Trial Outcomes & Findings for A Study of Palonosetron for the Prevention of Chemotherapy-Induced Nausea and Vomiting (CINV) in Participants Who Have Experienced CINV(Chemotherapy-Induced Nausea and Vomiting) During the Previous Cycle of Low Emetogenic Chemotherapy (LEC) (NCT NCT01054456)
NCT ID: NCT01054456
Last Updated: 2020-12-23
Results Overview
CR was defined as the participants without any emetic episodes and did not use any rescue medication during acute period (0-24 hours). An emetic episode was defined as 1) one occurrence of vomiting, or 2) a sequence of occurrences in very close succession not relieved by a period of relaxation of at least 1 minute, any number of occurrences of unproductive emesis (retches) in a unique 5-minute period, or 3) an episode of retching of less than 5 minute duration combined with vomiting not relieved by a period of relaxation of at least 1 minute. Participants who completed the diary for a given period and had no emetic episodes and no use of rescue medication were considered to have achieved CR, during the period.
COMPLETED
PHASE2
36 participants
From 0 to 24 hours after receiving treatment on Day 1
2020-12-23
Participant Flow
Participants took part in the study at 18 investigative sites in the United States from 27 October 2009 to 08 December 2010.
A total of 38 participants were screened, of which 02 were screen failures and 36 participants were enrolled and received the study treatment.
Participant milestones
| Measure |
All Participants: Palonosetron 0.25 mg/5 mL
Participants received palonosetron 0.25 milligram (mg) per (/) 5 milliliter (mL) intravenous injection 30 minutes prior to receiving a low emetogenic chemotherapy (LEC) agent on Day 1.
|
|---|---|
|
Overall Study
STARTED
|
36
|
|
Overall Study
COMPLETED
|
35
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
All Participants: Palonosetron 0.25 mg/5 mL
Participants received palonosetron 0.25 milligram (mg) per (/) 5 milliliter (mL) intravenous injection 30 minutes prior to receiving a low emetogenic chemotherapy (LEC) agent on Day 1.
|
|---|---|
|
Overall Study
Other
|
1
|
Baseline Characteristics
A Study of Palonosetron for the Prevention of Chemotherapy-Induced Nausea and Vomiting (CINV) in Participants Who Have Experienced CINV(Chemotherapy-Induced Nausea and Vomiting) During the Previous Cycle of Low Emetogenic Chemotherapy (LEC)
Baseline characteristics by cohort
| Measure |
All Participants: Palonosetron 0.25 mg/5 mL
n=36 Participants
Participants received palonosetron 0.25 mg/5 mL intravenous injection 30 minutes prior to receiving a LEC agent on Day 1.
|
|---|---|
|
Age, Continuous
|
64.6 years
STANDARD_DEVIATION 13.82 • n=5 Participants
|
|
Sex: Female, Male
Female
|
25 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
31 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
30 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From 0 to 24 hours after receiving treatment on Day 1Population: The intent-to-treat (ITT) population included all participants who received palonosetron, received at least one dose of the qualifying LEC agents on Day 1, and had at least 1 post-chemotherapy efficacy assessment.
CR was defined as the participants without any emetic episodes and did not use any rescue medication during acute period (0-24 hours). An emetic episode was defined as 1) one occurrence of vomiting, or 2) a sequence of occurrences in very close succession not relieved by a period of relaxation of at least 1 minute, any number of occurrences of unproductive emesis (retches) in a unique 5-minute period, or 3) an episode of retching of less than 5 minute duration combined with vomiting not relieved by a period of relaxation of at least 1 minute. Participants who completed the diary for a given period and had no emetic episodes and no use of rescue medication were considered to have achieved CR, during the period.
Outcome measures
| Measure |
All Participants: Palonosetron 0.25 mg/5 mL
n=34 Participants
Participants received palonosetron 0.25 mg/5 mL intravenous injection 30 minutes prior to receiving a LEC agent on Day 1.
|
|---|---|
|
Percentage of Participants With Complete Response (CR) During Acute Period (0 to 24 Hours) After Receiving Treatment on Day 1
|
88.2 percentage of participants
Interval 72.5 to 96.7
|
PRIMARY outcome
Timeframe: From 24 to 120 hours after receiving treatment on Day 1Population: The ITT population included all participants who received palonosetron, received at least one dose of the qualifying LEC agents on Day 1, and had at least 1 post-chemotherapy efficacy assessment.
CR was defined as the participants without any emetic episodes and did not use any rescue medication during delayed period (24-120 hours). An emetic episode was defined as 1) one occurrence of vomiting, or 2) a sequence of occurrences in very close succession not relieved by a period of relaxation of at least 1 minute, any number of occurrences of unproductive emesis (retches) in a unique 5-minute period, or 3) an episode of retching of less than 5 minute duration combined with vomiting not relieved by a period of relaxation of at least 1 minute. Participants who completed the diary for a given period and had no emetic episodes and no use of rescue medication were considered to have achieved CR, during the period.
