Trial Outcomes & Findings for Ondansetron Versus Aprepitant Plus Ondansetron for Emesis (NCT NCT00954941)
NCT ID: NCT00954941
Last Updated: 2015-06-25
Results Overview
Participant response defined as: Complete response - no emetic episode, no nausea and no rescue medication during the administration of chemotherapy; Partial response - less than or equal to one episode of emesis in 24 hours, no rescue medication, and no more than moderate nausea (grade 2 National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE)) during chemotherapy. Vomit was defined as expulsion of stomach contents through the mouth, nausea as stomach distress with distaste for food and an urge to vomit, and rescue medication as antiemetic medications given to treat nausea and/or vomit that did not respond to the initial prophylactic regimen. Treatment success was defined as no nausea, no vomiting and no need for rescue medication within the first 6 treatment days with continuous monitoring.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
100 participants
Primary outcome timeframe
First 6 treatment days
Results posted on
2015-06-25
Participant Flow
Recruitment Period: 11/11/09 to 3/20/2013. All participants registered at The University of Texas M.D. Anderson Cancer Center.
Of the 100 participants registered for screening on this study, fifty participants were randomized to Ondansetron alone (Group 1) and forty-eight participants to Ondansetron plus Aprepitant (Group 2).
Participant milestones
| Measure |
Group 1: Ondansetron
Ondansetron 8 mg bolus by vein from 30 minutes before receiving chemotherapy followed by 24 mg by vein continuous infusion daily while receiving chemotherapy until 12 hours after chemotherapy.
|
Group 2: Ondansetron + Aprepitant
Ondansetron 8 mg bolus by vein from 30 minutes before receiving chemotherapy followed by 24 mg by vein continuous infusion daily while receiving chemotherapy until 12 hours after chemotherapy. Aprepitant 125 mg capsule by mouth every morning while receiving chemotherapy followed by 80 mg capsule by mouth daily while receiving chemotherapy continued till 1 day after last chemotherapy dose.
|
|---|---|---|
|
Overall Study
STARTED
|
50
|
48
|
|
Overall Study
COMPLETED
|
42
|
41
|
|
Overall Study
NOT COMPLETED
|
8
|
7
|
Reasons for withdrawal
| Measure |
Group 1: Ondansetron
Ondansetron 8 mg bolus by vein from 30 minutes before receiving chemotherapy followed by 24 mg by vein continuous infusion daily while receiving chemotherapy until 12 hours after chemotherapy.
|
Group 2: Ondansetron + Aprepitant
Ondansetron 8 mg bolus by vein from 30 minutes before receiving chemotherapy followed by 24 mg by vein continuous infusion daily while receiving chemotherapy until 12 hours after chemotherapy. Aprepitant 125 mg capsule by mouth every morning while receiving chemotherapy followed by 80 mg capsule by mouth daily while receiving chemotherapy continued till 1 day after last chemotherapy dose.
|
|---|---|---|
|
Overall Study
Received treatment at home
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
|
Overall Study
Insurance Denial
|
2
|
2
|
|
Overall Study
Physician Decision
|
2
|
2
|
|
Overall Study
Ineligible
|
2
|
2
|
|
Overall Study
Adverse Event
|
0
|
1
|
Baseline Characteristics
Ondansetron Versus Aprepitant Plus Ondansetron for Emesis
Baseline characteristics by cohort
| Measure |
Group 1: Ondansetron
n=50 Participants
Ondansetron 8 mg bolus by vein from 30 minutes before receiving chemotherapy followed by 24 mg by vein continuous infusion daily while receiving chemotherapy until 12 hours after chemotherapy.
|
Group 2: Ondansetron + Aprepitant
n=48 Participants
Ondansetron 8 mg bolus by vein from 30 minutes before receiving chemotherapy followed by 24 mg by vein continuous infusion daily while receiving chemotherapy until 12 hours after chemotherapy. Aprepitant 125 mg capsule by mouth every morning while receiving chemotherapy followed by 80 mg capsule by mouth daily while receiving chemotherapy continued till 1 day after last chemotherapy dose.
|
Total
n=98 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
56 years
n=5 Participants
|
53 years
n=7 Participants
|
55 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
29 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
55 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
50 participants
n=5 Participants
|
48 participants
n=7 Participants
|
98 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: First 6 treatment daysPopulation: Of the 98 participants in the study, six (6) in Group 1: Ondansetron and nine (9) in Group 2: Ondansetron + Aprepitant were not.evaluable.
