Trial Outcomes & Findings for Palonosetron and Dexamethasone With or Without Dronabinol in Preventing Nausea and Vomiting in Patients Receiving Chemotherapy For Cancer (NCT NCT00553059)
NCT ID: NCT00553059
Last Updated: 2020-10-09
Results Overview
Total protection is defined as no vomiting, no rescue therapy, and no nausea as indicated by responses to the acute (0-24 hour), delayed (24-120 hour), and overall (0-120 hour) periods as indicated by responses to the Daily Assessment of Nausea and Vomiting questionnaire. Data to be recorded in the study diary during the 5-day study period. The assessment measures in detail the occurrence, duration, and severity of post-chemotherapy nausea and emesis using a 10-point Likert-type scale ranging from 0 (none) to 10 (as bad as it could be) if nausea or vomiting is present.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
62 participants
Primary outcome timeframe
5 Days (first 5 days of the first cycle of chemotherapy)
Results posted on
2020-10-09
Participant Flow
Recruitment Period: May 13, 2008 to October 26, 2011. Recruitment done in various medical clinics.
Participant milestones
| Measure |
Dronabinol
Dronabinol 1 capsule three times per day for 5 days
|
Placebo
Placebo 1 capsule three times per day for 5 days
|
|---|---|---|
|
Overall Study
STARTED
|
31
|
31
|
|
Overall Study
COMPLETED
|
30
|
29
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
Reasons for withdrawal
| Measure |
Dronabinol
Dronabinol 1 capsule three times per day for 5 days
|
Placebo
Placebo 1 capsule three times per day for 5 days
|
|---|---|---|
|
Overall Study
Deemed ineligible
|
1
|
1
|
|
Overall Study
Drug supply not available
|
0
|
1
|
Baseline Characteristics
Palonosetron and Dexamethasone With or Without Dronabinol in Preventing Nausea and Vomiting in Patients Receiving Chemotherapy For Cancer
Baseline characteristics by cohort
| Measure |
Dronabinol
n=31 Participants
Dronabinol 1 capsule three times per day for 5 days
|
Placebo
n=31 Participants
Placebo 1 capsule three times per day for 5 days
|
Total
n=62 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=113 Participants
|
0 Participants
n=163 Participants
|
0 Participants
n=160 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
18 Participants
n=113 Participants
|
19 Participants
n=163 Participants
|
37 Participants
n=160 Participants
|
|
Age, Categorical
>=65 years
|
13 Participants
n=113 Participants
|
12 Participants
n=163 Participants
|
25 Participants
n=160 Participants
|
|
Age, Continuous
|
59 years
n=113 Participants
|
57 years
n=163 Participants
|
58 years
n=160 Participants
|
|
Sex: Female, Male
Female
|
31 Participants
n=113 Participants
|
30 Participants
n=163 Participants
|
61 Participants
n=160 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=113 Participants
|
1 Participants
n=163 Participants
|
1 Participants
n=160 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=113 Participants
|
1 Participants
n=163 Participants
|
2 Participants
n=160 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
30 Participants
n=113 Participants
|
30 Participants
n=163 Participants
|
60 Participants
n=160 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=113 Participants
|
0 Participants
n=163 Participants
|
0 Participants
n=160 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=113 Participants
|
0 Participants
n=163 Participants
|
0 Participants
n=160 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=113 Participants
|
0 Participants
n=163 Participants
|
0 Participants
n=160 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=113 Participants
|
0 Participants
n=163 Participants
|
0 Participants
n=160 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=113 Participants
|
8 Participants
n=163 Participants
|
14 Participants
n=160 Participants
|
|
Race (NIH/OMB)
White
|
25 Participants
n=113 Participants
|
22 Participants
n=163 Participants
|
47 Participants
n=160 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=113 Participants
|
0 Participants
n=163 Participants
|
0 Participants
n=160 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=113 Participants
|
1 Participants
n=163 Participants
|
1 Participants
n=160 Participants
|
|
Region of Enrollment
United States
|
31 participants
n=113 Participants
|
31 participants
n=163 Participants
|
62 participants
n=160 Participants
|
|
Daily Assessment of Nausea and Vomiting
|
30 Participants
n=113 Participants
|
29 Participants
n=163 Participants
|
59 Participants
n=160 Participants
|
PRIMARY outcome
Timeframe: 5 Days (first 5 days of the first cycle of chemotherapy)Total protection is defined as no vomiting, no rescue therapy, and no nausea as indicated by responses to the acute (0-24 hour), delayed (24-120 hour), and overall (0-120 hour) periods as indicated by responses to the Daily Assessment of Nausea and Vomiting questionnaire. Data to be recorded in the study diary during the 5-day study period. The assessment measures in detail the occurrence, duration, and severity of post-chemotherapy nausea and emesis using a 10-point Likert-type scale ranging from 0 (none) to 10 (as bad as it could be) if nausea or vomiting is present.
