Trial Outcomes & Findings for Nintedanib in Treating Patients With Recurrent or Persistent Endometrial Cancer (NCT NCT01225887)
NCT ID: NCT01225887
Last Updated: 2017-10-09
Results Overview
The incidence of adverse events (grade 3 or higher) as assessed by the National Cancer Institute CTCAE version 4.0
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
37 participants
Primary outcome timeframe
Up to 5 years
Results posted on
2017-10-09
Participant Flow
Participant milestones
| Measure |
Treatment (Nintedanib)
Patients receive nintedanib PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Nintedanib: Given PO
|
|---|---|
|
Overall Study
STARTED
|
37
|
|
Overall Study
COMPLETED
|
32
|
|
Overall Study
NOT COMPLETED
|
5
|
Reasons for withdrawal
| Measure |
Treatment (Nintedanib)
Patients receive nintedanib PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Nintedanib: Given PO
|
|---|---|
|
Overall Study
Ineligible:required test not done
|
2
|
|
Overall Study
Ineligible;improper pre-protocol therapy
|
1
|
|
Overall Study
Ineligible:inadequate pathology
|
2
|
Baseline Characteristics
Nintedanib in Treating Patients With Recurrent or Persistent Endometrial Cancer
Baseline characteristics by cohort
| Measure |
Treatment (Nintedanib)
n=32 Participants
Patients receive nintedanib PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Nintedanib: Given PO
|
|---|---|
|
Age, Continuous
|
67.1 years
STANDARD_DEVIATION 9.8 • n=5 Participants
|
|
Age, Customized
30-39 years
|
1 Participants
n=5 Participants
|
|
Age, Customized
50-59 years
|
4 Participants
n=5 Participants
|
|
Age, Customized
60-69 years
|
14 Participants
n=5 Participants
|
|
Age, Customized
70-79 years
|
10 Participants
n=5 Participants
|
|
Age, Customized
80-89 years
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
32 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 5 yearsPopulation: Patients on study who experienced adverse events (Grade 3 or higher)
The incidence of adverse events (grade 3 or higher) as assessed by the National Cancer Institute CTCAE version 4.0
Outcome measures
| Measure |
Treatment (Nintedanib)
n=32 Participants
Patients receive nintedanib PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Nintedanib: Given PO
|
|---|---|
|
Number of Participants With Adverse Events
Leukopenia
|
1 Participants
|
|
Number of Participants With Adverse Events
Neutropenia
|
1 Participants
|
|
Number of Participants With Adverse Events
Anemia
|
2 Participants
|
|
Number of Participants With Adverse Events
Other Investigations
|
4 Participants
|
|
Number of Participants With Adverse Events
Nausea
|
2 Participants
|
|
Number of Participants With Adverse Events
Vomiting
|
2 Participants
|
|
Number of Participants With Adverse Events
Other Gastrointestinal
|
6 Participants
|
|
Number of Participants With Adverse Events
General & Administration site
|
3 Participants
|
|
Number of Participants With Adverse Events
Infections/infestations
|
1 Participants
|
|
Number of Participants With Adverse Events
Metabolism/nutrition
|
1 Participants
|
|
Number of Participants With Adverse Events
Musculoskeletal/connective tissue
|
2 Participants
|
|
Number of Participants With Adverse Events
Psychiatric
|
2 Participants
|
|
Number of Participants With Adverse Events
Renal/Urinary
|
4 Participants
|
|
Number of Participants With Adverse Events
Respiratory/thoracic/mediastinal
|
2 Participants
|
|
Number of Participants With Adverse Events
Vascular Disorders
|
1 Participants
|
PRIMARY outcome
Timeframe: For disease that can be evaluated by physical exam,response was assessed prior to each cycle CT scan or MRI if used to follow lesion for measurable disease every other cycle up to 5 years.Population: Eligible and Treated Patients
Complete and Partial Tumor Response by RECIST 1.1
Outcome measures
| Measure |
Treatment (Nintedanib)
n=32 Participants
Patients receive nintedanib PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Nintedanib: Given PO
|
|---|---|
|
Objective Tumor Response
|
9.4 percentage of participants
Interval 3.0 to 22.0
|
PRIMARY outcome
Timeframe: for disease that can be evaluated by physical exam, progression was assessed prior to each cycle. CT scan or MRI if used to follow lesion for measurable disease every other cycle up to 5 years.Population: Eligible and Treated Patients
Whether or not the patient survived progression-free for at least 6 months.
