013 until July 2021
One participant expired unrelated to the clinical trial treatment
|
|
Psychiatric disorders
Anxiety
|
6.5%
4/62 • Number of events 4 • 93 months from October 2013 until July 2021
One participant expired unrelated to the clinical trial treatment
|
|
Investigations
Aspartate aminotransferase increased
|
40.3%
25/62 • Number of events 41 • 93 months from October 2013 until July 2021
One participant expired unrelated to the clinical trial treatment
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.6%
1/62 • Number of events 1 • 93 months from October 2013 until July 2021
One participant expired unrelated to the clinical trial treatment
|
|
Gastrointestinal disorders
Bloating
|
3.2%
2/62 • Number of events 3 • 93 months from October 2013 until July 2021
One participant expired unrelated to the clinical trial treatment
|
|
Eye disorders
Blurred vision
|
6.5%
4/62 • Number of events 6 • 93 months from October 2013 until July 2021
One participant expired unrelated to the clinical trial treatment
|
|
Injury, poisoning and procedural complications
Bruising
|
1.6%
1/62 • Number of events 1 • 93 months from October 2013 until July 2021
One participant expired unrelated to the clinical trial treatment
|
|
General disorders
Chills
|
1.6%
1/62 • Number of events 1 • 93 months from October 2013 until July 2021
One participant expired unrelated to the clinical trial treatment
|
|
Investigations
Cholesterol high
|
37.1%
23/62 • Number of events 31 • 93 months from October 2013 until July 2021
One participant expired unrelated to the clinical trial treatment
|
|
Renal and urinary disorders
Chronic kidney disease
|
1.6%
1/62 • Number of events 1 • 93 months from October 2013 until July 2021
One participant expired unrelated to the clinical trial treatment
|
|
Gastrointestinal disorders
Constipation
|
4.8%
3/62 • Number of events 3 • 93 months from October 2013 until July 2021
One participant expired unrelated to the clinical trial treatment
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
6.5%
4/62 • Number of events 5 • 93 months from October 2013 until July 2021
One participant expired unrelated to the clinical trial treatment
|
|
Investigations
Creatinine increased
|
27.4%
17/62 • Number of events 29 • 93 months from October 2013 until July 2021
One participant expired unrelated to the clinical trial treatment
|
|
Metabolism and nutrition disorders
Dehydration
|
3.2%
2/62 • Number of events 3 • 93 months from October 2013 until July 2021
One participant expired unrelated to the clinical trial treatment
|
|
Psychiatric disorders
Depression
|
3.2%
2/62 • Number of events 2 • 93 months from October 2013 until July 2021
One participant expired unrelated to the clinical trial treatment
|
|
Gastrointestinal disorders
Diarrhea
|
53.2%
33/62 • Number of events 45 • 93 months from October 2013 until July 2021
One participant expired unrelated to the clinical trial treatment
|
|
Nervous system disorders
Dizziness
|
16.1%
10/62 • Number of events 12 • 93 months from October 2013 until July 2021
One participant expired unrelated to the clinical trial treatment
|
|
Eye disorders
Dry Eye
|
1.6%
1/62 • Number of events 1 • 93 months from October 2013 until July 2021
One participant expired unrelated to the clinical trial treatment
|
|
Gastrointestinal disorders
Dry mouth
|
3.2%
2/62 • Number of events 2 • 93 months from October 2013 until July 2021
One participant expired unrelated to the clinical trial treatment
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
9.7%
6/62 • Number of events 8 • 93 months from October 2013 until July 2021
One participant expired unrelated to the clinical trial treatment
|
|
Nervous system disorders
Dysgeusia
|
17.7%
11/62 • Number of events 11 • 93 months from October 2013 until July 2021
One participant expired unrelated to the clinical trial treatment
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory disorders - Other, nasal sores w mild bleeding
|
1.6%
1/62 • Number of events 1 • 93 months from October 2013 until July 2021
One participant expired unrelated to the clinical trial treatment
|
|
Infections and infestations
Sinusitis
|
3.2%
2/62 • Number of events 2 • 93 months from October 2013 until July 2021
One participant expired unrelated to the clinical trial treatment
|
|
Skin and subcutaneous tissue disorders
Skin & subcutaneous tissue disorders - Other, mild skin rash, no pustules
|
1.6%