Outcome measures
| Measure |
Dronabinol
n=31 Participants
Dronabinol 1 capsule three times per day for 5 days
|
Placebo
n=31 Participants
Placebo 1 capsule three times per day for 5 days
|
|---|---|---|
|
Number of Participants With Total Protection in the Acute, Delayed and Overall Periods
Acute
|
22 Participants
|
14 Participants
|
|
Number of Participants With Total Protection in the Acute, Delayed and Overall Periods
Delayed
|
11 Participants
|
5 Participants
|
|
Number of Participants With Total Protection in the Acute, Delayed and Overall Periods
Overall
|
11 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: Up to 5 days (first 5 days following first cycle of chemotherapy)Complete Protection is no vomiting, no rescue therapy, and no nausea evaluated for the acute (0-24 hour), delayed (24-120 hour), and overall (0-120 hour) periods as indicated by responses to the Daily Assessment of Nausea and Vomiting questionnaire. The assessment measures in detail the occurrence, duration, and severity of post-chemotherapy nausea and emesis using a 10-point Likert-type scale ranging from 0 (none) to 10 (as bad as it could be) if nausea or vomiting is present.
Outcome measures
| Measure |
Dronabinol
n=30 Participants
Dronabinol 1 capsule three times per day for 5 days
|
Placebo
n=29 Participants
Placebo 1 capsule three times per day for 5 days
|
|---|---|---|
|
Number of Participants With Complete Protection for the Acute, Delayed, and Overall Periods
Acute
|
22 Participants
|
18 Participants
|
|
Number of Participants With Complete Protection for the Acute, Delayed, and Overall Periods
Delayed
|
14 Participants
|
10 Participants
|
|
Number of Participants With Complete Protection for the Acute, Delayed, and Overall Periods
Overall
|
14 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: Up to 5 days (first 5 days following first cycle of chemotherapy)Complete response is defined as vomiting episodes with rescue medication evaluated for the acute (0-24 hour), delayed (24-120 hour), and overall (0-120 hour) periods as indicated by responses to the Daily Assessment of Nausea and Vomiting questionnaire. The assessment measures in detail the occurrence, duration, and severity of post-chemotherapy nausea and emesis using a 10-point Likert-type scale ranging from 0 (none) to 10 (as bad as it could be) if nausea or vomiting is present.
Outcome measures
| Measure |
Dronabinol
n=30 Participants
Dronabinol 1 capsule three times per day for 5 days
|
Placebo
n=29 Participants
Placebo 1 capsule three times per day for 5 days
|
|---|---|---|
|
Number of Participants With Complete Response for the Acute, Delayed, and Overall Periods
Acute
|
22 Participants
|
19 Participants
|
|
Number of Participants With Complete Response for the Acute, Delayed, and Overall Periods
Delayed
|
14 Participants
|
13 Participants
|
|
Number of Participants With Complete Response for the Acute, Delayed, and Overall Periods
Overall
|
15 Participants
|
12 Participants
|
SECONDARY outcome
Timeframe: 5 Days (first 5 days of the first cycle of chemotherapy)Number of Participants with Vomiting Acute, Delayed and Overall. Evaluated for the acute (0-24 hour), delayed (24-120 hour), and overall (0-120 hour) periods as indicated by responses to the Daily Assessment of Nausea and Vomiting questionnaire. The assessment measures in detail the occurrence, duration, and severity of post-chemotherapy nausea and emesis using a 10-point Likert-type scale ranging from 0 (none) to 10 (as bad as it could be) if nausea or vomiting is present.
