Trial Outcomes & Findings for Abiraterone Race in Metastatic Castrate-resistant Prostate Cancer (NCT NCT01940276)
NCT ID: NCT01940276
Last Updated: 2020-12-09
Results Overview
Time in months from the start of study treatment to the date of first progression according to Prostate Cancer Working Group 2 criteria, or to death due to any cause. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), 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. Patients alive who had not progressed as of the last follow-up had PFS censored at the last follow-up date. Median rPFS was estimated using a Kaplan-Meier curve.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
100 participants
Primary outcome timeframe
up to 2 years
Results posted on
2020-12-09
Participant Flow
Participant milestones
| Measure |
Abiraterone Acetate and Prednisone: White Men
Patients self identifying as white men who received 1000 mg of Abiraterone acetate and 10 mg of prednisone daily till treatment discontinuation.
|
Abiraterone Acetate and Prednisone: African American Men
Patients self identifying as African American who received 1000 mg of Abiraterone acetate and 10 mg of prednisone daily till treatment discontinuation.
|
|---|---|---|
|
Overall Study
STARTED
|
50
|
50
|
|
Overall Study
COMPLETED
|
50
|
50
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Abiraterone Race in Metastatic Castrate-resistant Prostate Cancer
Baseline characteristics by cohort
| Measure |
White
n=50 Participants
Patients self identifying as white who received the study regimen
|
Black
n=50 Participants
Patients self identifying as black who received the study regimen
|
Total
n=100 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
68.2 years
STANDARD_DEVIATION 7.8 • n=5 Participants
|
69.05 years
STANDARD_DEVIATION 9.2 • n=7 Participants
|
68.5 years
STANDARD_DEVIATION 8.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
50 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
100 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
50 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: up to 2 yearsTime in months from the start of study treatment to the date of first progression according to Prostate Cancer Working Group 2 criteria, or to death due to any cause. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), 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. Patients alive who had not progressed as of the last follow-up had PFS censored at the last follow-up date. Median rPFS was estimated using a Kaplan-Meier curve.
Outcome measures
| Measure |
Abiraterone Acetate and Prednisone: White Men
n=50 Participants
Patients self identifying as white who received 1000 mg of Abiraterone acetate and 10 mg of prednisone daily till treatment discontinuation.
|
Abiraterone Acetate and Prednisone: African American Men
n=50 Participants
Patients self identifying as African American who received 1000 mg of Abiraterone acetate and 10 mg of prednisone daily till treatment discontinuation.
|
|---|---|---|
|
Median Radiographic Progression Free Survival (PFS)
|
16.8 months
Interval 11.0 to 33.7
|
16.6 months
Interval 12.6 to 22.1
|
SECONDARY outcome
Timeframe: Baseline and up to 2 yearsPercent of men with Prostate Specific Antigen (PSA) declines \> 30%, \> 50% and \> 90%
Outcome measures
| Measure |
Abiraterone Acetate and Prednisone: White Men
n=50 Participants
Patients self identifying as white who received 1000 mg of Abiraterone acetate and 10 mg of prednisone daily till treatment discontinuation.
|
Abiraterone Acetate and Prednisone: African American Men
n=50 Participants
Patients self identifying as African American who received 1000 mg of Abiraterone acetate and 10 mg of prednisone daily till treatment discontinuation.
|
|---|---|---|
|
Change in PSA Response
Percent of men with PSA declines > 30%
|
78 percentage of participants
|
82 percentage of participants
|
|
Change in PSA Response
Percent of men with PSA declines > 50%
|
66 percentage of participants
|
74 percentage of participants
|
|
Change in PSA Response
Percent of men with PSA declines > 90%
|
38 percentage of participants
|
48 percentage of participants
|
SECONDARY outcome
Timeframe: up to 2 yearsTime to PSA progression as defined by PCWG 2 criteria is the date that a 25% or greater increase and an absolute increase of 2 ng/mL or more from the nadir is documented, which is confirmed by a second value obtained 3 or more weeks later.
Outcome measures
| Measure |
Abiraterone Acetate and Prednisone: White Men
n=50 Participants
Patients self identifying as white who received 1000 mg of Abiraterone acetate and 10 mg of prednisone daily till treatment discontinuation.
|
Abiraterone Acetate and Prednisone: African American Men
n=50 Participants
Patients self identifying as African American who received 1000 mg of Abiraterone acetate and 10 mg of prednisone daily till treatment discontinuation.
|
|---|---|---|
|
Median Time to PSA Progression
|
11.5 months
Interval 8.5 to 19.3
|
16.6 months
Interval 11.5 to
Upper limit was not achieved due to insufficient number of participants events
|
SECONDARY outcome
Timeframe: up to 2 yearsNumber of men who achieve a PSA decline to \< 0.1 and \< 0.2 ng/ml
Outcome measures
| Measure |
Abiraterone Acetate and Prednisone: White Men
n=50 Participants
Patients self identifying as white who received 1000 mg of Abiraterone acetate and 10 mg of prednisone daily till treatment discontinuation.
|
Abiraterone Acetate and Prednisone: African American Men
n=50 Participants
Patients self identifying as African American who received 1000 mg of Abiraterone acetate and 10 mg of prednisone daily till treatment discontinuation.
|
|---|---|---|
|
Number of Men With PSA Decline to < 0.1 and < 0.2 ng/ml
PSA decline to < 0.1
|
4 Participants
|
9 Participants
|
|
Number of Men With PSA Decline to < 0.1 and < 0.2 ng/ml
PSA decline to < 0.2
|
5 Participants
|
13 Participants
|
SECONDARY outcome
Timeframe: up to 2 yearsIncidence and grade of hypertension in the two populations. (Grade 1: Systolic BP 120 to 139 mmHg or diastolic BP 80 to 89 mmHg, Grade 2: Systolic BP 140 to 159 mmHg or diastolic BP 90 to 99 mmHg, Grade 3: Systolic BP ≥160 mmHg or diastolic BP ≥100 mmHg, Grade 4: Life-threatening consequences, urgent intervention indicated)
Outcome measures
| Measure |
Abiraterone Acetate and Prednisone: White Men
n=50 Participants
Patients self identifying as white who received 1000 mg of Abiraterone acetate and 10 mg of prednisone daily till treatment discontinuation.
|
Abiraterone Acetate and Prednisone: African American Men
n=50 Participants
Patients self identifying as African American who received 1000 mg of Abiraterone acetate and 10 mg of prednisone daily till treatment discontinuation.
