Trial Outcomes & Findings for The Effects of Ginseng on Cancer-Related Fatigue (NCT NCT01375114)
NCT ID: NCT01375114
Last Updated: 2026-05-04
Results Overview
"The FACIT-F fatigue subscale was used as the primary outcome measure. There are 13 items in this fatigue subscale. Using the subscale, patients rate the intensity of their fatigue and its related symptoms on a scale of 0 to 4. The total score ranges between 0 and 52, with higher scores denoting less fatigue. The objective was to determine whether the average improvement in FACIT-F fatigue from baseline to Day 29 in patients who received PG was greater than in those who received placebo. We used chi-square test to determine the p-value."
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE1/PHASE2
Target enrollment
165 participants
Primary outcome timeframe
Baseline and Day 29
Results posted on
2026-05-04
Participant Flow
Patients were recruited from the outpatient clinics for palliative care, pain management, internal medicine, and oncology at MD Anderson Cancer Center in Houston, Texas who have been diagnosed with cancer and currently undergoing outpatient chemotherapy at the cancer center, and experiencing Cancer Related Fatigue (CRF) with an average intensity of ≥4/10 on the Edmonton Symptom Assessment Scale (ESAS scale, 0-10) during the 24 hours prior to study enrollment.
A total of 165 patient were enrolled for this protocol. In Phase-l part of the study, 30 pt received Panax Ginseng and 2 patients withdrew consent. For Phase-II part of study, out of 133 participants, 127 participants were randomized. 6 participants were not randomized for this study for various reasons (participant withdrew n=3, withdrawn at oncologist's request n=1 and due to comorbidities n=2).
Participant milestones
| Measure |
Phase-I Panax Ginseng (Single Group)
Took one Panax Ginseng capsule (400mg) twice daily by mouth for 29 days
|
Phase-II Blinded Panax Ginseng
Took one Panax Ginseng capsule (400mg) twice daily by mouth for 29 days
|
Phase-ll Blinded Placebo
Took similar appearance colored Placebo capsule twice daily by mouth for 29 days
|
|---|---|---|---|
|
Overall Study
STARTED
|
30
|
63
|
64
|
|
Overall Study
COMPLETED
|
24
|
56
|
56
|
|
Overall Study
NOT COMPLETED
|
6
|
7
|
8
|
Reasons for withdrawal
| Measure |
Phase-I Panax Ginseng (Single Group)
Took one Panax Ginseng capsule (400mg) twice daily by mouth for 29 days
|
Phase-II Blinded Panax Ginseng
Took one Panax Ginseng capsule (400mg) twice daily by mouth for 29 days
|
Phase-ll Blinded Placebo
Took similar appearance colored Placebo capsule twice daily by mouth for 29 days
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
1
|
|
Overall Study
Disease Progression
|
3
|
2
|
2
|
|
Overall Study
Patient Changed Mind
|
0
|
0
|
2
|
|
Overall Study
Pruritus
|
0
|
0
|
1
|
|
Overall Study
Restlessness
|
0
|
0
|
1
|
|
Overall Study
Diarrhea
|
0
|
0
|
1
|
|
Overall Study
Pt enrolled in another clinical trial
|
0
|
1
|
0
|
|
Overall Study
Nausea
|
0
|
1
|
0
|
|
Overall Study
Increased AST/ALT
|
0
|
1
|
0
|
|
Overall Study
Vaginal Hemorrhage
|
0
|
1
|
0
|
|
Overall Study
Family problem
|
0
|
1
|
0
|
|
Overall Study
Protocol Violation
|
2
|
0
|
0
|
Baseline Characteristics
The Effects of Ginseng on Cancer-Related Fatigue
Baseline characteristics by cohort
| Measure |
Phase-I Panax Ginseng (Single Group)
n=30 Participants
Took one Panax Ginseng capsule (400mg) twice daily by mouth for 29 days
|
Phase-II Blinded Panax Ginseng
n=63 Participants
Took one Panax Ginseng capsule (400mg) twice daily by mouth for 29 days
|
Phase-ll Blinded Placebo
n=64 Participants
Took similar appearance colored Placebo capsule twice daily by mouth for 29 days
|
Total
n=157 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
58 years
n=54 Participants
|
61 years
n=60 Participants
|
61 years
n=114 Participants
|
60 years
n=1 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=54 Participants
|
29 Participants
n=60 Participants
|
24 Participants
n=114 Participants
|
67 Participants
n=1 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=54 Participants
|
34 Participants
n=60 Participants
|
40 Participants
n=114 Participants
|
90 Participants
n=1 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=54 Participants
|
10 Participants
n=60 Participants
|
1 Participants
n=114 Participants
|
11 Participants
n=1 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
30 Participants
n=54 Participants
|
53 Participants
n=60 Participants
|
63 Participants
n=114 Participants
|
146 Participants