Outcome measures
| Measure |
Dronabinol
n=30 Participants
Dronabinol 1 capsule three times per day for 5 days
|
Placebo
n=19 Participants
Placebo 1 capsule three times per day for 5 days
|
|---|---|---|
|
Number of Participants With Vomiting for the Acute, Delayed and Overall Periods
Acute
|
6 Participants
|
3 Participants
|
|
Number of Participants With Vomiting for the Acute, Delayed and Overall Periods
Delayed
|
10 Participants
|
9 Participants
|
|
Number of Participants With Vomiting for the Acute, Delayed and Overall Periods
Overall
|
19 Participants
|
19 Participants
|
SECONDARY outcome
Timeframe: 5 Days (first 5 days of the first cycle of chemotherapy)Number of Participants with Nausea for the Acute, Delayed and Overall Periods. Evaluated for the acute (0-24 hour), delayed (24-120 hour), and overall (0-120 hour) periods as indicated by responses to the Daily Assessment of Nausea and Vomiting questionnaire. The assessment measures in detail the occurrence, duration, and severity of post-chemotherapy nausea and emesis using a 10-point Likert-type scale ranging from 0 (none) to 10 (as bad as it could be) if nausea or vomiting is present.
Outcome measures
| Measure |
Dronabinol
n=30 Participants
Dronabinol 1 capsule three times per day for 5 days
|
Placebo
n=29 Participants
Placebo 1 capsule three times per day for 5 days
|
|---|---|---|
|
Number of Participants With Nausea for the Acute, Delayed and Overall Periods
Overall
|
11 Participants
|
5 Participants
|
|
Number of Participants With Nausea for the Acute, Delayed and Overall Periods
Acute
|
8 Participants
|
15 Participants
|
|
Number of Participants With Nausea for the Acute, Delayed and Overall Periods
Delayed
|
19 Participants
|
23 Participants
|
SECONDARY outcome
Timeframe: 5 Days (first 5 days of the first cycle of chemotherapy)Number of Participants With Nausea and Vomiting for the Acute, Delayed and Overall Periods. Evaluated for the acute (0-24 hour), delayed (24-120 hour), and overall (0-120 hour) periods as indicated by responses to the Daily Assessment of Nausea and Vomiting questionnaire. The assessment measures in detail the occurrence, duration, and severity of post-chemotherapy nausea and emesis using a 10-point Likert-type scale ranging from 0 (none) to 10 (as bad as it could be) if nausea or vomiting is present.
Outcome measures
| Measure |
Dronabinol
n=30 Participants
Dronabinol 1 capsule three times per day for 5 days
|
Placebo
n=29 Participants
Placebo 1 capsule three times per day for 5 days
|
|---|---|---|
|
Number of Participants With Nausea and Vomiting for the Acute, Delayed and Overall Periods
Acute
|
4 Participants
|
2 Participants
|
|
Number of Participants With Nausea and Vomiting for the Acute, Delayed and Overall Periods
Delayed
|
7 Participants
|
8 Participants
|
|
Number of Participants With Nausea and Vomiting for the Acute, Delayed and Overall Periods
Overall
|
15 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: 5 Days (first 5 days of the first cycle of chemotherapy)The assessment measures in detail the occurrence, duration, and severity of post-chemotherapy nausea and emesis using a 10-point Likert-type scale ranging from 0 (none) to 10 (as bad as it could be) if nausea or vomiting is present. The first section asks the patient to record presence and severity of nausea during the last 24 hours. The second section asks the patient to record vomiting episodes during the last 24 hours. The third section asks if the patient took medication for nausea or vomiting during the last 24 hours and asks how useful the treatment for nausea or vomiting was. The fourth section screens for toxicity by asking about side effects and problems experienced during the last 24 hours. Use of rescue antiemetic medication and adverse events also assessed and documented.
