Trial Outcomes & Findings for EGb761 in Maintaining Mental Clarity in Women Receiving Chemotherapy for Newly Diagnosed Breast Cancer (NCT NCT00046891)
NCT ID: NCT00046891
Last Updated: 2016-07-06
Results Overview
The primary analysis involved compiling each subscale score for the HSCS into area under the curve (AUC) scores for the data points from baseline to the 12 month data point. HSCS instrument contains questions regarding Memory (0-39), Language (0-30), Visual-motor (0-10), Spatial (0-8), Attention and Concentration (0-25), Self-Regulation and Planning (0-6) on a varying scales. Total is calculated by summing afore mentioned subscales, values of Total ranged from 0 to 125. Lower scores are better.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
226 participants
Primary outcome timeframe
Baseline, 12 months after starting Chemotherapy.
Results posted on
2016-07-06
Participant Flow
226 patients were enrolled to this study between October 2002 and October 2006. There were 14 cancellations and 2 ineligible patients removed from the analysis; these participants were randomized but withdrew before beginning any study interventions. Efficacy analyses use all patients that reported baseline and one value after baseline.
Participant milestones
| Measure |
Ginkgo Biloba
Ginkgo Biloba: Patients will take 120 mg per day (60 mg BID)
|
Placebo
Placebo: Patients will take 1 tablet BID
|
|---|---|---|
|
Overall Study
STARTED
|
113
|
113
|
|
Overall Study
COMPLETED
|
84
|
83
|
|
Overall Study
NOT COMPLETED
|
29
|
30
|
Reasons for withdrawal
| Measure |
Ginkgo Biloba
Ginkgo Biloba: Patients will take 120 mg per day (60 mg BID)
|
Placebo
Placebo: Patients will take 1 tablet BID
|
|---|---|---|
|
Overall Study
Cancels
|
5
|
9
|
|
Overall Study
Ineligible
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
18
|
15
|
|
Overall Study
Adverse Event
|
5
|
5
|
Baseline Characteristics
EGb761 in Maintaining Mental Clarity in Women Receiving Chemotherapy for Newly Diagnosed Breast Cancer
Baseline characteristics by cohort
| Measure |
Ginkgo Biloba
n=113 Participants
Ginkgo Biloba: Patients will take 120 mg per day (60 mg BID)
|
Placebo
n=113 Participants
Placebo: Patients will take 1 tablet BID
|
Total
n=226 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Sex: Female, Male
Female
|
113 Participants
n=5 Participants
|
113 Participants
n=7 Participants
|
226 Participants
n=5 Participants
|
|
Age, Customized
Age < 50
|
55 participants
n=5 Participants
|
54 participants
n=7 Participants
|
109 participants
n=5 Participants
|
|
Age, Customized
Age >= 50
|
58 participants
n=5 Participants
|
59 participants
n=7 Participants
|
117 participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
113 participants
n=5 Participants
|
113 participants
n=7 Participants
|
226 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, 12 months after starting Chemotherapy.Population: Efficacy analyses uses all patients that reported baseline and one value after baseline.
The primary analysis involved compiling each subscale score for the HSCS into area under the curve (AUC) scores for the data points from baseline to the 12 month data point. HSCS instrument contains questions regarding Memory (0-39), Language (0-30), Visual-motor (0-10), Spatial (0-8), Attention and Concentration (0-25), Self-Regulation and Planning (0-6) on a varying scales. Total is calculated by summing afore mentioned subscales, values of Total ranged from 0 to 125. Lower scores are better.
Outcome measures
| Measure |
Ginkgo Biloba
n=107 Participants
Ginkgo Biloba: Patients will take 120 mg per day (60 mg BID)
|
Placebo
n=103 Participants
Placebo: Patients will take 1 tablet BID
|
Balance Checkbook
Self-report cognition
|
|---|---|---|---|
|
The Level of Cognitive Dysfunction as Measured by the High Sensitivity Cognitive Screen (HSCS) Overall Score.
Memory
|
12.2 units on a scale*months
Standard Deviation 9.18
|
12.6 units on a scale*months
Standard Deviation 9.16
|
—
|
|
The Level of Cognitive Dysfunction as Measured by the High Sensitivity Cognitive Screen (HSCS) Overall Score.
Language
|
3.9 units on a scale*months
Standard Deviation 6.84
|
2.6 units on a scale*months
Standard Deviation 2.72
|
—
|
|
The Level of Cognitive Dysfunction as Measured by the High Sensitivity Cognitive Screen (HSCS) Overall Score.
Visual-motor
|
1.1 units on a scale*months
Standard Deviation 1.29
|
0.7 units on a scale*months
Standard Deviation 0.84
|
—
|
|
The Level of Cognitive Dysfunction as Measured by the High Sensitivity Cognitive Screen (HSCS) Overall Score.
Spatial
|
1.4 units on a scale*months
Standard Deviation 0.92
|
1.3 units on a scale*months
Standard Deviation 0.92
|
—
|
|
The Level of Cognitive Dysfunction as Measured by the High Sensitivity Cognitive Screen (HSCS) Overall Score.
Attention/concentration
|
2.2 units on a scale*months
Standard Deviation 3.59
|
1.8 units on a scale*months
Standard Deviation 2.16
|
—
|
|
The Level of Cognitive Dysfunction as Measured by the High Sensitivity Cognitive Screen (HSCS) Overall Score.
Self-regulation
|
2.4 units on a scale*months
Standard Deviation 2.14
|
2.0 units on a scale*months
Standard Deviation 2.10
|
—
|
|
The Level of Cognitive Dysfunction as Measured by the High Sensitivity Cognitive Screen (HSCS) Overall Score.
Total
|
20.7 units on a scale*months
Standard Deviation 19.59
|
18.0 units on a scale*months
Standard Deviation 12.26
|
—
|
SECONDARY outcome
Timeframe: Baseline, 1, 6, 12, 18 and 24 months time pointsPopulation: Secondary analyses uses all patients that reported data for all the time points.
The Trail Making Test is a measure of overall brain dysfunction. Time taken to complete TMT tests was recorded. For this analysis median values of the Trail Making tests are calculated at different time points.
Outcome measures
| Measure |
Ginkgo Biloba
n=73 Participants
Ginkgo Biloba: Patients will take 120 mg per day (60 mg BID)
|
Placebo
n=67 Participants
Placebo: Patients will take 1 tablet BID
|
Balance Checkbook
Self-report cognition
|
|---|---|---|---|
|
Median Scores for Trail Making Tests A and B (Lower Scores Are Better).
TMT A: Baseline
|
30 seconds
Interval 15.0 to 270.0
|
28 seconds
Interval 10.0 to 160.0
|
—
|
|
Median Scores for Trail Making Tests A and B (Lower Scores Are Better).
TMT A: 1 month
|
25 seconds
Interval 10.0 to 65.0
|
25 seconds
Interval 8.0 to 65.0
|
—
|
|
Median Scores for Trail Making Tests A and B (Lower Scores Are Better).
TMT A: 6 months
|
24 seconds
Interval 10.0 to 48.0
|
22 seconds
Interval 10.0 to 55.0
|
—
|
|
Median Scores for Trail Making Tests A and B (Lower Scores Are Better).
