Trial Outcomes & Findings for Preventing Anthracycline Cardiovascular Toxicity With Statins (PREVENT) (NCT NCT01988571)
NCT ID: NCT01988571
Last Updated: 2022-01-04
Results Overview
24 month estimated values of clinical measurements obtained from Cardiac MRI left ventricular ejection fraction by group. Linear model adjusts for baseline value and group assignment and multiple imputation was utilized for missing data.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
279 participants
Primary outcome timeframe
24 months
Results posted on
2022-01-04
Participant Flow
No reason for exclusion prior to randomization.
Participant milestones
| Measure |
Arm 1 - Atorvastatin
One 40 mg Atorvastatin tablet each morning by mouth for 24 months
Atorvastatin: 40 mg tablet taken by mouth each morning for 24 months.
|
Arm 2 - Placebo
One placebo tablet each morning by mouth for 24 months.
Atorvastatin: 40 mg tablet taken by mouth each morning for 24 months.
Placebo: One placebo tablet taken each morning orally for 24 months.
|
|---|---|---|
|
Overall Study
STARTED
|
139
|
140
|
|
Overall Study
Completed Baseline
|
136
|
139
|
|
Overall Study
Completed 6 Month Visit
|
122
|
126
|
|
Overall Study
COMPLETED
|
100
|
105
|
|
Overall Study
NOT COMPLETED
|
39
|
35
|
Reasons for withdrawal
| Measure |
Arm 1 - Atorvastatin
One 40 mg Atorvastatin tablet each morning by mouth for 24 months
Atorvastatin: 40 mg tablet taken by mouth each morning for 24 months.
|
Arm 2 - Placebo
One placebo tablet each morning by mouth for 24 months.
Atorvastatin: 40 mg tablet taken by mouth each morning for 24 months.
Placebo: One placebo tablet taken each morning orally for 24 months.
|
|---|---|---|
|
Overall Study
Death
|
3
|
1
|
|
Overall Study
Physician Decision
|
2
|
1
|
|
Overall Study
Lost to Follow-up
|
3
|
0
|
|
Overall Study
Withdrawal by Subject
|
31
|
33
|
Baseline Characteristics
Preventing Anthracycline Cardiovascular Toxicity With Statins (PREVENT)
Baseline characteristics by cohort
| Measure |
Arm 1 - Atorvastatin
n=139 Participants
One 40 mg Atorvastatin tablet each morning by mouth for 24 months
Atorvastatin: 40 mg tablet taken by mouth each morning for 24 months.
|
Arm 2 - Placebo
n=140 Participants
One placebo tablet each morning by mouth for 24 months.
Atorvastatin: 40 mg tablet taken by mouth each morning for 24 months.
Placebo: One placebo tablet taken each morning orally for 24 months.
|
Total
n=279 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
48.5 years
STANDARD_DEVIATION 12.5 • n=5 Participants
|
49.4 years
STANDARD_DEVIATION 11.5 • n=7 Participants
|
49.0 years
STANDARD_DEVIATION 12.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
129 Participants
n=5 Participants
|
127 Participants
n=7 Participants
|
256 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
134 Participants
n=5 Participants
|
136 Participants
n=7 Participants
|
270 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 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
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
4 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
16 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
115 Participants
n=5 Participants
|
116 Participants
n=7 Participants
|
231 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Medicare
|
16 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Medicaid
|
10 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Private Insurance
|
112 Participants
n=5 Participants
|
121 Participants
n=7 Participants
|
233 Participants
n=5 Participants
|
|
No Health Insurance
|
6 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Cancer Type
Lymphoma
|
20 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
|
Cancer Type
Breast Cancer
|
119 Participants
n=5 Participants
|
119 Participants
n=7 Participants
|
238 Participants
n=5 Participants
|
|
Cancer Stage
Stage 1
|
24 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
|
Cancer Stage
Stage 2
|
77 Participants
n=5 Participants
|
77 Participants
n=7 Participants
|
154 Participants
n=5 Participants
|
|
Cancer Stage
Stage 3
|
34 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
74 Participants
n=5 Participants
|
|
Cancer Stage
Stage 4
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Marital Status
Single, Never Married
|
23 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
|
Marital Status
Married
|
82 Participants
n=5 Participants
|
84 Participants
n=7 Participants
|
166 Participants
n=5 Participants
|
|
Marital Status
Living in a married like relationship
|
4 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Marital Status
Separated or Divorced
|
23 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
|
Marital Status
Widowed