Outcome measures
| Measure |
All Participants: Palonosetron 0.25 mg/5 mL
n=34 Participants
Participants received palonosetron 0.25 mg/5 mL intravenous injection 30 minutes prior to receiving a LEC agent on Day 1.
|
|---|---|
|
Percentage of Participants With CR During Delayed Period (24 to 120 Hours) After Receiving Treatment on Day 1
|
67.6 percentage of participants
Interval 49.5 to 82.6
|
PRIMARY outcome
Timeframe: From 0 to 120 hours after receiving treatment on Day 1Population: The ITT population included all participants who received palonosetron, received at least one dose of the qualifying LEC agents on Day 1, and had at least 1 post-chemotherapy efficacy assessment.
CR was defined as the participants without any emetic episodes and did not use any rescue medication during overall period (0-120 hours). An emetic episode was defined as 1) one occurrence of vomiting, or 2) a sequence of occurrences in very close succession not relieved by a period of relaxation of at least 1 minute, any number of occurrences of unproductive emesis (retches) in a unique 5-minute period, or 3) an episode of retching of less than 5 minute duration combined with vomiting not relieved by a period of relaxation of at least 1 minute. Participants who completed the diary for a given period and had no emetic episodes and no use of rescue medication were considered to have achieved CR, during the period.
Outcome measures
| Measure |
All Participants: Palonosetron 0.25 mg/5 mL
n=34 Participants
Participants received palonosetron 0.25 mg/5 mL intravenous injection 30 minutes prior to receiving a LEC agent on Day 1.
|
|---|---|
|
Percentage of Participants With CR During Overall Period (0 to 120 Hours) After Receiving Treatment on Day 1
|
67.6 percentage of participants
Interval 49.5 to 82.6
|
SECONDARY outcome
Timeframe: From 0 to 24 hours, 24 to 48 hours, 48 to 72 hours, 72 to 96 hours and 96 to 120 hours after receiving treatment on Day 1Population: ITT population included all participants who received palonosetron, received at least one dose of the qualifying LEC agents on Day 1, and had at least 1 post-chemotherapy efficacy assessment.
CR was defined as the participants without any emetic episodes and did not use any rescue medication. An emetic episode was defined as 1) one occurrence of vomiting, or 2) a sequence of occurrences in very close succession not relieved by a period of relaxation of at least 1 minute, any number of occurrences of unproductive emesis (retches) in a unique 5-minute period, or 3) an episode of retching of less than 5 minute duration combined with vomiting not relieved by a period of relaxation of at least 1 minute. Participants who completed the diary for a given period and had no emetic episodes and no use of rescue medication were considered to have achieved CR, during the period.
Outcome measures
| Measure |
All Participants: Palonosetron 0.25 mg/5 mL
n=34 Participants
Participants received palonosetron 0.25 mg/5 mL intravenous injection 30 minutes prior to receiving a LEC agent on Day 1.
|
|---|---|
|
Percentage of Participants With CR at Each 24 Hour Interval After Receiving Treatment on Day 1
0 to 24 hours
|
88.2 percentage of participants
Interval 72.5 to 96.7
|
|
Percentage of Participants With CR at Each 24 Hour Interval After Receiving Treatment on Day 1
24 to 48 hours
|
79.4 percentage of participants
Interval 62.1 to 91.3
|
|
Percentage of Participants With CR at Each 24 Hour Interval After Receiving Treatment on Day 1
48 to 72 hours
|
85.3 percentage of participants
Interval 68.9 to 95.0
|
|
Percentage of Participants With CR at Each 24 Hour Interval After Receiving Treatment on Day 1
72 to 96 hours
|
85.3 percentage of participants
Interval 68.9 to 95.0
|
|
Percentage of Participants With CR at Each 24 Hour Interval After Receiving Treatment on Day 1
96 to 120 hours
|
82.4 percentage of participants
Interval 65.5 to 93.2
|
SECONDARY outcome
Timeframe: From 0 to 48 hours, 0 to 72 hours, and 0 to 96 hours after receiving treatment on Day 1Population: ITT population included all participants who received palonosetron, received at least one dose of the qualifying LEC agents on Day 1, and had at least 1 post-chemotherapy efficacy assessment.
CR was defined as the participants without any emetic episodes and did not use any rescue medication. An emetic episode was defined as 1) one occurrence of vomiting, or 2) a sequence of occurrences in very close succession not relieved by a period of relaxation of at least 1 minute, any number of occurrences of unproductive emesis (retches) in a unique 5-minute period, or 3) an episode of retching of less than 5 minute duration combined with vomiting not relieved by a period of relaxation of at least 1 minute. Participants who completed the diary for a given period and had no emetic episodes and no use of rescue medication were considered to have achieved CR, during the period.
Outcome measures
| Measure |
All Participants: Palonosetron 0.25 mg/5 mL
n=34 Participants
Participants received palonosetron 0.25 mg/5 mL intravenous injection 30 minutes prior to receiving a LEC agent on Day 1.
|
|---|---|
|
Percentage of Participants With CR During 0 to 48, 0 to 72, and 0 to 96 Hours After Receiving Treatment on Day 1
0 to 48 hours
|
79.4 percentage of participants
Interval 62.1 to 91.3
|
|
Percentage of Participants With CR During 0 to 48, 0 to 72, and 0 to 96 Hours After Receiving Treatment on Day 1
0 to 72 hours
|
73.5 percentage of participants
Interval 55.6 to 87.1
|
|
Percentage of Participants With CR During 0 to 48, 0 to 72, and 0 to 96 Hours After Receiving Treatment on Day 1
0 to 96 hours
|
70.6 percentage of participants
Interval 52.5 to 84.9
|
SECONDARY outcome
Timeframe: From 0 to 24 hours, 24 to 120 hours, and 0 to 120 hours after receiving treatment on Day 1Population: ITT population included all participants who received palonosetron, received at least one dose of the qualifying LEC agents on Day 1, and had at least 1 post-chemotherapy efficacy assessment.