1/62 • Number of events 1 • 93 months from October 2013 until July 2021
One participant expired unrelated to the clinical trial treatment
|
|
Skin and subcutaneous tissue disorders
Skin & subcutaneous tissue disorders - Other, brittle, weak, cracking fingernails
|
1.6%
1/62 • Number of events 1 • 93 months from October 2013 until July 2021
One participant expired unrelated to the clinical trial treatment
|
|
Skin and subcutaneous tissue disorders
Skin & subcutaneous tissue disorders - Other, rash, not specified
|
11.3%
7/62 • Number of events 7 • 93 months from October 2013 until July 2021
One participant expired unrelated to the clinical trial treatment
|
|
Skin and subcutaneous tissue disorders
Skin & subcutaneous tissue disorders - Other, urethral tear
|
1.6%
1/62 • Number of events 1 • 93 months from October 2013 until July 2021
One participant expired unrelated to the clinical trial treatment
|
|
Skin and subcutaneous tissue disorders
Skin & subcutaneous tissue disorders - Other, R flank pimple
|
1.6%
1/62 • Number of events 1 • 93 months from October 2013 until July 2021
One participant expired unrelated to the clinical trial treatment
|
|
Infections and infestations
Skin infection
|
3.2%
2/62 • Number of events 2 • 93 months from October 2013 until July 2021
One participant expired unrelated to the clinical trial treatment
|
|
Skin and subcutaneous tissue disorders
Skin ulceration
|
3.2%
2/62 • Number of events 3 • 93 months from October 2013 until July 2021
One participant expired unrelated to the clinical trial treatment
|
|
Gastrointestinal disorders
Stomach pain
|
1.6%
1/62 • Number of events 1 • 93 months from October 2013 until July 2021
One participant expired unrelated to the clinical trial treatment
|
|
Vascular disorders
Thromboembolic event
|
4.8%
3/62 • Number of events 3 • 93 months from October 2013 until July 2021
One participant expired unrelated to the clinical trial treatment
|
|
Nervous system disorders
Tremor
|
4.8%
3/62 • Number of events 3 • 93 months from October 2013 until July 2021
One participant expired unrelated to the clinical trial treatment
|
|
Infections and infestations
Upper respiratory infection
|
3.2%
2/62 • Number of events 2 • 93 months from October 2013 until July 2021
One participant expired unrelated to the clinical trial treatment
|
|
Renal and urinary disorders
Urinary incontinence
|
1.6%
1/62 • Number of events 1 • 93 months from October 2013 until July 2021
One participant expired unrelated to the clinical trial treatment
|
|
Infections and infestations
Urinary tract infection
|
6.5%
4/62 • Number of events 4 • 93 months from October 2013 until July 2021
One participant expired unrelated to the clinical trial treatment
|
|
Renal and urinary disorders
Urinary tract pain
|
1.6%
1/62 • Number of events 1 • 93 months from October 2013 until July 2021
One participant expired unrelated to the clinical trial treatment
|
|
Renal and urinary disorders
Urinary urgency
|
1.6%
1/62 • Number of events 1 • 93 months from October 2013 until July 2021
One participant expired unrelated to the clinical trial treatment
|
|
Reproductive system and breast disorders
Vaginal hemorrhage
|
1.6%
1/62 • Number of events 3 • 93 months from October 2013 until July 2021
One participant expired unrelated to the clinical trial treatment
|
|
Infections and infestations
Vaginal infection
|
3.2%
2/62 • Number of events 2 • 93 months from October 2013 until July 2021
One participant expired unrelated to the clinical trial treatment
|
|
Vascular disorders
Vascular disorders - Other, night sweats
|
1.6%
1/62 • Number of events 1 • 93 months from October 2013 until July 2021
One participant expired unrelated to the clinical trial treatment
|
|
Gastrointestinal disorders
Vomiting
|
17.7%
11/62 • Number of events 15 • 93 months from October 2013 until July 2021
One participant expired unrelated to the clinical trial treatment
|
|
Investigations
Weight loss
|
11.3%
7/62 • Number of events 10 • 93 months from October 2013 until July 2021
One participant expired unrelated to the clinical trial treatment
|
|
Investigations
White blood cell decreased
|
30.6%
19/62 • Number of events 38 • 93 months from October 2013 until July 2021
One participant expired unrelated to the clinical trial treatment
|
Additional Information
Pamela T. Soliman, MD, MPH
The University of Texas MD Anderson Cancer Center
Phone: (713) 745-2352
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place