Trial Outcomes & Findings for AZD0530 in Treating Patients With Prostate Cancer That Did Not Respond to Hormone Therapy (NCT NCT00513071)
NCT ID: NCT00513071
Last Updated: 2018-04-19
Results Overview
Complete Response (CR), disappearance of all measurable and non-measurable disease. No new lesions. PSA ≤ 0.2 ng/mL; Partial Response (PR), a decline in PSA by at least 30%, confirmed by a second PSA value four or more weeks later; Overall Response (OR) = CR + PR
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
28 participants
Primary outcome timeframe
PSA measured every 4 weeks
Results posted on
2018-04-19
Participant Flow
Participant milestones
| Measure |
Treatment (Saracatinib)
Patients receive oral AZD0530 at 175 mg once daily. Treatment repeats every 4 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity.
saracatinib: Given orally
laboratory biomarker analysis: Correlative studies
|
|---|---|
|
Overall Study
STARTED
|
28
|
|
Overall Study
COMPLETED
|
23
|
|
Overall Study
NOT COMPLETED
|
5
|
Reasons for withdrawal
| Measure |
Treatment (Saracatinib)
Patients receive oral AZD0530 at 175 mg once daily. Treatment repeats every 4 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity.
saracatinib: Given orally
laboratory biomarker analysis: Correlative studies
|
|---|---|
|
Overall Study
Adverse Event
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Physician Decision
|
3
|
Baseline Characteristics
AZD0530 in Treating Patients With Prostate Cancer That Did Not Respond to Hormone Therapy
Baseline characteristics by cohort
| Measure |
Treatment (Saracatinib)
n=28 Participants
Patients receive oral AZD0530 at 175 mg once daily. Treatment repeats every 4 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity.
saracatinib: Given orally
laboratory biomarker analysis: Correlative studies
|
|---|---|
|
Age, Continuous
|
67 years
n=99 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
28 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
28 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: PSA measured every 4 weeksComplete Response (CR), disappearance of all measurable and non-measurable disease. No new lesions. PSA ≤ 0.2 ng/mL; Partial Response (PR), a decline in PSA by at least 30%, confirmed by a second PSA value four or more weeks later; Overall Response (OR) = CR + PR
Outcome measures
| Measure |
Treatment (Saracatinib)
n=28 Participants
Patients receive oral AZD0530 at 175 mg once daily. Treatment repeats every 4 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity.
saracatinib: Given orally
laboratory biomarker analysis: Correlative studies
|
|---|---|
|
PSA Response Rate
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: From start of treatment until progression or death, up to 2 yearsPFS defined as time between start of treatment and disease progression or death. Using the method of Kaplan-Meier. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Outcome measures
| Measure |
Treatment (Saracatinib)
n=28 Participants
Patients receive oral AZD0530 at 175 mg once daily. Treatment repeats every 4 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity.
saracatinib: Given orally
laboratory biomarker analysis: Correlative studies
|
|---|---|
|
Progression-free Survival (PFS)
|
1.9 Months
Interval 1.8 to 3.7
|
SECONDARY outcome
Timeframe: From first day of treatment until discontinuation of treatment, up to 2 yearsDefined as the time from start of treatment to the discontinuation of treatment for any reason, including disease progression, treatment toxicity, patient preference, or death Will be summarized using the Kaplan-Meier product-limit estimators. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
Outcome measures
| Measure |
Treatment (Saracatinib)
n=28 Participants
Patients receive oral AZD0530 at 175 mg once daily. Treatment repeats every 4 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity.
saracatinib: Given orally
laboratory biomarker analysis: Correlative studies
|
|---|---|
|
Time to Treatment Failure
|
1.9 Months
Interval 1.7 to 2.2
|
SECONDARY outcome
Timeframe: From start of treatment, up to 5 yearsEstimated using the product-limit method of Kaplan and Meier.
Outcome measures
| Measure |
Treatment (Saracatinib)
n=28 Participants
Patients receive oral AZD0530 at 175 mg once daily. Treatment repeats every 4 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity.
saracatinib: Given orally
laboratory biomarker analysis: Correlative studies
|
|---|---|
|
Overall Survival
|
26.0 Months
Interval 19.8 to 61.7
|
SECONDARY outcome
Timeframe: Up to 2 yearsPopulation: One patient died unexpectedly at home. No autopsy was performed. Treatment was listed as possible cause along with diabetes mellitus, morbid obesity, hypertension, hypercholesterolemia, and renal failure.