Complete Control was defined as the percentage of participants who had a CR and no more than mild nausea. CR was defined as the participants without any emetic episodes and did not use any rescue medication. An emetic episode was defined as 1) one occurrence of vomiting, or 2) a sequence of occurrences in very close succession not relieved by a period of relaxation of at least 1 minute, any number of occurrences of unproductive emesis (retches) in a unique 5-minute period, or 3) an episode of retching of less than 5 minute duration combined with vomiting not relieved by a period of relaxation of at least 1 minute. Participants who completed the diary for a given period and had no emetic episod es and no use of rescue medication were considered to have CR during the period. Those same participants were considered complete control for the period if they had no more than mild nausea during the period.
Outcome measures
| Measure |
All Participants: Palonosetron 0.25 mg/5 mL
n=34 Participants
Participants received palonosetron 0.25 mg/5 mL intravenous injection 30 minutes prior to receiving a LEC agent on Day 1.
|
|---|---|
|
Percentage of Participants With Complete Control During Acute Period (0 to 24 Hours), Delayed Period (24 to 120 Hours), and Overall Period (0 to 120 Hours) After Receiving Treatment on Day 1
Acute (0 to 24 hours)
|
85.3 percentage of participants
Interval 68.9 to 95.0
|
|
Percentage of Participants With Complete Control During Acute Period (0 to 24 Hours), Delayed Period (24 to 120 Hours), and Overall Period (0 to 120 Hours) After Receiving Treatment on Day 1
Delayed (24 to 120 hours)
|
64.7 percentage of participants
Interval 46.5 to 80.3
|
|
Percentage of Participants With Complete Control During Acute Period (0 to 24 Hours), Delayed Period (24 to 120 Hours), and Overall Period (0 to 120 Hours) After Receiving Treatment on Day 1
Overall (0 to 120 hours)
|
64.7 percentage of participants
Interval 46.5 to 80.3
|
SECONDARY outcome
Timeframe: From 0 to 24 hours, 24 to 48 hours, 48 to 72 hours, 72 to 96 hours and 96 to 120 hours after receiving treatment on Day 1Population: ITT population included all participants who received palonosetron, received at least one dose of the qualifying LEC agents on Day 1, and had at least 1 post-chemotherapy efficacy assessment.
Complete Control was defined as the percentage of participants who had a CR and no more than mild nausea. CR was defined as the participants without any emetic episodes and did not use any rescue medication. An emetic episode was defined as 1) one occurrence of vomiting, or 2) a sequence of occurrences in very close succession not relieved by a period of relaxation of at least 1 minute, any number of occurrences of unproductive emesis (retches) in a unique 5-minute period, or 3) an episode of retching of less than 5 minute duration combined with vomiting not relieved by a period of relaxation of at least 1 minute. Participants who completed the diary for a given period and had no emetic episod es and no use of rescue medication were considered to have CR during the period. Those same participants were considered complete control for the period if they had no more than mild nausea during the period.
Outcome measures
| Measure |
All Participants: Palonosetron 0.25 mg/5 mL
n=34 Participants
Participants received palonosetron 0.25 mg/5 mL intravenous injection 30 minutes prior to receiving a LEC agent on Day 1.
|
|---|---|
|
Percentage of Participants With Complete Control at Each 24 Hours Interval After Receiving Treatment on Day 1
0 to 24 hours
|
85.3 percentage of participants
Interval 68.9 to 95.0
|
|
Percentage of Participants With Complete Control at Each 24 Hours Interval After Receiving Treatment on Day 1
24 to 48 hours
|
76.5 percentage of participants
Interval 58.8 to 89.3
|
|
Percentage of Participants With Complete Control at Each 24 Hours Interval After Receiving Treatment on Day 1
48 to 72 hours
|
76.5 percentage of participants
Interval 58.8 to 89.3
|
|
Percentage of Participants With Complete Control at Each 24 Hours Interval After Receiving Treatment on Day 1
72 to 96 hours
|
82.4 percentage of participants
Interval 65.5 to 93.2
|
|
Percentage of Participants With Complete Control at Each 24 Hours Interval After Receiving Treatment on Day 1
96 to 120 hours
|
79.4 percentage of participants
Interval 62.1 to 91.3
|
SECONDARY outcome
Timeframe: From 0 to 48 hours, 0 to 72 hours, and 0 to 96 hours after receiving treatment on Day 1Population: ITT population included all participants who received palonosetron, received at least one dose of the qualifying LEC agents on Day 1, and had at least 1 post-chemotherapy efficacy assessment.