|
|---|---|---|
|
Percent of Subjects Experiencing Hypertension
All grades
|
20 Participants
|
23 Participants
|
|
Percent of Subjects Experiencing Hypertension
Grades 3 and 4
|
8 Participants
|
12 Participants
|
SECONDARY outcome
Timeframe: up to 3 yearsLength of patient's life after starting study
Outcome measures
| Measure |
Abiraterone Acetate and Prednisone: White Men
n=50 Participants
Patients self identifying as white who received 1000 mg of Abiraterone acetate and 10 mg of prednisone daily till treatment discontinuation.
|
Abiraterone Acetate and Prednisone: African American Men
n=50 Participants
Patients self identifying as African American who received 1000 mg of Abiraterone acetate and 10 mg of prednisone daily till treatment discontinuation.
|
|---|---|---|
|
Overall Survival
|
35.7 months
Interval 27.1 to
Upper limit was not achieved due to insufficient number of participants events.
|
35.9 months
Interval 24.5 to 43.0
|
Adverse Events
Abiraterone Acetate and Prednisone: White Men
Serious events: 14 serious events
Other events: 50 other events
Deaths: 0 deaths
Abiraterone Acetate and Prednisone: African American Men
Serious events: 14 serious events
Other events: 50 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Abiraterone Acetate and Prednisone: White Men
n=50 participants at risk
Patients self identifying as white who received 1000 mg of Abiraterone acetate and 10 mg of prednisone daily till treatment discontinuation.
|
Abiraterone Acetate and Prednisone: African American Men
n=50 participants at risk
Patients self identifying as African American who received 1000 mg of Abiraterone acetate and 10 mg of prednisone daily till treatment discontinuation.
|
|---|---|---|
|
Gastrointestinal disorders
Rectal hemorrhage
|
2.0%
1/50 • Up to 30 days post last dose
|
0.00%
0/50 • Up to 30 days post last dose
|
|
Gastrointestinal disorders
Colonic perforation
|
2.0%
1/50 • Up to 30 days post last dose
|
0.00%
0/50 • Up to 30 days post last dose
|
|
Gastrointestinal disorders
Ileus
|
2.0%
1/50 • Up to 30 days post last dose
|
0.00%
0/50 • Up to 30 days post last dose
|
|
General disorders
Fever
|
2.0%
1/50 • Up to 30 days post last dose
|
2.0%
1/50 • Up to 30 days post last dose
|
|
General disorders
Pain
|
4.0%
2/50 • Up to 30 days post last dose
|
0.00%
0/50 • Up to 30 days post last dose
|
|
General disorders
Flu like symptoms
|
2.0%
1/50 • Up to 30 days post last dose
|
0.00%
0/50 • Up to 30 days post last dose
|
|
Infections and infestations
Urinary tract infection
|
4.0%
2/50 • Up to 30 days post last dose
|
4.0%
2/50 • Up to 30 days post last dose
|
|
Metabolism and nutrition disorders
Hypokalemia
|
2.0%
1/50 • Up to 30 days post last dose
|
0.00%
0/50 • Up to 30 days post last dose
|
|
Metabolism and nutrition disorders
Dehydration
|
2.0%
1/50 • Up to 30 days post last dose
|
2.0%
1/50 • Up to 30 days post last dose
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
2.0%
1/50 • Up to 30 days post last dose
|
0.00%
0/50 • Up to 30 days post last dose
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
2.0%
1/50 • Up to 30 days post last dose
|
0.00%
0/50 • Up to 30 days post last dose
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
2.0%
1/50 • Up to 30 days post last dose
|
0.00%
0/50 • Up to 30 days post last dose
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
2.0%
1/50 • Up to 30 days post last dose
|
0.00%
0/50 • Up to 30 days post last dose
|
|
Nervous system disorders
Paresthesia
|
2.0%
1/50 • Up to 30 days post last dose
|
0.00%
0/50 • Up to 30 days post last dose
|
|
Psychiatric disorders
Confusion
|
2.0%
1/50 • Up to 30 days post last dose
|
0.00%
0/50 • Up to 30 days post last dose
|
|
Psychiatric disorders
Altered Mental State
|
2.0%
1/50 • Up to 30 days post last dose
|
0.00%
0/50 • Up to 30 days post last dose
|
|
Renal and urinary disorders
Urinary retention
|
2.0%
1/50 • Up to 30 days post last dose
|
6.0%
3/50 • Up to 30 days post last dose
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
2.0%
1/50 • Up to 30 days post last dose
|
0.00%
0/50 • Up to 30 days post last dose
|
|
Skin and subcutaneous tissue disorders
Squamous cell carcinoma of the face
|
2.0%
1/50 • Up to 30 days post last dose
|
0.00%
0/50 • Up to 30 days post last dose
|
|
Surgical and medical procedures
Surgical resection of neck cancer
|
2.0%
1/50 • Up to 30 days post last dose
|
0.00%
0/50 • Up to 30 days post last dose
|
|
Vascular disorders
Thromboembolic event
|
4.0%
2/50 • Up to 30 days post last dose
|
0.00%
0/50 • Up to 30 days post last dose
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/50 • Up to 30 days post last dose
|
2.0%
1/50 • Up to 30 days post last dose
|
|
Cardiac disorders
Acute Congestive Heart Failure
|
0.00%
0/50 • Up to 30 days post last dose
|
2.0%
1/50 • Up to 30 days post last dose
|
|
Gastrointestinal disorders
Gastroenteritis
|
0.00%
0/50 • Up to 30 days post last dose
|
2.0%
1/50 • Up to 30 days post last dose
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/50 • Up to 30 days post last dose
|
2.0%
1/50 • Up to 30 days post last dose
|
|
General disorders
Accidental Overdose
|
0.00%
0/50 • Up to 30 days post last dose
|
2.0%
1/50 • Up to 30 days post last dose
|
|
Infections and infestations
Sepsis
|
0.00%
0/50 • Up to 30 days post last dose
|
2.0%
1/50 • Up to 30 days post last dose
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/50 • Up to 30 days post last dose
|
4.0%
2/50 • Up to 30 days post last dose
|
|
Nervous system disorders
Seizure
|
0.00%
0/50 • Up to 30 days post last dose
|
2.0%
1/50 • Up to 30 days post last dose
|
|
Nervous system disorders
Transient ischemic attacks
|
0.00%
0/50 • Up to 30 days post last dose
|
2.0%
1/50 • Up to 30 days post last dose
|
|
Nervous system disorders
Cord Compression
|
0.00%
0/50 • Up to 30 days post last dose
|
2.0%
1/50 • Up to 30 days post last dose
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.00%
0/50 • Up to 30 days post last dose
|
4.0%
2/50 • Up to 30 days post last dose
|
|
Renal and urinary disorders
Hematuria
|
0.00%
0/50 • Up to 30 days post last dose
|
4.0%
2/50 • Up to 30 days post last dose
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/50 • Up to 30 days post last dose
|
2.0%
1/50 • Up to 30 days post last dose
|
|
Respiratory, thoracic and mediastinal disorders
Asthmatic episode
|
0.00%
0/50 • Up to 30 days post last dose
|
2.0%
1/50 • Up to 30 days post last dose
|
|
Respiratory, thoracic and mediastinal disorders
COPD exacerbation
|
0.00%
0/50 • Up to 30 days post last dose
|
2.0%
1/50 • Up to 30 days post last dose
|
|
Respiratory, thoracic and mediastinal disorders
Hypercapnic Respiratory Failure
|
0.00%
0/50 • Up to 30 days post last dose
|
2.0%
1/50 • Up to 30 days post last dose
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
0.00%
0/50 • Up to 30 days post last dose
|
2.0%
1/50 • Up to 30 days post last dose
|
|
Respiratory, thoracic and mediastinal disorders
Bilaterial pneumonia
|
0.00%
0/50 • Up to 30 days post last dose
|
2.0%
1/50 • Up to 30 days post last dose
|
Other adverse events
| Measure |
Abiraterone Acetate and Prednisone: White Men
n=50 participants at risk
Patients self identifying as white who received 1000 mg of Abiraterone acetate and 10 mg of prednisone daily till treatment discontinuation.
