Trial Outcomes & Findings for Apalutamide in Treating Patients With Prostate Cancer Who Are in Active Surveillance (NCT NCT02721979)
NCT ID: NCT02721979
Last Updated: 2023-02-09
Results Overview
Negative rate will be presented as the percent of subjects with a negative repeat biopsy, and will be calculated as: (number of patients with a negative biopsy following 90-days of apalutamide) / (total number of patients enrolled on the study) x 100. A 1-sample chi-square test will be used to compare the proportion with a negative repeat biopsy to the null hypothesis value of 20% (above). The 95% confidence interval will be computed.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
24 participants
Primary outcome timeframe
At 90 days
Results posted on
2023-02-09
Participant Flow
The screening study procedures are conducted within 30 days prior to enrollment. The only exception to this would be the surveillance prostate biopsy.
24 subjects signed consent for this study, but only 23 were eligible to enter into the treatment phase.
Participant milestones
| Measure |
Apalutamide
Day 1 until Day 90. Patients receive apalutamide PO QD for 90 days in the absence of disease progression or unacceptable toxicity.
Apalutamide: Given PO
Laboratory Biomarker Analysis: Correlative studies
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
|
|---|---|
|
Overall Study
STARTED
|
23
|
|
Overall Study
COMPLETED
|
22
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Only patients that did not screen fail are included in this analysis.
Baseline characteristics by cohort
| Measure |
Treatment (Apalutamide)
n=24 Participants
Patients receive apalutamide PO QD for 90 days in the absence of disease progression or unacceptable toxicity.
Apalutamide: Given PO
Laboratory Biomarker Analysis: Correlative studies
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=24 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=24 Participants
|
|
Age, Categorical
>=65 years
|
14 Participants
n=24 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=24 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
24 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=24 Participants
|
|
Race (NIH/OMB)
White
|
23 Participants
n=24 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=24 Participants
|
|
Region of Enrollment
United States
|
24 Participants
n=24 Participants
|
|
Patients with very low risk disease at baseline
|
9 Participants
n=23 Participants • Only patients that did not screen fail are included in this analysis.
|
PRIMARY outcome
Timeframe: At 90 daysPopulation: These are patients that had 90 days of treatment and had post-treatment biopsies.
Negative rate will be presented as the percent of subjects with a negative repeat biopsy, and will be calculated as: (number of patients with a negative biopsy following 90-days of apalutamide) / (total number of patients enrolled on the study) x 100. A 1-sample chi-square test will be used to compare the proportion with a negative repeat biopsy to the null hypothesis value of 20% (above). The 95% confidence interval will be computed.
Outcome measures
| Measure |
Apalutamide
n=22 Participants
Day 1 until Day 90. Patients receive apalutamide PO QD for 90 days in the absence of disease progression or unacceptable toxicity.
Apalutamide: Given PO
Laboratory Biomarker Analysis: Correlative studies
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
|
|---|---|
|
Negative (i.e. no Residual Carcinoma) Site Directed and Systematic Prostate Biopsy Rate
|
59 percentage of subjects
Interval 37.0 to 78.0
|
SECONDARY outcome
Timeframe: At 2 yearsThe percentage of patients who exited active surveillance due to pathologic reclassification (e.g. increasing tumor volume or gleason score) will be computed along with its 95% confidence interval.
Outcome measures
| Measure |
Apalutamide
n=22 Participants
Day 1 until Day 90. Patients receive apalutamide PO QD for 90 days in the absence of disease progression or unacceptable toxicity.
Apalutamide: Given PO
Laboratory Biomarker Analysis: Correlative studies
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
|
|---|---|
|
Percentage of Patients Exiting Active Surveillance Due to Pathologic Reclassification
|
18.2 Percentage of participants
Interval 6.6 to 41.2
|
SECONDARY outcome
Timeframe: At 2 yearsPercentage of patients exiting active surveillance for any reason will be computed along with its 95% confidence interval.