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Marital Status
Unknown
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Education
Grades 1-8
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Education
Grades 9-11
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Education
High School/GED
|
28 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
|
Education
Vocational/trading school
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Education
Some College/Assoicates
|
27 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
76 Participants
n=5 Participants
|
|
Education
College Degree (Bachelors)
|
36 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
68 Participants
n=5 Participants
|
|
Education
Some post college
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Education
Masters degree
|
21 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
Education
Doctoral degree
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Education
Unknown
|
11 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Income
Less than $10,000
|
11 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Income
$10,000-$20,000
|
14 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Income
$20,000-$35,000
|
12 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Income
$35,000-$50,000
|
15 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Income
$50,000-$75,000
|
27 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
57 Participants
n=5 Participants
|
|
Income
$75,000-$100,000
|
11 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Income
$100,000-$150,000
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Income
More than $150,000
|
7 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Income
Unknown
|
32 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
62 Participants
n=5 Participants
|
|
Job Status
Not currently working
|
16 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Job Status
Retired
|
15 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Job Status
Homemaker
|
10 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Job Status
Employed
|
83 Participants
n=5 Participants
|
95 Participants
n=7 Participants
|
178 Participants
n=5 Participants
|
|
Job Status
Disabled, unable to work
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Job Status
Other
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Job Status
Unknown
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Body Mass Index
|
29 kg/m^2
STANDARD_DEVIATION 6.43 • n=5 Participants
|
31 kg/m^2
STANDARD_DEVIATION 7.4 • n=7 Participants
|
30 kg/m^2
STANDARD_DEVIATION 7.0 • n=5 Participants
|
PRIMARY outcome
Timeframe: 24 monthsPopulation: All those with baseline and 24 month cardiac MRI (multiple imputation utilized for missing data).
24 month estimated values of clinical measurements obtained from Cardiac MRI left ventricular ejection fraction by group. Linear model adjusts for baseline value and group assignment and multiple imputation was utilized for missing data.
Outcome measures
| Measure |
Arm 1 - Atorvastatin
n=136 Participants
One 40 mg Atorvastatin tablet each morning by mouth for 24 months
Atorvastatin: 40 mg tablet taken by mouth each morning for 24 months.
|
Arm 2 - Placebo
n=139 Participants
One placebo tablet each morning by mouth for 24 months.
Atorvastatin: 40 mg tablet taken by mouth each morning for 24 months.
Placebo: One placebo tablet taken each morning orally for 24 months.
|
|---|---|---|
|
Left Ventricular Ejection Fraction (LVEF)
|
58.1 percent ejected from LV per heartbeat
Standard Error 0.555
|
57.9 percent ejected from LV per heartbeat
Standard Error 0.560
|
SECONDARY outcome
Timeframe: 24 monthsPopulation: All those with baseline and 24 month cardiac MRI (multiple imputation utilized for missing data).
24 month estimated values of clinical measurements obtained from Cardiac MRI End Diastolic Volume by group. Linear model adjusts for baseline value and group assignment and multiple imputation was utilized for missing data.
Outcome measures
| Measure |
Arm 1 - Atorvastatin
n=136 Participants
One 40 mg Atorvastatin tablet each morning by mouth for 24 months
Atorvastatin: 40 mg tablet taken by mouth each morning for 24 months.
|
Arm 2 - Placebo
n=139 Participants
One placebo tablet each morning by mouth for 24 months.
Atorvastatin: 40 mg tablet taken by mouth each morning for 24 months.
Placebo: One placebo tablet taken each morning orally for 24 months.
|
|---|---|---|
|
End Diastolic Volume
|
123 milliliters of blood
Standard Error 2.06
|
125 milliliters of blood
Standard Error 2.01
|
SECONDARY outcome
Timeframe: 24 monthsPopulation: All those with baseline and 24 month cardiac MRI (multiple imputation utilized for missing data).