|
Abiraterone Acetate and Prednisone: African American Men
n=50 participants at risk
Patients self identifying as African American who received 1000 mg of Abiraterone acetate and 10 mg of prednisone daily till treatment discontinuation.
|
|---|---|---|
|
Investigations
Neutrophil count decreased
|
0.00%
0/50 • Up to 30 days post last dose
|
2.0%
1/50 • Up to 30 days post last dose
|
|
Blood and lymphatic system disorders
Anemia
|
14.0%
7/50 • Up to 30 days post last dose
|
16.0%
8/50 • Up to 30 days post last dose
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/50 • Up to 30 days post last dose
|
2.0%
1/50 • Up to 30 days post last dose
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/50 • Up to 30 days post last dose
|
2.0%
1/50 • Up to 30 days post last dose
|
|
Investigations
Platelet count decreased
|
4.0%
2/50 • Up to 30 days post last dose
|
4.0%
2/50 • Up to 30 days post last dose
|
|
Investigations
White blood cell decreased
|
2.0%
1/50 • Up to 30 days post last dose
|
2.0%
1/50 • Up to 30 days post last dose
|
|
Blood and lymphatic system disorders
Increased bleeding tendency related to Eliquis
|
2.0%
1/50 • Up to 30 days post last dose
|
0.00%
0/50 • Up to 30 days post last dose
|
|
Investigations
Alanine aminotransferase increased
|
10.0%
5/50 • Up to 30 days post last dose
|
10.0%
5/50 • Up to 30 days post last dose
|
|
Investigations
Alkaline phosphatase increased
|
4.0%
2/50 • Up to 30 days post last dose
|
10.0%
5/50 • Up to 30 days post last dose
|
|
Investigations
Aspartate aminotransferase increased
|
10.0%
5/50 • Up to 30 days post last dose
|
10.0%
5/50 • Up to 30 days post last dose
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/50 • Up to 30 days post last dose
|
4.0%
2/50 • Up to 30 days post last dose
|
|
Investigations
Creatinine increased
|
2.0%
1/50 • Up to 30 days post last dose
|
4.0%
2/50 • Up to 30 days post last dose
|
|
Investigations
Elevated ANC
|
0.00%
0/50 • Up to 30 days post last dose
|
2.0%
1/50 • Up to 30 days post last dose
|
|
Investigations
Folic acid deficiency
|
2.0%
1/50 • Up to 30 days post last dose
|
0.00%
0/50 • Up to 30 days post last dose
|
|
Investigations
Urine output decreased
|
0.00%
0/50 • Up to 30 days post last dose
|
2.0%
1/50 • Up to 30 days post last dose
|
|
Investigations
Weight gain
|
10.0%
5/50 • Up to 30 days post last dose
|
4.0%
2/50 • Up to 30 days post last dose
|
|
Investigations
Weight loss
|
6.0%
3/50 • Up to 30 days post last dose
|
2.0%
1/50 • Up to 30 days post last dose
|
|
Cardiac disorders
Atrial fibrillation
|
2.0%
1/50 • Up to 30 days post last dose
|
0.00%
0/50 • Up to 30 days post last dose
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/50 • Up to 30 days post last dose
|
2.0%
1/50 • Up to 30 days post last dose
|
|
Cardiac disorders
Acute Congestive Heart Failure
|
0.00%
0/50 • Up to 30 days post last dose
|
2.0%
1/50 • Up to 30 days post last dose
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/50 • Up to 30 days post last dose
|
2.0%
1/50 • Up to 30 days post last dose
|
|
Cardiac disorders
Irregular heart beat
|
0.00%
0/50 • Up to 30 days post last dose
|
2.0%
1/50 • Up to 30 days post last dose
|
|
Cardiac disorders
Conduction disorder
|
0.00%
0/50 • Up to 30 days post last dose
|
2.0%
1/50 • Up to 30 days post last dose
|
|
Cardiac disorders
Sinus bradycardia
|
2.0%
1/50 • Up to 30 days post last dose
|
0.00%
0/50 • Up to 30 days post last dose
|
|
Cardiac disorders
Sinus tachycardia
|
2.0%
1/50 • Up to 30 days post last dose
|
0.00%
0/50 • Up to 30 days post last dose
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/50 • Up to 30 days post last dose
|
2.0%
1/50 • Up to 30 days post last dose
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/50 • Up to 30 days post last dose
|
2.0%
1/50 • Up to 30 days post last dose
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/50 • Up to 30 days post last dose
|
2.0%
1/50 • Up to 30 days post last dose
|
|
Endocrine disorders
Adrenal insufficiency
|
2.0%
1/50 • Up to 30 days post last dose
|
0.00%
0/50 • Up to 30 days post last dose
|
|
Eye disorders
Blurred vision
|
2.0%
1/50 • Up to 30 days post last dose
|
2.0%
1/50 • Up to 30 days post last dose
|
|
Eye disorders
Dry eye
|
2.0%
1/50 • Up to 30 days post last dose
|
0.00%
0/50 • Up to 30 days post last dose
|
|
Eye disorders
Conjunctival hemorrhage in right eye
|
2.0%
1/50 • Up to 30 days post last dose
|
0.00%
0/50 • Up to 30 days post last dose
|
|
Eye disorders
Redness of right eye
|
0.00%
0/50 • Up to 30 days post last dose
|
2.0%
1/50 • Up to 30 days post last dose
|
|
Eye disorders
Bilateral arcus senilis
|
0.00%
0/50 • Up to 30 days post last dose
|
2.0%
1/50 • Up to 30 days post last dose
|
|
Eye disorders
Eye pain
|
0.00%
0/50 • Up to 30 days post last dose
|
2.0%
1/50 • Up to 30 days post last dose
|
|
Eye disorders
Watering eyes
|
0.00%
0/50 • Up to 30 days post last dose
|
2.0%
1/50 • Up to 30 days post last dose
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/50 • Up to 30 days post last dose
|
2.0%
1/50 • Up to 30 days post last dose
|
|
Gastrointestinal disorders
Abdominal pain
|
8.0%
4/50 • Up to 30 days post last dose
|
0.00%
0/50 • Up to 30 days post last dose
|
|
Gastrointestinal disorders
Anal hemorrhage
|
0.00%
0/50 • Up to 30 days post last dose