Outcome measures
| Measure |
Apalutamide
n=22 Participants
Day 1 until Day 90. Patients receive apalutamide PO QD for 90 days in the absence of disease progression or unacceptable toxicity.
Apalutamide: Given PO
Laboratory Biomarker Analysis: Correlative studies
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
|
|---|---|
|
Percentage of Patients Exiting Active Surveillance for Any Reason
|
22.7 Percentage of participants
Interval 9.3 to 45.9
|
SECONDARY outcome
Timeframe: At 2 yearsComputed along with its 95% confidence interval.
Outcome measures
| Measure |
Apalutamide
n=19 Participants
Day 1 until Day 90. Patients receive apalutamide PO QD for 90 days in the absence of disease progression or unacceptable toxicity.
Apalutamide: Given PO
Laboratory Biomarker Analysis: Correlative studies
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
|
|---|---|
|
Percent of Men Undergoing Local Treatment
|
5 Participants
|
SECONDARY outcome
Timeframe: Up to 730 daysMedian treatment free survival will be estimated using Kaplan-Meier methods and 95% confidence interval will be calculated
Outcome measures
| Measure |
Apalutamide
n=22 Participants
Day 1 until Day 90. Patients receive apalutamide PO QD for 90 days in the absence of disease progression or unacceptable toxicity.
Apalutamide: Given PO
Laboratory Biomarker Analysis: Correlative studies
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
|
|---|---|
|
Local Treatment Free Survival
|
874 days
Interval 805.0 to 9999.0
|
SECONDARY outcome
Timeframe: At 2 yearsProstate-specific antigen progression rate is the proportion of patients that had PSA progression following treatment. PSA progression is as a confirmed rising prostate-specific antigen \>= 2 ng/mL, with subsequent PSA values obtained at least one week apart.
Outcome measures
| Measure |
Apalutamide
n=22 Participants
Day 1 until Day 90. Patients receive apalutamide PO QD for 90 days in the absence of disease progression or unacceptable toxicity.
Apalutamide: Given PO
Laboratory Biomarker Analysis: Correlative studies
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
|
|---|---|
|
Prostate-specific Antigen Progression Rate
|
100 Percentage of participants
|
SECONDARY outcome
Timeframe: At 2 yearsProstate-specific antigen progression free survival will be estimated using Kaplan-Meier methods and 95% confidence interval will be estimated using Greenwood's formula.
Outcome measures
| Measure |
Apalutamide
n=22 Participants
Day 1 until Day 90. Patients receive apalutamide PO QD for 90 days in the absence of disease progression or unacceptable toxicity.
Apalutamide: Given PO
Laboratory Biomarker Analysis: Correlative studies
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
|
|---|---|
|
Prostate-specific Antigen Progression Free Survival as Defined by the Prostate Cancer Working Group 2 Criteria
|
365 days
Interval 204.0 to 401.0
|
SECONDARY outcome
Timeframe: Baseline to up to 90 daysPopulation: Only 1 patient had paired MRI at baseline and again at post-treatment.
This calculates the percentage of participants with radiographic disappearance of magnetic resonance imaging detectable prostate cancer. This is only in patients with a baseline nodule that is Prostate Imaging Reporting and Data System 3 or more and \> 5 mm.
Outcome measures
| Measure |
Apalutamide
n=1 Participants
Day 1 until Day 90. Patients receive apalutamide PO QD for 90 days in the absence of disease progression or unacceptable toxicity.
Apalutamide: Given PO
Laboratory Biomarker Analysis: Correlative studies
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
|
|---|---|
|
Change in Radiographic Disappearance of Magnetic Resonance Imaging Detectable Prostate Cancer
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline compared to 730 daysPopulation: Only 14 subjects completed Day 730 survey.