n=1 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=54 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=114 Participants
|
0 Participants
n=1 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=54 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=114 Participants
|
0 Participants
n=1 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=54 Participants
|
0 Participants
n=60 Participants
|
6 Participants
n=114 Participants
|
6 Participants
n=1 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=54 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=114 Participants
|
0 Participants
n=1 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=54 Participants
|
4 Participants
n=60 Participants
|
3 Participants
n=114 Participants
|
11 Participants
n=1 Participants
|
|
Race (NIH/OMB)
White
|
26 Participants
n=54 Participants
|
59 Participants
n=60 Participants
|
55 Participants
n=114 Participants
|
140 Participants
n=1 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=54 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=114 Participants
|
0 Participants
n=1 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=54 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=114 Participants
|
0 Participants
n=1 Participants
|
|
Region of Enrollment
United States
|
30 participants
n=54 Participants
|
63 participants
n=60 Participants
|
64 participants
n=114 Participants
|
157 participants
n=1 Participants
|
PRIMARY outcome
Timeframe: Baseline and Day 29Population: Those who completed 29 days of trials
"The FACIT-F fatigue subscale was used as the primary outcome measure. There are 13 items in this fatigue subscale. Using the subscale, patients rate the intensity of their fatigue and its related symptoms on a scale of 0 to 4. The total score ranges between 0 and 52, with higher scores denoting less fatigue. The objective was to determine whether the average improvement in FACIT-F fatigue from baseline to Day 29 in patients who received PG was greater than in those who received placebo. We used chi-square test to determine the p-value."
Outcome measures
| Measure |
Phase-ll Blinded Placebo
n=56 Participants
Took similar appearance colored capsule twice daily for 29 days
|
Phase-I Panax Ginseng (SingleGroup)
n=24 Participants
Took one capsule (400mg) twice daily for 29 days
|
Phase-II Blinded Panax Ginseng
n=56 Participants
Took one capsule (400mg) twice daily for 29 days
|
|---|---|---|---|
|
Functional Assessment of Chronic Illness Therapy- Fatigue (FACIT-F) Subscale Score Change
|
6.5 score on a scale
Standard Deviation 9.9
|
14.2 score on a scale
Standard Deviation 17.5
|
7.5 score on a scale
Standard Deviation 12.7
|
SECONDARY outcome
Timeframe: Baseline and Day 29Population: Those who completed 29 days of trials
The ESAS evaluates 10 commonly experienced symptoms, including pain, fatigue, nausea, depression, anxiety, drowsiness, dyspnea, anorexia, sleep disturbance, and impaired feelings of well-being. The severity of ESAS fatigue was rated on a numerical scale of 0 to 10 (0 = no symptom, 10 = worst possible severity). The objective was to determine whether the average improvement in ESAS fatigue from baseline to Day 29 in patients who received PG was greater than in those who received placebo. We used chi-square test to determine the p-value.
Outcome measures
| Measure |
Phase-ll Blinded Placebo
n=56 Participants
Took similar appearance colored capsule twice daily for 29 days
|
Phase-I Panax Ginseng (SingleGroup)
n=24 Participants
Took one capsule (400mg) twice daily for 29 days
|
Phase-II Blinded Panax Ginseng
n=56 Participants
Took one capsule (400mg) twice daily for 29 days
|
|---|---|---|---|
|
Edmonton Symptom Assessment System (ESAS) Fatigue Score Change
|
-2.1 score on a scale
Standard Deviation 2.6
|
-2.5 score on a scale
Standard Deviation 2.2
|
-1.9 score on a scale
Standard Deviation 2.6
|
SECONDARY outcome
Timeframe: Baseline and Day 29Population: Those who completed 29 days of trials
The ESAS evaluates 10 commonly experienced symptoms, including pain, fatigue, nausea, depression, anxiety, drowsiness, dyspnea, anorexia, sleep disturbance, and impaired feelings of well-being. The severity of ESAS pain was rated on a numerical scale of 0 to 10 (0 = no symptom, 10 = worst possible severity). The objective was to determine whether the average improvement in ESAS pain from baseline to Day 29 in patients who received PG was greater than in those who received placebo. We used chi-square test to determine the p-value.