|
2.0%
1/50 • Up to 30 days post last dose
|
|
Gastrointestinal disorders
Colonic perforation
|
2.0%
1/50 • Up to 30 days post last dose
|
0.00%
0/50 • Up to 30 days post last dose
|
|
Gastrointestinal disorders
Constipation
|
10.0%
5/50 • Up to 30 days post last dose
|
28.0%
14/50 • Up to 30 days post last dose
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/50 • Up to 30 days post last dose
|
2.0%
1/50 • Up to 30 days post last dose
|
|
Gastrointestinal disorders
Diarrhea
|
12.0%
6/50 • Up to 30 days post last dose
|
6.0%
3/50 • Up to 30 days post last dose
|
|
Gastrointestinal disorders
Dry mouth
|
6.0%
3/50 • Up to 30 days post last dose
|
0.00%
0/50 • Up to 30 days post last dose
|
|
Gastrointestinal disorders
Dyspepsia
|
6.0%
3/50 • Up to 30 days post last dose
|
14.0%
7/50 • Up to 30 days post last dose
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/50 • Up to 30 days post last dose
|
2.0%
1/50 • Up to 30 days post last dose
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/50 • Up to 30 days post last dose
|
2.0%
1/50 • Up to 30 days post last dose
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
2.0%
1/50 • Up to 30 days post last dose
|
4.0%
2/50 • Up to 30 days post last dose
|
|
Gastrointestinal disorders
Blood in stool
|
0.00%
0/50 • Up to 30 days post last dose
|
2.0%
1/50 • Up to 30 days post last dose
|
|
Gastrointestinal disorders
Gastroenteritis
|
0.00%
0/50 • Up to 30 days post last dose
|
2.0%
1/50 • Up to 30 days post last dose
|
|
Gastrointestinal disorders
Heartburn
|
2.0%
1/50 • Up to 30 days post last dose
|
0.00%
0/50 • Up to 30 days post last dose
|
|
Gastrointestinal disorders
Hernia
|
2.0%
1/50 • Up to 30 days post last dose
|
0.00%
0/50 • Up to 30 days post last dose
|
|
Gastrointestinal disorders
Sick
|
0.00%
0/50 • Up to 30 days post last dose
|
2.0%
1/50 • Up to 30 days post last dose
|
|
Gastrointestinal disorders
Upset stomach
|
0.00%
0/50 • Up to 30 days post last dose
|
2.0%
1/50 • Up to 30 days post last dose
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
0.00%
0/50 • Up to 30 days post last dose
|
2.0%
1/50 • Up to 30 days post last dose
|
|
Gastrointestinal disorders
Hemorrhoids
|
0.00%
0/50 • Up to 30 days post last dose
|
4.0%
2/50 • Up to 30 days post last dose
|
|
Gastrointestinal disorders
Ileus
|
2.0%
1/50 • Up to 30 days post last dose
|
0.00%
0/50 • Up to 30 days post last dose
|
|
Gastrointestinal disorders
Nausea
|
16.0%
8/50 • Up to 30 days post last dose
|
16.0%
8/50 • Up to 30 days post last dose
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/50 • Up to 30 days post last dose
|
4.0%
2/50 • Up to 30 days post last dose
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
2.0%
1/50 • Up to 30 days post last dose
|
0.00%
0/50 • Up to 30 days post last dose
|
|
Gastrointestinal disorders
Stomach pain
|
2.0%
1/50 • Up to 30 days post last dose
|
0.00%
0/50 • Up to 30 days post last dose
|
|
Gastrointestinal disorders
Vomiting
|
16.0%
8/50 • Up to 30 days post last dose
|
6.0%
3/50 • Up to 30 days post last dose
|
|
General disorders
Chills
|
0.00%
0/50 • Up to 30 days post last dose
|
2.0%
1/50 • Up to 30 days post last dose
|
|
General disorders
Edema face
|
0.00%
0/50 • Up to 30 days post last dose
|
4.0%
2/50 • Up to 30 days post last dose
|
|
General disorders
Edema limbs
|
16.0%
8/50 • Up to 30 days post last dose
|
26.0%
13/50 • Up to 30 days post last dose
|
|
General disorders
Fatigue
|
42.0%
21/50 • Up to 30 days post last dose
|
26.0%
13/50 • Up to 30 days post last dose
|
|
General disorders
Fever
|
6.0%
3/50 • Up to 30 days post last dose
|
4.0%
2/50 • Up to 30 days post last dose
|
|
General disorders
Flu like symptoms
|
10.0%
5/50 • Up to 30 days post last dose
|
8.0%
4/50 • Up to 30 days post last dose
|
|
General disorders
Gait disturbance
|
2.0%
1/50 • Up to 30 days post last dose
|
0.00%
0/50 • Up to 30 days post last dose
|
|
General disorders
Accidental overdose
|
0.00%
0/50 • Up to 30 days post last dose
|
2.0%
1/50 • Up to 30 days post last dose
|
|
General disorders
Edema face and neck
|
0.00%
0/50 • Up to 30 days post last dose
|
2.0%
1/50 • Up to 30 days post last dose
|
|
General disorders
Cold-like symptoms
|
2.0%
1/50 • Up to 30 days post last dose
|
0.00%
0/50 • Up to 30 days post last dose
|
|
General disorders
Overdose
|
0.00%
0/50 • Up to 30 days post last dose
|
2.0%
1/50 • Up to 30 days post last dose
|
|
General disorders
Irritability
|
2.0%
1/50 • Up to 30 days post last dose
|
0.00%
0/50 • Up to 30 days post last dose
|
|
General disorders
Localized edema
|
0.00%
0/50 • Up to 30 days post last dose
|
2.0%
1/50 • Up to 30 days post last dose
|
|
General disorders
Malaise
|
2.0%
1/50 • Up to 30 days post last dose
|
0.00%
0/50 • Up to 30 days post last dose
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/50 • Up to 30 days post last dose
|
4.0%
2/50 • Up to 30 days post last dose
|
|
General disorders
Pain
|
24.0%
12/50 • Up to 30 days post last dose
|
24.0%
12/50 • Up to 30 days post last dose
|
|
Hepatobiliary disorders
Gallbladder pain
|
2.0%
1/50 • Up to 30 days post last dose
|
0.00%
0/50 • Up to 30 days post last dose
|
|
Immune system disorders
Allergic reaction
|
4.0%
2/50 • Up to 30 days post last dose
|
0.00%
0/50 • Up to 30 days post last dose
|
|