24 month estimated values of clinical measurements obtained from Cardiac MRI End Systolic Volume by group. Linear model adjusts for baseline value and group assignment and multiple imputation was utilized for missing data.
Outcome measures
| Measure |
Arm 1 - Atorvastatin
n=136 Participants
One 40 mg Atorvastatin tablet each morning by mouth for 24 months
Atorvastatin: 40 mg tablet taken by mouth each morning for 24 months.
|
Arm 2 - Placebo
n=139 Participants
One placebo tablet each morning by mouth for 24 months.
Atorvastatin: 40 mg tablet taken by mouth each morning for 24 months.
Placebo: One placebo tablet taken each morning orally for 24 months.
|
|---|---|---|
|
End Systolic Volume
|
51.8 milliliters of blood
Standard Error 1.27
|
52.9 milliliters of blood
Standard Error 1.25
|
SECONDARY outcome
Timeframe: 24 monthsPopulation: All those with baseline and 24 month cardiac MRI (multiple imputation utilized for missing data).
24 month estimated values of clinical measurements obtained from Cardiac MRI Stroke Volume by group. Linear model adjusts for baseline value and group assignment and multiple imputation was utilized for missing data.
Outcome measures
| Measure |
Arm 1 - Atorvastatin
n=136 Participants
One 40 mg Atorvastatin tablet each morning by mouth for 24 months
Atorvastatin: 40 mg tablet taken by mouth each morning for 24 months.
|
Arm 2 - Placebo
n=139 Participants
One placebo tablet each morning by mouth for 24 months.
Atorvastatin: 40 mg tablet taken by mouth each morning for 24 months.
Placebo: One placebo tablet taken each morning orally for 24 months.
|
|---|---|---|
|
Stroke Volume
|
71 milliliters per minute
Standard Error 1.58
|
72.2 milliliters per minute
Standard Error 1.50
|
SECONDARY outcome
Timeframe: 24 monthsPopulation: All those with baseline and 24 month cardiac MRI (multiple imputation utilized for missing data).
24 month estimated values of clinical measurements obtained from Cardiac MRI left ventricular mass by group. Linear model adjusts for baseline value and group assignment and multiple imputation was utilized for missing data.
Outcome measures
| Measure |
Arm 1 - Atorvastatin
n=136 Participants
One 40 mg Atorvastatin tablet each morning by mouth for 24 months
Atorvastatin: 40 mg tablet taken by mouth each morning for 24 months.
|
Arm 2 - Placebo
n=139 Participants
One placebo tablet each morning by mouth for 24 months.
Atorvastatin: 40 mg tablet taken by mouth each morning for 24 months.
Placebo: One placebo tablet taken each morning orally for 24 months.
|
|---|---|---|
|
Left Ventricular (LV) Mass
|
88.4 gram per meter squared
Standard Error 1.68
|
87.5 gram per meter squared
Standard Error 1.65
|
SECONDARY outcome
Timeframe: 24 monthsPopulation: All those with baseline and 24 month cardiac MRI (multiple imputation utilized for missing data).
24 month estimated values of clinical measurements obtained from Cardiac MRI pulse wave velocity by group. Linear model adjusts for baseline value and group assignment and multiple imputation was utilized for missing data.
Outcome measures
| Measure |
Arm 1 - Atorvastatin
n=136 Participants
One 40 mg Atorvastatin tablet each morning by mouth for 24 months
Atorvastatin: 40 mg tablet taken by mouth each morning for 24 months.
|
Arm 2 - Placebo
n=139 Participants
One placebo tablet each morning by mouth for 24 months.
Atorvastatin: 40 mg tablet taken by mouth each morning for 24 months.
Placebo: One placebo tablet taken each morning orally for 24 months.
|
|---|---|---|
|
Pulse Wave Velocity
|
5.73 m/s
Standard Error 0.247
|
5.51 m/s
Standard Error 0.24
|
SECONDARY outcome
Timeframe: 24 monthsPopulation: Those with data available at baseline and 24 months.
24 month estimated values Hopkins Verbal Learning test (HVLT) total recall by group. Linear model adjusts for baseline value and group assignment. No missing imputation performed. Ranges from 0 to 36 and higher numbers reflect better recall.