Toxicity assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. All grade 3 or worse toxicities (Possibly, Probably, or Definitely) attributed to AZD0530.
Outcome measures
| Measure |
Treatment (Saracatinib)
n=28 Participants
Patients receive oral AZD0530 at 175 mg once daily. Treatment repeats every 4 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity.
saracatinib: Given orally
laboratory biomarker analysis: Correlative studies
|
|---|---|
|
Toxicity Data
Grade 3 : Nausea
|
1 participants
|
|
Toxicity Data
Grade 3 : Vomiting
|
1 participants
|
|
Toxicity Data
Grade 3 : Lymphopenia
|
1 participants
|
|
Toxicity Data
Grade 3 : Death, not associated with CTC term
|
0 participants
|
|
Toxicity Data
Grade 5 : Alanine aminotransferase (ALT)
|
0 participants
|
|
Toxicity Data
Grade 3 : Alanine aminotransferase (ALT)
|
1 participants
|
|
Toxicity Data
Grade 3 : Asparate aminotransferase (AST)
|
1 participants
|
|
Toxicity Data
Grade 5 : Asparate aminotransferase (AST)
|
0 participants
|
|
Toxicity Data
Grade 5 : Nausea
|
0 participants
|
|
Toxicity Data
Grade 5 : Vomiting
|
0 participants
|
|
Toxicity Data
Grade 5 : Lymphopenia
|
0 participants
|
|
Toxicity Data
Grade 5 : Death, not associated with CTC term
|
1 participants
|
SECONDARY outcome
Timeframe: Up to 2 yearsPopulation: Laboratory correlates were not collected.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At baseline, at 6 hours, at each course (day 1), and at 2 yearsPopulation: Bone marker data was not collected.
Outcome measures
Outcome data not reported
Adverse Events
Treatment (Saracatinib)
Serious events: 5 serious events
Other events: 26 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Treatment (Saracatinib)
n=28 participants at risk
Patients receive oral AZD0530 at 175 mg once daily. Treatment repeats every 4 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity.
saracatinib: Given orally
laboratory biomarker analysis: Correlative studies
|
|---|---|
|
Blood and lymphatic system disorders
Hemoglobin decreased
|
3.6%
1/28 • Number of events 1 • Adverse events over a 23 month time period.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Cardiac disorders
Myocardial ischemia
|
3.6%
1/28 • Number of events 1 • Adverse events over a 23 month time period.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Constipation
|
3.6%
1/28 • Number of events 1 • Adverse events over a 23 month time period.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Nausea
|
3.6%
1/28 • Number of events 1 • Adverse events over a 23 month time period.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Vomiting
|
3.6%
1/28 • Number of events 1 • Adverse events over a 23 month time period.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
General disorders
Disease progression
|
3.6%
1/28 • Number of events 1 • Adverse events over a 23 month time period.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
General disorders
Sudden death
|
3.6%
1/28 • Number of events 1 • Adverse events over a 23 month time period.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Anorexia
|
3.6%
1/28 • Number of events 1 • Adverse events over a 23 month time period.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Nervous system disorders
Neurological disorder NOS
|
7.1%
2/28 • Number of events 2 • Adverse events over a 23 month time period.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
Other adverse events
| Measure |
Treatment (Saracatinib)
n=28 participants at risk
Patients receive oral AZD0530 at 175 mg once daily. Treatment repeats every 4 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity.