Outcome measures
| Measure |
Dronabinol
n=30 Participants
Dronabinol 1 capsule three times per day for 5 days
|
Placebo
n=29 Participants
Placebo 1 capsule three times per day for 5 days
|
|---|---|---|
|
Number of Participants Received Rescue Medication in the Acute, Delayed and Overall Periods
Acute
|
3 Participants
|
5 Participants
|
|
Number of Participants Received Rescue Medication in the Acute, Delayed and Overall Periods
Delayed
|
11 Participants
|
15 Participants
|
|
Number of Participants Received Rescue Medication in the Acute, Delayed and Overall Periods
Response
|
10 Participants
|
12 Participants
|
Adverse Events
Dronabinol
Serious events: 1 serious events
Other events: 26 other events
Deaths: 0 deaths
Placebo
Serious events: 1 serious events
Other events: 25 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Dronabinol
n=30 participants at risk
Dronabinol 1 capsule three times per day for 5 days
|
Placebo
n=29 participants at risk
Placebo 1 capsule three times per day for 5 days
|
|---|---|---|
|
Blood and lymphatic system disorders
Neutropenia
|
3.3%
1/30 • 2 years, 8 months
An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE) version 4.0.
|
0.00%
0/29 • 2 years, 8 months
An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE) version 4.0.
|
|
Gastrointestinal disorders
Dehydration
|
3.3%
1/30 • 2 years, 8 months
An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE) version 4.0.
|
0.00%
0/29 • 2 years, 8 months
An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE) version 4.0.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
3.3%
1/30 • 2 years, 8 months
An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE) version 4.0.
|
0.00%
0/29 • 2 years, 8 months
An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE) version 4.0.
|
|
Gastrointestinal disorders
Diarrhea
|
3.3%
1/30 • 2 years, 8 months
An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE) version 4.0.
|
0.00%
0/29 • 2 years, 8 months
An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE) version 4.0.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/30 • 2 years, 8 months
An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE) version 4.0.
|
3.4%
1/29 • 2 years, 8 months
An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE) version 4.0.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/30 • 2 years, 8 months
An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE) version 4.0.
|
3.4%
1/29 • 2 years, 8 months
An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE) version 4.0.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/30 • 2 years, 8 months
An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE) version 4.0.
|
3.4%
1/29 • 2 years, 8 months
An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE) version 4.0.
|
Other adverse events
| Measure |
Dronabinol
n=30 participants at risk
Dronabinol 1 capsule three times per day for 5 days
|
Placebo
n=29 participants at risk
Placebo 1 capsule three times per day for 5 days
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Other
|
16.7%
5/30 • 2 years, 8 months
An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE) version 4.0.
|
3.4%
1/29 • 2 years, 8 months
An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE) version 4.0.
|
|
Vascular disorders
Hot Flashes
|
3.3%
1/30 • 2 years, 8 months
An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE) version 4.0.
|
0.00%
0/29 • 2 years, 8 months
An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE) version 4.0.
|
|
Vascular disorders
Other
|
3.3%
1/30 • 2 years, 8 months
An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE) version 4.0.
|
0.00%
0/29 • 2 years, 8 months
An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE) version 4.0.
|
|
Blood and lymphatic system disorders
Anemia
|
10.0%
3/30 • 2 years, 8 months
An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE) version 4.0.
|
3.4%
1/29 • 2 years, 8 months
An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE) version 4.0.
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
3.3%
1/30 • 2 years, 8 months
An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE) version 4.0.
|
0.00%
0/29 • 2 years, 8 months
An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE) version 4.0.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
6.7%
2/30 • 2 years, 8 months
An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE) version 4.0.
|
0.00%
0/29 • 2 years, 8 months
An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE) version 4.0.
|
|
Blood and lymphatic system disorders
Other
|
23.3%
7/30 • 2 years, 8 months
An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE) version 4.0.
|
37.9%
11/29 • 2 years, 8 months
An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE) version 4.0.
|
|
Cardiac disorders
Chest Pain
|
3.3%
1/30 • 2 years, 8 months
An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE) version 4.0.
|
3.4%
1/29 • 2 years, 8 months
An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE) version 4.0.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/30 • 2 years, 8 months
An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE) version 4.0.
|
3.4%
1/29 • 2 years, 8 months
An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE) version 4.0.
|
|
Eye disorders
Blurred Vision
|
3.3%
1/30 • 2 years, 8 months
An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE) version 4.0.
|
0.00%
0/29 • 2 years, 8 months
An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE) version 4.0.