Outcome measures
| Measure |
Arm 1 - Atorvastatin
n=136 Participants
One 40 mg Atorvastatin tablet each morning by mouth for 24 months
Atorvastatin: 40 mg tablet taken by mouth each morning for 24 months.
|
Arm 2 - Placebo
n=139 Participants
One placebo tablet each morning by mouth for 24 months.
Atorvastatin: 40 mg tablet taken by mouth each morning for 24 months.
Placebo: One placebo tablet taken each morning orally for 24 months.
|
|---|---|---|
|
Hopkins Verbal Learning Test (HVLT) Total Recall
|
28.5 score on a scale
Standard Error 0.518
|
27.5 score on a scale
Standard Error 0.503
|
SECONDARY outcome
Timeframe: 24 monthsPopulation: Those with data available at baseline and 24 months.
24 month estimated values Controlled Oral Word Association (COWA) by group. Linear model adjusts for baseline value and group assignment. No missing imputation performed. The COWA uses the three letter set of C, F, and L to assess phonemic fluency. Individuals are given 1 min to name as many words as possible beginning with one of the letters. The procedure is then repeated for the remaining two letters. Ranges from 0 to the total number of correct words that begin with one of the letters in the set. There is no ceiling of a maximum score. Higher numbers reflect better verbal fluency.
Outcome measures
| Measure |
Arm 1 - Atorvastatin
n=136 Participants
One 40 mg Atorvastatin tablet each morning by mouth for 24 months
Atorvastatin: 40 mg tablet taken by mouth each morning for 24 months.
|
Arm 2 - Placebo
n=139 Participants
One placebo tablet each morning by mouth for 24 months.
Atorvastatin: 40 mg tablet taken by mouth each morning for 24 months.
Placebo: One placebo tablet taken each morning orally for 24 months.
|
|---|---|---|
|
Controlled Oral Word Association (COWA)
|
41.6 score on a scale
Standard Error 1.07
|
44.7 score on a scale
Standard Error 1.06
|
SECONDARY outcome
Timeframe: 24 monthsPopulation: Those with baseline and 24 month assessment completed. Multiple imputation was utilized for missing data.
Patient reported quality of life outcomes obtained from patient-reported outcomes measurement (PROMIS) questionnaire - Applied Cognition - General Concerns - Short Form 4a . Scores range from 4-20 and then adjusted by t-scores ranging from 30.1-63.8. Higher scores reflect better cognition. Linear models include baseline assessment and group and multiple imputation was utilized.
Outcome measures
| Measure |
Arm 1 - Atorvastatin
n=136 Participants
One 40 mg Atorvastatin tablet each morning by mouth for 24 months
Atorvastatin: 40 mg tablet taken by mouth each morning for 24 months.
|
Arm 2 - Placebo
n=139 Participants
One placebo tablet each morning by mouth for 24 months.
Atorvastatin: 40 mg tablet taken by mouth each morning for 24 months.
Placebo: One placebo tablet taken each morning orally for 24 months.
|
|---|---|---|
|
Patient-reported Outcomes Measurement (PROMIS) Questionnaire - Applied Cognition - General Concerns - Short Form 4a
|
45.57 t-score
Standard Error 1.1
|
46.55 t-score
Standard Error 1.14
|
SECONDARY outcome
Timeframe: 24 monthsPopulation: Those with baseline and 24 month assessment completed. Multiple imputation was utilized for missing data.
Patient reported quality of life outcomes obtained from patient-reported outcomes measurement (PROMIS) questionnaire - Fatigue Short Form 41. Scores range from 4-20 and then adjusted by t-scores ranging from 33.7-75.8. Higher scores reflect worse fatigue. Linear models include baseline assessment and group and multiple imputation was utilized.
Outcome measures
| Measure |
Arm 1 - Atorvastatin
n=136 Participants
One 40 mg Atorvastatin tablet each morning by mouth for 24 months
Atorvastatin: 40 mg tablet taken by mouth each morning for 24 months.
|
Arm 2 - Placebo
n=139 Participants
One placebo tablet each morning by mouth for 24 months.