TMT A: 12 months
|
23.5 seconds
Interval 9.0 to 60.0
|
25 seconds
Interval 12.0 to 75.0
|
—
|
|
Median Scores for Trail Making Tests A and B (Lower Scores Are Better).
TMT A: 18 months
|
25 seconds
Interval 10.0 to 75.0
|
23 seconds
Interval 12.0 to 65.0
|
—
|
|
Median Scores for Trail Making Tests A and B (Lower Scores Are Better).
TMT A: 24 months
|
23 seconds
Interval 7.0 to 58.0
|
21 seconds
Interval 10.0 to 50.0
|
—
|
|
Median Scores for Trail Making Tests A and B (Lower Scores Are Better).
TMT B: Baseline
|
48 seconds
Interval 20.0 to 417.0
|
50 seconds
Interval 17.0 to 560.0
|
—
|
|
Median Scores for Trail Making Tests A and B (Lower Scores Are Better).
TMT B: 1 month
|
45 seconds
Interval 13.0 to 275.0
|
44 seconds
Interval 20.0 to 100.0
|
—
|
|
Median Scores for Trail Making Tests A and B (Lower Scores Are Better).
TMT B: 6 months
|
41 seconds
Interval 20.0 to 99.0
|
42 seconds
Interval 18.0 to 160.0
|
—
|
|
Median Scores for Trail Making Tests A and B (Lower Scores Are Better).
TMT B: 12 months
|
40 seconds
Interval 19.0 to 130.0
|
45 seconds
Interval 18.0 to 180.0
|
—
|
|
Median Scores for Trail Making Tests A and B (Lower Scores Are Better).
TMT B: 18 months
|
44.5 seconds
Interval 10.0 to 145.0
|
40 seconds
Interval 16.0 to 125.0
|
—
|
|
Median Scores for Trail Making Tests A and B (Lower Scores Are Better).
TMT B: 24 months
|
40 seconds
Interval 19.0 to 235.0
|
40 seconds
Interval 19.0 to 143.0
|
—
|
SECONDARY outcome
Timeframe: Baseline, 1, 6, 12, 18 and 24 months post chemotherapy.Population: Secondary analysis uses all patients that reported baseline and at least one post baseline time point data.
TMT A and B were analyzed by evaluating median changes from baseline to different time points. Lower scores are better. The Trail Making Test will provide additional validity and verification for the assessment of overall cognitive dysfunction. Abbreviations used for category titles in the table below: Baseline (BL), change (chg), month (mth).
Outcome measures
| Measure |
Ginkgo Biloba
n=107 Participants
Ginkgo Biloba: Patients will take 120 mg per day (60 mg BID)
|
Placebo
n=103 Participants
Placebo: Patients will take 1 tablet BID
|
Balance Checkbook
Self-report cognition
|
|---|---|---|---|
|
Secondary Measure of Cognitive Function Using Trail Making Tests (TMT) A and B.
Chg in 1st Visit Post Chemo TMT A Score from BL
|
-4 seconds
Interval -237.0 to 20.0
|
-4 seconds
Interval -117.0 to 21.0
|
—
|
|
Secondary Measure of Cognitive Function Using Trail Making Tests (TMT) A and B.
Chg in 1st Visit Post Chemo TMT B Score from BL
|
-6.5 seconds
Interval -312.0 to 221.0
|
-6.5 seconds
Interval -480.0 to 22.0
|
—
|
|
Secondary Measure of Cognitive Function Using Trail Making Tests (TMT) A and B.
Chg in 6mth Visit Post Chemo TMT A Score from BL
|
-5 seconds
Interval -28.0 to 15.0
|
-5 seconds
Interval -130.0 to 12.0
|
—
|
|
Secondary Measure of Cognitive Function Using Trail Making Tests (TMT) A and B.
Chg in 6mth Visit Post Chemo TMT B Score from BL
|
-6.7 seconds
Interval -318.0 to 30.0
|
-8 seconds
Interval -478.0 to 65.0
|
—
|
|
Secondary Measure of Cognitive Function Using Trail Making Tests (TMT) A and B.
Chg in 12mth Visit Post Chemo TMT A Score from BL
|
-5 seconds
Interval -35.0 to 17.0
|
-2 seconds
Interval -40.0 to 15.0
|
—
|
|
Secondary Measure of Cognitive Function Using Trail Making Tests (TMT) A and B.
Chg in 12mth Visit Post Chemo TMT B Score from BL
|
-7 seconds
Interval -352.0 to 85.0
|
-3 seconds
Interval -250.0 to 135.0
|
—
|
|
Secondary Measure of Cognitive Function Using Trail Making Tests (TMT) A and B.
Chg in 18mth Visit Post Chemo TMT A Score from
|
-3.8 seconds
Interval -40.0 to 30.0
|
-4 seconds
Interval -40.0 to 29.0
|
—
|
|
Secondary Measure of Cognitive Function Using Trail Making Tests (TMT) A and B.
Chg in 18mth Visit Post Chemo TMT B Score from
|
-7 seconds
Interval -352.0 to 56.6
|
-9 seconds
Interval -205.0 to 27.0
|
—
|
|
Secondary Measure of Cognitive Function Using Trail Making Tests (TMT) A and B.
Chg in 24mth Visit Post Chemo TMT A Score from
|
-7 seconds
Interval -25.0 to 28.0
|
-5 seconds
Interval -35.0 to 5.0
|
—
|
|
Secondary Measure of Cognitive Function Using Trail Making Tests (TMT) A and B.
Chg in 24mth Visit Post Chemo TMT B Score from
|
-5 seconds
Interval -256.0 to 190.0
|
-7 seconds
Interval -173.0 to 45.0
|
—
|
SECONDARY outcome
Timeframe: Baseline, 1st evaluation of post chemotherapy.Population: Secondary analyses uses all patients that reported data for baseline and post chemo visit.
Self-reported symptoms or side effects mean change from baseline to 1st post chemo visit (negative numbers indicate worsening symptoms). A descriptive report of the toxicities experienced by participants will be measured with a Symptom Experience Diary. Participants will complete this questionnaire. This patient diary contains several questions related to potential side effects and side benefits of Ginko Biloba measured on a numeric analogue scale (based on 0-10 scale with 10 being worst toxicity).