As assessed using the Functional Assessment of Cancer Therapy-Prostate (FACT-P) surveys. Functional Assessment of Cancer Therapy-Prostate is a validated quality of life survey specific for patients with prostate cancer. The total FACT-P score ranges from 0 to 156, with higher scores indicating better quality of life. The change in FACT-P score between baseline and day 730 is reported.
Outcome measures
| Measure |
Apalutamide
n=14 Participants
Day 1 until Day 90. Patients receive apalutamide PO QD for 90 days in the absence of disease progression or unacceptable toxicity.
Apalutamide: Given PO
Laboratory Biomarker Analysis: Correlative studies
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
|
|---|---|
|
Change in Quality of Life: FACT-P Assessment
|
3.17 Change in median FACT-P score
Interval -3.0 to 9.0
|
SECONDARY outcome
Timeframe: Baseline compared to 730 daysPopulation: Only 14 subjects completed Day 730 survey.
As assessed using the Short Form-36 (SF-36) survey physical functioning subscale. Short Form-36 is a validated quality of life survey. This is a generic survey to assess an individual's overall well-being, and is not specific to one disease. The SF-36 physical functioning subscale score ranges from 0 to 100, with higher scores indicating better quality of life. The change in SF-36 energy/fatigue subscale score between baseline and day 730 is reported.
Outcome measures
| Measure |
Apalutamide
n=14 Participants
Day 1 until Day 90. Patients receive apalutamide PO QD for 90 days in the absence of disease progression or unacceptable toxicity.
Apalutamide: Given PO
Laboratory Biomarker Analysis: Correlative studies
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
|
|---|---|
|
Change in Quality of Life: SF-36 Physical Functioning
|
-17.65 Change in median SF-36 subscale score
Interval 0.5 to 50.0
|
SECONDARY outcome
Timeframe: Baseline compared to 730 daysPopulation: Only 14 subjects completed Day 730 survey.
As assessed using the Short Form-36 (SF-36) survey energy/fatigue subscale. Short Form-36 is a validated quality of life survey. This is a generic survey to assess an individual's overall well-being, and is not specific to one disease. The SF-36 energy/fatigue subscale score ranges from 0 to 100, with higher scores indicating better quality of life. The change in SF-36 energy/fatigue subscale score between baseline and day 730 is reported.
Outcome measures
| Measure |
Apalutamide
n=14 Participants
Day 1 until Day 90. Patients receive apalutamide PO QD for 90 days in the absence of disease progression or unacceptable toxicity.
Apalutamide: Given PO
Laboratory Biomarker Analysis: Correlative studies
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
|
|---|---|
|
Change in Quality of Life: SF-36 Energy/Fatigue
|
12.5 Change in median SF-36 subscale score
Interval -5.0 to 20.0
|
SECONDARY outcome
Timeframe: Baseline compared to 730 daysPopulation: Only 14 subjects completed Day 730 survey.
As assessed using the Short Form-36 (SF-36) survey emotional well being subscale. Short Form-36 is a validated quality of life survey. This is a generic survey to assess an individual's overall well-being, and is not specific to one disease. The SF-36 emotional well being subscale score ranges from 0 to 100, with higher scores indicating better quality of life. The change in SF-36 emotional well being subscale score between baseline and day 730 is reported.
Outcome measures
| Measure |
Apalutamide
n=14 Participants
Day 1 until Day 90. Patients receive apalutamide PO QD for 90 days in the absence of disease progression or unacceptable toxicity.
Apalutamide: Given PO
Laboratory Biomarker Analysis: Correlative studies
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
|
|---|---|
|
Change in Quality of Life: SF-36 Emotional Well Being
|
6 Change in median SF-36 subscale score
Interval -4.0 to 24.0
|
Adverse Events
Apalutamide
Serious events: 0 serious events
Other events: 23 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Apalutamide
n=23 participants at risk
Day 1 until Day 90. Patients receive apalutamide PO QD for 90 days in the absence of disease progression or unacceptable toxicity.