Outcome measures
| Measure |
Phase-ll Blinded Placebo
n=56 Participants
Took similar appearance colored capsule twice daily for 29 days
|
Phase-I Panax Ginseng (SingleGroup)
n=24 Participants
Took one capsule (400mg) twice daily for 29 days
|
Phase-II Blinded Panax Ginseng
n=56 Participants
Took one capsule (400mg) twice daily for 29 days
|
|---|---|---|---|
|
Edmonton Symptom Assessment System (ESAS) Pain Score Change
|
-0.1 score on a scale
Standard Deviation 3.0
|
-0.9 score on a scale
Standard Deviation 1.7
|
-0.6 score on a scale
Standard Deviation 2.0
|
SECONDARY outcome
Timeframe: Baseline and Day 29Population: Those who completed 29 days of trials
The ESAS evaluates 10 commonly experienced symptoms, including pain, fatigue, nausea, depression, anxiety, drowsiness, dyspnea, anorexia, sleep disturbance, and impaired feelings of well-being. The severity of ESAS depression was rated on a numerical scale of 0 to 10 (0 = no symptom, 10 = worst possible severity). The objective was to determine whether the average improvement in ESAS depression from baseline to Day 29 in patients who received PG was greater than in those who received placebo. We used chi-square test to determine the p-value.
Outcome measures
| Measure |
Phase-ll Blinded Placebo
n=56 Participants
Took similar appearance colored capsule twice daily for 29 days
|
Phase-I Panax Ginseng (SingleGroup)
n=24 Participants
Took one capsule (400mg) twice daily for 29 days
|
Phase-II Blinded Panax Ginseng
n=56 Participants
Took one capsule (400mg) twice daily for 29 days
|
|---|---|---|---|
|
Edmonton Symptom Assessment System (ESAS) Depression Score Change
|
0.1 score on a scale
Standard Deviation 2.2
|
0.0 score on a scale
Standard Deviation 1.7
|
-0.3 score on a scale
Standard Deviation 2.2
|
SECONDARY outcome
Timeframe: Baseline and Day 29Population: Those who completed 29 days of trials
The ESAS evaluates 10 commonly experienced symptoms, including pain, fatigue, nausea, depression, anxiety, drowsiness, dyspnea, anorexia, sleep disturbance, and impaired feelings of well-being. The severity of ESAS drowsiness was rated on a numerical scale of 0 to 10 (0 = no symptom, 10 = worst possible severity). The objective was to determine whether the average improvement in ESAS drowsiness from baseline to Day 29 in patients who received PG was greater than in those who received placebo. We used chi-square test to determine the p-value.
Outcome measures
| Measure |
Phase-ll Blinded Placebo
n=56 Participants
Took similar appearance colored capsule twice daily for 29 days
|
Phase-I Panax Ginseng (SingleGroup)
n=24 Participants
Took one capsule (400mg) twice daily for 29 days
|
Phase-II Blinded Panax Ginseng
n=56 Participants
Took one capsule (400mg) twice daily for 29 days
|
|---|---|---|---|
|
Edmonton Symptom Assessment System (ESAS) Drowsiness Score Change
|
-0.6 score on a scale
Standard Deviation 3.2
|
-0.8 score on a scale
Standard Deviation 2.2
|
-0.9 score on a scale
Standard Deviation 3.1
|
Adverse Events
Phase-I Panax Ginseng (Single Group)
Serious events: 3 serious events
Other events: 4 other events
Deaths: 1 deaths
Phase-II Blinded Panax Ginseng
Serious events: 2 serious events
Other events: 6 other events
Deaths: 1 deaths
Phase-ll Blinded Placebo
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
Open Label Extension
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Phase-I Panax Ginseng (Single Group)
n=30 participants at risk
Took one Panax Ginseng capsule (400mg) twice daily by mouth for 29 days
|
Phase-II Blinded Panax Ginseng
n=63 participants at risk
Took one Panax Ginseng capsule (400mg) twice daily by mouth for 29 days
|
Phase-ll Blinded Placebo
n=64 participants at risk
Took similar appearance colored Placebo capsule twice daily by mouth for 29 days
|
Open Label Extension
n=102 participants at risk
One capsule 400mg by mouth twice a day for 29 days
|
|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/30 • Baseline up to 57 days
Adverse events that were reported by the patient
|
1.6%
1/63 • Baseline up to 57 days