Participant response defined as: Complete response - no emetic episode, no nausea and no rescue medication during the administration of chemotherapy; Partial response - less than or equal to one episode of emesis in 24 hours, no rescue medication, and no more than moderate nausea (grade 2 National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE)) during chemotherapy. Vomit was defined as expulsion of stomach contents through the mouth, nausea as stomach distress with distaste for food and an urge to vomit, and rescue medication as antiemetic medications given to treat nausea and/or vomit that did not respond to the initial prophylactic regimen. Treatment success was defined as no nausea, no vomiting and no need for rescue medication within the first 6 treatment days with continuous monitoring.
Outcome measures
| Measure |
Group 1: Ondansetron
n=42 Participants
Ondansetron 8 mg bolus by vein from 30 minutes before receiving chemotherapy followed by 24 mg by vein continuous infusion daily while receiving chemotherapy until 12 hours after chemotherapy.
Ondansetron : 8 mg bolus by vein from 30 minutes before receiving chemotherapy followed by 24 mg by vein continuous infusion daily while receiving chemotherapy until 12 hours after chemotherapy.
|
Group 2: Ondansetron + Aprepitant
n=41 Participants
Ondansetron 8 mg bolus by vein from 30 minutes before receiving chemotherapy followed by 24 mg by vein continuous infusion daily while receiving chemotherapy until 12 hours after chemotherapy. Aprepitant 125 mg capsule by mouth every morning while receiving chemotherapy followed by 80 mg capsule by mouth daily while receiving chemotherapy continued till 1 day after last chemotherapy dose.
Ondansetron : 8 mg bolus by vein from 30 minutes before receiving chemotherapy followed by 24 mg by vein continuous infusion daily while receiving chemotherapy until 12 hours after chemotherapy.
Aprepitant : 125 mg capsule by mouth every morning while receiving chemotherapy followed by 80 mg capsule by mouth daily while receiving chemotherapy continued till 1 day after last chemotherapy dose.
|
|---|---|---|
|
Participant Responses
Complete Response
|
20 participants
|
21 participants
|
|
Participant Responses
Partial Response
|
9 participants
|
12 participants
|
|
Participant Responses
No Response
|
13 participants
|
8 participants
|
PRIMARY outcome
Timeframe: First 6 treatment daysPopulation: Of the 98 participants in the study, six (6) in Group 1: Ondansetron and nine (9) in Group 2: Ondansetron + Aprepitant were not.evaluable.
Treatment success is defined as no nausea, no vomiting and no need for rescue medication (or complete response) within the first 6 treatment days. Treatment success rate defined as percentage of participants achieving treatment success.
Outcome measures
| Measure |
Group 1: Ondansetron
n=42 Participants
Ondansetron 8 mg bolus by vein from 30 minutes before receiving chemotherapy followed by 24 mg by vein continuous infusion daily while receiving chemotherapy until 12 hours after chemotherapy.
Ondansetron : 8 mg bolus by vein from 30 minutes before receiving chemotherapy followed by 24 mg by vein continuous infusion daily while receiving chemotherapy until 12 hours after chemotherapy.
|
Group 2: Ondansetron + Aprepitant
n=41 Participants
Ondansetron 8 mg bolus by vein from 30 minutes before receiving chemotherapy followed by 24 mg by vein continuous infusion daily while receiving chemotherapy until 12 hours after chemotherapy. Aprepitant 125 mg capsule by mouth every morning while receiving chemotherapy followed by 80 mg capsule by mouth daily while receiving chemotherapy continued till 1 day after last chemotherapy dose.
Ondansetron : 8 mg bolus by vein from 30 minutes before receiving chemotherapy followed by 24 mg by vein continuous infusion daily while receiving chemotherapy until 12 hours after chemotherapy.