Infections and infestations
Bronchial infection
|
6.0%
3/50 • Up to 30 days post last dose
|
0.00%
0/50 • Up to 30 days post last dose
|
|
Infections and infestations
Black hairy tongue
|
2.0%
1/50 • Up to 30 days post last dose
|
0.00%
0/50 • Up to 30 days post last dose
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/50 • Up to 30 days post last dose
|
2.0%
1/50 • Up to 30 days post last dose
|
|
Infections and infestations
Thrush, related to chemo
|
2.0%
1/50 • Up to 30 days post last dose
|
0.00%
0/50 • Up to 30 days post last dose
|
|
Infections and infestations
Viral infection
|
2.0%
1/50 • Up to 30 days post last dose
|
0.00%
0/50 • Up to 30 days post last dose
|
|
Infections and infestations
Mouth sores
|
0.00%
0/50 • Up to 30 days post last dose
|
2.0%
1/50 • Up to 30 days post last dose
|
|
Infections and infestations
Lung infection
|
0.00%
0/50 • Up to 30 days post last dose
|
4.0%
2/50 • Up to 30 days post last dose
|
|
Infections and infestations
Mucosal infection
|
0.00%
0/50 • Up to 30 days post last dose
|
2.0%
1/50 • Up to 30 days post last dose
|
|
Infections and infestations
Papulopustular rash
|
0.00%
0/50 • Up to 30 days post last dose
|
4.0%
2/50 • Up to 30 days post last dose
|
|
Infections and infestations
Sepsis
|
0.00%
0/50 • Up to 30 days post last dose
|
2.0%
1/50 • Up to 30 days post last dose
|
|
Infections and infestations
Skin infection
|
0.00%
0/50 • Up to 30 days post last dose
|
2.0%
1/50 • Up to 30 days post last dose
|
|
Infections and infestations
Tooth infection
|
0.00%
0/50 • Up to 30 days post last dose
|
2.0%
1/50 • Up to 30 days post last dose
|
|
Infections and infestations
Upper respiratory infection
|
4.0%
2/50 • Up to 30 days post last dose
|
8.0%
4/50 • Up to 30 days post last dose
|
|
Infections and infestations
Urinary tract infection
|
10.0%
5/50 • Up to 30 days post last dose
|
12.0%
6/50 • Up to 30 days post last dose
|
|
Injury, poisoning and procedural complications
Bruising
|
6.0%
3/50 • Up to 30 days post last dose
|
2.0%
1/50 • Up to 30 days post last dose
|
|
Injury, poisoning and procedural complications
Fall
|
14.0%
7/50 • Up to 30 days post last dose
|
8.0%
4/50 • Up to 30 days post last dose
|
|
Injury, poisoning and procedural complications
Fracture
|
4.0%
2/50 • Up to 30 days post last dose
|
2.0%
1/50 • Up to 30 days post last dose
|
|
Injury, poisoning and procedural complications
Wound complication
|
2.0%
1/50 • Up to 30 days post last dose
|
0.00%
0/50 • Up to 30 days post last dose
|
|
Metabolism and nutrition disorders
Anorexia
|
4.0%
2/50 • Up to 30 days post last dose
|
20.0%
10/50 • Up to 30 days post last dose
|
|
Metabolism and nutrition disorders
Dehydration
|
4.0%
2/50 • Up to 30 days post last dose
|
2.0%
1/50 • Up to 30 days post last dose
|
|
Metabolism and nutrition disorders
Glucose intolerance
|
0.00%
0/50 • Up to 30 days post last dose
|
2.0%
1/50 • Up to 30 days post last dose
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
2.0%
1/50 • Up to 30 days post last dose
|
4.0%
2/50 • Up to 30 days post last dose
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
14.0%
7/50 • Up to 30 days post last dose
|
26.0%
13/50 • Up to 30 days post last dose
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
6.0%
3/50 • Up to 30 days post last dose
|
2.0%
1/50 • Up to 30 days post last dose
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
2.0%
1/50 • Up to 30 days post last dose
|
2.0%
1/50 • Up to 30 days post last dose
|
|
Metabolism and nutrition disorders
Hypernatremia
|
0.00%
0/50 • Up to 30 days post last dose
|
2.0%
1/50 • Up to 30 days post last dose
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
2.0%
1/50 • Up to 30 days post last dose
|
6.0%
3/50 • Up to 30 days post last dose
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
6.0%
3/50 • Up to 30 days post last dose
|
4.0%
2/50 • Up to 30 days post last dose
|
|
Metabolism and nutrition disorders
Hypokalemia
|
20.0%
10/50 • Up to 30 days post last dose
|
34.0%
17/50 • Up to 30 days post last dose
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
8.0%
4/50 • Up to 30 days post last dose
|
16.0%
8/50 • Up to 30 days post last dose
|
|
Metabolism and nutrition disorders
Hyponatremia
|
4.0%
2/50 • Up to 30 days post last dose
|
6.0%
3/50 • Up to 30 days post last dose
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
4.0%
2/50 • Up to 30 days post last dose
|
6.0%
3/50 • Up to 30 days post last dose
|
|
Metabolism and nutrition disorders
Increased appetite
|
2.0%
1/50 • Up to 30 days post last dose
|
0.00%
0/50 • Up to 30 days post last dose
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
2.0%
1/50 • Up to 30 days post last dose
|
6.0%
3/50 • Up to 30 days post last dose
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/50 • Up to 30 days post last dose
|
2.0%
1/50 • Up to 30 days post last dose
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
6.0%
3/50 • Up to 30 days post last dose
|
10.0%
5/50 • Up to 30 days post last dose
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
4.0%
2/50 • Up to 30 days post last dose
|
2.0%
1/50 • Up to 30 days post last dose
|
|
Musculoskeletal and connective tissue disorders
Buttock pain
|
2.0%
1/50 • Up to 30 days post last dose
|
0.00%
0/50 • Up to 30 days post last dose