Adverse events that were reported by the patient
|
0.00%
0/64 • Baseline up to 57 days
Adverse events that were reported by the patient
|
0.00%
0/102 • Baseline up to 57 days
Adverse events that were reported by the patient
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/30 • Baseline up to 57 days
Adverse events that were reported by the patient
|
1.6%
1/63 • Baseline up to 57 days
Adverse events that were reported by the patient
|
0.00%
0/64 • Baseline up to 57 days
Adverse events that were reported by the patient
|
0.00%
0/102 • Baseline up to 57 days
Adverse events that were reported by the patient
|
|
Infections and infestations
Breast Infection
|
0.00%
0/30 • Baseline up to 57 days
Adverse events that were reported by the patient
|
1.6%
1/63 • Baseline up to 57 days
Adverse events that were reported by the patient
|
0.00%
0/64 • Baseline up to 57 days
Adverse events that were reported by the patient
|
0.00%
0/102 • Baseline up to 57 days
Adverse events that were reported by the patient
|
|
Investigations
White Blood Cell disorder
|
3.3%
1/30 • Baseline up to 57 days
Adverse events that were reported by the patient
|
0.00%
0/63 • Baseline up to 57 days
Adverse events that were reported by the patient
|
0.00%
0/64 • Baseline up to 57 days
Adverse events that were reported by the patient
|
0.00%
0/102 • Baseline up to 57 days
Adverse events that were reported by the patient
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
0.00%
0/30 • Baseline up to 57 days
Adverse events that were reported by the patient
|
1.6%
1/63 • Baseline up to 57 days
Adverse events that were reported by the patient
|
0.00%
0/64 • Baseline up to 57 days
Adverse events that were reported by the patient
|
0.00%
0/102 • Baseline up to 57 days
Adverse events that were reported by the patient
|
|
Musculoskeletal and connective tissue disorders
Gait disturbance
|
0.00%
0/30 • Baseline up to 57 days
Adverse events that were reported by the patient
|
1.6%
1/63 • Baseline up to 57 days
Adverse events that were reported by the patient
|
0.00%
0/64 • Baseline up to 57 days
Adverse events that were reported by the patient
|
0.00%
0/102 • Baseline up to 57 days
Adverse events that were reported by the patient
|
|
General disorders
Pain
|
3.3%
1/30 • Baseline up to 57 days
Adverse events that were reported by the patient
|
0.00%
0/63 • Baseline up to 57 days
Adverse events that were reported by the patient
|
0.00%
0/64 • Baseline up to 57 days
Adverse events that were reported by the patient
|
0.00%
0/102 • Baseline up to 57 days
Adverse events that were reported by the patient
|
|
Gastrointestinal disorders
Nausea
|
3.3%
1/30 • Baseline up to 57 days
Adverse events that were reported by the patient
|
0.00%
0/63 • Baseline up to 57 days
Adverse events that were reported by the patient
|
0.00%
0/64 • Baseline up to 57 days
Adverse events that were reported by the patient
|
0.00%
0/102 • Baseline up to 57 days
Adverse events that were reported by the patient
|
|
Gastrointestinal disorders
Gastrointestinal disorder (Other)
|
0.00%
0/30 • Baseline up to 57 days
Adverse events that were reported by the patient
|
0.00%
0/63 • Baseline up to 57 days
Adverse events that were reported by the patient
|
1.6%
1/64 • Baseline up to 57 days
Adverse events that were reported by the patient
|
0.00%
0/102 • Baseline up to 57 days
Adverse events that were reported by the patient
|
Other adverse events
| Measure |
Phase-I Panax Ginseng (Single Group)
n=30 participants at risk
Took one Panax Ginseng capsule (400mg) twice daily by mouth for 29 days
|
Phase-II Blinded Panax Ginseng
n=63 participants at risk
Took one Panax Ginseng capsule (400mg) twice daily by mouth for 29 days
|
Phase-ll Blinded Placebo
n=64 participants at risk
Took similar appearance colored Placebo capsule twice daily by mouth for 29 days
|
Open Label Extension
n=102 participants at risk
One capsule 400mg by mouth twice a day for 29 days
|
|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/30 • Baseline up to 57 days
Adverse events that were reported by the patient
|
1.6%
1/63 • Baseline up to 57 days