Outcome measures
| Measure |
Ginkgo Biloba
n=73 Participants
Ginkgo Biloba: Patients will take 120 mg per day (60 mg BID)
|
Placebo
n=67 Participants
Placebo: Patients will take 1 tablet BID
|
Balance Checkbook
Self-report cognition
|
|---|---|---|---|
|
Self-reported Symptoms or Side Effects Using Symptom Experience Diary (SED)
Appetite loss
|
-0.5 units on a scale
Standard Deviation 2.90
|
-0.8 units on a scale
Standard Deviation 2.81
|
—
|
|
Self-reported Symptoms or Side Effects Using Symptom Experience Diary (SED)
Nausea
|
-0.1 units on a scale
Standard Deviation 2.78
|
-0.9 units on a scale
Standard Deviation 2.67
|
—
|
|
Self-reported Symptoms or Side Effects Using Symptom Experience Diary (SED)
Dizziness
|
-0.4 units on a scale
Standard Deviation 1.96
|
-0.3 units on a scale
Standard Deviation 2.07
|
—
|
|
Self-reported Symptoms or Side Effects Using Symptom Experience Diary (SED)
Constipation
|
-0.7 units on a scale
Standard Deviation 2.77
|
-0.9 units on a scale
Standard Deviation 2.68
|
—
|
|
Self-reported Symptoms or Side Effects Using Symptom Experience Diary (SED)
Headache
|
-0.6 units on a scale
Standard Deviation 2.13
|
-1.2 units on a scale
Standard Deviation 2.31
|
—
|
|
Self-reported Symptoms or Side Effects Using Symptom Experience Diary (SED)
Diarrhea
|
-0.3 units on a scale
Standard Deviation 1.74
|
0.0 units on a scale
Standard Deviation 2.10
|
—
|
|
Self-reported Symptoms or Side Effects Using Symptom Experience Diary (SED)
Indigestion
|
0 units on a scale
Standard Deviation 2.61
|
-0.4 units on a scale
Standard Deviation 2.67
|
—
|
|
Self-reported Symptoms or Side Effects Using Symptom Experience Diary (SED)
Bruising
|
-0.4 units on a scale
Standard Deviation 2.33
|
-0.9 units on a scale
Standard Deviation 2.42
|
—
|
|
Self-reported Symptoms or Side Effects Using Symptom Experience Diary (SED)
Overall QOL
|
-0.4 units on a scale
Standard Deviation 2.08
|
-0.6 units on a scale
Standard Deviation 2.40
|
—
|
|
Self-reported Symptoms or Side Effects Using Symptom Experience Diary (SED)
Thinks memory affects QOL
|
0.5 units on a scale
Standard Deviation 2.82
|
-0.5 units on a scale
Standard Deviation 3.06
|
—
|
SECONDARY outcome
Timeframe: Baseline, 1, 6, 12, 18 and 24 months time pointsPopulation: Secondary analyses uses all patients that reported data for baseline and one of the post baseline time points.
Pearson correlation coefficients conceptually related objective HSCS and subjective self-reported cognition. For this analysis data from both arms are combined. In the table below, numbers closer to 1 indicate positive correlation; numbers closer to -1 indicate negative correlation.
Outcome measures
| Measure |
Ginkgo Biloba
n=158 Participants
Ginkgo Biloba: Patients will take 120 mg per day (60 mg BID)
|
Placebo
n=158 Participants
Placebo: Patients will take 1 tablet BID
|
Balance Checkbook
n=158 Participants
Self-report cognition
|
|---|---|---|---|
|
Associations Between Self-reported Cognition and the HSCS.
HSCS attention concentration at 1 month
|
0.01 Pearson correlation coefficient
|
0.08 Pearson correlation coefficient
|
-0.02 Pearson correlation coefficient
|
|
Associations Between Self-reported Cognition and the HSCS.
HSCS attention concentration at 6 months
|
-0.06 Pearson correlation coefficient
|
0.00 Pearson correlation coefficient
|
-0.02 Pearson correlation coefficient
|
|
Associations Between Self-reported Cognition and the HSCS.
HSCS attention concentration at 12 months
|
-0.02 Pearson correlation coefficient
|
0.02 Pearson correlation coefficient
|
-0.08 Pearson correlation coefficient
|
|
Associations Between Self-reported Cognition and the HSCS.
HSCS attention concentration at 18 months
|
0.14 Pearson correlation coefficient
|
0.07 Pearson correlation coefficient
|
-0.10 Pearson correlation coefficient
|
|
Associations Between Self-reported Cognition and the HSCS.
HSCS attention concentration at 24 months
|
-0.06 Pearson correlation coefficient
|
-0.07 Pearson correlation coefficient
|
-0.10 Pearson correlation coefficient
|
SECONDARY outcome
Timeframe: Baseline, 1, 6, 12, 18 and 24 months time pointsPopulation: Secondary analyses uses all patients that reported data for baseline and one of the post baseline time points.
Pearson correlation coefficients conceptually related objective TMT A and B and subjective self-report measures of cognition. For this analysis data from both arms are combined. In the table below, numbers closer to 1 indicate positive correlation; numbers closer to -1 indicate negative correlation.
Outcome measures
| Measure |
Ginkgo Biloba
n=158 Participants
Ginkgo Biloba: Patients will take 120 mg per day (60 mg BID)
|
Placebo
n=158 Participants
Placebo: Patients will take 1 tablet BID
|
Balance Checkbook
n=158 Participants
Self-report cognition
|
|---|---|---|---|
|
Associations Between Self-report Measures of Cognition and the Trail Making Test (TMT) A and B.
TMT A at 1 month
|
-0.01 Pearson correlation coefficient
|
0.05 Pearson correlation coefficient
|
-0.05 Pearson correlation coefficient
|
|
Associations Between Self-report Measures of Cognition and the Trail Making Test (TMT) A and B.
TMT A at 6 months
|
0.04 Pearson correlation coefficient
|
.20 Pearson correlation coefficient
|
0.10 Pearson correlation coefficient
|
|
Associations Between Self-report Measures of Cognition and the Trail Making Test (TMT) A and B.
TMT A at 12 months
|
-0.09 Pearson correlation coefficient
|
0.03 Pearson correlation coefficient
|
-0.01 Pearson correlation coefficient
|
|
Associations Between Self-report Measures of Cognition and the Trail Making Test (TMT) A and B.
TMT A at 18 months
|
0.06 Pearson correlation coefficient
|
0.08 Pearson correlation coefficient
|
0.08 Pearson correlation coefficient
|
|
Associations Between Self-report Measures of Cognition and the Trail Making Test (TMT) A and B.
TMT A at 24 months
|
-0.01 Pearson correlation coefficient
|
-0.02 Pearson correlation coefficient
|
-0.02 Pearson correlation coefficient
|
|
Associations Between Self-report Measures of Cognition and the Trail Making Test (TMT) A and B.
TMT B at 1 month
|
-0.08 Pearson correlation coefficient
|
-0.02 Pearson correlation coefficient
|
-0.06 Pearson correlation coefficient
|
|
Associations Between Self-report Measures of Cognition and the Trail Making Test (TMT) A and B.
TMT B at 6 months
|
0.09 Pearson correlation coefficient
|
0.28 Pearson correlation coefficient
|
0.21 Pearson correlation coefficient
|
|
Associations Between Self-report Measures of Cognition and the Trail Making Test (TMT) A and B.
TMT B at 12 months
|
0.13 Pearson correlation coefficient
|
0.16 Pearson correlation coefficient
|
0.10 Pearson correlation coefficient
|
|
Associations Between Self-report Measures of Cognition and the Trail Making Test (TMT) A and B.
TMT B at 18 months
|
0.06 Pearson correlation coefficient
|
0.08 Pearson correlation coefficient
|
0.10 Pearson correlation coefficient
|
|
Associations Between Self-report Measures of Cognition and the Trail Making Test (TMT) A and B.