Complete Control was defined as the percentage of participants who had a CR and no more than mild nausea. CR was defined as the participants without any emetic episodes and did not use any rescue medication. An emetic episode was defined as 1) one occurrence of vomiting, or 2) a sequence of occurrences in very close succession not relieved by a period of relaxation of at least 1 minute, any number of occurrences of unproductive emesis (retches) in a unique 5-minute period, or 3) an episode of retching of less than 5 minute duration combined with vomiting not relieved by a period of relaxation of at least 1 minute. Participants who completed the diary for a given period and had no emetic episod es and no use of rescue medication were considered to have CR during the period. Those same participants were considered complete control for the period if they had no more than mild nausea during the period.
Outcome measures
| Measure |
All Participants: Palonosetron 0.25 mg/5 mL
n=34 Participants
Participants received palonosetron 0.25 mg/5 mL intravenous injection 30 minutes prior to receiving a LEC agent on Day 1.
|
|---|---|
|
Percentage of Participants With Complete Control During 0 to 48, 0 to 72, and 0 to 96 Hours After Receiving Treatment on Day 1
0 to 48 hours
|
76.5 percentage of participant
Interval 58.8 to 89.3
|
|
Percentage of Participants With Complete Control During 0 to 48, 0 to 72, and 0 to 96 Hours After Receiving Treatment on Day 1
0 to 72 hours
|
70.6 percentage of participant
Interval 52.5 to 84.9
|
|
Percentage of Participants With Complete Control During 0 to 48, 0 to 72, and 0 to 96 Hours After Receiving Treatment on Day 1
0 to 96 hours
|
67.6 percentage of participant
Interval 49.5 to 82.6
|
SECONDARY outcome
Timeframe: From 0 to 24 hours, 24 to 120 hours, and 0 to 120 hours after receiving treatment on Day 1Population: ITT population included all participants who received palonosetron, received at least one dose of the qualifying LEC agents on Day 1, and had at least 1 post-chemotherapy efficacy assessment.
An emetic episode was defined as 1) one occurrence of vomiting, or 2) a sequence of occurrences in very close succession not relieved by a period of relaxation of at least 1 minute, any number of occurrences of unproductive emesis (retches) in a unique 5-minute period, or 3) an episode of retching of less than 5 minute duration combined with vomiting not relieved by a period of relaxation of at least 1 minute.
Outcome measures
| Measure |
All Participants: Palonosetron 0.25 mg/5 mL
n=34 Participants
Participants received palonosetron 0.25 mg/5 mL intravenous injection 30 minutes prior to receiving a LEC agent on Day 1.
|
|---|---|
|
Percentage of Participants With No Emetic Episodes During Acute Period (0 to 24 Hours), Delayed Period (24 to 120 Hours), and Overall Period (0 to 120 Hours) After Receiving Treatment on Day 1
Acute (0 to 24 hours)
|
91.2 percentage of participants
Interval 76.3 to 98.1
|
|
Percentage of Participants With No Emetic Episodes During Acute Period (0 to 24 Hours), Delayed Period (24 to 120 Hours), and Overall Period (0 to 120 Hours) After Receiving Treatment on Day 1
Delayed (24 to 120 hours)
|
79.4 percentage of participants
Interval 62.1 to 91.3
|
|
Percentage of Participants With No Emetic Episodes During Acute Period (0 to 24 Hours), Delayed Period (24 to 120 Hours), and Overall Period (0 to 120 Hours) After Receiving Treatment on Day 1
Overall (0 to 120 hours)
|
79.4 percentage of participants
Interval 62.1 to 91.3
|
SECONDARY outcome
Timeframe: From 0 to 24 hours, 24 to 48 hours, 48 to 72 hours, 72 to 96 hours and 96 to 120 hours after receiving treatment on Day 1Population: ITT population included all participants who received palonosetron, received at least one dose of the qualifying LEC agents on Day 1, and had at least 1 post-chemotherapy efficacy assessment.
An emetic episode was defined as 1) one occurrence of vomiting, or 2) a sequence of occurrences in very close succession not relieved by a period of relaxation of at least 1 minute, any number of occurrences of unproductive emesis (retches) in a unique 5-minute period, or 3) an episode of retching of less than 5 minute duration combined with vomiting not relieved by a period of relaxation of at least 1 minute.
Outcome measures
| Measure |
All Participants: Palonosetron 0.25 mg/5 mL
n=34 Participants
Participants received palonosetron 0.25 mg/5 mL intravenous injection 30 minutes prior to receiving a LEC agent on Day 1.
|
|---|---|
|
Percentage of Participants With No Emetic Episodes At Each 24 Hours Interval After Receiving Treatment on Day 1
0 to 24 hours
|
91.2 percentage of participants
Interval 76.3 to 98.1
|
|
Percentage of Participants With No Emetic Episodes At Each 24 Hours Interval After Receiving Treatment on Day 1
24 to 48 hours
|
94.1 percentage of participants
Interval 80.3 to 99.3
|
|
Percentage of Participants With No Emetic Episodes At Each 24 Hours Interval After Receiving Treatment on Day 1
48 to 72 hours
|
88.2 percentage of participants
Interval 72.5 to 96.7
|
|
Percentage of Participants With No Emetic Episodes At Each 24 Hours Interval After Receiving Treatment on Day 1
72 to 96 hours
|
91.2 percentage of participants
Interval 76.3 to 98.1
|
|
Percentage of Participants With No Emetic Episodes At Each 24 Hours Interval After Receiving Treatment on Day 1
96 to 120 hours
|
88.2 percentage of participants
Interval 72.5 to 96.7
|
SECONDARY outcome
Timeframe: From 0 to 48 hours, 0 to 72 hours, and 0 to 96 hours after receiving treatment on Day 1Population: ITT population included all participants who received palonosetron, received at least one dose of the qualifying LEC agents on Day 1, and had at least 1 post-chemotherapy efficacy assessment.
