Trial Outcomes & Findings for Study of Pasireotide Long Acting Release (LAR) in Patients With Metastatic Neuroendocrine Tumors (NETs) (NCT NCT01253161)
NCT ID: NCT01253161
Last Updated: 2023-03-06
Results Overview
PFS: Defined as the time from the date of first study treatment to the date of the first documented disease progression, by Response Evaluation Criteria in Solid Tumors (RECIST 1.0) guidelines, or death due to any cause. Progressive Disease (PD): at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
29 participants
Primary outcome timeframe
12 months
Results posted on
2023-03-06
Participant Flow
Participant milestones
| Measure |
Pasireotide LAR Treatment
The investigational drug used in this study is pasireotide long acting release (LAR) 60 mg.
Pasireotide Long Acting Release (LAR): Pasireotide will be administered as an intramuscular injection at the beginning of every cycle which is defined as 28 days (+/- 3 days). Study treatment should begin within 14 days following enrollment into the study and continue until disease progression, unacceptable toxicity, or withdrawal of consent.
|
|---|---|
|
Overall Study
STARTED
|
29
|
|
Overall Study
COMPLETED
|
28
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Pasireotide LAR Treatment
The investigational drug used in this study is pasireotide long acting release (LAR) 60 mg.
Pasireotide Long Acting Release (LAR): Pasireotide will be administered as an intramuscular injection at the beginning of every cycle which is defined as 28 days (+/- 3 days). Study treatment should begin within 14 days following enrollment into the study and continue until disease progression, unacceptable toxicity, or withdrawal of consent.
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|---|---|
|
Overall Study
Adverse Event
|
1
|
Baseline Characteristics
Study of Pasireotide Long Acting Release (LAR) in Patients With Metastatic Neuroendocrine Tumors (NETs)
Baseline characteristics by cohort
| Measure |
Pasireotide LAR Treatment
n=29 Participants
The investigational drug used in this study is pasireotide long acting release (LAR) 60 mg.
Pasireotide Long Acting Release (LAR): Pasireotide will be administered as an intramuscular injection at the beginning of every cycle which is defined as 28 days (+/- 3 days). Study treatment should begin within 14 days following enrollment into the study and continue until disease progression, unacceptable toxicity, or withdrawal of consent.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
22 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
7 Participants
n=99 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
25 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
23 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
29 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: Evaluable participants
PFS: Defined as the time from the date of first study treatment to the date of the first documented disease progression, by Response Evaluation Criteria in Solid Tumors (RECIST 1.0) guidelines, or death due to any cause. Progressive Disease (PD): at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions.
Outcome measures
| Measure |
Pasireotide LAR Treatment
n=28 Participants
The investigational drug used in this study is pasireotide long acting release (LAR) 60 mg.
Pasireotide Long Acting Release (LAR): Pasireotide will be administered as an intramuscular injection at the beginning of every cycle which is defined as 28 days (+/- 3 days). Study treatment should begin within 14 days following enrollment into the study and continue until disease progression, unacceptable toxicity, or withdrawal of consent.
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|---|---|
|
Progression-free Survival (PFS) at One Year
|
11 months
Interval 7.6 to 16.0
|
SECONDARY outcome
Timeframe: Up to 48 monthsPopulation: evaluable participants
Complete response (CR): complete disappearance of all target lesions, confirmed by repeat assessments at no less than 4 weeks after the criteria for response are first met. Partial response (PR): at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter. This must be confirmed by repeat assessment at no less than 4 weeks after the criteria for response are first met. Stable Disease (SD): neither sufficient decrease to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum longest diameter since the treatment started.
Outcome measures
| Measure |
Pasireotide LAR Treatment
n=28 Participants
The investigational drug used in this study is pasireotide long acting release (LAR) 60 mg.
Pasireotide Long Acting Release (LAR): Pasireotide will be administered as an intramuscular injection at the beginning of every cycle which is defined as 28 days (+/- 3 days). Study treatment should begin within 14 days following enrollment into the study and continue until disease progression, unacceptable toxicity, or withdrawal of consent.
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|---|---|
|
Overall Radiographic Response Rate (ORR)
Partial Response
|
4 percentage of participants
|
|
Overall Radiographic Response Rate (ORR)
Stable Disease
|
60 percentage of participants
|
|
Overall Radiographic Response Rate (ORR)
Progressive Disease
|
36 percentage of participants
|
SECONDARY outcome
Timeframe: Up to 48 monthsPopulation: All participants who received at least one dose of study drug
Adverse Events (AEs) and Serious Adverse Events (SAEs) will be evaluated continuously throughout the study. Safety and tolerability will be assessed according to the NIH/NCI Common Terminology Criteria for Adverse Events version 4.0 (CTCAE v4.0).