TMT B at 24 months
|
0.00 Pearson correlation coefficient
|
-.05 Pearson correlation coefficient
|
0.00 Pearson correlation coefficient
|
Adverse Events
Ginkgo Biloba
Serious events: 4 serious events
Other events: 89 other events
Deaths: 0 deaths
Placebo
Serious events: 3 serious events
Other events: 94 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Ginkgo Biloba
n=104 participants at risk
Ginkgo Biloba: Patients will take 120 mg per day (60 mg BID)
|
Placebo
n=101 participants at risk
Placebo: Patients will take 1 tablet BID
|
|---|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/104 • 12 months during treatment.
Total of 104 and 101 patients from Ginko and placebo arms respectively are evaluable for toxicity evaluation. There were 14 cancellations and 2 ineligible patients removed from the analysis. Five patients went off study before they were evaluated for toxicity.
|
0.99%
1/101 • Number of events 1 • 12 months during treatment.
Total of 104 and 101 patients from Ginko and placebo arms respectively are evaluable for toxicity evaluation. There were 14 cancellations and 2 ineligible patients removed from the analysis. Five patients went off study before they were evaluated for toxicity.
|
|
Infections and infestations
Infection with grade 3 or 4 neutropenia
|
0.96%
1/104 • Number of events 1 • 12 months during treatment.
Total of 104 and 101 patients from Ginko and placebo arms respectively are evaluable for toxicity evaluation. There were 14 cancellations and 2 ineligible patients removed from the analysis. Five patients went off study before they were evaluated for toxicity.
|
0.00%
0/101 • 12 months during treatment.
Total of 104 and 101 patients from Ginko and placebo arms respectively are evaluable for toxicity evaluation. There were 14 cancellations and 2 ineligible patients removed from the analysis. Five patients went off study before they were evaluated for toxicity.
|
|
Investigations
Leukocyte count decreased
|
0.96%
1/104 • Number of events 1 • 12 months during treatment.
Total of 104 and 101 patients from Ginko and placebo arms respectively are evaluable for toxicity evaluation. There were 14 cancellations and 2 ineligible patients removed from the analysis. Five patients went off study before they were evaluated for toxicity.
|
2.0%
2/101 • Number of events 2 • 12 months during treatment.
Total of 104 and 101 patients from Ginko and placebo arms respectively are evaluable for toxicity evaluation. There were 14 cancellations and 2 ineligible patients removed from the analysis. Five patients went off study before they were evaluated for toxicity.
|
|
Investigations
Neutrophil count decreased
|
3.8%
4/104 • Number of events 6 • 12 months during treatment.
Total of 104 and 101 patients from Ginko and placebo arms respectively are evaluable for toxicity evaluation. There were 14 cancellations and 2 ineligible patients removed from the analysis. Five patients went off study before they were evaluated for toxicity.
|
2.0%
2/101 • Number of events 2 • 12 months during treatment.
Total of 104 and 101 patients from Ginko and placebo arms respectively are evaluable for toxicity evaluation. There were 14 cancellations and 2 ineligible patients removed from the analysis. Five patients went off study before they were evaluated for toxicity.
|
|
Investigations
Platelet count decreased
|
0.96%
1/104 • Number of events 1 • 12 months during treatment.
Total of 104 and 101 patients from Ginko and placebo arms respectively are evaluable for toxicity evaluation. There were 14 cancellations and 2 ineligible patients removed from the analysis. Five patients went off study before they were evaluated for toxicity.
|
0.00%
0/101 • 12 months during treatment.
Total of 104 and 101 patients from Ginko and placebo arms respectively are evaluable for toxicity evaluation. There were 14 cancellations and 2 ineligible patients removed from the analysis. Five patients went off study before they were evaluated for toxicity.
|
Other adverse events
| Measure |
Ginkgo Biloba
n=104 participants at risk
Ginkgo Biloba: Patients will take 120 mg per day (60 mg BID)
|
Placebo
n=101 participants at risk
Placebo: Patients will take 1 tablet BID
|
|---|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
3.8%
4/104 • Number of events 4 • 12 months during treatment.
Total of 104 and 101 patients from Ginko and placebo arms respectively are evaluable for toxicity evaluation. There were 14 cancellations and 2 ineligible patients removed from the analysis. Five patients went off study before they were evaluated for toxicity.
|
0.00%
0/101 • 12 months during treatment.
Total of 104 and 101 patients from Ginko and placebo arms respectively are evaluable for toxicity evaluation. There were 14 cancellations and 2 ineligible patients removed from the analysis. Five patients went off study before they were evaluated for toxicity.
|
|
Blood and lymphatic system disorders
Hemoglobin decreased
|
63.5%
66/104 • Number of events 186 • 12 months during treatment.
Total of 104 and 101 patients from Ginko and placebo arms respectively are evaluable for toxicity evaluation. There were 14 cancellations and 2 ineligible patients removed from the analysis. Five patients went off study before they were evaluated for toxicity.
|
71.3%
72/101 • Number of events 186 • 12 months during treatment.
Total of 104 and 101 patients from Ginko and placebo arms respectively are evaluable for toxicity evaluation. There were 14 cancellations and 2 ineligible patients removed from the analysis. Five patients went off study before they were evaluated for toxicity.
|
|
Blood and lymphatic system disorders
Transfusion: pRBCs
|
0.96%
1/104 • Number of events 1 • 12 months during treatment.
Total of 104 and 101 patients from Ginko and placebo arms respectively are evaluable for toxicity evaluation. There were 14 cancellations and 2 ineligible patients removed from the analysis. Five patients went off study before they were evaluated for toxicity.
|
0.00%
0/101 • 12 months during treatment.
Total of 104 and 101 patients from Ginko and placebo arms respectively are evaluable for toxicity evaluation. There were 14 cancellations and 2 ineligible patients removed from the analysis. Five patients went off study before they were evaluated for toxicity.
|
|
Eye disorders
Dry eye syndrome
|
0.00%
0/104 • 12 months during treatment.
Total of 104 and 101 patients from Ginko and placebo arms respectively are evaluable for toxicity evaluation. There were 14 cancellations and 2 ineligible patients removed from the analysis. Five patients went off study before they were evaluated for toxicity.
|
0.99%
1/101 • Number of events 1 • 12 months during treatment.
Total of 104 and 101 patients from Ginko and placebo arms respectively are evaluable for toxicity evaluation. There were 14 cancellations and 2 ineligible patients removed from the analysis. Five patients went off study before they were evaluated for toxicity.
|
|
Eye disorders
Photophobia
|
0.00%
0/104 • 12 months during treatment.
Total of 104 and 101 patients from Ginko and placebo arms respectively are evaluable for toxicity evaluation. There were 14 cancellations and 2 ineligible patients removed from the analysis. Five patients went off study before they were evaluated for toxicity.
|
0.99%
1/101 • Number of events 5 • 12 months during treatment.
Total of 104 and 101 patients from Ginko and placebo arms respectively are evaluable for toxicity evaluation. There were 14 cancellations and 2 ineligible patients removed from the analysis. Five patients went off study before they were evaluated for toxicity.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/104 • 12 months during treatment.