Outcome measures
| Measure |
Treatment (Nintedanib)
n=32 Participants
Patients receive nintedanib PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Nintedanib: Given PO
|
|---|---|
|
Progression-free Survival > 6 Months
|
21.9 percentage of participants
Interval 11.0 to 37.0
|
SECONDARY outcome
Timeframe: From study entry to death or last contact, up to 5 yearsPopulation: Eligible and treated patients
The observed length of life from entry into the study to death or the date of last contact.
Outcome measures
| Measure |
Treatment (Nintedanib)
n=32 Participants
Patients receive nintedanib PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Nintedanib: Given PO
|
|---|---|
|
Overall Survival
|
10.1 months
Interval 5.5 to 14.0
|
SECONDARY outcome
Timeframe: The duration of time from study entry to time of progression or death, whichever occurs first, assessed up to 5 yearsPopulation: The time in months that a patient survived progression-free.
the period of progression free survival for patients with persistent or recurrent endometrial cancer treated with study drug.
Outcome measures
| Measure |
Treatment (Nintedanib)
n=32 Participants
Patients receive nintedanib PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Nintedanib: Given PO
|
|---|---|
|
Progression Free Survival
|
3.3 months
Interval 1.9 to 3.8
|
Adverse Events
Treatment (Nintedanib)
Serious events: 14 serious events
Other events: 32 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Treatment (Nintedanib)
n=32 participants at risk
Patients receive nintedanib PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Nintedanib: Given PO
|
|---|---|
|
Gastrointestinal disorders
Colonic Obstruction
|
3.1%
1/32 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Gastrointestinal disorders
Diarrhea
|
3.1%
1/32 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Gastrointestinal disorders
Nausea
|
3.1%
1/32 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Gastrointestinal disorders
Ascites
|
3.1%
1/32 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Gastrointestinal disorders
Jejunal Obstruction
|
3.1%
1/32 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
General disorders
Fever
|
3.1%
1/32 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Infections and infestations
Kidney Infection
|
3.1%
1/32 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Investigations
Aspartate Aminotransferase Increased
|
3.1%
1/32 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Investigations
Alanine Aminotransferase Increased
|
3.1%
1/32 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Musculoskeletal and connective tissue disorders
Flank Pain
|
3.1%
1/32 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Renal and urinary disorders
Urinary Tract Obstruction
|
3.1%
1/32 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Renal and urinary disorders
Acute Kidney Injury
|
3.1%
1/32 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
3.1%
1/32 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Vascular disorders
Thromboembolic Event
|
6.2%
2/32 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Vascular disorders
Hypertension
|
3.1%
1/32 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
Other adverse events
| Measure |
Treatment (Nintedanib)
n=32 participants at risk
Patients receive nintedanib PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Nintedanib: Given PO
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
46.9%
15/32 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Cardiac disorders
Cardiac Disorders - Other
|
3.1%
1/32 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Cardiac disorders
Sinus Tachycardia
|
6.2%
2/32 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Ear and labyrinth disorders
Tinnitus
|
6.2%
2/32 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Eye disorders
Glaucoma
|
3.1%
1/32 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Gastrointestinal disorders
Dyspepsia
|
3.1%
1/32 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Gastrointestinal disorders
Dry Mouth
|
6.2%
2/32 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Gastrointestinal disorders
Colonic Hemorrhage
|
3.1%
1/32 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Gastrointestinal disorders
Constipation
|
18.8%
6/32 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Gastrointestinal disorders
Diarrhea
|
65.6%
21/32 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Gastrointestinal disorders
Vomiting
|
40.6%
13/32 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Gastrointestinal disorders
Abdominal Pain
|
40.6%
13/32 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Gastrointestinal disorders
Rectal Hemorrhage
|
3.1%
1/32 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Gastrointestinal disorders
Abdominal Distension
|
9.4%
3/32 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Gastrointestinal disorders
Nausea
|
65.6%
21/32 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Gastrointestinal disorders
Ascites
|
3.1%
1/32 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Gastrointestinal disorders
Flatulence
|
6.2%
2/32 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Gastrointestinal disorders
Gastritis
|
3.1%
1/32 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
General disorders
Pain
|
12.5%
4/32 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
General disorders
Malaise
|
3.1%
1/32 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
General disorders
Non-Cardiac Chest Pain
|
3.1%
1/32 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
General disorders
Edema Limbs
|
9.4%
3/32 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
General disorders
Fatigue
|
56.2%
18/32 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
General disorders
Fever
|
3.1%
1/32 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Hepatobiliary disorders
Portal Vein Thrombosis
|
3.1%
1/32 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Infections and infestations
Upper Respiratory Infection
|
3.1%
1/32 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Infections and infestations
Skin Infection
|
3.1%
1/32 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Infections and infestations
Esophageal Infection
|
3.1%
1/32 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Infections and infestations