Outcome measures
| Measure |
Pasireotide LAR Treatment
n=29 Participants
The investigational drug used in this study is pasireotide long acting release (LAR) 60 mg.
Pasireotide Long Acting Release (LAR): Pasireotide will be administered as an intramuscular injection at the beginning of every cycle which is defined as 28 days (+/- 3 days). Study treatment should begin within 14 days following enrollment into the study and continue until disease progression, unacceptable toxicity, or withdrawal of consent.
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|---|---|
|
Adverse Events Possibly Related to Study Treatment
|
42 events
|
Adverse Events
Pasireotide LAR Treatment
Serious events: 12 serious events
Other events: 28 other events
Deaths: 6 deaths
Serious adverse events
| Measure |
Pasireotide LAR Treatment
n=29 participants at risk
The investigational drug used in this study is pasireotide long acting release (LAR) 60 mg.
Pasireotide Long Acting Release (LAR): Pasireotide will be administered as an intramuscular injection at the beginning of every cycle which is defined as 28 days (+/- 3 days). Study treatment should begin within 14 days following enrollment into the study and continue until disease progression, unacceptable toxicity, or withdrawal of consent.
|
|---|---|
|
Investigations
Platelet count decreased
|
3.4%
1/29 • Number of events 1 • Adverse events collected for 28 days after last dose of study drug, up to 60 months.
|
|
Infections and infestations
Kidney infection
|
3.4%
1/29 • Number of events 1 • Adverse events collected for 28 days after last dose of study drug, up to 60 months.
|
|
Infections and infestations
Skin infection
|
3.4%
1/29 • Number of events 1 • Adverse events collected for 28 days after last dose of study drug, up to 60 months.
|
|
Cardiac disorders
Cardiac Disorders - Other
|
3.4%
1/29 • Number of events 1 • Adverse events collected for 28 days after last dose of study drug, up to 60 months.
|
|
Gastrointestinal disorders
Dueodenal obstruction
|
3.4%
1/29 • Number of events 1 • Adverse events collected for 28 days after last dose of study drug, up to 60 months.
|
|
Infections and infestations
Lung infection
|
3.4%
1/29 • Number of events 1 • Adverse events collected for 28 days after last dose of study drug, up to 60 months.
|
|
Cardiac disorders
Sinus tachycardia
|
3.4%
1/29 • Number of events 1 • Adverse events collected for 28 days after last dose of study drug, up to 60 months.
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other
|
3.4%
1/29 • Number of events 1 • Adverse events collected for 28 days after last dose of study drug, up to 60 months.
|
|
Gastrointestinal disorders
Nausea
|
6.9%
2/29 • Number of events 2 • Adverse events collected for 28 days after last dose of study drug, up to 60 months.
|
|
Gastrointestinal disorders
Anorexia
|
3.4%
1/29 • Number of events 1 • Adverse events collected for 28 days after last dose of study drug, up to 60 months.
|
|
Gastrointestinal disorders
Abdominal pain
|
6.9%
2/29 • Number of events 2 • Adverse events collected for 28 days after last dose of study drug, up to 60 months.
|
|
Gastrointestinal disorders
Colonic perforation
|
3.4%
1/29 • Number of events 1 • Adverse events collected for 28 days after last dose of study drug, up to 60 months.
|
|
Gastrointestinal disorders
Vomiting
|
3.4%
1/29 • Number of events 1 • Adverse events collected for 28 days after last dose of study drug, up to 60 months.
|
|
Infections and infestations
Bladder infection
|
3.4%
1/29 • Number of events 1 • Adverse events collected for 28 days after last dose of study drug, up to 60 months.
|
|
Investigations
Creatinine increased
|
3.4%
1/29 • Number of events 1 • Adverse events collected for 28 days after last dose of study drug, up to 60 months.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
3.4%
1/29 • Number of events 1 • Adverse events collected for 28 days after last dose of study drug, up to 60 months.
|
|
Gastrointestinal disorders
Ileal obstruction
|
3.4%
1/29 • Number of events 2 • Adverse events collected for 28 days after last dose of study drug, up to 60 months.
|
Other adverse events
| Measure |
Pasireotide LAR Treatment
n=29 participants at risk
The investigational drug used in this study is pasireotide long acting release (LAR) 60 mg.