Atorvastatin: 40 mg tablet taken by mouth each morning for 24 months.
Placebo: One placebo tablet taken each morning orally for 24 months.
|
|---|---|---|
|
Patient-reported Outcomes Measurement (PROMIS) Questionnaire - Fatigue Short Form 41
|
48.17 t-score
Standard Error 1.08
|
49.29 t-score
Standard Error 1.12
|
Adverse Events
Arm 1 - Atorvastatin
Serious events: 17 serious events
Other events: 0 other events
Deaths: 3 deaths
Arm 2 - Placebo
Serious events: 18 serious events
Other events: 0 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Arm 1 - Atorvastatin
n=139 participants at risk
One 40 mg Atorvastatin tablet each morning by mouth for 24 months
Atorvastatin: 40 mg tablet taken by mouth each morning for 24 months.
|
Arm 2 - Placebo
n=140 participants at risk
One placebo tablet each morning by mouth for 24 months.
Atorvastatin: 40 mg tablet taken by mouth each morning for 24 months.
Placebo: One placebo tablet taken each morning orally for 24 months.
|
|---|---|---|
|
Infections and infestations
Febrile neutropenia
|
2.2%
3/139 • Adverse events were collected during the entire trial and up to 30 days post-completion of statin or placebo (approximately 25 months)
Serious Adverse Event reporting begins after the informed consent is signed. Serious Adverse Events occurring within 30 days of study completion must be reported via FDA Form 3500 (MedWatch).
|
5.0%
7/140 • Adverse events were collected during the entire trial and up to 30 days post-completion of statin or placebo (approximately 25 months)
Serious Adverse Event reporting begins after the informed consent is signed. Serious Adverse Events occurring within 30 days of study completion must be reported via FDA Form 3500 (MedWatch).
|
|
Surgical and medical procedures
Hospitalization for Reconstructive Surgery
|
2.2%
3/139 • Adverse events were collected during the entire trial and up to 30 days post-completion of statin or placebo (approximately 25 months)
Serious Adverse Event reporting begins after the informed consent is signed. Serious Adverse Events occurring within 30 days of study completion must be reported via FDA Form 3500 (MedWatch).
|
1.4%
2/140 • Adverse events were collected during the entire trial and up to 30 days post-completion of statin or placebo (approximately 25 months)
Serious Adverse Event reporting begins after the informed consent is signed. Serious Adverse Events occurring within 30 days of study completion must be reported via FDA Form 3500 (MedWatch).
|
|
Metabolism and nutrition disorders
Dehydration
|
0.72%
1/139 • Adverse events were collected during the entire trial and up to 30 days post-completion of statin or placebo (approximately 25 months)
Serious Adverse Event reporting begins after the informed consent is signed. Serious Adverse Events occurring within 30 days of study completion must be reported via FDA Form 3500 (MedWatch).
|
1.4%
2/140 • Adverse events were collected during the entire trial and up to 30 days post-completion of statin or placebo (approximately 25 months)
Serious Adverse Event reporting begins after the informed consent is signed. Serious Adverse Events occurring within 30 days of study completion must be reported via FDA Form 3500 (MedWatch).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/139 • Adverse events were collected during the entire trial and up to 30 days post-completion of statin or placebo (approximately 25 months)
Serious Adverse Event reporting begins after the informed consent is signed. Serious Adverse Events occurring within 30 days of study completion must be reported via FDA Form 3500 (MedWatch).
|
1.4%
2/140 • Adverse events were collected during the entire trial and up to 30 days post-completion of statin or placebo (approximately 25 months)
Serious Adverse Event reporting begins after the informed consent is signed. Serious Adverse Events occurring within 30 days of study completion must be reported via FDA Form 3500 (MedWatch).
|
|
Infections and infestations
Herpes simplex reactivation
|
0.72%
1/139 • Adverse events were collected during the entire trial and up to 30 days post-completion of statin or placebo (approximately 25 months)
Serious Adverse Event reporting begins after the informed consent is signed. Serious Adverse Events occurring within 30 days of study completion must be reported via FDA Form 3500 (MedWatch).