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/50 • Up to 30 days post last dose
|
2.0%
1/50 • Up to 30 days post last dose
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
6.0%
3/50 • Up to 30 days post last dose
|
4.0%
2/50 • Up to 30 days post last dose
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness left-sided
|
2.0%
1/50 • Up to 30 days post last dose
|
0.00%
0/50 • Up to 30 days post last dose
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
0.00%
0/50 • Up to 30 days post last dose
|
6.0%
3/50 • Up to 30 days post last dose
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness right-sided
|
0.00%
0/50 • Up to 30 days post last dose
|
2.0%
1/50 • Up to 30 days post last dose
|
|
Musculoskeletal and connective tissue disorders
Back stiffness
|
0.00%
0/50 • Up to 30 days post last dose
|
2.0%
1/50 • Up to 30 days post last dose
|
|
Musculoskeletal and connective tissue disorders
Bilateral leg cramps
|
2.0%
1/50 • Up to 30 days post last dose
|
0.00%
0/50 • Up to 30 days post last dose
|
|
Musculoskeletal and connective tissue disorders
Muscle spasm in right hand
|
0.00%
0/50 • Up to 30 days post last dose
|
2.0%
1/50 • Up to 30 days post last dose
|
|
Musculoskeletal and connective tissue disorders
Neck stiffness
|
0.00%
0/50 • Up to 30 days post last dose
|
2.0%
1/50 • Up to 30 days post last dose
|
|
Musculoskeletal and connective tissue disorders
Bilateral leg weakness
|
2.0%
1/50 • Up to 30 days post last dose
|
0.00%
0/50 • Up to 30 days post last dose
|
|
Musculoskeletal and connective tissue disorders
Bilateral lower leg cramps
|
4.0%
2/50 • Up to 30 days post last dose
|
0.00%
0/50 • Up to 30 days post last dose
|
|
Musculoskeletal and connective tissue disorders
Burning sensation in bilateral lower extremeties
|
2.0%
1/50 • Up to 30 days post last dose
|
0.00%
0/50 • Up to 30 days post last dose
|
|
Musculoskeletal and connective tissue disorders
Muscle spasm
|
0.00%
0/50 • Up to 30 days post last dose
|
2.0%
1/50 • Up to 30 days post last dose
|
|
Musculoskeletal and connective tissue disorders
Right leg aching
|
0.00%
0/50 • Up to 30 days post last dose
|
2.0%
1/50 • Up to 30 days post last dose
|
|
Musculoskeletal and connective tissue disorders
Weakness, mild and intermittent left upper knee
|
0.00%
0/50 • Up to 30 days post last dose
|
2.0%
1/50 • Up to 30 days post last dose
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/50 • Up to 30 days post last dose
|
6.0%
3/50 • Up to 30 days post last dose
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/50 • Up to 30 days post last dose
|
2.0%
1/50 • Up to 30 days post last dose
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
18.0%
9/50 • Up to 30 days post last dose
|
14.0%
7/50 • Up to 30 days post last dose
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
2.0%
1/50 • Up to 30 days post last dose
|
0.00%
0/50 • Up to 30 days post last dose
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma, neck
|
2.0%
1/50 • Up to 30 days post last dose
|
0.00%
0/50 • Up to 30 days post last dose
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Smoldering myeloma
|
2.0%
1/50 • Up to 30 days post last dose
|
0.00%
0/50 • Up to 30 days post last dose
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
2.0%
1/50 • Up to 30 days post last dose
|
0.00%
0/50 • Up to 30 days post last dose
|
|
Nervous system disorders
Dizziness
|
8.0%
4/50 • Up to 30 days post last dose
|
10.0%
5/50 • Up to 30 days post last dose
|
|
Nervous system disorders
Dysgeusia
|
4.0%
2/50 • Up to 30 days post last dose
|
0.00%
0/50 • Up to 30 days post last dose
|
|
Nervous system disorders
Headache
|
18.0%
9/50 • Up to 30 days post last dose
|
6.0%
3/50 • Up to 30 days post last dose
|
|
Nervous system disorders
Memory impairment
|
4.0%
2/50 • Up to 30 days post last dose
|
2.0%
1/50 • Up to 30 days post last dose
|
|
Nervous system disorders
Movements involuntary
|
2.0%
1/50 • Up to 30 days post last dose
|
0.00%
0/50 • Up to 30 days post last dose
|
|
Nervous system disorders
Cord Compression
|
0.00%
0/50 • Up to 30 days post last dose
|
2.0%
1/50 • Up to 30 days post last dose
|
|
Nervous system disorders
Tingling in bilateral legs at HS "like restless legs"
|
0.00%
0/50 • Up to 30 days post last dose
|
2.0%
1/50 • Up to 30 days post last dose
|
|
Nervous system disorders
Paresthesia
|
10.0%
5/50 • Up to 30 days post last dose
|
4.0%
2/50 • Up to 30 days post last dose
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
6.0%
3/50 • Up to 30 days post last dose
|
6.0%
3/50 • Up to 30 days post last dose
|
|
Nervous system disorders
Seizure
|
0.00%
0/50 • Up to 30 days post last dose
|
2.0%
1/50 • Up to 30 days post last dose
|
|
Nervous system disorders
Sinus pain
|
0.00%
0/50 • Up to 30 days post last dose
|
2.0%
1/50 • Up to 30 days post last dose
|
|
Nervous system disorders
Somnolence
|
2.0%
1/50 • Up to 30 days post last dose
|
0.00%
0/50 • Up to 30 days post last dose
|
|
Nervous system disorders
Syncope
|
0.00%
0/50 • Up to 30 days post last dose
|
2.0%
1/50 • Up to 30 days post last dose
|
|
Nervous system disorders
Transient ischemic attacks
|
0.00%
0/50 • Up to 30 days post last dose
|
2.0%
1/50 • Up to 30 days post last dose
|
|
Psychiatric disorders
Agitation
|
0.00%
0/50 • Up to 30 days post last dose