|
|
Eye disorders
Conjuctivitis
|
0.00%
0/30 • 2 years, 8 months
An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE) version 4.0.
|
3.4%
1/29 • 2 years, 8 months
An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE) version 4.0.
|
|
Eye disorders
Watering
|
3.3%
1/30 • 2 years, 8 months
An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE) version 4.0.
|
3.4%
1/29 • 2 years, 8 months
An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE) version 4.0.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/30 • 2 years, 8 months
An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE) version 4.0.
|
3.4%
1/29 • 2 years, 8 months
An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE) version 4.0.
|
|
Gastrointestinal disorders
Constipation
|
46.7%
14/30 • 2 years, 8 months
An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE) version 4.0.
|
37.9%
11/29 • 2 years, 8 months
An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE) version 4.0.
|
|
Gastrointestinal disorders
Diarrhea
|
43.3%
13/30 • 2 years, 8 months
An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE) version 4.0.
|
20.7%
6/29 • 2 years, 8 months
An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE) version 4.0.
|
|
Gastrointestinal disorders
Dry Mouth
|
3.3%
1/30 • 2 years, 8 months
An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE) version 4.0.
|
0.00%
0/29 • 2 years, 8 months
An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE) version 4.0.
|
|
Gastrointestinal disorders
Dyspepsia
|
6.7%
2/30 • 2 years, 8 months
An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE) version 4.0.
|
6.9%
2/29 • 2 years, 8 months
An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE) version 4.0.
|
|
Gastrointestinal disorders
Esophagitis
|
0.00%
0/30 • 2 years, 8 months
An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE) version 4.0.
|
3.4%
1/29 • 2 years, 8 months
An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE) version 4.0.
|
|
Gastrointestinal disorders
Flatulence
|
3.3%
1/30 • 2 years, 8 months
An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE) version 4.0.
|
0.00%
0/29 • 2 years, 8 months
An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE) version 4.0.
|
|
Gastrointestinal disorders
Mucositis - Oral
|
6.7%
2/30 • 2 years, 8 months
An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE) version 4.0.
|
0.00%
0/29 • 2 years, 8 months
An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE) version 4.0.
|
|
Gastrointestinal disorders
Nausea
|
86.7%
26/30 • 2 years, 8 months
An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE) version 4.0.
|
86.2%
25/29 • 2 years, 8 months
An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE) version 4.0.
|
|
Gastrointestinal disorders
Oral Pain
|
0.00%
0/30 • 2 years, 8 months
An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE) version 4.0.
|
3.4%
1/29 • 2 years, 8 months
An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE) version 4.0.
|
|
Gastrointestinal disorders
Vomiting
|
36.7%
11/30 • 2 years, 8 months
An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE) version 4.0.
|
37.9%
11/29 • 2 years, 8 months
An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE) version 4.0.
|
|
Gastrointestinal disorders
Other
|
53.3%
16/30 • 2 years, 8 months
An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE) version 4.0.
|
41.4%
12/29 • 2 years, 8 months
An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE) version 4.0.
|
|
General disorders
Chills
|
3.3%
1/30 • 2 years, 8 months
An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE) version 4.0.
|
10.3%
3/29 • 2 years, 8 months
An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE) version 4.0.
|
|
General disorders
Edema - Limbs
|
0.00%
0/30 • 2 years, 8 months
An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE) version 4.0.
|
3.4%
1/29 • 2 years, 8 months
An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE) version 4.0.
|
|
General disorders
Fatigue
|
56.7%
17/30 • 2 years, 8 months
An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE) version 4.0.
|
37.9%
11/29 • 2 years, 8 months
An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE) version 4.0.
|
|
General disorders
Fever
|
3.3%
1/30 • 2 years, 8 months
An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE) version 4.0.
|
3.4%
1/29 • 2 years, 8 months
An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE) version 4.0.
|
|
General disorders
Flu-Like Symptoms
|
3.3%
1/30 • 2 years, 8 months
An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE) version 4.0.
|
0.00%
0/29 • 2 years, 8 months
An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE) version 4.0.
|
|
General disorders
Malaise
|
3.3%
1/30 • 2 years, 8 months
An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE) version 4.0.
|
0.00%
0/29 • 2 years, 8 months
An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE) version 4.0.