Adverse events that were reported by the patient
|
1.6%
1/64 • Baseline up to 57 days
Adverse events that were reported by the patient
|
0.98%
1/102 • Baseline up to 57 days
Adverse events that were reported by the patient
|
|
Respiratory, thoracic and mediastinal disorders
Lung Infection
|
0.00%
0/30 • Baseline up to 57 days
Adverse events that were reported by the patient
|
0.00%
0/63 • Baseline up to 57 days
Adverse events that were reported by the patient
|
1.6%
1/64 • Baseline up to 57 days
Adverse events that were reported by the patient
|
0.00%
0/102 • Baseline up to 57 days
Adverse events that were reported by the patient
|
|
Nervous system disorders
Fatigue
|
0.00%
0/30 • Baseline up to 57 days
Adverse events that were reported by the patient
|
0.00%
0/63 • Baseline up to 57 days
Adverse events that were reported by the patient
|
1.6%
1/64 • Baseline up to 57 days
Adverse events that were reported by the patient
|
0.98%
1/102 • Baseline up to 57 days
Adverse events that were reported by the patient
|
|
Cardiac disorders
Hypokalemia
|
0.00%
0/30 • Baseline up to 57 days
Adverse events that were reported by the patient
|
0.00%
0/63 • Baseline up to 57 days
Adverse events that were reported by the patient
|
0.00%
0/64 • Baseline up to 57 days
Adverse events that were reported by the patient
|
0.98%
1/102 • Baseline up to 57 days
Adverse events that were reported by the patient
|
|
Cardiac disorders
Allergic reaction
|
0.00%
0/30 • Baseline up to 57 days
Adverse events that were reported by the patient
|
0.00%
0/63 • Baseline up to 57 days
Adverse events that were reported by the patient
|
0.00%
0/64 • Baseline up to 57 days
Adverse events that were reported by the patient
|
0.98%
1/102 • Baseline up to 57 days
Adverse events that were reported by the patient
|
|
Skin and subcutaneous tissue disorders
Infections and Infestations
|
0.00%
0/30 • Baseline up to 57 days
Adverse events that were reported by the patient
|
1.6%
1/63 • Baseline up to 57 days
Adverse events that were reported by the patient
|
0.00%
0/64 • Baseline up to 57 days
Adverse events that were reported by the patient
|
0.00%
0/102 • Baseline up to 57 days
Adverse events that were reported by the patient
|
|
Vascular disorders
Thrombotic Thrombocytopenic purpura
|
0.00%
0/30 • Baseline up to 57 days
Adverse events that were reported by the patient
|
0.00%
0/63 • Baseline up to 57 days
Adverse events that were reported by the patient
|
0.00%
0/64 • Baseline up to 57 days
Adverse events that were reported by the patient
|
0.98%
1/102 • Baseline up to 57 days
Adverse events that were reported by the patient
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/30 • Baseline up to 57 days
Adverse events that were reported by the patient
|
1.6%
1/63 • Baseline up to 57 days
Adverse events that were reported by the patient
|
0.00%
0/64 • Baseline up to 57 days
Adverse events that were reported by the patient
|
0.00%
0/102 • Baseline up to 57 days
Adverse events that were reported by the patient
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/30 • Baseline up to 57 days
Adverse events that were reported by the patient
|
0.00%
0/63 • Baseline up to 57 days
Adverse events that were reported by the patient
|
0.00%
0/64 • Baseline up to 57 days
Adverse events that were reported by the patient
|
0.98%
1/102 • Baseline up to 57 days
Adverse events that were reported by the patient
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
3.3%
1/30 • Baseline up to 57 days
Adverse events that were reported by the patient
|
1.6%
1/63 • Baseline up to 57 days
Adverse events that were reported by the patient
|
0.00%
0/64 • Baseline up to 57 days
Adverse events that were reported by the patient
|
0.00%
0/102 • Baseline up to 57 days
Adverse events that were reported by the patient
|
|
Gastrointestinal disorders
Nausea
|
3.3%
1/30 • Baseline up to 57 days
Adverse events that were reported by the patient
|
1.6%
1/63 • Baseline up to 57 days
Adverse events that were reported by the patient
|
0.00%
0/64 • Baseline up to 57 days