|
2.0%
1/50 • Up to 30 days post last dose
|
|
Psychiatric disorders
Anxiety
|
2.0%
1/50 • Up to 30 days post last dose
|
0.00%
0/50 • Up to 30 days post last dose
|
|
Psychiatric disorders
Confusion
|
4.0%
2/50 • Up to 30 days post last dose
|
0.00%
0/50 • Up to 30 days post last dose
|
|
Psychiatric disorders
Depression
|
2.0%
1/50 • Up to 30 days post last dose
|
0.00%
0/50 • Up to 30 days post last dose
|
|
Psychiatric disorders
Insomnia
|
4.0%
2/50 • Up to 30 days post last dose
|
12.0%
6/50 • Up to 30 days post last dose
|
|
Psychiatric disorders
Altered mental state
|
2.0%
1/50 • Up to 30 days post last dose
|
0.00%
0/50 • Up to 30 days post last dose
|
|
Psychiatric disorders
Altered mental status
|
0.00%
0/50 • Up to 30 days post last dose
|
2.0%
1/50 • Up to 30 days post last dose
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/50 • Up to 30 days post last dose
|
4.0%
2/50 • Up to 30 days post last dose
|
|
Renal and urinary disorders
Bladder spasm
|
2.0%
1/50 • Up to 30 days post last dose
|
4.0%
2/50 • Up to 30 days post last dose
|
|
Renal and urinary disorders
Cystitis noninfective
|
4.0%
2/50 • Up to 30 days post last dose
|
0.00%
0/50 • Up to 30 days post last dose
|
|
Renal and urinary disorders
Hematuria
|
6.0%
3/50 • Up to 30 days post last dose
|
10.0%
5/50 • Up to 30 days post last dose
|
|
Renal and urinary disorders
Left hydronephrosis
|
2.0%
1/50 • Up to 30 days post last dose
|
0.00%
0/50 • Up to 30 days post last dose
|
|
Renal and urinary disorders
Nocturia
|
2.0%
1/50 • Up to 30 days post last dose
|
2.0%
1/50 • Up to 30 days post last dose
|
|
Renal and urinary disorders
Burning during urination
|
2.0%
1/50 • Up to 30 days post last dose
|
0.00%
0/50 • Up to 30 days post last dose
|
|
Renal and urinary disorders
Burning upon urinating
|
0.00%
0/50 • Up to 30 days post last dose
|
2.0%
1/50 • Up to 30 days post last dose
|
|
Renal and urinary disorders
Increased BUN
|
2.0%
1/50 • Up to 30 days post last dose
|
0.00%
0/50 • Up to 30 days post last dose
|
|
Renal and urinary disorders
Pain during urination
|
0.00%
0/50 • Up to 30 days post last dose
|
2.0%
1/50 • Up to 30 days post last dose
|
|
Renal and urinary disorders
Renal calculi
|
4.0%
2/50 • Up to 30 days post last dose
|
0.00%
0/50 • Up to 30 days post last dose
|
|
Renal and urinary disorders
Renal colic
|
2.0%
1/50 • Up to 30 days post last dose
|
0.00%
0/50 • Up to 30 days post last dose
|
|
Renal and urinary disorders
Urinary frequency
|
10.0%
5/50 • Up to 30 days post last dose
|
10.0%
5/50 • Up to 30 days post last dose
|
|
Renal and urinary disorders
Urinary incontinence
|
6.0%
3/50 • Up to 30 days post last dose
|
6.0%
3/50 • Up to 30 days post last dose
|
|
Renal and urinary disorders
Urinary retention
|
8.0%
4/50 • Up to 30 days post last dose
|
8.0%
4/50 • Up to 30 days post last dose
|
|
Renal and urinary disorders
Urinary tract obstruction
|
2.0%
1/50 • Up to 30 days post last dose
|
4.0%
2/50 • Up to 30 days post last dose
|
|
Renal and urinary disorders
Urinary tract pain
|
2.0%
1/50 • Up to 30 days post last dose
|
4.0%
2/50 • Up to 30 days post last dose
|
|
Renal and urinary disorders
Urinary urgency
|
4.0%
2/50 • Up to 30 days post last dose
|
2.0%
1/50 • Up to 30 days post last dose
|
|
Reproductive system and breast disorders
Breast pain
|
2.0%
1/50 • Up to 30 days post last dose
|
0.00%
0/50 • Up to 30 days post last dose
|
|
Reproductive system and breast disorders
Penile erosion
|
0.00%
0/50 • Up to 30 days post last dose
|
2.0%
1/50 • Up to 30 days post last dose
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
4.0%
2/50 • Up to 30 days post last dose
|
2.0%
1/50 • Up to 30 days post last dose
|
|
Respiratory, thoracic and mediastinal disorders
Bronchopulmonary hemorrhage
|
0.00%
0/50 • Up to 30 days post last dose
|
2.0%
1/50 • Up to 30 days post last dose
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
30.0%
15/50 • Up to 30 days post last dose
|
18.0%
9/50 • Up to 30 days post last dose
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
14.0%
7/50 • Up to 30 days post last dose
|
18.0%
9/50 • Up to 30 days post last dose
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/50 • Up to 30 days post last dose
|
2.0%
1/50 • Up to 30 days post last dose
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
4.0%
2/50 • Up to 30 days post last dose
|
4.0%
2/50 • Up to 30 days post last dose
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal mucositis
|
2.0%
1/50 • Up to 30 days post last dose
|
0.00%
0/50 • Up to 30 days post last dose
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
2.0%
1/50 • Up to 30 days post last dose
|
0.00%
0/50 • Up to 30 days post last dose
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
2.0%
1/50 • Up to 30 days post last dose
|
0.00%
0/50 • Up to 30 days post last dose
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/50 • Up to 30 days post last dose
|
2.0%
1/50 • Up to 30 days post last dose
|
|
Respiratory, thoracic and mediastinal disorders
Asthmatic episode
|
0.00%
0/50 • Up to 30 days post last dose
|
2.0%
1/50 • Up to 30 days post last dose
|
|
Respiratory, thoracic and mediastinal disorders
Bilaterial pneumonia
|
0.00%
0/50 • Up to 30 days post last dose
|
2.0%
1/50 • Up to 30 days post last dose
|
|