Aprepitant : 125 mg capsule by mouth every morning while receiving chemotherapy followed by 80 mg capsule by mouth daily while receiving chemotherapy continued till 1 day after last chemotherapy dose.
|
|---|---|---|
|
Treatment Success Rate
|
48 percentage of participants
|
51 percentage of participants
|
Adverse Events
Group 1: Ondansetron
Serious events: 3 serious events
Other events: 43 other events
Deaths: 0 deaths
Group 2: Ondansetron + Aprepitant
Serious events: 3 serious events
Other events: 41 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Group 1: Ondansetron
n=46 participants at risk
Ondansetron 8 mg bolus by vein from 30 minutes before receiving chemotherapy followed by 24 mg by vein continuous infusion daily while receiving chemotherapy until 12 hours after chemotherapy.
|
Group 2: Ondansetron + Aprepitant
n=44 participants at risk
Ondansetron 8 mg bolus by vein from 30 minutes before receiving chemotherapy followed by 24 mg by vein continuous infusion daily while receiving chemotherapy until 12 hours after chemotherapy. Aprepitant 125 mg capsule by mouth every morning while receiving chemotherapy followed by 80 mg capsule by mouth daily while receiving chemotherapy continued till 1 day after last chemotherapy dose.
|
|---|---|---|
|
General disorders
Death
|
2.2%
1/46 • Number of events 1 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug. The full study reporting period was three years four months.
Of the 98 participants registered in the study, 90 participants are included in Adverse Event Reporting as evaluable for toxicity having received one dose of treatment medication.
|
0.00%
0/44 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug. The full study reporting period was three years four months.
Of the 98 participants registered in the study, 90 participants are included in Adverse Event Reporting as evaluable for toxicity having received one dose of treatment medication.
|
|
General disorders
Headache
|
0.00%
0/46 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug. The full study reporting period was three years four months.
Of the 98 participants registered in the study, 90 participants are included in Adverse Event Reporting as evaluable for toxicity having received one dose of treatment medication.
|
4.5%
2/44 • Number of events 2 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug. The full study reporting period was three years four months.
Of the 98 participants registered in the study, 90 participants are included in Adverse Event Reporting as evaluable for toxicity having received one dose of treatment medication.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/46 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug. The full study reporting period was three years four months.
Of the 98 participants registered in the study, 90 participants are included in Adverse Event Reporting as evaluable for toxicity having received one dose of treatment medication.
|
2.3%
1/44 • Number of events 1 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug. The full study reporting period was three years four months.
Of the 98 participants registered in the study, 90 participants are included in Adverse Event Reporting as evaluable for toxicity having received one dose of treatment medication.
|
|
Nervous system disorders
Syncope
|
2.2%
1/46 • Number of events 1 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug. The full study reporting period was three years four months.
Of the 98 participants registered in the study, 90 participants are included in Adverse Event Reporting as evaluable for toxicity having received one dose of treatment medication.
|
0.00%
0/44 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug. The full study reporting period was three years four months.
Of the 98 participants registered in the study, 90 participants are included in Adverse Event Reporting as evaluable for toxicity having received one dose of treatment medication.
|
|
Gastrointestinal disorders
Nausea/Vomiting
|
2.2%
1/46 • Number of events 1 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug. The full study reporting period was three years four months.
Of the 98 participants registered in the study, 90 participants are included in Adverse Event Reporting as evaluable for toxicity having received one dose of treatment medication.
|
0.00%
0/44 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug. The full study reporting period was three years four months.
Of the 98 participants registered in the study, 90 participants are included in Adverse Event Reporting as evaluable for toxicity having received one dose of treatment medication.
|
Other adverse events
| Measure |
Group 1: Ondansetron
n=46 participants at risk
Ondansetron 8 mg bolus by vein from 30 minutes before receiving chemotherapy followed by 24 mg by vein continuous infusion daily while receiving chemotherapy until 12 hours after chemotherapy.
|
Group 2: Ondansetron + Aprepitant
n=44 participants at risk
Ondansetron 8 mg bolus by vein from 30 minutes before receiving chemotherapy followed by 24 mg by vein continuous infusion daily while receiving chemotherapy until 12 hours after chemotherapy. Aprepitant 125 mg capsule by mouth every morning while receiving chemotherapy followed by 80 mg capsule by mouth daily while receiving chemotherapy continued till 1 day after last chemotherapy dose.
|
|---|---|---|
|
General disorders
Pain
|
37.0%
17/46 • Number of events 17 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug. The full study reporting period was three years four months.