Pasireotide Long Acting Release (LAR): Pasireotide will be administered as an intramuscular injection at the beginning of every cycle which is defined as 28 days (+/- 3 days). Study treatment should begin within 14 days following enrollment into the study and continue until disease progression, unacceptable toxicity, or withdrawal of consent.
|
|---|---|
|
Metabolism and nutrition disorders
Hyperglycemia
|
82.8%
24/29 • Number of events 147 • Adverse events collected for 28 days after last dose of study drug, up to 60 months.
|
|
Metabolism and nutrition disorders
Anorexia
|
13.8%
4/29 • Number of events 5 • Adverse events collected for 28 days after last dose of study drug, up to 60 months.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
6.9%
2/29 • Number of events 14 • Adverse events collected for 28 days after last dose of study drug, up to 60 months.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
6.9%
2/29 • Number of events 12 • Adverse events collected for 28 days after last dose of study drug, up to 60 months.
|
|
Metabolism and nutrition disorders
Dehydration
|
3.4%
1/29 • Number of events 1 • Adverse events collected for 28 days after last dose of study drug, up to 60 months.
|
|
Metabolism and nutrition disorders
Glucose intolerance
|
3.4%
1/29 • Number of events 1 • Adverse events collected for 28 days after last dose of study drug, up to 60 months.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
3.4%
1/29 • Number of events 5 • Adverse events collected for 28 days after last dose of study drug, up to 60 months.
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
3.4%
1/29 • Number of events 1 • Adverse events collected for 28 days after last dose of study drug, up to 60 months.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
3.4%
1/29 • Number of events 1 • Adverse events collected for 28 days after last dose of study drug, up to 60 months.
|
|
Gastrointestinal disorders
Diarrhea
|
37.9%
11/29 • Number of events 13 • Adverse events collected for 28 days after last dose of study drug, up to 60 months.
|
|
Gastrointestinal disorders
Abdominal pain
|
31.0%
9/29 • Number of events 17 • Adverse events collected for 28 days after last dose of study drug, up to 60 months.
|
|
Gastrointestinal disorders
Constipation
|
20.7%
6/29 • Number of events 7 • Adverse events collected for 28 days after last dose of study drug, up to 60 months.
|
|
Gastrointestinal disorders
Nausea
|
17.2%
5/29 • Number of events 6 • Adverse events collected for 28 days after last dose of study drug, up to 60 months.
|
|
Gastrointestinal disorders
Vomiting
|
17.2%
5/29 • Number of events 6 • Adverse events collected for 28 days after last dose of study drug, up to 60 months.
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other
|
13.8%
4/29 • Number of events 4 • Adverse events collected for 28 days after last dose of study drug, up to 60 months.
|
|
Gastrointestinal disorders
Bloating
|
6.9%
2/29 • Number of events 5 • Adverse events collected for 28 days after last dose of study drug, up to 60 months.
|
|
Gastrointestinal disorders
Dyspepsia
|
3.4%
1/29 • Number of events 1 • Adverse events collected for 28 days after last dose of study drug, up to 60 months.
|
|
Gastrointestinal disorders
Flatulence
|
3.4%
1/29 • Number of events 2 • Adverse events collected for 28 days after last dose of study drug, up to 60 months.
|
|
Gastrointestinal disorders
Gastritis
|
3.4%
1/29 • Number of events 1 • Adverse events collected for 28 days after last dose of study drug, up to 60 months.
|
|
Gastrointestinal disorders
Malabsorption
|
3.4%
1/29 • Number of events 1 • Adverse events collected for 28 days after last dose of study drug, up to 60 months.
|
|
Gastrointestinal disorders
Mucositis oral
|
3.4%
1/29 • Number of events 1 • Adverse events collected for 28 days after last dose of study drug, up to 60 months.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
3.4%
1/29 • Number of events 1 • Adverse events collected for 28 days after last dose of study drug, up to 60 months.
|
|
General disorders
Fatigue
|
41.4%
12/29 • Number of events 19 • Adverse events collected for 28 days after last dose of study drug, up to 60 months.
|
|
General disorders
Edema limbs
|
13.8%
4/29 • Number of events 4 • Adverse events collected for 28 days after last dose of study drug, up to 60 months.
|
|
General disorders
Pain
|
10.3%
3/29 • Number of events 3 • Adverse events collected for 28 days after last dose of study drug, up to 60 months.