Adverse events that were reported by the patient
|
0.00%
0/102 • Baseline up to 57 days
Adverse events that were reported by the patient
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/30 • Baseline up to 57 days
Adverse events that were reported by the patient
|
0.00%
0/63 • Baseline up to 57 days
Adverse events that were reported by the patient
|
0.00%
0/64 • Baseline up to 57 days
Adverse events that were reported by the patient
|
0.98%
1/102 • Baseline up to 57 days
Adverse events that were reported by the patient
|
|
Gastrointestinal disorders
Oral Mucositis
|
0.00%
0/30 • Baseline up to 57 days
Adverse events that were reported by the patient
|
0.00%
0/63 • Baseline up to 57 days
Adverse events that were reported by the patient
|
0.00%
0/64 • Baseline up to 57 days
Adverse events that were reported by the patient
|
0.98%
1/102 • Baseline up to 57 days
Adverse events that were reported by the patient
|
|
Gastrointestinal disorders
Vomiting
|
3.3%
1/30 • Baseline up to 57 days
Adverse events that were reported by the patient
|
0.00%
0/63 • Baseline up to 57 days
Adverse events that were reported by the patient
|
0.00%
0/64 • Baseline up to 57 days
Adverse events that were reported by the patient
|
0.00%
0/102 • Baseline up to 57 days
Adverse events that were reported by the patient
|
|
Infections and infestations
Breast Infection
|
0.00%
0/30 • Baseline up to 57 days
Adverse events that were reported by the patient
|
1.6%
1/63 • Baseline up to 57 days
Adverse events that were reported by the patient
|
0.00%
0/64 • Baseline up to 57 days
Adverse events that were reported by the patient
|
0.00%
0/102 • Baseline up to 57 days
Adverse events that were reported by the patient
|
|
General disorders
General disorders (other)
|
0.00%
0/30 • Baseline up to 57 days
Adverse events that were reported by the patient
|
1.6%
1/63 • Baseline up to 57 days
Adverse events that were reported by the patient
|
0.00%
0/64 • Baseline up to 57 days
Adverse events that were reported by the patient
|
0.00%
0/102 • Baseline up to 57 days
Adverse events that were reported by the patient
|
|
Nervous system disorders
Akathisia
|
0.00%
0/30 • Baseline up to 57 days
Adverse events that were reported by the patient
|
0.00%
0/63 • Baseline up to 57 days
Adverse events that were reported by the patient
|
1.6%
1/64 • Baseline up to 57 days
Adverse events that were reported by the patient
|
0.00%
0/102 • Baseline up to 57 days
Adverse events that were reported by the patient
|
|
Nervous system disorders
Headache
|
0.00%
0/30 • Baseline up to 57 days
Adverse events that were reported by the patient
|
1.6%
1/63 • Baseline up to 57 days
Adverse events that were reported by the patient
|
0.00%
0/64 • Baseline up to 57 days
Adverse events that were reported by the patient
|
0.00%
0/102 • Baseline up to 57 days
Adverse events that were reported by the patient
|
|
Nervous system disorders
Syncope
|
0.00%
0/30 • Baseline up to 57 days
Adverse events that were reported by the patient
|
0.00%
0/63 • Baseline up to 57 days
Adverse events that were reported by the patient
|
0.00%
0/64 • Baseline up to 57 days
Adverse events that were reported by the patient
|
0.98%
1/102 • Baseline up to 57 days
Adverse events that were reported by the patient
|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/30 • Baseline up to 57 days
Adverse events that were reported by the patient
|
0.00%
0/63 • Baseline up to 57 days
Adverse events that were reported by the patient
|
1.6%
1/64 • Baseline up to 57 days
Adverse events that were reported by the patient
|
0.00%
0/102 • Baseline up to 57 days
Adverse events that were reported by the patient
|
|
Blood and lymphatic system disorders
Thrombocytopenic purpura
|
0.00%
0/30 • Baseline up to 57 days
Adverse events that were reported by the patient
|
0.00%
0/63 • Baseline up to 57 days
Adverse events that were reported by the patient
|
0.00%
0/64 • Baseline up to 57 days
Adverse events that were reported by the patient
|
0.98%
1/102 • Baseline up to 57 days
Adverse events that were reported by the patient
|
|
Investigations