Of the 98 participants registered in the study, 90 participants are included in Adverse Event Reporting as evaluable for toxicity having received one dose of treatment medication.
|
27.3%
12/44 • Number of events 12 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug. The full study reporting period was three years four months.
Of the 98 participants registered in the study, 90 participants are included in Adverse Event Reporting as evaluable for toxicity having received one dose of treatment medication.
|
|
General disorders
Abdominal Cramps
|
2.2%
1/46 • Number of events 1 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug. The full study reporting period was three years four months.
Of the 98 participants registered in the study, 90 participants are included in Adverse Event Reporting as evaluable for toxicity having received one dose of treatment medication.
|
2.3%
1/44 • Number of events 1 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug. The full study reporting period was three years four months.
Of the 98 participants registered in the study, 90 participants are included in Adverse Event Reporting as evaluable for toxicity having received one dose of treatment medication.
|
|
Cardiac disorders
Atrial Fibrillation
|
2.2%
1/46 • Number of events 1 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug. The full study reporting period was three years four months.
Of the 98 participants registered in the study, 90 participants are included in Adverse Event Reporting as evaluable for toxicity having received one dose of treatment medication.
|
2.3%
1/44 • Number of events 1 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug. The full study reporting period was three years four months.
Of the 98 participants registered in the study, 90 participants are included in Adverse Event Reporting as evaluable for toxicity having received one dose of treatment medication.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
2.2%
1/46 • Number of events 1 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug. The full study reporting period was three years four months.
Of the 98 participants registered in the study, 90 participants are included in Adverse Event Reporting as evaluable for toxicity having received one dose of treatment medication.
|
0.00%
0/44 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug. The full study reporting period was three years four months.
Of the 98 participants registered in the study, 90 participants are included in Adverse Event Reporting as evaluable for toxicity having received one dose of treatment medication.
|
|
Gastrointestinal disorders
Anorexia
|
2.2%
1/46 • Number of events 1 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug. The full study reporting period was three years four months.
Of the 98 participants registered in the study, 90 participants are included in Adverse Event Reporting as evaluable for toxicity having received one dose of treatment medication.
|
4.5%
2/44 • Number of events 2 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug. The full study reporting period was three years four months.
Of the 98 participants registered in the study, 90 participants are included in Adverse Event Reporting as evaluable for toxicity having received one dose of treatment medication.
|
|
Nervous system disorders
Anxiety
|
4.3%
2/46 • Number of events 2 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug. The full study reporting period was three years four months.
Of the 98 participants registered in the study, 90 participants are included in Adverse Event Reporting as evaluable for toxicity having received one dose of treatment medication.
|
4.5%
2/44 • Number of events 2 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug. The full study reporting period was three years four months.
Of the 98 participants registered in the study, 90 participants are included in Adverse Event Reporting as evaluable for toxicity having received one dose of treatment medication.
|
|
Respiratory, thoracic and mediastinal disorders
Adult Respiratory Distress Syndrome
|
2.2%
1/46 • Number of events 1 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug. The full study reporting period was three years four months.
Of the 98 participants registered in the study, 90 participants are included in Adverse Event Reporting as evaluable for toxicity having received one dose of treatment medication.
|
0.00%
0/44 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug. The full study reporting period was three years four months.
Of the 98 participants registered in the study, 90 participants are included in Adverse Event Reporting as evaluable for toxicity having received one dose of treatment medication.
|
|
Blood and lymphatic system disorders
Brusing
|
0.00%
0/46 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug. The full study reporting period was three years four months.
Of the 98 participants registered in the study, 90 participants are included in Adverse Event Reporting as evaluable for toxicity having received one dose of treatment medication.
|
2.3%
1/44 • Number of events 1 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug. The full study reporting period was three years four months.
Of the 98 participants registered in the study, 90 participants are included in Adverse Event Reporting as evaluable for toxicity having received one dose of treatment medication.
|
|
General disorders
Chills
|
2.2%
1/46 • Number of events 1 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug. The full study reporting period was three years four months.
Of the 98 participants registered in the study, 90 participants are included in Adverse Event Reporting as evaluable for toxicity having received one dose of treatment medication.
|
4.5%
2/44 • Number of events 2 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug. The full study reporting period was three years four months.