Total of 104 and 101 patients from Ginko and placebo arms respectively are evaluable for toxicity evaluation. There were 14 cancellations and 2 ineligible patients removed from the analysis. Five patients went off study before they were evaluated for toxicity.
|
0.99%
1/101 • Number of events 1 • 12 months during treatment.
Total of 104 and 101 patients from Ginko and placebo arms respectively are evaluable for toxicity evaluation. There were 14 cancellations and 2 ineligible patients removed from the analysis. Five patients went off study before they were evaluated for toxicity.
|
|
Gastrointestinal disorders
Constipation
|
0.96%
1/104 • Number of events 4 • 12 months during treatment.
Total of 104 and 101 patients from Ginko and placebo arms respectively are evaluable for toxicity evaluation. There were 14 cancellations and 2 ineligible patients removed from the analysis. Five patients went off study before they were evaluated for toxicity.
|
0.00%
0/101 • 12 months during treatment.
Total of 104 and 101 patients from Ginko and placebo arms respectively are evaluable for toxicity evaluation. There were 14 cancellations and 2 ineligible patients removed from the analysis. Five patients went off study before they were evaluated for toxicity.
|
|
Gastrointestinal disorders
Diarrhea
|
1.9%
2/104 • Number of events 2 • 12 months during treatment.
Total of 104 and 101 patients from Ginko and placebo arms respectively are evaluable for toxicity evaluation. There were 14 cancellations and 2 ineligible patients removed from the analysis. Five patients went off study before they were evaluated for toxicity.
|
2.0%
2/101 • Number of events 2 • 12 months during treatment.
Total of 104 and 101 patients from Ginko and placebo arms respectively are evaluable for toxicity evaluation. There were 14 cancellations and 2 ineligible patients removed from the analysis. Five patients went off study before they were evaluated for toxicity.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.96%
1/104 • Number of events 1 • 12 months during treatment.
Total of 104 and 101 patients from Ginko and placebo arms respectively are evaluable for toxicity evaluation. There were 14 cancellations and 2 ineligible patients removed from the analysis. Five patients went off study before they were evaluated for toxicity.
|
0.00%
0/101 • 12 months during treatment.
Total of 104 and 101 patients from Ginko and placebo arms respectively are evaluable for toxicity evaluation. There were 14 cancellations and 2 ineligible patients removed from the analysis. Five patients went off study before they were evaluated for toxicity.
|
|
Gastrointestinal disorders
Esophagitis
|
0.96%
1/104 • Number of events 1 • 12 months during treatment.
Total of 104 and 101 patients from Ginko and placebo arms respectively are evaluable for toxicity evaluation. There were 14 cancellations and 2 ineligible patients removed from the analysis. Five patients went off study before they were evaluated for toxicity.
|
0.00%
0/101 • 12 months during treatment.
Total of 104 and 101 patients from Ginko and placebo arms respectively are evaluable for toxicity evaluation. There were 14 cancellations and 2 ineligible patients removed from the analysis. Five patients went off study before they were evaluated for toxicity.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/104 • 12 months during treatment.
Total of 104 and 101 patients from Ginko and placebo arms respectively are evaluable for toxicity evaluation. There were 14 cancellations and 2 ineligible patients removed from the analysis. Five patients went off study before they were evaluated for toxicity.
|
0.99%
1/101 • Number of events 1 • 12 months during treatment.
Total of 104 and 101 patients from Ginko and placebo arms respectively are evaluable for toxicity evaluation. There were 14 cancellations and 2 ineligible patients removed from the analysis. Five patients went off study before they were evaluated for toxicity.
|
|
Gastrointestinal disorders
Mucositis due to radiation
|
0.96%
1/104 • Number of events 1 • 12 months during treatment.
Total of 104 and 101 patients from Ginko and placebo arms respectively are evaluable for toxicity evaluation. There were 14 cancellations and 2 ineligible patients removed from the analysis. Five patients went off study before they were evaluated for toxicity.
|
0.00%
0/101 • 12 months during treatment.
Total of 104 and 101 patients from Ginko and placebo arms respectively are evaluable for toxicity evaluation. There were 14 cancellations and 2 ineligible patients removed from the analysis. Five patients went off study before they were evaluated for toxicity.
|
|
Gastrointestinal disorders
Mucositis oral
|
0.96%
1/104 • Number of events 1 • 12 months during treatment.
Total of 104 and 101 patients from Ginko and placebo arms respectively are evaluable for toxicity evaluation. There were 14 cancellations and 2 ineligible patients removed from the analysis. Five patients went off study before they were evaluated for toxicity.
|
0.00%
0/101 • 12 months during treatment.
Total of 104 and 101 patients from Ginko and placebo arms respectively are evaluable for toxicity evaluation. There were 14 cancellations and 2 ineligible patients removed from the analysis. Five patients went off study before they were evaluated for toxicity.
|
|
Gastrointestinal disorders
Nausea
|
65.4%
68/104 • Number of events 151 • 12 months during treatment.
Total of 104 and 101 patients from Ginko and placebo arms respectively are evaluable for toxicity evaluation. There were 14 cancellations and 2 ineligible patients removed from the analysis. Five patients went off study before they were evaluated for toxicity.
|
65.3%
66/101 • Number of events 159 • 12 months during treatment.
Total of 104 and 101 patients from Ginko and placebo arms respectively are evaluable for toxicity evaluation. There were 14 cancellations and 2 ineligible patients removed from the analysis. Five patients went off study before they were evaluated for toxicity.
|
|
Gastrointestinal disorders
Vomiting
|
30.8%
32/104 • Number of events 53 • 12 months during treatment.
Total of 104 and 101 patients from Ginko and placebo arms respectively are evaluable for toxicity evaluation. There were 14 cancellations and 2 ineligible patients removed from the analysis. Five patients went off study before they were evaluated for toxicity.
|
36.6%
37/101 • Number of events 64 • 12 months during treatment.
Total of 104 and 101 patients from Ginko and placebo arms respectively are evaluable for toxicity evaluation. There were 14 cancellations and 2 ineligible patients removed from the analysis. Five patients went off study before they were evaluated for toxicity.
|
|
General disorders
Chest pain
|
0.00%
0/104 • 12 months during treatment.
Total of 104 and 101 patients from Ginko and placebo arms respectively are evaluable for toxicity evaluation. There were 14 cancellations and 2 ineligible patients removed from the analysis. Five patients went off study before they were evaluated for toxicity.
|
0.99%
1/101 • Number of events 2 • 12 months during treatment.
Total of 104 and 101 patients from Ginko and placebo arms respectively are evaluable for toxicity evaluation. There were 14 cancellations and 2 ineligible patients removed from the analysis. Five patients went off study before they were evaluated for toxicity.
|
|
General disorders
Fatigue
|
5.8%
6/104 • Number of events 6 • 12 months during treatment.
Total of 104 and 101 patients from Ginko and placebo arms respectively are evaluable for toxicity evaluation. There were 14 cancellations and 2 ineligible patients removed from the analysis. Five patients went off study before they were evaluated for toxicity.
|
5.0%
5/101 • Number of events 6 • 12 months during treatment.