|
|
General disorders
Non-Cardiac Chest Pain
|
3.3%
1/30 • 2 years, 8 months
An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE) version 4.0.
|
0.00%
0/29 • 2 years, 8 months
An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE) version 4.0.
|
|
General disorders
Pain
|
13.3%
4/30 • 2 years, 8 months
An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE) version 4.0.
|
6.9%
2/29 • 2 years, 8 months
An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE) version 4.0.
|
|
General disorders
Other
|
13.3%
4/30 • 2 years, 8 months
An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE) version 4.0.
|
3.4%
1/29 • 2 years, 8 months
An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE) version 4.0.
|
|
Immune system disorders
Allergeric Reaction
|
3.3%
1/30 • 2 years, 8 months
An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE) version 4.0.
|
0.00%
0/29 • 2 years, 8 months
An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE) version 4.0.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/30 • 2 years, 8 months
An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE) version 4.0.
|
6.9%
2/29 • 2 years, 8 months
An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE) version 4.0.
|
|
Infections and infestations
Other
|
0.00%
0/30 • 2 years, 8 months
An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE) version 4.0.
|
3.4%
1/29 • 2 years, 8 months
An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE) version 4.0.
|
|
Injury, poisoning and procedural complications
Other
|
6.7%
2/30 • 2 years, 8 months
An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE) version 4.0.
|
0.00%
0/29 • 2 years, 8 months
An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE) version 4.0.
|
|
Investigations
Alanine Aminotransferase Increase
|
3.3%
1/30 • 2 years, 8 months
An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE) version 4.0.
|
3.4%
1/29 • 2 years, 8 months
An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE) version 4.0.
|
|
Investigations
Alkaline Phosphatase Increase
|
6.7%
2/30 • 2 years, 8 months
An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE) version 4.0.
|
0.00%
0/29 • 2 years, 8 months
An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE) version 4.0.
|
|
Investigations
Asparate Aminotransferase Increase
|
3.3%
1/30 • 2 years, 8 months
An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE) version 4.0.
|
3.4%
1/29 • 2 years, 8 months
An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE) version 4.0.
|
|
Investigations
INR Increase
|
6.7%
2/30 • 2 years, 8 months
An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE) version 4.0.
|
0.00%
0/29 • 2 years, 8 months
An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE) version 4.0.
|
|
Investigations
Neutrophil Count Decrease
|
10.0%
3/30 • 2 years, 8 months
An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE) version 4.0.
|
0.00%
0/29 • 2 years, 8 months
An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE) version 4.0.
|
|
Investigations
Platelet Count Decrease
|
13.3%
4/30 • 2 years, 8 months
An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE) version 4.0.
|
3.4%
1/29 • 2 years, 8 months
An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE) version 4.0.
|
|
Investigations
WBC Decrease
|
16.7%
5/30 • 2 years, 8 months
An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE) version 4.0.
|
6.9%
2/29 • 2 years, 8 months
An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE) version 4.0.
|
|
Investigations
Other
|
0.00%
0/30 • 2 years, 8 months
An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE) version 4.0.
|
20.7%
6/29 • 2 years, 8 months
An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE) version 4.0.
|
|
Metabolism and nutrition disorders
Anorexia
|
23.3%
7/30 • 2 years, 8 months
An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE) version 4.0.
|
27.6%
8/29 • 2 years, 8 months
An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE) version 4.0.
|
|
Metabolism and nutrition disorders
Dehydration
|
6.7%
2/30 • 2 years, 8 months
An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE) version 4.0.
|
0.00%
0/29 • 2 years, 8 months
An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE) version 4.0.
|
|
Metabolism and nutrition disorders
Glucose intolerance
|
0.00%
0/30 • 2 years, 8 months
An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE) version 4.0.
|
3.4%
1/29 • 2 years, 8 months
An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE) version 4.0.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
0.00%
0/30 • 2 years, 8 months
An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE) version 4.0.
|
3.4%
1/29 • 2 years, 8 months
An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE) version 4.0.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
6.7%
2/30 • 2 years, 8 months
An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE) version 4.0.
|
6.9%
2/29 • 2 years, 8 months
An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE) version 4.0.