Of the 98 participants registered in the study, 90 participants are included in Adverse Event Reporting as evaluable for toxicity having received one dose of treatment medication.
|
|
Gastrointestinal disorders
Constipation
|
15.2%
7/46 • Number of events 7 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug. The full study reporting period was three years four months.
Of the 98 participants registered in the study, 90 participants are included in Adverse Event Reporting as evaluable for toxicity having received one dose of treatment medication.
|
31.8%
14/44 • Number of events 14 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug. The full study reporting period was three years four months.
Of the 98 participants registered in the study, 90 participants are included in Adverse Event Reporting as evaluable for toxicity having received one dose of treatment medication.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
13.0%
6/46 • Number of events 6 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug. The full study reporting period was three years four months.
Of the 98 participants registered in the study, 90 participants are included in Adverse Event Reporting as evaluable for toxicity having received one dose of treatment medication.
|
6.8%
3/44 • Number of events 3 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug. The full study reporting period was three years four months.
Of the 98 participants registered in the study, 90 participants are included in Adverse Event Reporting as evaluable for toxicity having received one dose of treatment medication.
|
|
Gastrointestinal disorders
Diarrhea
|
37.0%
17/46 • Number of events 17 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug. The full study reporting period was three years four months.
Of the 98 participants registered in the study, 90 participants are included in Adverse Event Reporting as evaluable for toxicity having received one dose of treatment medication.
|
34.1%
15/44 • Number of events 15 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug. The full study reporting period was three years four months.
Of the 98 participants registered in the study, 90 participants are included in Adverse Event Reporting as evaluable for toxicity having received one dose of treatment medication.
|
|
Nervous system disorders
Dizziness
|
6.5%
3/46 • Number of events 3 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug. The full study reporting period was three years four months.
Of the 98 participants registered in the study, 90 participants are included in Adverse Event Reporting as evaluable for toxicity having received one dose of treatment medication.
|
4.5%
2/44 • Number of events 2 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug. The full study reporting period was three years four months.
Of the 98 participants registered in the study, 90 participants are included in Adverse Event Reporting as evaluable for toxicity having received one dose of treatment medication.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
4.3%
2/46 • Number of events 2 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug. The full study reporting period was three years four months.
Of the 98 participants registered in the study, 90 participants are included in Adverse Event Reporting as evaluable for toxicity having received one dose of treatment medication.
|
0.00%
0/44 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug. The full study reporting period was three years four months.
Of the 98 participants registered in the study, 90 participants are included in Adverse Event Reporting as evaluable for toxicity having received one dose of treatment medication.
|
|
General disorders
Dry Mouth
|
0.00%
0/46 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug. The full study reporting period was three years four months.
Of the 98 participants registered in the study, 90 participants are included in Adverse Event Reporting as evaluable for toxicity having received one dose of treatment medication.
|
2.3%
1/44 • Number of events 1 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug. The full study reporting period was three years four months.
Of the 98 participants registered in the study, 90 participants are included in Adverse Event Reporting as evaluable for toxicity having received one dose of treatment medication.
|
|
Blood and lymphatic system disorders
edema
|
8.7%
4/46 • Number of events 4 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug. The full study reporting period was three years four months.
Of the 98 participants registered in the study, 90 participants are included in Adverse Event Reporting as evaluable for toxicity having received one dose of treatment medication.
|
18.2%
8/44 • Number of events 8 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug. The full study reporting period was three years four months.
Of the 98 participants registered in the study, 90 participants are included in Adverse Event Reporting as evaluable for toxicity having received one dose of treatment medication.
|
|
General disorders
Fatigue
|
19.6%
9/46 • Number of events 9 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug. The full study reporting period was three years four months.
Of the 98 participants registered in the study, 90 participants are included in Adverse Event Reporting as evaluable for toxicity having received one dose of treatment medication.
|
27.3%
12/44 • Number of events 12 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug. The full study reporting period was three years four months.
Of the 98 participants registered in the study, 90 participants are included in Adverse Event Reporting as evaluable for toxicity having received one dose of treatment medication.
|
|
General disorders
Fever
|
4.3%
2/46 • Number of events 2 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug. The full study reporting period was three years four months.