An emetic episode was defined as 1) one occurrence of vomiting, or 2) a sequence of occurrences in very close succession not relieved by a period of relaxation of at least 1 minute, any number of occurrences of unproductive emesis (retches) in a unique 5-minute period, or 3) an episode of retching of less than 5 minute duration combined with vomiting not relieved by a period of relaxation of at least 1 minute.
Outcome measures
| Measure |
All Participants: Palonosetron 0.25 mg/5 mL
n=34 Participants
Participants received palonosetron 0.25 mg/5 mL intravenous injection 30 minutes prior to receiving a LEC agent on Day 1.
|
|---|---|
|
Percentage of Participants With No Emetic Episodes During 0 to 48 Hours, 0 to 72 Hours, and 0 to 96 Hours After Receiving Treatment on Day 1
0 to 48 hours
|
91.2 percentage of participants
Interval 76.3 to 98.1
|
|
Percentage of Participants With No Emetic Episodes During 0 to 48 Hours, 0 to 72 Hours, and 0 to 96 Hours After Receiving Treatment on Day 1
0 to 72 hours
|
85.3 percentage of participants
Interval 68.9 to 95.0
|
|
Percentage of Participants With No Emetic Episodes During 0 to 48 Hours, 0 to 72 Hours, and 0 to 96 Hours After Receiving Treatment on Day 1
0 to 96 hours
|
85.3 percentage of participants
Interval 68.9 to 95.0
|
SECONDARY outcome
Timeframe: From 0 to 24 hours, 24 to 120 hours, and 0 to 120 hours after receiving treatment on Day 1Population: ITT population included all participants who received palonosetron, received at least one dose of the qualifying LEC agents on Day 1, and had at least 1 post-chemotherapy efficacy assessment.
The 4-point Likert scale was used to measure the severity and intensity of nausea. The participant was asked "How much nausea did you experience on average during the last 24 hours?" The scale was defined as follows: 0 = none, 1 = mild, 2 = moderate, 3 = severe.
Outcome measures
| Measure |
All Participants: Palonosetron 0.25 mg/5 mL
n=34 Participants
Participants received palonosetron 0.25 mg/5 mL intravenous injection 30 minutes prior to receiving a LEC agent on Day 1.
|
|---|---|
|
Percentage of Participants With Nausea Based on Severity and Intensity During Acute Period (0 to 24 Hours), Delayed Period (24 to 120 Hours), and Overall Period (0 to 120 Hours) After Receiving Treatment on Day 1
Acute (0 to 24 hours); None
|
73.5 percentage of participants
Interval 55.6 to 87.1
|
|
Percentage of Participants With Nausea Based on Severity and Intensity During Acute Period (0 to 24 Hours), Delayed Period (24 to 120 Hours), and Overall Period (0 to 120 Hours) After Receiving Treatment on Day 1
Acute (0 to 24 hours); Mild
|
11.8 percentage of participants
Interval 3.3 to 27.5
|
|
Percentage of Participants With Nausea Based on Severity and Intensity During Acute Period (0 to 24 Hours), Delayed Period (24 to 120 Hours), and Overall Period (0 to 120 Hours) After Receiving Treatment on Day 1
Acute (0 to 24 hours); Moderate
|
11.8 percentage of participants
Interval 3.3 to 27.5
|
|
Percentage of Participants With Nausea Based on Severity and Intensity During Acute Period (0 to 24 Hours), Delayed Period (24 to 120 Hours), and Overall Period (0 to 120 Hours) After Receiving Treatment on Day 1
Acute (0 to 24 hours); Severe
|
2.9 percentage of participants
Interval 0.1 to 15.3
|
|
Percentage of Participants With Nausea Based on Severity and Intensity During Acute Period (0 to 24 Hours), Delayed Period (24 to 120 Hours), and Overall Period (0 to 120 Hours) After Receiving Treatment on Day 1
Delayed (24 to 120 hours), None
|
52.9 percentage of participants
Interval 35.1 to 70.2
|
|
Percentage of Participants With Nausea Based on Severity and Intensity During Acute Period (0 to 24 Hours), Delayed Period (24 to 120 Hours), and Overall Period (0 to 120 Hours) After Receiving Treatment on Day 1
Delayed (24 to 120 hours), Mild
|
26.5 percentage of participants
Interval 12.9 to 44.4
|
|
Percentage of Participants With Nausea Based on Severity and Intensity During Acute Period (0 to 24 Hours), Delayed Period (24 to 120 Hours), and Overall Period (0 to 120 Hours) After Receiving Treatment on Day 1
Delayed (24 to 120 hours), Moderate
|
11.8 percentage of participants
Interval 3.3 to 27.5
|
|
Percentage of Participants With Nausea Based on Severity and Intensity During Acute Period (0 to 24 Hours), Delayed Period (24 to 120 Hours), and Overall Period (0 to 120 Hours) After Receiving Treatment on Day 1
Delayed (24 to 120 hours), Severe
|
8.8 percentage of participants
Interval 1.9 to 23.7
|
|
Percentage of Participants With Nausea Based on Severity and Intensity During Acute Period (0 to 24 Hours), Delayed Period (24 to 120 Hours), and Overall Period (0 to 120 Hours) After Receiving Treatment on Day 1
Overall (0 to 120 hours); None
|
50.0 percentage of participants
Interval 32.4 to 67.6
|
|