Urinary Tract Infection
|
3.1%
1/32 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Investigations
Weight Loss
|
12.5%
4/32 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Investigations
Platelet Count Decreased
|
9.4%
3/32 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Investigations
Lymphocyte Count Decreased
|
6.2%
2/32 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Investigations
Inr Increased
|
6.2%
2/32 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Investigations
Ggt Increased
|
3.1%
1/32 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Investigations
Creatinine Increased
|
12.5%
4/32 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Investigations
Cholesterol High
|
3.1%
1/32 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Investigations
Neutrophil Count Decreased
|
12.5%
4/32 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Investigations
Blood Bilirubin Increased
|
6.2%
2/32 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Investigations
White Blood Cell Decreased
|
18.8%
6/32 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Investigations
Aspartate Aminotransferase Increased
|
40.6%
13/32 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Investigations
Alkaline Phosphatase Increased
|
34.4%
11/32 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Investigations
Alanine Aminotransferase Increased
|
40.6%
13/32 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
3.1%
1/32 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
12.5%
4/32 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
18.8%
6/32 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
21.9%
7/32 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
3.1%
1/32 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
12.5%
4/32 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
15.6%
5/32 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
3.1%
1/32 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
3.1%
1/32 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Metabolism and nutrition disorders
Hypernatremia
|
3.1%
1/32 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
28.1%
9/32 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Metabolism and nutrition disorders
Dehydration
|
6.2%
2/32 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Metabolism and nutrition disorders
Anorexia
|
31.2%
10/32 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Metabolism and nutrition disorders
Acidosis
|
3.1%
1/32 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Musculoskeletal and connective tissue disorders
Pain In Extremity
|
9.4%
3/32 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
3.1%
1/32 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Musculoskeletal and connective tissue disorders
Generalized Muscle Weakness
|
3.1%
1/32 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Musculoskeletal and connective tissue disorders
Flank Pain
|
3.1%
1/32 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Musculoskeletal and connective tissue disorders
Bone Pain
|
3.1%
1/32 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
12.5%
4/32 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Nervous system disorders
Peripheral Sensory Neuropathy
|
15.6%
5/32 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Nervous system disorders
Memory Impairment
|
3.1%
1/32 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Nervous system disorders
Headache
|
21.9%
7/32 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Nervous system disorders
Dysgeusia
|
6.2%
2/32 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Nervous system disorders
Dizziness
|
6.2%
2/32 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Psychiatric disorders
Insomnia
|
12.5%
4/32 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Psychiatric disorders
Depression
|
15.6%
5/32 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Psychiatric disorders
Confusion
|
3.1%
1/32 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Psychiatric disorders
Anxiety
|
6.2%
2/32 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Renal and urinary disorders
Urinary Urgency
|
3.1%
1/32 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Renal and urinary disorders
Urinary Frequency
|
6.2%
2/32 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Renal and urinary disorders
Proteinuria
|
3.1%
1/32 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Renal and urinary disorders
Hematuria
|
15.6%
5/32 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Renal and urinary disorders
Acute Kidney Injury
|
6.2%
2/32 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Reproductive system and breast disorders
Vaginal Hemorrhage
|
6.2%
2/32 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Reproductive system and breast disorders
Dyspareunia
|
3.1%
1/32 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Sore Throat
|
3.1%
1/32 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal Drip
|
6.2%
2/32 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
3.1%
1/32 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
6.2%
2/32 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
12.5%
4/32 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
18.8%
6/32 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Allergic Rhinitis
|
3.1%
1/32 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Adult Respiratory Distress Syndrome
|
3.1%
1/32 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Skin and subcutaneous tissue disorders
Skin Hyperpigmentation
|
3.1%
1/32 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Skin and subcutaneous tissue disorders
Rash Acneiform
|
3.1%
1/32 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
6.2%
2/32 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Skin and subcutaneous tissue disorders
Rash Maculo-Papular
|
3.1%
1/32 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
3.1%
1/32 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Vascular disorders
Thromboembolic Event
|
6.2%
2/32 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Vascular disorders
Lymphedema
|
3.1%
1/32 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
|
Vascular disorders
Hypertension
|
15.6%
5/32 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place