Of the 98 participants registered in the study, 90 participants are included in Adverse Event Reporting as evaluable for toxicity having received one dose of treatment medication.
|
2.3%
1/44 • Number of events 1 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug. The full study reporting period was three years four months.
Of the 98 participants registered in the study, 90 participants are included in Adverse Event Reporting as evaluable for toxicity having received one dose of treatment medication.
|
|
Skin and subcutaneous tissue disorders
Flushing
|
2.2%
1/46 • Number of events 1 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug. The full study reporting period was three years four months.
Of the 98 participants registered in the study, 90 participants are included in Adverse Event Reporting as evaluable for toxicity having received one dose of treatment medication.
|
0.00%
0/44 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug. The full study reporting period was three years four months.
Of the 98 participants registered in the study, 90 participants are included in Adverse Event Reporting as evaluable for toxicity having received one dose of treatment medication.
|
|
General disorders
headache
|
26.1%
12/46 • Number of events 12 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug. The full study reporting period was three years four months.
Of the 98 participants registered in the study, 90 participants are included in Adverse Event Reporting as evaluable for toxicity having received one dose of treatment medication.
|
25.0%
11/44 • Number of events 11 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug. The full study reporting period was three years four months.
Of the 98 participants registered in the study, 90 participants are included in Adverse Event Reporting as evaluable for toxicity having received one dose of treatment medication.
|
|
Gastrointestinal disorders
Heartburn
|
2.2%
1/46 • Number of events 1 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug. The full study reporting period was three years four months.
Of the 98 participants registered in the study, 90 participants are included in Adverse Event Reporting as evaluable for toxicity having received one dose of treatment medication.
|
0.00%
0/44 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug. The full study reporting period was three years four months.
Of the 98 participants registered in the study, 90 participants are included in Adverse Event Reporting as evaluable for toxicity having received one dose of treatment medication.
|
|
Renal and urinary disorders
Hematuria
|
0.00%
0/46 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug. The full study reporting period was three years four months.
Of the 98 participants registered in the study, 90 participants are included in Adverse Event Reporting as evaluable for toxicity having received one dose of treatment medication.
|
2.3%
1/44 • Number of events 1 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug. The full study reporting period was three years four months.
Of the 98 participants registered in the study, 90 participants are included in Adverse Event Reporting as evaluable for toxicity having received one dose of treatment medication.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
2.2%
1/46 • Number of events 1 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug. The full study reporting period was three years four months.
Of the 98 participants registered in the study, 90 participants are included in Adverse Event Reporting as evaluable for toxicity having received one dose of treatment medication.
|
0.00%
0/44 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug. The full study reporting period was three years four months.
Of the 98 participants registered in the study, 90 participants are included in Adverse Event Reporting as evaluable for toxicity having received one dose of treatment medication.
|
|
Cardiac disorders
Hypotension
|
0.00%
0/46 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug. The full study reporting period was three years four months.
Of the 98 participants registered in the study, 90 participants are included in Adverse Event Reporting as evaluable for toxicity having received one dose of treatment medication.
|
2.3%
1/44 • Number of events 1 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug. The full study reporting period was three years four months.
Of the 98 participants registered in the study, 90 participants are included in Adverse Event Reporting as evaluable for toxicity having received one dose of treatment medication.
|
|
Gastrointestinal disorders
Indigestion
|
0.00%
0/46 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug. The full study reporting period was three years four months.
Of the 98 participants registered in the study, 90 participants are included in Adverse Event Reporting as evaluable for toxicity having received one dose of treatment medication.
|
2.3%
1/44 • Number of events 1 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug. The full study reporting period was three years four months.
Of the 98 participants registered in the study, 90 participants are included in Adverse Event Reporting as evaluable for toxicity having received one dose of treatment medication.
|
|
Infections and infestations
Infection
|
8.7%
4/46 • Number of events 4 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug. The full study reporting period was three years four months.
Of the 98 participants registered in the study, 90 participants are included in Adverse Event Reporting as evaluable for toxicity having received one dose of treatment medication.
|
13.6%
6/44 • Number of events 6 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug. The full study reporting period was three years four months.
Of the 98 participants registered in the study, 90 participants are included in Adverse Event Reporting as evaluable for toxicity having received one dose of treatment medication.
|
|
General disorders
Insomnia
|
2.2%
1/46 • Number of events 1 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug. The full study reporting period was three years four months.