Percentage of Participants With Nausea Based on Severity and Intensity During Acute Period (0 to 24 Hours), Delayed Period (24 to 120 Hours), and Overall Period (0 to 120 Hours) After Receiving Treatment on Day 1
Overall (0 to 120 hours); Mild
|
26.5 percentage of participants
Interval 12.9 to 44.4
|
|
Percentage of Participants With Nausea Based on Severity and Intensity During Acute Period (0 to 24 Hours), Delayed Period (24 to 120 Hours), and Overall Period (0 to 120 Hours) After Receiving Treatment on Day 1
Overall (0 to 120 hours); Moderate
|
14.7 percentage of participants
Interval 5.0 to 31.1
|
|
Percentage of Participants With Nausea Based on Severity and Intensity During Acute Period (0 to 24 Hours), Delayed Period (24 to 120 Hours), and Overall Period (0 to 120 Hours) After Receiving Treatment on Day 1
Overall (0 to 120 hours); Severe
|
8.8 percentage of participants
Interval 1.9 to 23.7
|
SECONDARY outcome
Timeframe: From 0 to 24 hours, 24 to 48 hours, 48 to 72 hours, 72 to 96 hours and 96 to 120 hours after receiving treatment on Day 1Population: ITT population included all participants who received palonosetron, received at least one dose of the qualifying LEC agents on Day 1, and had at least 1 post-chemotherapy efficacy assessment.
The 4-point Likert scale was used to measure the severity and intensity of nausea. The participant was asked "How much nausea did you experience on average during the last 24 hours?" The scale was defined as follows: 0 = none, 1 = mild, 2 = moderate, 3 = severe.
Outcome measures
| Measure |
All Participants: Palonosetron 0.25 mg/5 mL
n=34 Participants
Participants received palonosetron 0.25 mg/5 mL intravenous injection 30 minutes prior to receiving a LEC agent on Day 1.
|
|---|---|
|
Percentage of Participants With Nausea Based on Severity and Intensity At Each 24 Hours Interval After Receiving Treatment on Day 1
48 to 72 hours: None
|
76.5 percentage of participants
Interval 58.8 to 89.3
|
|
Percentage of Participants With Nausea Based on Severity and Intensity At Each 24 Hours Interval After Receiving Treatment on Day 1
0 to 24 hours: None
|
73.5 percentage of participants
Interval 55.6 to 87.1
|
|
Percentage of Participants With Nausea Based on Severity and Intensity At Each 24 Hours Interval After Receiving Treatment on Day 1
0 to 24 hours: Mild
|
11.8 percentage of participants
Interval 3.3 to 27.5
|
|
Percentage of Participants With Nausea Based on Severity and Intensity At Each 24 Hours Interval After Receiving Treatment on Day 1
0 to 24 hours: Moderate
|
11.8 percentage of participants
Interval 3.3 to 27.5
|
|
Percentage of Participants With Nausea Based on Severity and Intensity At Each 24 Hours Interval After Receiving Treatment on Day 1
0 to 24 hours: Severe
|
2.9 percentage of participants
Interval 0.1 to 15.3
|
|
Percentage of Participants With Nausea Based on Severity and Intensity At Each 24 Hours Interval After Receiving Treatment on Day 1
24 to 48 hours: None
|
73.5 percentage of participants
Interval 55.6 to 87.1
|
|
Percentage of Participants With Nausea Based on Severity and Intensity At Each 24 Hours Interval After Receiving Treatment on Day 1
24 to 48 hours: Mild
|
11.8 percentage of participants
Interval 3.3 to 27.5
|
|
Percentage of Participants With Nausea Based on Severity and Intensity At Each 24 Hours Interval After Receiving Treatment on Day 1
24 to 48 hours: Moderate
|
11.8 percentage of participants
Interval 3.3 to 27.5
|
|
Percentage of Participants With Nausea Based on Severity and Intensity At Each 24 Hours Interval After Receiving Treatment on Day 1
24 to 48 hours: Severe
|
2.9 percentage of participants
Interval 0.1 to 15.3
|
|
Percentage of Participants With Nausea Based on Severity and Intensity At Each 24 Hours Interval After Receiving Treatment on Day 1
48 to 72 hours: Mild
|
5.9 percentage of participants
Interval 0.7 to 19.7
|
|
Percentage of Participants With Nausea Based on Severity and Intensity At Each 24 Hours Interval After Receiving Treatment on Day 1
48 to 72 hours: Moderate
|
11.8 percentage of participants
Interval 3.3 to 27.5
|
|
Percentage of Participants With Nausea Based on Severity and Intensity At Each 24 Hours Interval After Receiving Treatment on Day 1
48 to 72 hours: Severe
|
5.9 percentage of participants
Interval 0.7 to 19.7
|
|
Percentage of Participants With Nausea Based on Severity and Intensity At Each 24 Hours Interval After Receiving Treatment on Day 1
72 to 96 hours: None
|
67.6 percentage of participants
Interval 49.5 to 82.6
|
|
Percentage of Participants With Nausea Based on Severity and Intensity At Each 24 Hours Interval After Receiving Treatment on Day 1
72 to 96 hours: Mild
|
20.6 percentage of participants
Interval 8.7 to 37.9
|
|
Percentage of Participants With Nausea Based on Severity and Intensity At Each 24 Hours Interval After Receiving Treatment on Day 1
72 to 96 hours: Moderate
|
8.8 percentage of participants
Interval 1.9 to 23.7
|
|