Total of 104 and 101 patients from Ginko and placebo arms respectively are evaluable for toxicity evaluation. There were 14 cancellations and 2 ineligible patients removed from the analysis. Five patients went off study before they were evaluated for toxicity.
|
|
General disorders
Pain
|
0.96%
1/104 • Number of events 2 • 12 months during treatment.
Total of 104 and 101 patients from Ginko and placebo arms respectively are evaluable for toxicity evaluation. There were 14 cancellations and 2 ineligible patients removed from the analysis. Five patients went off study before they were evaluated for toxicity.
|
0.00%
0/101 • 12 months during treatment.
Total of 104 and 101 patients from Ginko and placebo arms respectively are evaluable for toxicity evaluation. There were 14 cancellations and 2 ineligible patients removed from the analysis. Five patients went off study before they were evaluated for toxicity.
|
|
Immune system disorders
Hypersensitivity
|
1.9%
2/104 • Number of events 2 • 12 months during treatment.
Total of 104 and 101 patients from Ginko and placebo arms respectively are evaluable for toxicity evaluation. There were 14 cancellations and 2 ineligible patients removed from the analysis. Five patients went off study before they were evaluated for toxicity.
|
0.00%
0/101 • 12 months during treatment.
Total of 104 and 101 patients from Ginko and placebo arms respectively are evaluable for toxicity evaluation. There were 14 cancellations and 2 ineligible patients removed from the analysis. Five patients went off study before they were evaluated for toxicity.
|
|
Infections and infestations
Infection
|
0.96%
1/104 • Number of events 1 • 12 months during treatment.
Total of 104 and 101 patients from Ginko and placebo arms respectively are evaluable for toxicity evaluation. There were 14 cancellations and 2 ineligible patients removed from the analysis. Five patients went off study before they were evaluated for toxicity.
|
0.00%
0/101 • 12 months during treatment.
Total of 104 and 101 patients from Ginko and placebo arms respectively are evaluable for toxicity evaluation. There were 14 cancellations and 2 ineligible patients removed from the analysis. Five patients went off study before they were evaluated for toxicity.
|
|
Infections and infestations
Infection with grade 3 or 4 neutropenia
|
0.96%
1/104 • Number of events 1 • 12 months during treatment.
Total of 104 and 101 patients from Ginko and placebo arms respectively are evaluable for toxicity evaluation. There were 14 cancellations and 2 ineligible patients removed from the analysis. Five patients went off study before they were evaluated for toxicity.
|
0.99%
1/101 • Number of events 1 • 12 months during treatment.
Total of 104 and 101 patients from Ginko and placebo arms respectively are evaluable for toxicity evaluation. There were 14 cancellations and 2 ineligible patients removed from the analysis. Five patients went off study before they were evaluated for toxicity.
|
|
Infections and infestations
Infection with unknown ANC
|
0.96%
1/104 • Number of events 1 • 12 months during treatment.
Total of 104 and 101 patients from Ginko and placebo arms respectively are evaluable for toxicity evaluation. There were 14 cancellations and 2 ineligible patients removed from the analysis. Five patients went off study before they were evaluated for toxicity.
|
0.00%
0/101 • 12 months during treatment.
Total of 104 and 101 patients from Ginko and placebo arms respectively are evaluable for toxicity evaluation. There were 14 cancellations and 2 ineligible patients removed from the analysis. Five patients went off study before they were evaluated for toxicity.
|
|
Infections and infestations
Infection without neutropenia
|
1.9%
2/104 • Number of events 2 • 12 months during treatment.
Total of 104 and 101 patients from Ginko and placebo arms respectively are evaluable for toxicity evaluation. There were 14 cancellations and 2 ineligible patients removed from the analysis. Five patients went off study before they were evaluated for toxicity.
|
2.0%
2/101 • Number of events 2 • 12 months during treatment.
Total of 104 and 101 patients from Ginko and placebo arms respectively are evaluable for toxicity evaluation. There were 14 cancellations and 2 ineligible patients removed from the analysis. Five patients went off study before they were evaluated for toxicity.
|
|
Infections and infestations
Wound-infectious
|
0.00%
0/104 • 12 months during treatment.
Total of 104 and 101 patients from Ginko and placebo arms respectively are evaluable for toxicity evaluation. There were 14 cancellations and 2 ineligible patients removed from the analysis. Five patients went off study before they were evaluated for toxicity.
|
0.99%
1/101 • Number of events 1 • 12 months during treatment.
Total of 104 and 101 patients from Ginko and placebo arms respectively are evaluable for toxicity evaluation. There were 14 cancellations and 2 ineligible patients removed from the analysis. Five patients went off study before they were evaluated for toxicity.
|
|
Injury, poisoning and procedural complications
Bruising
|
0.00%
0/104 • 12 months during treatment.
Total of 104 and 101 patients from Ginko and placebo arms respectively are evaluable for toxicity evaluation. There were 14 cancellations and 2 ineligible patients removed from the analysis. Five patients went off study before they were evaluated for toxicity.
|
0.99%
1/101 • Number of events 1 • 12 months during treatment.
Total of 104 and 101 patients from Ginko and placebo arms respectively are evaluable for toxicity evaluation. There were 14 cancellations and 2 ineligible patients removed from the analysis. Five patients went off study before they were evaluated for toxicity.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/104 • 12 months during treatment.
Total of 104 and 101 patients from Ginko and placebo arms respectively are evaluable for toxicity evaluation. There were 14 cancellations and 2 ineligible patients removed from the analysis. Five patients went off study before they were evaluated for toxicity.
|
0.99%
1/101 • Number of events 1 • 12 months during treatment.
Total of 104 and 101 patients from Ginko and placebo arms respectively are evaluable for toxicity evaluation. There were 14 cancellations and 2 ineligible patients removed from the analysis. Five patients went off study before they were evaluated for toxicity.
|
|
Investigations
INR increased
|
0.00%
0/104 • 12 months during treatment.
Total of 104 and 101 patients from Ginko and placebo arms respectively are evaluable for toxicity evaluation. There were 14 cancellations and 2 ineligible patients removed from the analysis. Five patients went off study before they were evaluated for toxicity.
|
0.99%
1/101 • Number of events 1 • 12 months during treatment.
Total of 104 and 101 patients from Ginko and placebo arms respectively are evaluable for toxicity evaluation. There were 14 cancellations and 2 ineligible patients removed from the analysis. Five patients went off study before they were evaluated for toxicity.
|
|
Investigations
Leukocyte count decreased
|
53.8%
56/104 • Number of events 119 • 12 months during treatment.
Total of 104 and 101 patients from Ginko and placebo arms respectively are evaluable for toxicity evaluation. There were 14 cancellations and 2 ineligible patients removed from the analysis. Five patients went off study before they were evaluated for toxicity.
|
59.4%
60/101 • Number of events 126 • 12 months during treatment.
Total of 104 and 101 patients from Ginko and placebo arms respectively are evaluable for toxicity evaluation. There were 14 cancellations and 2 ineligible patients removed from the analysis. Five patients went off study before they were evaluated for toxicity.