Increased ALT
|
0.00%
0/30 • Baseline up to 57 days
Adverse events that were reported by the patient
|
1.6%
1/63 • Baseline up to 57 days
Adverse events that were reported by the patient
|
0.00%
0/64 • Baseline up to 57 days
Adverse events that were reported by the patient
|
0.00%
0/102 • Baseline up to 57 days
Adverse events that were reported by the patient
|
|
Investigations
Increased AST
|
0.00%
0/30 • Baseline up to 57 days
Adverse events that were reported by the patient
|
1.6%
1/63 • Baseline up to 57 days
Adverse events that were reported by the patient
|
0.00%
0/64 • Baseline up to 57 days
Adverse events that were reported by the patient
|
0.00%
0/102 • Baseline up to 57 days
Adverse events that were reported by the patient
|
|
Musculoskeletal and connective tissue disorders
Generalized Muscle Weakness
|
0.00%
0/30 • Baseline up to 57 days
Adverse events that were reported by the patient
|
1.6%
1/63 • Baseline up to 57 days
Adverse events that were reported by the patient
|
0.00%
0/64 • Baseline up to 57 days
Adverse events that were reported by the patient
|
0.00%
0/102 • Baseline up to 57 days
Adverse events that were reported by the patient
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/30 • Baseline up to 57 days
Adverse events that were reported by the patient
|
0.00%
0/63 • Baseline up to 57 days
Adverse events that were reported by the patient
|
0.00%
0/64 • Baseline up to 57 days
Adverse events that were reported by the patient
|
0.98%
1/102 • Baseline up to 57 days
Adverse events that were reported by the patient
|
|
Nervous system disorders
Delirium
|
3.3%
1/30 • Baseline up to 57 days
Adverse events that were reported by the patient
|
0.00%
0/63 • Baseline up to 57 days
Adverse events that were reported by the patient
|
0.00%
0/64 • Baseline up to 57 days
Adverse events that were reported by the patient
|
0.00%
0/102 • Baseline up to 57 days
Adverse events that were reported by the patient
|
|
Nervous system disorders
Insomnia
|
0.00%
0/30 • Baseline up to 57 days
Adverse events that were reported by the patient
|
1.6%
1/63 • Baseline up to 57 days
Adverse events that were reported by the patient
|
0.00%
0/64 • Baseline up to 57 days
Adverse events that were reported by the patient
|
0.00%
0/102 • Baseline up to 57 days
Adverse events that were reported by the patient
|
|
Vascular disorders
Hypertension
|
3.3%
1/30 • Baseline up to 57 days
Adverse events that were reported by the patient
|
0.00%
0/63 • Baseline up to 57 days
Adverse events that were reported by the patient
|
0.00%
0/64 • Baseline up to 57 days
Adverse events that were reported by the patient
|
0.00%
0/102 • Baseline up to 57 days
Adverse events that were reported by the patient
|
|
Cardiac disorders
Chest pain
|
3.3%
1/30 • Baseline up to 57 days
Adverse events that were reported by the patient
|
0.00%
0/63 • Baseline up to 57 days
Adverse events that were reported by the patient
|
0.00%
0/64 • Baseline up to 57 days
Adverse events that were reported by the patient
|
0.00%
0/102 • Baseline up to 57 days
Adverse events that were reported by the patient
|
|
Gastrointestinal disorders
Hyperglycemia
|
0.00%
0/30 • Baseline up to 57 days
Adverse events that were reported by the patient
|
0.00%
0/63 • Baseline up to 57 days
Adverse events that were reported by the patient
|
0.00%
0/64 • Baseline up to 57 days
Adverse events that were reported by the patient
|
0.98%
1/102 • Baseline up to 57 days
Adverse events that were reported by the patient
|
|
Gastrointestinal disorders
Appendicitis
|
0.00%
0/30 • Baseline up to 57 days
Adverse events that were reported by the patient
|
0.00%
0/63 • Baseline up to 57 days
Adverse events that were reported by the patient
|
1.6%
1/64 • Baseline up to 57 days
Adverse events that were reported by the patient
|
0.00%
0/102 • Baseline up to 57 days
Adverse events that were reported by the patient
|
Additional Information
Dr. Sriram Yennu, MD-Professor, Palliative Care Med
UT MD Anderson Cancer Center
Phone: (713) 792-3938
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place