|
|
General disorders
Chills
|
6.9%
2/29 • Number of events 2 • Adverse events collected for 28 days after last dose of study drug, up to 60 months.
|
|
General disorders
Fever
|
6.9%
2/29 • Number of events 2 • Adverse events collected for 28 days after last dose of study drug, up to 60 months.
|
|
General disorders
Non-cardiac chest pain
|
3.4%
1/29 • Number of events 1 • Adverse events collected for 28 days after last dose of study drug, up to 60 months.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
13.8%
4/29 • Number of events 6 • Adverse events collected for 28 days after last dose of study drug, up to 60 months.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
10.3%
3/29 • Number of events 3 • Adverse events collected for 28 days after last dose of study drug, up to 60 months.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
6.9%
2/29 • Number of events 2 • Adverse events collected for 28 days after last dose of study drug, up to 60 months.
|
|
General disorders
Pain in extremity
|
6.9%
2/29 • Number of events 2 • Adverse events collected for 28 days after last dose of study drug, up to 60 months.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
3.4%
1/29 • Number of events 1 • Adverse events collected for 28 days after last dose of study drug, up to 60 months.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other
|
3.4%
1/29 • Number of events 1 • Adverse events collected for 28 days after last dose of study drug, up to 60 months.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
3.4%
1/29 • Number of events 1 • Adverse events collected for 28 days after last dose of study drug, up to 60 months.
|
|
Investigations
Alkaline phosphatase increased
|
10.3%
3/29 • Number of events 4 • Adverse events collected for 28 days after last dose of study drug, up to 60 months.
|
|
Investigations
Alanine aminotransferase increased
|
6.9%
2/29 • Number of events 8 • Adverse events collected for 28 days after last dose of study drug, up to 60 months.
|
|
Investigations
Aspartate aminotransferase increased
|
6.9%
2/29 • Number of events 2 • Adverse events collected for 28 days after last dose of study drug, up to 60 months.
|
|
Investigations
Creatinine increased
|
6.9%
2/29 • Number of events 5 • Adverse events collected for 28 days after last dose of study drug, up to 60 months.
|
|
Investigations
Weight loss
|
6.9%
2/29 • Number of events 3 • Adverse events collected for 28 days after last dose of study drug, up to 60 months.
|
|
Investigations
Blood bilirubin increased
|
3.4%
1/29 • Number of events 1 • Adverse events collected for 28 days after last dose of study drug, up to 60 months.
|
|
Investigations
Investigations - Other
|
3.4%
1/29 • Number of events 1 • Adverse events collected for 28 days after last dose of study drug, up to 60 months.
|
|
Investigations
Pancreatic enzymes decreased
|
3.4%
1/29 • Number of events 1 • Adverse events collected for 28 days after last dose of study drug, up to 60 months.
|
|
Investigations
Platelet count decreased
|
3.4%
1/29 • Number of events 3 • Adverse events collected for 28 days after last dose of study drug, up to 60 months.
|
|
Investigations
Weight gain
|
3.4%
1/29 • Number of events 2 • Adverse events collected for 28 days after last dose of study drug, up to 60 months.
|
|
Vascular disorders
Hypertension
|
27.6%
8/29 • Number of events 30 • Adverse events collected for 28 days after last dose of study drug, up to 60 months.
|
|
Vascular disorders
Flushing
|
3.4%
1/29 • Number of events 1 • Adverse events collected for 28 days after last dose of study drug, up to 60 months.
|
|
Vascular disorders
Hot flashes
|
3.4%
1/29 • Number of events 1 • Adverse events collected for 28 days after last dose of study drug, up to 60 months.
|
|
Nervous system disorders
Headache
|
17.2%
5/29 • Number of events 7 • Adverse events collected for 28 days after last dose of study drug, up to 60 months.
|
|
Nervous system disorders
Dizziness
|
13.8%
4/29 • Number of events 4 • Adverse events collected for 28 days after last dose of study drug, up to 60 months.
|
|
Nervous system disorders
Dysgeusia
|
3.4%
1/29 • Number of events 1 • Adverse events collected for 28 days after last dose of study drug, up to 60 months.
|
|
Nervous system disorders
Nervous system disorders - Other
|
3.4%
1/29 • Number of events 1 • Adverse events collected for 28 days after last dose of study drug, up to 60 months.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
3.4%
1/29 • Number of events 1 • Adverse events collected for 28 days after last dose of study drug, up to 60 months.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
17.2%
5/29 • Number of events 5 • Adverse events collected for 28 days after last dose of study drug, up to 60 months.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
6.9%
2/29 • Number of events 2 • Adverse events collected for 28 days after last dose of study drug, up to 60 months.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other
|
6.9%
2/29 • Number of events 2 • Adverse events collected for 28 days after last dose of study drug, up to 60 months.