Of the 98 participants registered in the study, 90 participants are included in Adverse Event Reporting as evaluable for toxicity having received one dose of treatment medication.
|
0.00%
0/44 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug. The full study reporting period was three years four months.
Of the 98 participants registered in the study, 90 participants are included in Adverse Event Reporting as evaluable for toxicity having received one dose of treatment medication.
|
|
Gastrointestinal disorders
Mucositis
|
0.00%
0/46 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug. The full study reporting period was three years four months.
Of the 98 participants registered in the study, 90 participants are included in Adverse Event Reporting as evaluable for toxicity having received one dose of treatment medication.
|
2.3%
1/44 • Number of events 1 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug. The full study reporting period was three years four months.
Of the 98 participants registered in the study, 90 participants are included in Adverse Event Reporting as evaluable for toxicity having received one dose of treatment medication.
|
|
Metabolism and nutrition disorders
Jaundice
|
2.2%
1/46 • Number of events 1 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug. The full study reporting period was three years four months.
Of the 98 participants registered in the study, 90 participants are included in Adverse Event Reporting as evaluable for toxicity having received one dose of treatment medication.
|
0.00%
0/44 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug. The full study reporting period was three years four months.
Of the 98 participants registered in the study, 90 participants are included in Adverse Event Reporting as evaluable for toxicity having received one dose of treatment medication.
|
|
General disorders
Leg Cramps
|
2.2%
1/46 • Number of events 1 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug. The full study reporting period was three years four months.
Of the 98 participants registered in the study, 90 participants are included in Adverse Event Reporting as evaluable for toxicity having received one dose of treatment medication.
|
0.00%
0/44 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug. The full study reporting period was three years four months.
Of the 98 participants registered in the study, 90 participants are included in Adverse Event Reporting as evaluable for toxicity having received one dose of treatment medication.
|
|
Gastrointestinal disorders
Nausa
|
2.2%
1/46 • Number of events 1 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug. The full study reporting period was three years four months.
Of the 98 participants registered in the study, 90 participants are included in Adverse Event Reporting as evaluable for toxicity having received one dose of treatment medication.
|
0.00%
0/44 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug. The full study reporting period was three years four months.
Of the 98 participants registered in the study, 90 participants are included in Adverse Event Reporting as evaluable for toxicity having received one dose of treatment medication.
|
|
Blood and lymphatic system disorders
Nosebleed
|
4.3%
2/46 • Number of events 2 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug. The full study reporting period was three years four months.
Of the 98 participants registered in the study, 90 participants are included in Adverse Event Reporting as evaluable for toxicity having received one dose of treatment medication.
|
4.5%
2/44 • Number of events 2 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug. The full study reporting period was three years four months.
Of the 98 participants registered in the study, 90 participants are included in Adverse Event Reporting as evaluable for toxicity having received one dose of treatment medication.
|
|
General disorders
Nasal Congestion
|
0.00%
0/46 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug. The full study reporting period was three years four months.
Of the 98 participants registered in the study, 90 participants are included in Adverse Event Reporting as evaluable for toxicity having received one dose of treatment medication.
|
2.3%
1/44 • Number of events 1 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug. The full study reporting period was three years four months.
Of the 98 participants registered in the study, 90 participants are included in Adverse Event Reporting as evaluable for toxicity having received one dose of treatment medication.
|
|
Cardiac disorders
Prolonged QTc
|
0.00%
0/46 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug. The full study reporting period was three years four months.
Of the 98 participants registered in the study, 90 participants are included in Adverse Event Reporting as evaluable for toxicity having received one dose of treatment medication.
|
2.3%
1/44 • Number of events 1 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug. The full study reporting period was three years four months.
Of the 98 participants registered in the study, 90 participants are included in Adverse Event Reporting as evaluable for toxicity having received one dose of treatment medication.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
4.3%
2/46 • Number of events 2 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug. The full study reporting period was three years four months.
Of the 98 participants registered in the study, 90 participants are included in Adverse Event Reporting as evaluable for toxicity having received one dose of treatment medication.
|
4.5%
2/44 • Number of events 2 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug. The full study reporting period was three years four months.