|
0.71%
1/140 • Adverse events were collected during the entire trial and up to 30 days post-completion of statin or placebo (approximately 25 months)
Serious Adverse Event reporting begins after the informed consent is signed. Serious Adverse Events occurring within 30 days of study completion must be reported via FDA Form 3500 (MedWatch).
|
|
Investigations
Decreased neutophils
|
0.72%
1/139 • Adverse events were collected during the entire trial and up to 30 days post-completion of statin or placebo (approximately 25 months)
Serious Adverse Event reporting begins after the informed consent is signed. Serious Adverse Events occurring within 30 days of study completion must be reported via FDA Form 3500 (MedWatch).
|
0.71%
1/140 • Adverse events were collected during the entire trial and up to 30 days post-completion of statin or placebo (approximately 25 months)
Serious Adverse Event reporting begins after the informed consent is signed. Serious Adverse Events occurring within 30 days of study completion must be reported via FDA Form 3500 (MedWatch).
|
|
Blood and lymphatic system disorders
White blood cells decreased
|
0.00%
0/139 • Adverse events were collected during the entire trial and up to 30 days post-completion of statin or placebo (approximately 25 months)
Serious Adverse Event reporting begins after the informed consent is signed. Serious Adverse Events occurring within 30 days of study completion must be reported via FDA Form 3500 (MedWatch).
|
0.71%
1/140 • Adverse events were collected during the entire trial and up to 30 days post-completion of statin or placebo (approximately 25 months)
Serious Adverse Event reporting begins after the informed consent is signed. Serious Adverse Events occurring within 30 days of study completion must be reported via FDA Form 3500 (MedWatch).
|
|
Cardiac disorders
Cardiac Disorder
|
0.00%
0/139 • Adverse events were collected during the entire trial and up to 30 days post-completion of statin or placebo (approximately 25 months)
Serious Adverse Event reporting begins after the informed consent is signed. Serious Adverse Events occurring within 30 days of study completion must be reported via FDA Form 3500 (MedWatch).
|
0.71%
1/140 • Adverse events were collected during the entire trial and up to 30 days post-completion of statin or placebo (approximately 25 months)
Serious Adverse Event reporting begins after the informed consent is signed. Serious Adverse Events occurring within 30 days of study completion must be reported via FDA Form 3500 (MedWatch).
|
|
Infections and infestations
Meningitis
|
0.00%
0/139 • Adverse events were collected during the entire trial and up to 30 days post-completion of statin or placebo (approximately 25 months)
Serious Adverse Event reporting begins after the informed consent is signed. Serious Adverse Events occurring within 30 days of study completion must be reported via FDA Form 3500 (MedWatch).
|
0.71%
1/140 • Adverse events were collected during the entire trial and up to 30 days post-completion of statin or placebo (approximately 25 months)
Serious Adverse Event reporting begins after the informed consent is signed. Serious Adverse Events occurring within 30 days of study completion must be reported via FDA Form 3500 (MedWatch).
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.72%
1/139 • Adverse events were collected during the entire trial and up to 30 days post-completion of statin or placebo (approximately 25 months)
Serious Adverse Event reporting begins after the informed consent is signed. Serious Adverse Events occurring within 30 days of study completion must be reported via FDA Form 3500 (MedWatch).
|
0.00%
0/140 • Adverse events were collected during the entire trial and up to 30 days post-completion of statin or placebo (approximately 25 months)
Serious Adverse Event reporting begins after the informed consent is signed. Serious Adverse Events occurring within 30 days of study completion must be reported via FDA Form 3500 (MedWatch).
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.72%
1/139 • Adverse events were collected during the entire trial and up to 30 days post-completion of statin or placebo (approximately 25 months)
Serious Adverse Event reporting begins after the informed consent is signed. Serious Adverse Events occurring within 30 days of study completion must be reported via FDA Form 3500 (MedWatch).
|
0.00%
0/140 • Adverse events were collected during the entire trial and up to 30 days post-completion of statin or placebo (approximately 25 months)
Serious Adverse Event reporting begins after the informed consent is signed. Serious Adverse Events occurring within 30 days of study completion must be reported via FDA Form 3500 (MedWatch).