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
3.4%
1/29 • Number of events 1 • Adverse events collected for 28 days after last dose of study drug, up to 60 months.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
3.4%
1/29 • Number of events 1 • Adverse events collected for 28 days after last dose of study drug, up to 60 months.
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
3.4%
1/29 • Number of events 1 • Adverse events collected for 28 days after last dose of study drug, up to 60 months.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
3.4%
1/29 • Number of events 1 • Adverse events collected for 28 days after last dose of study drug, up to 60 months.
|
|
Infections and infestations
Bladder infection
|
3.4%
1/29 • Number of events 1 • Adverse events collected for 28 days after last dose of study drug, up to 60 months.
|
|
Infections and infestations
Bronchial infection
|
3.4%
1/29 • Number of events 1 • Adverse events collected for 28 days after last dose of study drug, up to 60 months.
|
|
Infections and infestations
Infections and infestations - Other
|
3.4%
1/29 • Number of events 1 • Adverse events collected for 28 days after last dose of study drug, up to 60 months.
|
|
Infections and infestations
Skin infection
|
3.4%
1/29 • Number of events 1 • Adverse events collected for 28 days after last dose of study drug, up to 60 months.
|
|
Infections and infestations
Urinary tract infection
|
3.4%
1/29 • Number of events 1 • Adverse events collected for 28 days after last dose of study drug, up to 60 months.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
10.3%
3/29 • Number of events 3 • Adverse events collected for 28 days after last dose of study drug, up to 60 months.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other
|
6.9%
2/29 • Number of events 2 • Adverse events collected for 28 days after last dose of study drug, up to 60 months.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
3.4%
1/29 • Number of events 1 • Adverse events collected for 28 days after last dose of study drug, up to 60 months.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
3.4%
1/29 • Number of events 1 • Adverse events collected for 28 days after last dose of study drug, up to 60 months.
|
|
Eye disorders
Blurred vision
|
6.9%
2/29 • Number of events 2 • Adverse events collected for 28 days after last dose of study drug, up to 60 months.
|
|
Eye disorders
Eye disorders - Other
|
3.4%
1/29 • Number of events 1 • Adverse events collected for 28 days after last dose of study drug, up to 60 months.
|
|
Psychiatric disorders
Depression
|
6.9%
2/29 • Number of events 3 • Adverse events collected for 28 days after last dose of study drug, up to 60 months.
|
|
Psychiatric disorders
Anxiety
|
3.4%
1/29 • Number of events 1 • Adverse events collected for 28 days after last dose of study drug, up to 60 months.
|
|
Psychiatric disorders
Insomnia
|
3.4%
1/29 • Number of events 1 • Adverse events collected for 28 days after last dose of study drug, up to 60 months.
|
|
Blood and lymphatic system disorders
Anemia
|
6.9%
2/29 • Number of events 6 • Adverse events collected for 28 days after last dose of study drug, up to 60 months.
|
|
Cardiac disorders
Cardiac disorders - Other
|
6.9%
2/29 • Number of events 3 • Adverse events collected for 28 days after last dose of study drug, up to 60 months.
|
|
Renal and urinary disorders
Renal and urinary disorders - Other
|
3.4%
1/29 • Number of events 2 • Adverse events collected for 28 days after last dose of study drug, up to 60 months.
|
|
Renal and urinary disorders
Urinary frequency
|
3.4%
1/29 • Number of events 1 • Adverse events collected for 28 days after last dose of study drug, up to 60 months.
|
|
Reproductive system and breast disorders
Breast pain
|
3.4%
1/29 • Number of events 1 • Adverse events collected for 28 days after last dose of study drug, up to 60 months.
|
|
Reproductive system and breast disorders
Vaginal discharge
|
3.4%
1/29 • Number of events 1 • Adverse events collected for 28 days after last dose of study drug, up to 60 months.
|
|
Hepatobiliary disorders
Cholecystitis
|
3.4%
1/29 • Number of events 1 • Adverse events collected for 28 days after last dose of study drug, up to 60 months.
|
|
Injury, poisoning and procedural complications
Bruising
|
3.4%
1/29 • Number of events 1 • Adverse events collected for 28 days after last dose of study drug, up to 60 months.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place