Of the 98 participants registered in the study, 90 participants are included in Adverse Event Reporting as evaluable for toxicity having received one dose of treatment medication.
|
|
Skin and subcutaneous tissue disorders
Rash
|
6.5%
3/46 • Number of events 3 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug. The full study reporting period was three years four months.
Of the 98 participants registered in the study, 90 participants are included in Adverse Event Reporting as evaluable for toxicity having received one dose of treatment medication.
|
9.1%
4/44 • Number of events 4 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug. The full study reporting period was three years four months.
Of the 98 participants registered in the study, 90 participants are included in Adverse Event Reporting as evaluable for toxicity having received one dose of treatment medication.
|
|
General disorders
Sore Throat
|
2.2%
1/46 • Number of events 1 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug. The full study reporting period was three years four months.
Of the 98 participants registered in the study, 90 participants are included in Adverse Event Reporting as evaluable for toxicity having received one dose of treatment medication.
|
0.00%
0/44 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug. The full study reporting period was three years four months.
Of the 98 participants registered in the study, 90 participants are included in Adverse Event Reporting as evaluable for toxicity having received one dose of treatment medication.
|
|
General disorders
Sweating
|
0.00%
0/46 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug. The full study reporting period was three years four months.
Of the 98 participants registered in the study, 90 participants are included in Adverse Event Reporting as evaluable for toxicity having received one dose of treatment medication.
|
4.5%
2/44 • Number of events 2 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug. The full study reporting period was three years four months.
Of the 98 participants registered in the study, 90 participants are included in Adverse Event Reporting as evaluable for toxicity having received one dose of treatment medication.
|
|
Nervous system disorders
Syncope
|
2.2%
1/46 • Number of events 1 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug. The full study reporting period was three years four months.
Of the 98 participants registered in the study, 90 participants are included in Adverse Event Reporting as evaluable for toxicity having received one dose of treatment medication.
|
0.00%
0/44 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug. The full study reporting period was three years four months.
Of the 98 participants registered in the study, 90 participants are included in Adverse Event Reporting as evaluable for toxicity having received one dose of treatment medication.
|
|
Gastrointestinal disorders
Taste Alteration
|
2.2%
1/46 • Number of events 1 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug. The full study reporting period was three years four months.
Of the 98 participants registered in the study, 90 participants are included in Adverse Event Reporting as evaluable for toxicity having received one dose of treatment medication.
|
0.00%
0/44 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug. The full study reporting period was three years four months.
Of the 98 participants registered in the study, 90 participants are included in Adverse Event Reporting as evaluable for toxicity having received one dose of treatment medication.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/46 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug. The full study reporting period was three years four months.
Of the 98 participants registered in the study, 90 participants are included in Adverse Event Reporting as evaluable for toxicity having received one dose of treatment medication.
|
2.3%
1/44 • Number of events 1 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug. The full study reporting period was three years four months.
Of the 98 participants registered in the study, 90 participants are included in Adverse Event Reporting as evaluable for toxicity having received one dose of treatment medication.
|
|
Gastrointestinal disorders
Vomiting
|
2.2%
1/46 • Number of events 1 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug. The full study reporting period was three years four months.
Of the 98 participants registered in the study, 90 participants are included in Adverse Event Reporting as evaluable for toxicity having received one dose of treatment medication.
|
0.00%
0/44 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug. The full study reporting period was three years four months.
Of the 98 participants registered in the study, 90 participants are included in Adverse Event Reporting as evaluable for toxicity having received one dose of treatment medication.
|
|
General disorders
Numbness
|
2.2%
1/46 • Number of events 1 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug. The full study reporting period was three years four months.
Of the 98 participants registered in the study, 90 participants are included in Adverse Event Reporting as evaluable for toxicity having received one dose of treatment medication.
|
0.00%
0/44 • Adverse events captured from the time of participant consent until 30 days after the last dose of drug. The full study reporting period was three years four months.
Of the 98 participants registered in the study, 90 participants are included in Adverse Event Reporting as evaluable for toxicity having received one dose of treatment medication.
|
Additional Information
Jorge Cortes, MD / Professor
The University of Texas MD Anderson Cancer Center
Phone: 713-794-5783
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place