saracatinib: Given orally
laboratory biomarker analysis: Correlative studies
|
|---|---|
|
Blood and lymphatic system disorders
Hemoglobin decreased
|
71.4%
20/28 • Number of events 33 • Adverse events over a 23 month time period.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Cardiac disorders
Palpitations
|
3.6%
1/28 • Number of events 1 • Adverse events over a 23 month time period.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Cardiac disorders
Sinus tachycardia
|
3.6%
1/28 • Number of events 1 • Adverse events over a 23 month time period.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Eye disorders
Diplopia
|
3.6%
1/28 • Number of events 1 • Adverse events over a 23 month time period.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Eye disorders
Eye disorder
|
3.6%
1/28 • Number of events 1 • Adverse events over a 23 month time period.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Abdominal distension
|
7.1%
2/28 • Number of events 4 • Adverse events over a 23 month time period.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Abdominal pain
|
7.1%
2/28 • Number of events 2 • Adverse events over a 23 month time period.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Constipation
|
21.4%
6/28 • Number of events 9 • Adverse events over a 23 month time period.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Diarrhea
|
25.0%
7/28 • Number of events 9 • Adverse events over a 23 month time period.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Dyspepsia
|
7.1%
2/28 • Number of events 4 • Adverse events over a 23 month time period.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Flatulence
|
3.6%
1/28 • Number of events 1 • Adverse events over a 23 month time period.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
3.6%
1/28 • Number of events 1 • Adverse events over a 23 month time period.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Nausea
|
25.0%
7/28 • Number of events 8 • Adverse events over a 23 month time period.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
3.6%
1/28 • Number of events 1 • Adverse events over a 23 month time period.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Gastrointestinal disorders
Vomiting
|
10.7%
3/28 • Number of events 5 • Adverse events over a 23 month time period.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
General disorders
Chills
|
10.7%
3/28 • Number of events 3 • Adverse events over a 23 month time period.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
General disorders
Disease progression
|
14.3%
4/28 • Number of events 4 • Adverse events over a 23 month time period.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
General disorders
Edema limbs
|
14.3%
4/28 • Number of events 4 • Adverse events over a 23 month time period.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
General disorders
Fatigue
|
46.4%
13/28 • Number of events 23 • Adverse events over a 23 month time period.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
General disorders
Fever
|
14.3%
4/28 • Number of events 5 • Adverse events over a 23 month time period.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
General disorders
Flu-like symptoms
|
3.6%
1/28 • Number of events 1 • Adverse events over a 23 month time period.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
General disorders
General symptom
|
3.6%
1/28 • Number of events 1 • Adverse events over a 23 month time period.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
General disorders
Pain
|
7.1%
2/28 • Number of events 2 • Adverse events over a 23 month time period.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Infections and infestations
Upper respiratory infection
|
7.1%
2/28 • Number of events 2 • Adverse events over a 23 month time period.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Activated partial thromboplastin time prolonged
|
7.1%
2/28 • Number of events 2 • Adverse events over a 23 month time period.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Alanine aminotransferase increased
|
14.3%
4/28 • Number of events 10 • Adverse events over a 23 month time period.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Alkaline phosphatase increased
|
17.9%
5/28 • Number of events 7 • Adverse events over a 23 month time period.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Aspartate aminotransferase increased
|
57.1%
16/28 • Number of events 39 • Adverse events over a 23 month time period.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Bilirubin increased
|
3.6%
1/28 • Number of events 1 • Adverse events over a 23 month time period.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Creatinine increased
|
17.9%
5/28 • Number of events 8 • Adverse events over a 23 month time period.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
INR increased
|
7.1%
2/28 • Number of events 3 • Adverse events over a 23 month time period.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Leukocyte count decreased
|
14.3%
4/28 • Number of events 6 • Adverse events over a 23 month time period.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Lymphocyte count decreased
|
21.4%
6/28 • Number of events 6 • Adverse events over a 23 month time period.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Neutrophil count decreased
|
7.1%
2/28 • Number of events 5 • Adverse events over a 23 month time period.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Platelet count decreased
|
3.6%
1/28 • Number of events 1 • Adverse events over a 23 month time period.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Weight gain
|
3.6%
1/28 • Number of events 2 • Adverse events over a 23 month time period.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Investigations
Weight loss
|
3.6%
1/28 • Number of events 1 • Adverse events over a 23 month time period.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Anorexia
|
25.0%
7/28 • Number of events 9 • Adverse events over a 23 month time period.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Blood glucose increased
|
35.7%
10/28 • Number of events 18 • Adverse events over a 23 month time period.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Dehydration
|
7.1%
2/28 • Number of events 2 • Adverse events over a 23 month time period.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Obesity