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/104 • 12 months during treatment.
Total of 104 and 101 patients from Ginko and placebo arms respectively are evaluable for toxicity evaluation. There were 14 cancellations and 2 ineligible patients removed from the analysis. Five patients went off study before they were evaluated for toxicity.
|
0.99%
1/101 • Number of events 1 • 12 months during treatment.
Total of 104 and 101 patients from Ginko and placebo arms respectively are evaluable for toxicity evaluation. There were 14 cancellations and 2 ineligible patients removed from the analysis. Five patients went off study before they were evaluated for toxicity.
|
|
Investigations
Neutrophil count decreased
|
14.4%
15/104 • Number of events 21 • 12 months during treatment.
Total of 104 and 101 patients from Ginko and placebo arms respectively are evaluable for toxicity evaluation. There were 14 cancellations and 2 ineligible patients removed from the analysis. Five patients went off study before they were evaluated for toxicity.
|
12.9%
13/101 • Number of events 20 • 12 months during treatment.
Total of 104 and 101 patients from Ginko and placebo arms respectively are evaluable for toxicity evaluation. There were 14 cancellations and 2 ineligible patients removed from the analysis. Five patients went off study before they were evaluated for toxicity.
|
|
Investigations
Neutrophils/granulocytes (ANC/AGC) for BMT studies, if specified in the protocol.
|
0.96%
1/104 • Number of events 1 • 12 months during treatment.
Total of 104 and 101 patients from Ginko and placebo arms respectively are evaluable for toxicity evaluation. There were 14 cancellations and 2 ineligible patients removed from the analysis. Five patients went off study before they were evaluated for toxicity.
|
0.00%
0/101 • 12 months during treatment.
Total of 104 and 101 patients from Ginko and placebo arms respectively are evaluable for toxicity evaluation. There were 14 cancellations and 2 ineligible patients removed from the analysis. Five patients went off study before they were evaluated for toxicity.
|
|
Investigations
Platelet count decreased
|
24.0%
25/104 • Number of events 58 • 12 months during treatment.
Total of 104 and 101 patients from Ginko and placebo arms respectively are evaluable for toxicity evaluation. There were 14 cancellations and 2 ineligible patients removed from the analysis. Five patients went off study before they were evaluated for toxicity.
|
31.7%
32/101 • Number of events 53 • 12 months during treatment.
Total of 104 and 101 patients from Ginko and placebo arms respectively are evaluable for toxicity evaluation. There were 14 cancellations and 2 ineligible patients removed from the analysis. Five patients went off study before they were evaluated for toxicity.
|
|
Metabolism and nutrition disorders
Anorexia
|
0.96%
1/104 • Number of events 1 • 12 months during treatment.
Total of 104 and 101 patients from Ginko and placebo arms respectively are evaluable for toxicity evaluation. There were 14 cancellations and 2 ineligible patients removed from the analysis. Five patients went off study before they were evaluated for toxicity.
|
0.00%
0/101 • 12 months during treatment.
Total of 104 and 101 patients from Ginko and placebo arms respectively are evaluable for toxicity evaluation. There were 14 cancellations and 2 ineligible patients removed from the analysis. Five patients went off study before they were evaluated for toxicity.
|
|
Metabolism and nutrition disorders
Blood glucose increased
|
0.96%
1/104 • Number of events 3 • 12 months during treatment.
Total of 104 and 101 patients from Ginko and placebo arms respectively are evaluable for toxicity evaluation. There were 14 cancellations and 2 ineligible patients removed from the analysis. Five patients went off study before they were evaluated for toxicity.
|
0.00%
0/101 • 12 months during treatment.
Total of 104 and 101 patients from Ginko and placebo arms respectively are evaluable for toxicity evaluation. There were 14 cancellations and 2 ineligible patients removed from the analysis. Five patients went off study before they were evaluated for toxicity.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/104 • 12 months during treatment.
Total of 104 and 101 patients from Ginko and placebo arms respectively are evaluable for toxicity evaluation. There were 14 cancellations and 2 ineligible patients removed from the analysis. Five patients went off study before they were evaluated for toxicity.
|
2.0%
2/101 • Number of events 2 • 12 months during treatment.
Total of 104 and 101 patients from Ginko and placebo arms respectively are evaluable for toxicity evaluation. There were 14 cancellations and 2 ineligible patients removed from the analysis. Five patients went off study before they were evaluated for toxicity.
|
|
Metabolism and nutrition disorders
Serum phosphate decreased
|
0.00%
0/104 • 12 months during treatment.
Total of 104 and 101 patients from Ginko and placebo arms respectively are evaluable for toxicity evaluation. There were 14 cancellations and 2 ineligible patients removed from the analysis. Five patients went off study before they were evaluated for toxicity.
|
0.99%
1/101 • Number of events 1 • 12 months during treatment.
Total of 104 and 101 patients from Ginko and placebo arms respectively are evaluable for toxicity evaluation. There were 14 cancellations and 2 ineligible patients removed from the analysis. Five patients went off study before they were evaluated for toxicity.
|
|
Metabolism and nutrition disorders
Serum potassium decreased
|
0.00%
0/104 • 12 months during treatment.
Total of 104 and 101 patients from Ginko and placebo arms respectively are evaluable for toxicity evaluation. There were 14 cancellations and 2 ineligible patients removed from the analysis. Five patients went off study before they were evaluated for toxicity.
|
0.99%
1/101 • Number of events 2 • 12 months during treatment.
Total of 104 and 101 patients from Ginko and placebo arms respectively are evaluable for toxicity evaluation. There were 14 cancellations and 2 ineligible patients removed from the analysis. Five patients went off study before they were evaluated for toxicity.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.96%
1/104 • Number of events 1 • 12 months during treatment.
Total of 104 and 101 patients from Ginko and placebo arms respectively are evaluable for toxicity evaluation. There were 14 cancellations and 2 ineligible patients removed from the analysis. Five patients went off study before they were evaluated for toxicity.
|
0.00%
0/101 • 12 months during treatment.
Total of 104 and 101 patients from Ginko and placebo arms respectively are evaluable for toxicity evaluation. There were 14 cancellations and 2 ineligible patients removed from the analysis. Five patients went off study before they were evaluated for toxicity.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.96%
1/104 • Number of events 1 • 12 months during treatment.
Total of 104 and 101 patients from Ginko and placebo arms respectively are evaluable for toxicity evaluation. There were 14 cancellations and 2 ineligible patients removed from the analysis. Five patients went off study before they were evaluated for toxicity.
|
0.99%
1/101 • Number of events 1 • 12 months during treatment.
Total of 104 and 101 patients from Ginko and placebo arms respectively are evaluable for toxicity evaluation. There were 14 cancellations and 2 ineligible patients removed from the analysis. Five patients went off study before they were evaluated for toxicity.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.96%
1/104 • Number of events 1 • 12 months during treatment.
Total of 104 and 101 patients from Ginko and placebo arms respectively are evaluable for toxicity evaluation. There were 14 cancellations and 2 ineligible patients removed from the analysis. Five patients went off study before they were evaluated for toxicity.
|
0.00%
0/101 • 12 months during treatment.