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
0.00%
0/30 • 2 years, 8 months
An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE) version 4.0.
|
3.4%
1/29 • 2 years, 8 months
An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE) version 4.0.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
3.3%
1/30 • 2 years, 8 months
An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE) version 4.0.
|
0.00%
0/29 • 2 years, 8 months
An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE) version 4.0.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
3.3%
1/30 • 2 years, 8 months
An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE) version 4.0.
|
3.4%
1/29 • 2 years, 8 months
An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE) version 4.0.
|
|
Metabolism and nutrition disorders
Other
|
10.0%
3/30 • 2 years, 8 months
An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE) version 4.0.
|
13.8%
4/29 • 2 years, 8 months
An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE) version 4.0.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
3.3%
1/30 • 2 years, 8 months
An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE) version 4.0.
|
3.4%
1/29 • 2 years, 8 months
An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE) version 4.0.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/30 • 2 years, 8 months
An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE) version 4.0.
|
3.4%
1/29 • 2 years, 8 months
An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE) version 4.0.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
23.3%
7/30 • 2 years, 8 months
An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE) version 4.0.
|
6.9%
2/29 • 2 years, 8 months
An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE) version 4.0.
|
|
Musculoskeletal and connective tissue disorders
Bone Pain
|
3.3%
1/30 • 2 years, 8 months
An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE) version 4.0.
|
10.3%
3/29 • 2 years, 8 months
An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE) version 4.0.
|
|
Musculoskeletal and connective tissue disorders
General Muscle Weakness
|
6.7%
2/30 • 2 years, 8 months
An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE) version 4.0.
|
0.00%
0/29 • 2 years, 8 months
An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE) version 4.0.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
3.3%
1/30 • 2 years, 8 months
An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE) version 4.0.
|
0.00%
0/29 • 2 years, 8 months
An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE) version 4.0.
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
6.7%
2/30 • 2 years, 8 months
An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE) version 4.0.
|
3.4%
1/29 • 2 years, 8 months
An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE) version 4.0.
|
|
Musculoskeletal and connective tissue disorders
Other
|
13.3%
4/30 • 2 years, 8 months
An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE) version 4.0.
|
10.3%
3/29 • 2 years, 8 months
An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE) version 4.0.
|
|
Nervous system disorders
Concentration Impairment
|
0.00%
0/30 • 2 years, 8 months
An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE) version 4.0.
|
3.4%
1/29 • 2 years, 8 months
An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE) version 4.0.
|
|
Nervous system disorders
Dizziness
|
46.7%
14/30 • 2 years, 8 months
An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE) version 4.0.
|
24.1%
7/29 • 2 years, 8 months
An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE) version 4.0.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/30 • 2 years, 8 months
An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE) version 4.0.
|
3.4%
1/29 • 2 years, 8 months
An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE) version 4.0.
|
|
Nervous system disorders
Headache
|
53.3%
16/30 • 2 years, 8 months
An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE) version 4.0.
|
55.2%
16/29 • 2 years, 8 months
An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE) version 4.0.
|
|
Nervous system disorders
Hypersomnia
|
0.00%
0/30 • 2 years, 8 months
An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE) version 4.0.
|
6.9%
2/29 • 2 years, 8 months
An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE) version 4.0.
|
|
Nervous system disorders
Lethargy
|
3.3%
1/30 • 2 years, 8 months
An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE) version 4.0.
|
3.4%
1/29 • 2 years, 8 months
An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE) version 4.0.
|
|
Nervous system disorders
Paresthesia
|
6.7%
2/30 • 2 years, 8 months
An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE) version 4.0.
|
0.00%
0/29 • 2 years, 8 months
An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE) version 4.0.
|
|
Nervous system disorders
Somnolence
|
16.7%
5/30 • 2 years, 8 months
An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE) version 4.0.
|
10.3%
3/29 • 2 years, 8 months
An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE) version 4.0.
|
|
Nervous system disorders
Other
|
3.3%
1/30 • 2 years, 8 months
An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE) version 4.0.
|
13.8%
4/29 • 2 years, 8 months
An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE) version 4.0.
|
|
Psychiatric disorders
Agitation
|
0.00%
0/30 • 2 years, 8 months
An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE) version 4.0.
|
3.4%
1/29 • 2 years, 8 months
An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE) version 4.0.