|
3.6%
1/28 • Number of events 2 • Adverse events over a 23 month time period.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Serum albumin decreased
|
10.7%
3/28 • Number of events 3 • Adverse events over a 23 month time period.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Serum calcium decreased
|
17.9%
5/28 • Number of events 5 • Adverse events over a 23 month time period.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Serum calcium increased
|
3.6%
1/28 • Number of events 1 • Adverse events over a 23 month time period.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Serum glucose decreased
|
7.1%
2/28 • Number of events 2 • Adverse events over a 23 month time period.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Serum magnesium increased
|
7.1%
2/28 • Number of events 2 • Adverse events over a 23 month time period.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Serum phosphate decreased
|
10.7%
3/28 • Number of events 3 • Adverse events over a 23 month time period.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Serum potassium decreased
|
3.6%
1/28 • Number of events 1 • Adverse events over a 23 month time period.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Metabolism and nutrition disorders
Serum sodium decreased
|
10.7%
3/28 • Number of events 4 • Adverse events over a 23 month time period.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
3.6%
1/28 • Number of events 2 • Adverse events over a 23 month time period.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
21.4%
6/28 • Number of events 7 • Adverse events over a 23 month time period.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
17.9%
5/28 • Number of events 7 • Adverse events over a 23 month time period.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
3.6%
1/28 • Number of events 1 • Adverse events over a 23 month time period.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Musculoskeletal and connective tissue disorders
Joint pain
|
3.6%
1/28 • Number of events 1 • Adverse events over a 23 month time period.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness
|
3.6%
1/28 • Number of events 1 • Adverse events over a 23 month time period.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
3.6%
1/28 • Number of events 1 • Adverse events over a 23 month time period.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
7.1%
2/28 • Number of events 2 • Adverse events over a 23 month time period.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
3.6%
1/28 • Number of events 1 • Adverse events over a 23 month time period.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Nervous system disorders
Abducens nerve disorder
|
3.6%
1/28 • Number of events 1 • Adverse events over a 23 month time period.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Nervous system disorders
Dizziness
|
10.7%
3/28 • Number of events 3 • Adverse events over a 23 month time period.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Psychiatric disorders
Anxiety
|
3.6%
1/28 • Number of events 1 • Adverse events over a 23 month time period.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Renal and urinary disorders
Hemorrhage urinary tract
|
3.6%
1/28 • Number of events 1 • Adverse events over a 23 month time period.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Renal and urinary disorders
Urethral stenosis
|
3.6%
1/28 • Number of events 2 • Adverse events over a 23 month time period.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Renal and urinary disorders
Urinary frequency
|
14.3%
4/28 • Number of events 5 • Adverse events over a 23 month time period.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Renal and urinary disorders
Urinary incontinence
|
7.1%
2/28 • Number of events 3 • Adverse events over a 23 month time period.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Renal and urinary disorders
Urinary retention
|
3.6%
1/28 • Number of events 2 • Adverse events over a 23 month time period.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Renal and urinary disorders
Urine discoloration
|
3.6%
1/28 • Number of events 1 • Adverse events over a 23 month time period.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
14.3%
4/28 • Number of events 6 • Adverse events over a 23 month time period.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
10.7%
3/28 • Number of events 4 • Adverse events over a 23 month time period.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
3.6%
1/28 • Number of events 1 • Adverse events over a 23 month time period.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory disorder
|
7.1%
2/28 • Number of events 2 • Adverse events over a 23 month time period.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
3.6%
1/28 • Number of events 1 • Adverse events over a 23 month time period.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Skin and subcutaneous tissue disorders
Rash desquamating
|
3.6%
1/28 • Number of events 1 • Adverse events over a 23 month time period.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Skin and subcutaneous tissue disorders
Skin disorder
|
3.6%
1/28 • Number of events 1 • Adverse events over a 23 month time period.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Skin and subcutaneous tissue disorders
Sweating
|
3.6%
1/28 • Number of events 1 • Adverse events over a 23 month time period.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Vascular disorders
Flushing
|
3.6%
1/28 • Number of events 1 • Adverse events over a 23 month time period.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Vascular disorders
Hemorrhage
|
3.6%
1/28 • Number of events 1 • Adverse events over a 23 month time period.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Vascular disorders
Hot flashes
|
3.6%
1/28 • Number of events 1 • Adverse events over a 23 month time period.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Vascular disorders
Hypertension
|
3.6%
1/28 • Number of events 1 • Adverse events over a 23 month time period.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
|
Vascular disorders
Hypotension
|
3.6%
1/28 • Number of events 1 • Adverse events over a 23 month time period.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60