Percentage of Participants With Nausea Based on Severity and Intensity At Each 24 Hours Interval After Receiving Treatment on Day 1
72 to 96 hours: Severe
|
2.9 percentage of participants
Interval 0.1 to 15.3
|
|
Percentage of Participants With Nausea Based on Severity and Intensity At Each 24 Hours Interval After Receiving Treatment on Day 1
96 to 120 hours: None
|
82.4 percentage of participants
Interval 65.5 to 93.2
|
|
Percentage of Participants With Nausea Based on Severity and Intensity At Each 24 Hours Interval After Receiving Treatment on Day 1
96 to 120 hours: Mild
|
11.8 percentage of participants
Interval 3.3 to 27.5
|
|
Percentage of Participants With Nausea Based on Severity and Intensity At Each 24 Hours Interval After Receiving Treatment on Day 1
96 to 120 hours: Moderate
|
5.9 percentage of participants
Interval 0.7 to 19.7
|
|
Percentage of Participants With Nausea Based on Severity and Intensity At Each 24 Hours Interval After Receiving Treatment on Day 1
96 to 120 hours: Severe
|
0 percentage of participants
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: From 0 to 48 hours, 0 to 72 hours, and 0 to 96 hours after receiving treatment on Day 1Population: ITT population included all participants who received palonosetron, received at least one dose of the qualifying LEC agents on Day 1, and had at least 1 post-chemotherapy efficacy assessment.
The 4-point Likert scale was used to measure the severity and intensity of nausea. The participant was asked "How much nausea did you experience on average during the last 24 hours?" The scale was defined as follows: 0 = none, 1 = mild, 2 = moderate, 3 = severe.
Outcome measures
| Measure |
All Participants: Palonosetron 0.25 mg/5 mL
n=34 Participants
Participants received palonosetron 0.25 mg/5 mL intravenous injection 30 minutes prior to receiving a LEC agent on Day 1.
|
|---|---|
|
Percentage of Participants With Nausea Based on Severity and Intensity During 0 to 48, 0 to 72, and 0 to 96 Hours After Receiving Treatment on Day 1
0 to 48 hours: None
|
67.6 percentage of participants
Interval 49.5 to 82.6
|
|
Percentage of Participants With Nausea Based on Severity and Intensity During 0 to 48, 0 to 72, and 0 to 96 Hours After Receiving Treatment on Day 1
0 to 48 hours: Mild
|
14.7 percentage of participants
Interval 5.0 to 31.1
|
|
Percentage of Participants With Nausea Based on Severity and Intensity During 0 to 48, 0 to 72, and 0 to 96 Hours After Receiving Treatment on Day 1
0 to 48 hours: Moderate
|
11.8 percentage of participants
Interval 3.3 to 27.5
|
|
Percentage of Participants With Nausea Based on Severity and Intensity During 0 to 48, 0 to 72, and 0 to 96 Hours After Receiving Treatment on Day 1
0 to 48 hours: Severe
|
5.9 percentage of participants
Interval 0.7 to 19.7
|
|
Percentage of Participants With Nausea Based on Severity and Intensity During 0 to 48, 0 to 72, and 0 to 96 Hours After Receiving Treatment on Day 1
0 to 72 hours: None
|
61.8 percentage of participants
Interval 43.6 to 77.8
|
|
Percentage of Participants With Nausea Based on Severity and Intensity During 0 to 48, 0 to 72, and 0 to 96 Hours After Receiving Treatment on Day 1
0 to 72 hours: Mild
|
14.7 percentage of participants
Interval 5.0 to 31.1
|
|
Percentage of Participants With Nausea Based on Severity and Intensity During 0 to 48, 0 to 72, and 0 to 96 Hours After Receiving Treatment on Day 1
0 to 72 hours: Moderate
|
14.7 percentage of participants
Interval 5.0 to 31.1
|
|
Percentage of Participants With Nausea Based on Severity and Intensity During 0 to 48, 0 to 72, and 0 to 96 Hours After Receiving Treatment on Day 1
0 to 72 hours: Severe
|
8.8 percentage of participants
Interval 1.9 to 23.7
|
|
Percentage of Participants With Nausea Based on Severity and Intensity During 0 to 48, 0 to 72, and 0 to 96 Hours After Receiving Treatment on Day 1
0 to 96 hours: None
|
52.9 percentage of participants
Interval 35.1 to 70.2
|
|
Percentage of Participants With Nausea Based on Severity and Intensity During 0 to 48, 0 to 72, and 0 to 96 Hours After Receiving Treatment on Day 1
0 to 96 hours: Mild
|
23.5 percentage of participants
Interval 10.7 to 41.2
|
|
Percentage of Participants With Nausea Based on Severity and Intensity During 0 to 48, 0 to 72, and 0 to 96 Hours After Receiving Treatment on Day 1
0 to 96 hours: Moderate
|
14.7 percentage of participants
Interval 5.0 to 31.1
|
|
Percentage of Participants With Nausea Based on Severity and Intensity During 0 to 48, 0 to 72, and 0 to 96 Hours After Receiving Treatment on Day 1
0 to 96 hours: Severe
|
8.8 percentage of participants
Interval 1.9 to 23.7
|
SECONDARY outcome
Timeframe: From (Day 2-5) to the End of Study (Day 8)Population: ITT population included all participants who received palonosetron, received at least one dose of the qualifying LEC agents on Day 1, and had at least 1 post-chemotherapy efficacy assessment.