|
|
Psychiatric disorders
Anxiety
|
3.3%
1/30 • 2 years, 8 months
An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE) version 4.0.
|
6.9%
2/29 • 2 years, 8 months
An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE) version 4.0.
|
|
Psychiatric disorders
Euphoria
|
10.0%
3/30 • 2 years, 8 months
An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE) version 4.0.
|
13.8%
4/29 • 2 years, 8 months
An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE) version 4.0.
|
|
Psychiatric disorders
Insomnia
|
50.0%
15/30 • 2 years, 8 months
An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE) version 4.0.
|
13.8%
4/29 • 2 years, 8 months
An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE) version 4.0.
|
|
Psychiatric disorders
Other
|
6.7%
2/30 • 2 years, 8 months
An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE) version 4.0.
|
6.9%
2/29 • 2 years, 8 months
An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE) version 4.0.
|
|
Renal and urinary disorders
Urinary Retention
|
6.7%
2/30 • 2 years, 8 months
An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE) version 4.0.
|
0.00%
0/29 • 2 years, 8 months
An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE) version 4.0.
|
|
General disorders
Reproductive & Breast
|
3.3%
1/30 • 2 years, 8 months
An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE) version 4.0.
|
0.00%
0/29 • 2 years, 8 months
An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE) version 4.0.
|
|
Respiratory, thoracic and mediastinal disorders
Allergic Rhinitis
|
6.7%
2/30 • 2 years, 8 months
An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE) version 4.0.
|
3.4%
1/29 • 2 years, 8 months
An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE) version 4.0.
|
|
Respiratory, thoracic and mediastinal disorders
Dry Skin
|
0.00%
0/30 • 2 years, 8 months
An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE) version 4.0.
|
3.4%
1/29 • 2 years, 8 months
An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE) version 4.0.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
3.3%
1/30 • 2 years, 8 months
An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE) version 4.0.
|
3.4%
1/29 • 2 years, 8 months
An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE) version 4.0.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
0.00%
0/30 • 2 years, 8 months
An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE) version 4.0.
|
3.4%
1/29 • 2 years, 8 months
An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE) version 4.0.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus
|
3.3%
1/30 • 2 years, 8 months
An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE) version 4.0.
|
0.00%
0/29 • 2 years, 8 months
An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE) version 4.0.
|
|
Respiratory, thoracic and mediastinal disorders
Sore Throat
|
0.00%
0/30 • 2 years, 8 months
An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE) version 4.0.
|
3.4%
1/29 • 2 years, 8 months
An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE) version 4.0.
|
|
Respiratory, thoracic and mediastinal disorders
Other
|
3.3%
1/30 • 2 years, 8 months
An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE) version 4.0.
|
3.4%
1/29 • 2 years, 8 months
An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE) version 4.0.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
13.3%
4/30 • 2 years, 8 months
An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE) version 4.0.
|
10.3%
3/29 • 2 years, 8 months
An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE) version 4.0.
|
|
Skin and subcutaneous tissue disorders
Nail Loss
|
3.3%
1/30 • 2 years, 8 months
An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE) version 4.0.
|
0.00%
0/29 • 2 years, 8 months
An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE) version 4.0.
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
3.3%
1/30 • 2 years, 8 months
An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE) version 4.0.
|
0.00%
0/29 • 2 years, 8 months
An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE) version 4.0.
|
|
Skin and subcutaneous tissue disorders
Scalp Pain
|
0.00%
0/30 • 2 years, 8 months
An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE) version 4.0.
|
3.4%
1/29 • 2 years, 8 months
An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE) version 4.0.
|
|
Skin and subcutaneous tissue disorders
Skin Ulceration
|
3.3%
1/30 • 2 years, 8 months
An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE) version 4.0.
|
0.00%
0/29 • 2 years, 8 months
An adverse event (AE) is any condition that appears or worsens after the subject is enrolled in an investigational study. AEs will be graded by numerical score according to the NCI Common Terminology Criteria Adverse Events (CTCAE) version 4.0.
|
Additional Information
Michael J. Fisch, MD/Department of General Oncology
University of Texas (UT) MD Anderson Cancer Center
Phone: 713-563-9905
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place