|
|
Injury, poisoning and procedural complications
Back Pain
|
0.72%
1/139 • Adverse events were collected during the entire trial and up to 30 days post-completion of statin or placebo (approximately 25 months)
Serious Adverse Event reporting begins after the informed consent is signed. Serious Adverse Events occurring within 30 days of study completion must be reported via FDA Form 3500 (MedWatch).
|
0.00%
0/140 • Adverse events were collected during the entire trial and up to 30 days post-completion of statin or placebo (approximately 25 months)
Serious Adverse Event reporting begins after the informed consent is signed. Serious Adverse Events occurring within 30 days of study completion must be reported via FDA Form 3500 (MedWatch).
|
|
Infections and infestations
Breast Infection
|
0.72%
1/139 • Adverse events were collected during the entire trial and up to 30 days post-completion of statin or placebo (approximately 25 months)
Serious Adverse Event reporting begins after the informed consent is signed. Serious Adverse Events occurring within 30 days of study completion must be reported via FDA Form 3500 (MedWatch).
|
0.00%
0/140 • Adverse events were collected during the entire trial and up to 30 days post-completion of statin or placebo (approximately 25 months)
Serious Adverse Event reporting begins after the informed consent is signed. Serious Adverse Events occurring within 30 days of study completion must be reported via FDA Form 3500 (MedWatch).
|
|
Gastrointestinal disorders
Diarrhea
|
0.72%
1/139 • Adverse events were collected during the entire trial and up to 30 days post-completion of statin or placebo (approximately 25 months)
Serious Adverse Event reporting begins after the informed consent is signed. Serious Adverse Events occurring within 30 days of study completion must be reported via FDA Form 3500 (MedWatch).
|
0.00%
0/140 • Adverse events were collected during the entire trial and up to 30 days post-completion of statin or placebo (approximately 25 months)
Serious Adverse Event reporting begins after the informed consent is signed. Serious Adverse Events occurring within 30 days of study completion must be reported via FDA Form 3500 (MedWatch).
|
|
Gastrointestinal disorders
Dysphagia
|
0.72%
1/139 • Adverse events were collected during the entire trial and up to 30 days post-completion of statin or placebo (approximately 25 months)
Serious Adverse Event reporting begins after the informed consent is signed. Serious Adverse Events occurring within 30 days of study completion must be reported via FDA Form 3500 (MedWatch).
|
0.00%
0/140 • Adverse events were collected during the entire trial and up to 30 days post-completion of statin or placebo (approximately 25 months)
Serious Adverse Event reporting begins after the informed consent is signed. Serious Adverse Events occurring within 30 days of study completion must be reported via FDA Form 3500 (MedWatch).
|
|
Infections and infestations
Upper respiratory infection
|
0.72%
1/139 • Adverse events were collected during the entire trial and up to 30 days post-completion of statin or placebo (approximately 25 months)
Serious Adverse Event reporting begins after the informed consent is signed. Serious Adverse Events occurring within 30 days of study completion must be reported via FDA Form 3500 (MedWatch).
|
0.00%
0/140 • Adverse events were collected during the entire trial and up to 30 days post-completion of statin or placebo (approximately 25 months)
Serious Adverse Event reporting begins after the informed consent is signed. Serious Adverse Events occurring within 30 days of study completion must be reported via FDA Form 3500 (MedWatch).
|
|
Nervous system disorders
Nervous System Disorder
|
0.72%
1/139 • Adverse events were collected during the entire trial and up to 30 days post-completion of statin or placebo (approximately 25 months)
Serious Adverse Event reporting begins after the informed consent is signed. Serious Adverse Events occurring within 30 days of study completion must be reported via FDA Form 3500 (MedWatch).
|
0.00%
0/140 • Adverse events were collected during the entire trial and up to 30 days post-completion of statin or placebo (approximately 25 months)
Serious Adverse Event reporting begins after the informed consent is signed. Serious Adverse Events occurring within 30 days of study completion must be reported via FDA Form 3500 (MedWatch).
|
Other adverse events
Adverse event data not reported
Additional Information
Lead Biostatistician
Wake Forest NCI Community Oncology Research Program Research Base
Phone: 336-716-0891
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place