FLIE is a patient-completed quality of life assessment modified from the original Functional Living Index - Cancer questionnaire. FLIE contains two domains: nausea and vomiting with nine items in each domain. The first item asks the patient to rate how much nausea (or vomiting) has occurred over a 5 day period. The remaining eight items ask patients to rate the impact of nausea (or vomiting) on various aspects of a patient's life (for example, ability to enjoy meals/liquids). Each item is answered using a 7 point visual analog scale with 7 being "none /not at all" and 1 being "a great deal". The two domains are summed for a total score with a possible range of 18-126. Higher scores indicate a more favorable quality of life. A total score of \>108 defines those patients who had a minimal impact of Chemotherapy-Induced Nausea and Vomiting (CINV) on quality of life.
Outcome measures
| Measure |
All Participants: Palonosetron 0.25 mg/5 mL
n=34 Participants
Participants received palonosetron 0.25 mg/5 mL intravenous injection 30 minutes prior to receiving a LEC agent on Day 1.
|
|---|---|
|
Mean Change From Follow Up Period (Day 2-5) in Scores on Functional Living Index-Emesis [FLIE] Assessment Questionnaires to the End of Study (Day 8)
|
18.3 scores on a scale
Interval -76.1 to 112.8
|
Adverse Events
All Participants: Palonosetron 0.25 mg/5 mL
Serious adverse events
| Measure |
All Participants: Palonosetron 0.25 mg/5 mL
n=36 participants at risk
Participants received palonosetron 0.25 mg/5 mL intravenous injection 30 minutes prior to receiving a LEC agent on Day 1.
|
|---|---|
|
Gastrointestinal disorders
Dysphagia
|
2.8%
1/36 • From date of administration of study drug (Day 1) up to 192 hours (Day 8)
|
|
Gastrointestinal disorders
Melaena
|
2.8%
1/36 • From date of administration of study drug (Day 1) up to 192 hours (Day 8)
|
|
Infections and infestations
Pneumonia
|
2.8%
1/36 • From date of administration of study drug (Day 1) up to 192 hours (Day 8)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
2.8%
1/36 • From date of administration of study drug (Day 1) up to 192 hours (Day 8)
|
Other adverse events
| Measure |
All Participants: Palonosetron 0.25 mg/5 mL
n=36 participants at risk
Participants received palonosetron 0.25 mg/5 mL intravenous injection 30 minutes prior to receiving a LEC agent on Day 1.
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract congestion
|
2.8%
1/36 • From date of administration of study drug (Day 1) up to 192 hours (Day 8)
|
|
Nervous system disorders
Headache
|
5.6%
2/36 • From date of administration of study drug (Day 1) up to 192 hours (Day 8)
|
|
Metabolism and nutrition disorders
Dehydration
|
2.8%
1/36 • From date of administration of study drug (Day 1) up to 192 hours (Day 8)
|
|
Metabolism and nutrition disorders
Decreased appetite
|
5.6%
2/36 • From date of administration of study drug (Day 1) up to 192 hours (Day 8)
|
|
General disorders
Pyrexia
|
5.6%
2/36 • From date of administration of study drug (Day 1) up to 192 hours (Day 8)
|
|
General disorders
Fatigue
|
5.6%
2/36 • From date of administration of study drug (Day 1) up to 192 hours (Day 8)
|
|
General disorders
Chills
|
2.8%
1/36 • From date of administration of study drug (Day 1) up to 192 hours (Day 8)
|
|
General disorders
Asthenia
|
2.8%
1/36 • From date of administration of study drug (Day 1) up to 192 hours (Day 8)
|
|
Gastrointestinal disorders
Nausea
|
2.8%
1/36 • From date of administration of study drug (Day 1) up to 192 hours (Day 8)
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
2.8%
1/36 • From date of administration of study drug (Day 1) up to 192 hours (Day 8)
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
2.8%
1/36 • From date of administration of study drug (Day 1) up to 192 hours (Day 8)
|
|
Gastrointestinal disorders
Constipation
|
2.8%
1/36 • From date of administration of study drug (Day 1) up to 192 hours (Day 8)
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
2.8%
1/36 • From date of administration of study drug (Day 1) up to 192 hours (Day 8)
|
|
Blood and lymphatic system disorders
Neutropenia
|
2.8%
1/36 • From date of administration of study drug (Day 1) up to 192 hours (Day 8)
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
2.8%
1/36 • From date of administration of study drug (Day 1) up to 192 hours (Day 8)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER