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This study is designed to assess the safety and efficacy of palonesetron in preventing chemotherapy-induced nausea and vomiting (CINV) when administered to participants who have experienced either vomiting and or at least moderate nausea during their last cycle of low emetogenic chemotherapy.
Palonosetron is currently approved for prevention of acute and delayed nausea and vomiting associated with initial and repeat CINV caused by moderate and highly emetogenic chemotherapy. This study is designed to assess the safety and efficacy of palonesetron in preventing CINV when administered to patients who have experienced either vomiting and or at least moderate nausea during their last cycle of low emetogenic chemotherapy.
Palonosetron will be given intravenously approximately 30 minutes prior to the start of the chemotherapy regimen. Efficacy and safety including episodes of nausea, retching and or vomiting will be assessed over five 24 hour periods starting on Day 1 and ending on Day 6 in patient diaries. On Day 2 and Day 6 a FLIE (Functional Living Index- Emesis) assessment will also be completed in order to help evaluate the patient's quality of life from the start of the chemotherapy cycle through Day 6.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| All Participants: Palonosetron 0.25 mg/5 mL | Experimental | Participants will receive 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| palonesetron | Drug | One dose administered intravenously 30 minutes pre-chemotherapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Complete Response (CR) During Acute Period (0 to 24 Hours) After Receiving Treatment on Day 1 | 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. | From 0 to 24 hours after receiving treatment on Day 1 |
| Percentage of Participants With CR During Delayed Period (24 to 120 Hours) After Receiving Treatment on Day 1 | 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. | From 24 to 120 hours after receiving treatment on Day 1 |
| Percentage of Participants With CR During Overall Period (0 to 120 Hours) After Receiving Treatment on Day 1 | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With CR at Each 24 Hour Interval After Receiving Treatment on Day 1 | 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. |
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Inclusion Criteria
In order to be eligible for enrollment, subjects must meet the following inclusion criteria:
Subjects who meet any of the following criteria will be excluded from this study:
Inability or unwillingness to understand or cooperate with the study procedures as determined by the Investigator
Women who are pregnant, nursing or planning to become pregnant, women of childbearing potential who are not using an effective method of pregnancy prevention (including implants, injectables, combined oral contraceptives, some intrauterine devices, vasectomized partner or sexual abstinence), or women who have had a positive serum pregnancy test at screening or within 7 days prior to receiving chemo on Day 1. Non-childbearing potential includes women who are post-menopausal (12 months of amenorrhea with no other demonstrable cause, in the appropriate age group) or documented surgical sterilization, or hysterectomy at least 3 months before study start.
Previous use of palonosetron in association with a LEC regimen
Received more than one antiemetic agent for prevention of CINV (Chemotherapy-Induced Nausea and Vomiting) during their last cycle of LEC (other than dexamethasone or prednisone as outlined in number 7 below). The use of an antiemetic in addition to a corticosteroid during the last cycle of LEC is allowed if the corticosteroid is intended for the prophylactic treatment of taxane-related hypersensitivity or pemetrexed-related skin reactions as long as the corticosteroid regimen remains unchanged during the trial
Suspected or confirmed ongoing vomiting for any organic etiology (e.g., food poisoning, gastroenteritis, etc)
Received any drug with potential anti-emetic effect within 24 hours prior to the start of qualifying LEC agent
Scheduled to receive an antiemetic (with the exception of administration of the palonosetron) at any time during the trial, listed below
-5-HT3 receptor antagonists
Having received any investigational drugs or devices within 30 days before study entry
Any vomiting, retching, or National Cancer Institute Common Terminology Criteria for Adverse Events, v.3 (NCI CTCAE) Grade 2 to 4 nausea in the 24 hours preceding chemotherapy
History of alcohol or drug abuse
Scheduled to receive any other emetogenic chemotherapeutic agents during the study other than those specified in this protocol
Any known hypersensitivity/contraindication to 5-HT3 antagonists or study drug excipients
Scheduled to receive or have received radiotherapy within 1 week prior to or during the study
Any condition that, in the judgment of the Principal Investigator, would make a subject ineligible for participation in the study
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sheridan Clinical Research | Sunrise | Florida | 33323 | United States | ||
| Medical and Surgical Specialists |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22733373 | Derived | Hesketh PJ, Morrow G, Komorowski AW, Ahmed R, Cox D. Efficacy and safety of palonosetron as salvage treatment in the prevention of chemotherapy-induced nausea and vomiting in patients receiving low emetogenic chemotherapy (LEC). Support Care Cancer. 2012 Oct;20(10):2633-7. doi: 10.1007/s00520-012-1527-3. Epub 2012 Jun 24. |
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A total of 38 participants were screened, of which 02 were screen failures and 36 participants were enrolled and received the study treatment.
Participants took part in the study at 18 investigative sites in the United States from 27 October 2009 to 08 December 2010.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| From 0 to 120 hours after receiving treatment on Day 1 |
| 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 1 |
| Percentage of Participants With CR During 0 to 48, 0 to 72, and 0 to 96 Hours After Receiving Treatment on Day 1 | 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. | From 0 to 48 hours, 0 to 72 hours, and 0 to 96 hours after receiving treatment 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 | 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. | From 0 to 24 hours, 24 to 120 hours, and 0 to 120 hours after receiving treatment on Day 1 |
| Percentage of Participants With Complete Control at Each 24 Hours Interval After Receiving Treatment on Day 1 | 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. | 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 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 | 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. | From 0 to 48 hours, 0 to 72 hours, and 0 to 96 hours after receiving treatment 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 | 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. | From 0 to 24 hours, 24 to 120 hours, and 0 to 120 hours after receiving treatment on Day 1 |
| Percentage of Participants With No Emetic Episodes At Each 24 Hours Interval After Receiving Treatment on Day 1 | 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. | 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 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 | 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. | From 0 to 48 hours, 0 to 72 hours, and 0 to 96 hours after receiving treatment 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 | 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. | From 0 to 24 hours, 24 to 120 hours, and 0 to 120 hours after receiving treatment on Day 1 |
| Percentage of Participants With Nausea Based on Severity and Intensity At Each 24 Hours Interval After Receiving Treatment on Day 1 | 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. | 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 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 | 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. | From 0 to 48 hours, 0 to 72 hours, and 0 to 96 hours after receiving treatment 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) | 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. | From (Day 2-5) to the End of Study (Day 8) |
| Galesburg |
| Illinois |
| 61401 |
| United States |
| Orchard Healthcare Research Inc | Skokie | Illinois | 60076 | United States |
| Trover Center for Clinical Studies; Merle Mahr Cancer Center | Madisonville | Kentucky | 42431 | United States |
| Hematology- Oncology Associates of Rockland, PC | Nyack | New York | 10960 | United States |
| Signal Point Clinical Research | Middletown | Ohio | 45042 | United States |
| Scott and White Clinic- College Station | College Station | Texas | 77840 | United States |
| Scott and White Healthcare- Round Rock | Round Rock | Texas | 76559 | United States |
| Scott and White Memorial Hospital | Temple | Texas | 76508 | United States |
| COMPLETED |
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| NOT COMPLETED |
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The safety population included all participants who received study medication (palonosetron) and had at least 1 safety assessment after treatment.
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| ID | Title | Description |
|---|---|---|
| BG000 | All Participants: Palonosetron 0.25 mg/5 mL | Participants received palonosetron 0.25 mg/5 mL intravenous injection 30 minutes prior to receiving a LEC agent on Day 1. |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants With Complete Response (CR) During Acute Period (0 to 24 Hours) After Receiving Treatment on Day 1 | 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. | 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. | Posted | Number | 95% Confidence Interval | percentage of participants | From 0 to 24 hours after receiving treatment on Day 1 |
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| Primary | Percentage of Participants With CR During Delayed Period (24 to 120 Hours) After Receiving Treatment on Day 1 | 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. | 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. | Posted | Number | 95% Confidence Interval | percentage of participants | From 24 to 120 hours after receiving treatment on Day 1 |
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| Primary | Percentage of Participants With CR During Overall Period (0 to 120 Hours) After Receiving Treatment on Day 1 | 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. | 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. | Posted | Number | 95% Confidence Interval | percentage of participants | From 0 to 120 hours after receiving treatment on Day 1 |
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| Secondary | Percentage of Participants With CR at Each 24 Hour Interval After Receiving Treatment on Day 1 | 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. | 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. | Posted | Number | 95% Confidence Interval | percentage of participants | 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 1 |
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| Secondary | Percentage of Participants With CR During 0 to 48, 0 to 72, and 0 to 96 Hours After Receiving Treatment on Day 1 | 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. | 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. | Posted | Number | 95% Confidence Interval | percentage of participants | From 0 to 48 hours, 0 to 72 hours, and 0 to 96 hours after receiving treatment on Day 1 |
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| Secondary | 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 | 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. | 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. | Posted | Number | 95% Confidence Interval | percentage of participants | From 0 to 24 hours, 24 to 120 hours, and 0 to 120 hours after receiving treatment on Day 1 |
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| Secondary | Percentage of Participants With Complete Control at Each 24 Hours Interval After Receiving Treatment on Day 1 | 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. | 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. | Posted | Number | 95% Confidence Interval | percentage of participants | 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 1 |
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| Secondary | Percentage of Participants With Complete Control During 0 to 48, 0 to 72, and 0 to 96 Hours After Receiving Treatment on Day 1 | 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. | 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. | Posted | Number | 95% Confidence Interval | percentage of participant | From 0 to 48 hours, 0 to 72 hours, and 0 to 96 hours after receiving treatment on Day 1 |
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| Secondary | 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 | 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. | 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. | Posted | Number | 95% Confidence Interval | percentage of participants | From 0 to 24 hours, 24 to 120 hours, and 0 to 120 hours after receiving treatment on Day 1 |
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| Secondary | Percentage of Participants With No Emetic Episodes At Each 24 Hours Interval After Receiving Treatment on Day 1 | 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. | 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. | Posted | Number | 95% Confidence Interval | percentage of participants | 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 1 |
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| Secondary | 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 | 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. | 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. | Posted | Number | 95% Confidence Interval | percentage of participants | From 0 to 48 hours, 0 to 72 hours, and 0 to 96 hours after receiving treatment on Day 1 |
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| Secondary | 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 | 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. | 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. | Posted | Number | 95% Confidence Interval | percentage of participants | From 0 to 24 hours, 24 to 120 hours, and 0 to 120 hours after receiving treatment on Day 1 |
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| Secondary | Percentage of Participants With Nausea Based on Severity and Intensity At Each 24 Hours Interval After Receiving Treatment on Day 1 | 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. | 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. | Posted | Number | 95% Confidence Interval | percentage of participants | 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 1 |
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| Secondary | 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 | 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. | 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. | Posted | Number | 95% Confidence Interval | percentage of participants | From 0 to 48 hours, 0 to 72 hours, and 0 to 96 hours after receiving treatment on Day 1 |
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| Secondary | 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) | 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. | 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. | Posted | Mean | 95% Confidence Interval | scores on a scale | From (Day 2-5) to the End of Study (Day 8) |
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From date of administration of study drug (Day 1) up to 192 hours (Day 8)
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | All Participants: Palonosetron 0.25 mg/5 mL | Participants received palonosetron 0.25 mg/5 mL intravenous injection 30 minutes prior to receiving a LEC agent on Day 1. | 0 | 36 | 3 | 36 | 13 | 36 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dysphagia | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
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| Melaena | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Respiratory tract congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
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| Dehydration | Metabolism and nutrition disorders | MedDRA 13.1 | Systematic Assessment |
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| Decreased appetite | Metabolism and nutrition disorders | MedDRA 13.1 | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA 13.1 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA 13.1 | Systematic Assessment |
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| Chills | General disorders | MedDRA 13.1 | Systematic Assessment |
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| Asthenia | General disorders | MedDRA 13.1 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
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| Haemorrhoidal haemorrhage | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
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| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
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| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 13.1 | Systematic Assessment |
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| Neutropenia | Blood and lymphatic system disorders | MedDRA 13.1 | Systematic Assessment |
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| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 13.1 | Systematic Assessment |
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Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Eisai Medical Services | Eisai, Inc. | 1-888-422-4743 | esi_medinfo@eisai.com |
| ID | Term |
|---|---|
| D009325 | Nausea |
| D014839 | Vomiting |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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