Apalutamide: Given PO
Laboratory Biomarker Analysis: Correlative studies
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
|
|---|---|
|
Gastrointestinal disorders
Nausea
|
8.7%
2/23 • Number of events 2 • Through study completion, which corresponded to a median time of 753 days.
|
|
Vascular disorders
Hot Flashes
|
21.7%
5/23 • Number of events 5 • Through study completion, which corresponded to a median time of 753 days.
|
|
Endocrine disorders
Hypothyroidism
|
4.3%
1/23 • Number of events 1 • Through study completion, which corresponded to a median time of 753 days.
|
|
Nervous system disorders
Dysgeusia
|
30.4%
7/23 • Number of events 7 • Through study completion, which corresponded to a median time of 753 days.
|
|
General disorders
Fatigue/Decreased Energy
|
78.3%
18/23 • Number of events 18 • Through study completion, which corresponded to a median time of 753 days.
|
|
Psychiatric disorders
Insomnia
|
8.7%
2/23 • Number of events 2 • Through study completion, which corresponded to a median time of 753 days.
|
|
Psychiatric disorders
Libido Decreased
|
21.7%
5/23 • Number of events 5 • Through study completion, which corresponded to a median time of 753 days.
|
|
Psychiatric disorders
Labile Mood
|
4.3%
1/23 • Number of events 1 • Through study completion, which corresponded to a median time of 753 days.
|
|
Psychiatric disorders
Cognitive Disturbance
|
4.3%
1/23 • Number of events 1 • Through study completion, which corresponded to a median time of 753 days.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
4.3%
1/23 • Number of events 1 • Through study completion, which corresponded to a median time of 753 days.
|
|
Gastrointestinal disorders
Rectal Hemorrhage
|
4.3%
1/23 • Number of events 1 • Through study completion, which corresponded to a median time of 753 days.
|
|
Reproductive system and breast disorders
Gynecomastia
|
26.1%
6/23 • Number of events 6 • Through study completion, which corresponded to a median time of 753 days.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
26.1%
6/23 • Number of events 6 • Through study completion, which corresponded to a median time of 753 days.
|
|
Reproductive system and breast disorders
Nipple Sensitivity/Tenderness
|
47.8%
11/23 • Number of events 11 • Through study completion, which corresponded to a median time of 753 days.
|
|
General disorders
Flu Like Symptoms
|
4.3%
1/23 • Number of events 1 • Through study completion, which corresponded to a median time of 753 days.
|
|
Metabolism and nutrition disorders
Weight Loss/Anorexia
|
21.7%
5/23 • Number of events 7 • Through study completion, which corresponded to a median time of 753 days.
|
|
Reproductive system and breast disorders
Mastodynia
|
8.7%
2/23 • Number of events 2 • Through study completion, which corresponded to a median time of 753 days.
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
13.0%
3/23 • Number of events 3 • Through study completion, which corresponded to a median time of 753 days.
|
|
Infections and infestations
Rhinorrhea
|
4.3%
1/23 • Number of events 1 • Through study completion, which corresponded to a median time of 753 days.
|
|
Investigations
Increased/Elevated TSH
|
17.4%
4/23 • Number of events 4 • Through study completion, which corresponded to a median time of 753 days.
|
|
Investigations
Alanine Aminotransferase Increased
|
4.3%
1/23 • Number of events 1 • Through study completion, which corresponded to a median time of 753 days.
|
|
Investigations
Aspartate Aminotransferase Increased
|
8.7%
2/23 • Number of events 2 • Through study completion, which corresponded to a median time of 753 days.
|
|
Injury, poisoning and procedural complications
Fall
|
4.3%
1/23 • Number of events 1 • Through study completion, which corresponded to a median time of 753 days.
|
|
Psychiatric disorders
Memory Impairment/Forgetfulness/Amnesia
|
13.0%
3/23 • Number of events 3 • Through study completion, which corresponded to a median time of 753 days.
|
|
Reproductive system and breast disorders
Erectile Dysfunction
|
4.3%
1/23 • Number of events 1 • Through study completion, which corresponded to a median time of 753 days.
|
|
Skin and subcutaneous tissue disorders
Rash
|
30.4%
7/23 • Number of events 7 • Through study completion, which corresponded to a median time of 753 days.
|
|
Infections and infestations
Shingles
|
4.3%
1/23 • Number of events 1 • Through study completion, which corresponded to a median time of 753 days.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
4.3%
1/23 • Number of events 1 • Through study completion, which corresponded to a median time of 753 days.
|
|
Gastrointestinal disorders
Constipation
|
4.3%
1/23 • Number of events 1 • Through study completion, which corresponded to a median time of 753 days.
|
|
Musculoskeletal and connective tissue disorders
Edema
|
4.3%
1/23 • Number of events 1 • Through study completion, which corresponded to a median time of 753 days.
|
|
Gastrointestinal disorders
Increased Bowel Movement Frequency
|
4.3%
1/23 • Number of events 1 • Through study completion, which corresponded to a median time of 753 days.
|
|
Renal and urinary disorders
Lower Urinary Tract Symptoms
|
8.7%
2/23 • Number of events 2 • Through study completion, which corresponded to a median time of 753 days.
|
|
Immune system disorders
Sinusitis
|
4.3%
1/23 • Number of events 1 • Through study completion, which corresponded to a median time of 753 days.
|
|
Nervous system disorders
Tingling
|
4.3%
1/23 • Number of events 1 • Through study completion, which corresponded to a median time of 753 days.
|
|
Psychiatric disorders
Brain Fog
|
4.3%
1/23 • Number of events 1 • Through study completion, which corresponded to a median time of 753 days.
|
|
Nervous system disorders
Postural Dizziness/Balance Changes
|
17.4%
4/23 • Number of events 4 • Through study completion, which corresponded to a median time of 753 days.
|
|
Psychiatric disorders
Concentration Impairment
|
4.3%
1/23 • Number of events 1 • Through study completion, which corresponded to a median time of 753 days.
|
|
Psychiatric disorders
Anxiety
|
4.3%
1/23 • Number of events 1 • Through study completion, which corresponded to a median time of 753 days.
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
13.0%
3/23 • Number of events 3 • Through study completion, which corresponded to a median time of 753 days.
|
|
Gastrointestinal disorders
Muscositis Oral
|
4.3%
1/23 • Number of events 1 • Through study completion, which corresponded to a median time of 753 days.
|
|
Gastrointestinal disorders
Stomach Pain
|
4.3%
1/23 • Number of events 1 • Through study completion, which corresponded to a median time of 753 days.
|
|
Gastrointestinal disorders
Dyspepsia
|
4.3%
1/23 • Number of events 1 • Through study completion, which corresponded to a median time of 753 days.
|
|
Skin and subcutaneous tissue disorders
Cellulitis
|
4.3%
1/23 • Number of events 1 • Through study completion, which corresponded to a median time of 753 days.
|
|
Renal and urinary disorders
Dribbling
|
4.3%
1/23 • Number of events 1 • Through study completion, which corresponded to a median time of 753 days.
|
|
Blood and lymphatic system disorders
Anemia
|
4.3%
1/23 • Number of events 1 • Through study completion, which corresponded to a median time of 753 days.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
8.7%
2/23 • Number of events 2 • Through study completion, which corresponded to a median time of 753 days.
|
|
Reproductive system and breast disorders
Breast Tenderness
|
4.3%
1/23 • Number of events 1 • Through study completion, which corresponded to a median time of 753 days.
|
|
Nervous system disorders
Lightheadedness
|
8.7%
2/23 • Number of events 2 • Through study completion, which corresponded to a median time of 753 days.
|
|
Skin and subcutaneous tissue disorders
Lack of Body Odor
|
4.3%
1/23 • Number of events 1 • Through study completion, which corresponded to a median time of 753 days.
|
|
Reproductive system and breast disorders
Ejaculation Disorder
|
4.3%
1/23 • Number of events 1 • Through study completion, which corresponded to a median time of 753 days.
|
|
Skin and subcutaneous tissue disorders
Burning Sensation
|
4.3%
1/23 • Number of events 1 • Through study completion, which corresponded to a median time of 753 days.
|
|
Psychiatric disorders
Decreased Mental Acuity
|
4.3%
1/23 • Number of events 1 • Through study completion, which corresponded to a median time of 753 days.
|
|
Musculoskeletal and connective tissue disorders
Cramp
|
4.3%
1/23 • Number of events 1 • Through study completion, which corresponded to a median time of 753 days.
|
|
Reproductive system and breast disorders
Nipple Itchiness
|
4.3%
1/23 • Number of events 1 • Through study completion, which corresponded to a median time of 753 days.
|
|
Vascular disorders
Warmer Body
|
8.7%
2/23 • Number of events 2 • Through study completion, which corresponded to a median time of 753 days.
|
|
Musculoskeletal and connective tissue disorders
Akathisia
|
4.3%
1/23 • Number of events 1 • Through study completion, which corresponded to a median time of 753 days.
|
|
Blood and lymphatic system disorders
Hypocalcemia
|
4.3%
1/23 • Number of events 1 • Through study completion, which corresponded to a median time of 753 days.
|
|
Immune system disorders
Sore Throat
|
4.3%
1/23 • Number of events 1 • Through study completion, which corresponded to a median time of 753 days.
|
|
Skin and subcutaneous tissue disorders
Painful Callus Bumps
|
4.3%
1/23 • Number of events 1 • Through study completion, which corresponded to a median time of 753 days.
|
|
Respiratory, thoracic and mediastinal disorders
Upper Respiratory Infection Symptoms
|
8.7%
2/23 • Number of events 2 • Through study completion, which corresponded to a median time of 753 days.
|
|
Eye disorders
Impaired Vision
|
4.3%
1/23 • Number of events 1 • Through study completion, which corresponded to a median time of 753 days.
|
|
Nervous system disorders
Headache
|
4.3%
1/23 • Number of events 1 • Through study completion, which corresponded to a median time of 753 days.
|
|
Reproductive system and breast disorders
Perceived Shrinking of Genitals
|
4.3%
1/23 • Number of events 1 • Through study completion, which corresponded to a median time of 753 days.
|
|
Reproductive system and breast disorders
Testicle Pain
|
4.3%
1/23 • Number of events 1 • Through study completion, which corresponded to a median time of 753 days.
|
|
Renal and urinary disorders
Hematuria
|
4.3%
1/23 • Number of events 1 • Through study completion, which corresponded to a median time of 753 days.
|
|
Blood and lymphatic system disorders
Hypertension
|
4.3%
1/23 • Number of events 1 • Through study completion, which corresponded to a median time of 753 days.
|
|
Cardiac disorders
Tachycardia
|
4.3%
1/23 • Number of events 1 • Through study completion, which corresponded to a median time of 753 days.
|
|
Reproductive system and breast disorders
Bronchitis
|
4.3%
1/23 • Number of events 1 • Through study completion, which corresponded to a median time of 753 days.
|
|
Respiratory, thoracic and mediastinal disorders
Chest Tightness
|
4.3%
1/23 • Number of events 1 • Through study completion, which corresponded to a median time of 753 days.
|
|
Gastrointestinal disorders
Clostridium Difficile Enteritis
|
4.3%
1/23 • Number of events 1 • Through study completion, which corresponded to a median time of 753 days.
|
|
Cardiac disorders
Atrial Flutter
|
4.3%
1/23 • Number of events 1 • Through study completion, which corresponded to a median time of 753 days.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place