Total of 104 and 101 patients from Ginko and placebo arms respectively are evaluable for toxicity evaluation. There were 14 cancellations and 2 ineligible patients removed from the analysis. Five patients went off study before they were evaluated for toxicity.
|
|
Nervous system disorders
Headache
|
3.8%
4/104 • Number of events 4 • 12 months during treatment.
Total of 104 and 101 patients from Ginko and placebo arms respectively are evaluable for toxicity evaluation. There were 14 cancellations and 2 ineligible patients removed from the analysis. Five patients went off study before they were evaluated for toxicity.
|
2.0%
2/101 • Number of events 2 • 12 months during treatment.
Total of 104 and 101 patients from Ginko and placebo arms respectively are evaluable for toxicity evaluation. There were 14 cancellations and 2 ineligible patients removed from the analysis. Five patients went off study before they were evaluated for toxicity.
|
|
Nervous system disorders
Peripheral motor neuropathy
|
0.96%
1/104 • Number of events 1 • 12 months during treatment.
Total of 104 and 101 patients from Ginko and placebo arms respectively are evaluable for toxicity evaluation. There were 14 cancellations and 2 ineligible patients removed from the analysis. Five patients went off study before they were evaluated for toxicity.
|
0.00%
0/101 • 12 months during treatment.
Total of 104 and 101 patients from Ginko and placebo arms respectively are evaluable for toxicity evaluation. There were 14 cancellations and 2 ineligible patients removed from the analysis. Five patients went off study before they were evaluated for toxicity.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
1.9%
2/104 • Number of events 2 • 12 months during treatment.
Total of 104 and 101 patients from Ginko and placebo arms respectively are evaluable for toxicity evaluation. There were 14 cancellations and 2 ineligible patients removed from the analysis. Five patients went off study before they were evaluated for toxicity.
|
0.99%
1/101 • Number of events 1 • 12 months during treatment.
Total of 104 and 101 patients from Ginko and placebo arms respectively are evaluable for toxicity evaluation. There were 14 cancellations and 2 ineligible patients removed from the analysis. Five patients went off study before they were evaluated for toxicity.
|
|
Psychiatric disorders
Anxiety
|
0.96%
1/104 • Number of events 1 • 12 months during treatment.
Total of 104 and 101 patients from Ginko and placebo arms respectively are evaluable for toxicity evaluation. There were 14 cancellations and 2 ineligible patients removed from the analysis. Five patients went off study before they were evaluated for toxicity.
|
2.0%
2/101 • Number of events 2 • 12 months during treatment.
Total of 104 and 101 patients from Ginko and placebo arms respectively are evaluable for toxicity evaluation. There were 14 cancellations and 2 ineligible patients removed from the analysis. Five patients went off study before they were evaluated for toxicity.
|
|
Psychiatric disorders
Depression
|
0.00%
0/104 • 12 months during treatment.
Total of 104 and 101 patients from Ginko and placebo arms respectively are evaluable for toxicity evaluation. There were 14 cancellations and 2 ineligible patients removed from the analysis. Five patients went off study before they were evaluated for toxicity.
|
2.0%
2/101 • Number of events 3 • 12 months during treatment.
Total of 104 and 101 patients from Ginko and placebo arms respectively are evaluable for toxicity evaluation. There were 14 cancellations and 2 ineligible patients removed from the analysis. Five patients went off study before they were evaluated for toxicity.
|
|
Psychiatric disorders
Insomnia
|
2.9%
3/104 • Number of events 3 • 12 months during treatment.
Total of 104 and 101 patients from Ginko and placebo arms respectively are evaluable for toxicity evaluation. There were 14 cancellations and 2 ineligible patients removed from the analysis. Five patients went off study before they were evaluated for toxicity.
|
0.00%
0/101 • 12 months during treatment.
Total of 104 and 101 patients from Ginko and placebo arms respectively are evaluable for toxicity evaluation. There were 14 cancellations and 2 ineligible patients removed from the analysis. Five patients went off study before they were evaluated for toxicity.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
0.00%
0/104 • 12 months during treatment.
Total of 104 and 101 patients from Ginko and placebo arms respectively are evaluable for toxicity evaluation. There were 14 cancellations and 2 ineligible patients removed from the analysis. Five patients went off study before they were evaluated for toxicity.
|
3.0%
3/101 • Number of events 3 • 12 months during treatment.
Total of 104 and 101 patients from Ginko and placebo arms respectively are evaluable for toxicity evaluation. There were 14 cancellations and 2 ineligible patients removed from the analysis. Five patients went off study before they were evaluated for toxicity.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/104 • 12 months during treatment.
Total of 104 and 101 patients from Ginko and placebo arms respectively are evaluable for toxicity evaluation. There were 14 cancellations and 2 ineligible patients removed from the analysis. Five patients went off study before they were evaluated for toxicity.
|
2.0%
2/101 • Number of events 2 • 12 months during treatment.
Total of 104 and 101 patients from Ginko and placebo arms respectively are evaluable for toxicity evaluation. There were 14 cancellations and 2 ineligible patients removed from the analysis. Five patients went off study before they were evaluated for toxicity.
|
|
Skin and subcutaneous tissue disorders
Hand-and-foot syndrome
|
2.9%
3/104 • Number of events 3 • 12 months during treatment.
Total of 104 and 101 patients from Ginko and placebo arms respectively are evaluable for toxicity evaluation. There were 14 cancellations and 2 ineligible patients removed from the analysis. Five patients went off study before they were evaluated for toxicity.
|
0.00%
0/101 • 12 months during treatment.
Total of 104 and 101 patients from Ginko and placebo arms respectively are evaluable for toxicity evaluation. There were 14 cancellations and 2 ineligible patients removed from the analysis. Five patients went off study before they were evaluated for toxicity.
|
|
Vascular disorders
Hemorrhage
|
18.3%
19/104 • Number of events 26 • 12 months during treatment.
Total of 104 and 101 patients from Ginko and placebo arms respectively are evaluable for toxicity evaluation. There were 14 cancellations and 2 ineligible patients removed from the analysis. Five patients went off study before they were evaluated for toxicity.
|
16.8%
17/101 • Number of events 25 • 12 months during treatment.
Total of 104 and 101 patients from Ginko and placebo arms respectively are evaluable for toxicity evaluation. There were 14 cancellations and 2 ineligible patients removed from the analysis. Five patients went off study before they were evaluated for toxicity.
|
|
Vascular disorders
Thrombosis
|
0.96%
1/104 • Number of events 1 • 12 months during treatment.
Total of 104 and 101 patients from Ginko and placebo arms respectively are evaluable for toxicity evaluation. There were 14 cancellations and 2 ineligible patients removed from the analysis. Five patients went off study before they were evaluated for toxicity.
|
4.0%
4/101 • Number of events 4 • 12 months during treatment.
Total of 104 and 101 patients from Ginko and placebo arms respectively are evaluable for toxicity evaluation. There were 14 cancellations and 2 ineligible patients removed from the analysis. Five patients went off study before they were evaluated for toxicity.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place