Respiratory, thoracic and mediastinal disorders
COPD exacerbation
|
0.00%
0/50 • Up to 30 days post last dose
|
2.0%
1/50 • Up to 30 days post last dose
|
|
Respiratory, thoracic and mediastinal disorders
Hypercapnic Respiratory Failure
|
0.00%
0/50 • Up to 30 days post last dose
|
2.0%
1/50 • Up to 30 days post last dose
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
0.00%
0/50 • Up to 30 days post last dose
|
2.0%
1/50 • Up to 30 days post last dose
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
0.00%
0/50 • Up to 30 days post last dose
|
4.0%
2/50 • Up to 30 days post last dose
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
2.0%
1/50 • Up to 30 days post last dose
|
0.00%
0/50 • Up to 30 days post last dose
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
2.0%
1/50 • Up to 30 days post last dose
|
0.00%
0/50 • Up to 30 days post last dose
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
2.0%
1/50 • Up to 30 days post last dose
|
2.0%
1/50 • Up to 30 days post last dose
|
|
Skin and subcutaneous tissue disorders
Periorbital edema
|
0.00%
0/50 • Up to 30 days post last dose
|
2.0%
1/50 • Up to 30 days post last dose
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
2.0%
1/50 • Up to 30 days post last dose
|
2.0%
1/50 • Up to 30 days post last dose
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
2.0%
1/50 • Up to 30 days post last dose
|
4.0%
2/50 • Up to 30 days post last dose
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
10.0%
5/50 • Up to 30 days post last dose
|
2.0%
1/50 • Up to 30 days post last dose
|
|
Skin and subcutaneous tissue disorders
Other
|
4.0%
2/50 • Up to 30 days post last dose
|
0.00%
0/50 • Up to 30 days post last dose
|
|
Skin and subcutaneous tissue disorders
"Poison ivy" per patient, dermatitis on left forearm
|
0.00%
0/50 • Up to 30 days post last dose
|
2.0%
1/50 • Up to 30 days post last dose
|
|
Skin and subcutaneous tissue disorders
Skin ulceration gluteal fold bilaterally
|
0.00%
0/50 • Up to 30 days post last dose
|
2.0%
1/50 • Up to 30 days post last dose
|
|
Skin and subcutaneous tissue disorders
Blotchy red spot forearm
|
2.0%
1/50 • Up to 30 days post last dose
|
0.00%
0/50 • Up to 30 days post last dose
|
|
Skin and subcutaneous tissue disorders
Boils-Four on right leg only
|
0.00%
0/50 • Up to 30 days post last dose
|
2.0%
1/50 • Up to 30 days post last dose
|
|
Skin and subcutaneous tissue disorders
Erythema & swelling of abd incision
|
2.0%
1/50 • Up to 30 days post last dose
|
0.00%
0/50 • Up to 30 days post last dose
|
|
Skin and subcutaneous tissue disorders
Rash in groin
|
0.00%
0/50 • Up to 30 days post last dose
|
2.0%
1/50 • Up to 30 days post last dose
|
|
Skin and subcutaneous tissue disorders
Redness in hands and feet
|
2.0%
1/50 • Up to 30 days post last dose
|
0.00%
0/50 • Up to 30 days post last dose
|
|
Skin and subcutaneous tissue disorders
Basal skin cancer (removed from the nose)
|
2.0%
1/50 • Up to 30 days post last dose
|
0.00%
0/50 • Up to 30 days post last dose
|
|
Skin and subcutaneous tissue disorders
Open wound to left hip
|
0.00%
0/50 • Up to 30 days post last dose
|
2.0%
1/50 • Up to 30 days post last dose
|
|
Skin and subcutaneous tissue disorders
Sebaceous cyst
|
2.0%
1/50 • Up to 30 days post last dose
|
0.00%
0/50 • Up to 30 days post last dose
|
|
Skin and subcutaneous tissue disorders
Squamous cell carcinoma of the face
|
2.0%
1/50 • Up to 30 days post last dose
|
0.00%
0/50 • Up to 30 days post last dose
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
0.00%
0/50 • Up to 30 days post last dose
|
2.0%
1/50 • Up to 30 days post last dose
|
|
Skin and subcutaneous tissue disorders
Skin hypopigmentation
|
2.0%
1/50 • Up to 30 days post last dose
|
0.00%
0/50 • Up to 30 days post last dose
|
|
Surgical and medical procedures
Bilateral Blepharoplasty
|
2.0%
1/50 • Up to 30 days post last dose
|
0.00%
0/50 • Up to 30 days post last dose
|
|
Surgical and medical procedures
Colostomy Reversal
|
2.0%
1/50 • Up to 30 days post last dose
|
0.00%
0/50 • Up to 30 days post last dose
|
|
Surgical and medical procedures
Tooth extractions
|
0.00%
0/50 • Up to 30 days post last dose
|
2.0%
1/50 • Up to 30 days post last dose
|
|
Surgical and medical procedures
Surgical resection of neck cancer
|
2.0%
1/50 • Up to 30 days post last dose
|
0.00%
0/50 • Up to 30 days post last dose
|
|
Vascular disorders
Flushing
|
2.0%
1/50 • Up to 30 days post last dose
|
0.00%
0/50 • Up to 30 days post last dose
|
|
Vascular disorders
Hematoma
|
0.00%
0/50 • Up to 30 days post last dose
|
2.0%
1/50 • Up to 30 days post last dose
|
|
Vascular disorders
Hot flashes
|
2.0%
1/50 • Up to 30 days post last dose
|
20.0%
10/50 • Up to 30 days post last dose
|
|
Vascular disorders
Hypertension
|
40.0%
20/50 • Up to 30 days post last dose
|
46.0%
23/50 • Up to 30 days post last dose
|
|
Vascular disorders
Hypotension
|
2.0%
1/50 • Up to 30 days post last dose
|
0.00%
0/50 • Up to 30 days post last dose
|
|
Vascular disorders
Peripheral ischemia
|
2.0%
1/50 • Up to 30 days post last dose
|
0.00%
0/50 • Up to 30 days post last dose
|
|
Vascular disorders
Thromboembolic event
|
12.0%
6/50 • Up to 30 days post last dose
|
2.0%
1/50 • Up to 30 days post last dose
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place