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| ID | Type | Description | Link |
|---|---|---|---|
| 20-0833 | Other Identifier | UNC Institutional Review Board |
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| Name | Class |
|---|---|
| University of North Carolina, Chapel Hill | OTHER |
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The purpose of this research study is to see if olanzapine helps to prevent nausea and/or vomiting (throwing up) when it is added to other medicines in subjects having stem cell transplants. Subjects will either be given olanzapine or an inactive pill (called a placebo) before getting any chemotherapy that is known to cause nausea and vomiting. During the study, the study coordinators will ask the subjects to complete surveys to understand if the patient is having nausea and vomiting, and if so, how bad it is making the patient feel.
This trial will split subjects into two groups: one group will be given an inactive pill (placebo), and the other group will be given the active pill (olanzapine). Study coordinators will collect surveys every morning before chemotherapy and 5 days after the last dose of chemotherapy. These surveys may be given by members of the study team or possibly on a mobile device.
Subjects may benefit from being in this research study because olanzapine may reduce the frequency or severity of chemotherapy-induced nausea and vomiting (CINV). The most common risks of using olanzapine include possibly becoming more tired, mild dizziness, mild low blood pressure, and mild muscle "quivering." Other possible adverse effects include low blood pressure, muscle weakness, increased appetite, weight gain, constipation, and liver function test changes however these risks are less common in subjects with cancer. In addition, there may be a change detected in heart rhythm however subjects will be screened for this ahead of time.
Chemotherapy induced nausea and vomiting (CINV) occurs in up to 80% of patients on active therapy and remains a significant barrier to quality of life. CINV can alter electrolytes and enteral nutrition which can have a detrimental effect on patient adherence and health outcomes. Hematopoietic Stem Cell Transplant (HCT) patients are at increased risk for CINV because many of the conditioning regimens require multiple days of high-dose chemotherapy that are, in many cases, associated with highly-emetogenic potential.
Thus, most conditioning regimens require a 3-drug regimen for optimal CINV prophylaxis.
Current Standard of Care Current guidelines support the use of olanzapine in addition to a 3 drug CINV regimen for highly emetogenic chemotherapy, however some controversy remains as to olanzapine's place in therapy with moderately emetogenic chemotherapy. In HCT, current practice at University of North Carolina utilizes an neurokinin-1 receptor antagonist (NK1 RA), serotonin receptor antagonists (5-HT3 RA) and corticosteroid for CINV prophylaxis in conditioning regimens including moderate and highly emetogenic chemotherapy in accordance with American Society of Clinical Oncology (ASCO) and National Comprehensive Cancer Network (NCCN) recommendations.
Olanzapine, an atypical antipsychotic, antagonizes dopamine, serotonin, catecholamines, acetylcholine, and histamine receptors which helps prevent acute, breakthrough and delayed nausea. Olanzapine has shown benefit when used as prophylaxis in solid tumor patients receiving single-day highly emetogenic chemotherapy. The addition of olanzapine to 5HT-3 antagonist, NK-1 antagonist, and dexamethasone resulted in significantly more complete responses (CR) and more patients without CINV when compared to placebo in the acute, delayed and overall time periods. Data with olanzapine as CINV prophylaxis is not clear in HCT patients, but one retrospective study by Trifilio et. al. illustrates possible benefit in HCT. They compared an aprepitant-based regimen (aprepitant, ondansetron, and steroid) to an olanzapine-based regimen (olanzapine, ondansetron, and steroid) and found that patients in the olanzapine group had significantly less acute and delayed nausea. In addition, the olanzapine-based regimen required significantly less PRN rescue medication compared to the aprepitant based regimen. These results ultimately provided the foundation for the FOND-O study, a prospective trial that added olanzapine as part of CINV prophylaxis in both hematologic malignancies and HCT patients. The FOND-O study compared fosaprepitant, ondansetron, and dexamethasone (FOND) to fosaprepitant, ondansetron, dexamethasone and olanzapine (FOND-O). The inclusion of olanzapine resulted in significantly less delayed and overall nausea but did not affect the acute phase. While the FOND-O study was the first to look at utilizing olanzapine as part of 4 drug CINV prophylaxis in HCT, there were only 68 HCT patients included in the study. Only 24 allogeneic transplants and 44 autologous transplants were enrolled, and only 34 of these patients actually received olanzapine.
In addition, the FOND-O study utilized an olanzapine dose of 10 mg on each day of chemotherapy continued through chemotherapy day 3. Rationale for Clinical Study The purpose of our proposed study is to build upon the FOND-O results by doing a prospective, randomized, placebo-controlled study, focused entirely on HCT recipients, and powered to detect olanzapine's potential role in CINV prophylaxis in recipients of HCT. Based upon the available literature in both solid and hematologic malignancies the benefit outweighs the risk of adding olanzapine to standard CINV prophylaxis. The primary endpoint is complete response- defined as no emesis and no more than minimal nausea starting with the first dose of highly or moderately emetogenic conditioning chemotherapy and continuing 5 days beyond the last dose of highly or moderately emetogenic conditioning chemotherapy. Secondary endpoints are defined explicitly
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Olanzapine Arm | Experimental | Olanzapine 5mg tablet with chemotherapy, and 3 days after |
|
| Placebo Arm | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Olanzapine 5 MG | Drug | It will be a de-identified pill created by investigational drug services at University of North Carolina |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Complete Response | The number of subjects who completed the study and the overall rate of complete response were assessed. Complete response achievement requires all three of the following criteria for the entire duration of the study assessment period: 1. No emesis, 2. Response to PRO-CTCAE question "In the last 24 hours, how often did you have nausea?" is no higher than rarely and 3. Response to PRO-CTCAE question "In the last 24 hours, what was the severity of your nausea at its worst? a score no higher than "mild". | End of study assessment period, until 5 days after last chemotherapy administration (2- 12 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Total Number of Rescue Medications Needed Acute | The total number of rescue medications needed acute was calculated, starting from the first dose of highly or moderately emetogenic conditioning chemotherapy and continuing for one day after the last dose of highly or moderately emetogenic conditioning chemotherapy. The rescue medication is defined as documented administration of an anti-emetic agent other than those that are scheduled for chemotherapy-induced nausea and vomiting (CINV) prophylaxis. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jonathan Ptachcinski, PharmD | jonathan.Ptachcinski@unchealth.unc.edu | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UNC Hospital | Chapel Hill | North Carolina | 27514 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31635549 | Background | Monson T, Greer D, Kreikemeier E, Liewer S. Olanzapine as a rescue antiemetic in hematopoietic stem cell transplant. J Oncol Pharm Pract. 2020 Jun;26(4):918-922. doi: 10.1177/1078155219879215. Epub 2019 Oct 21. | |
| 27410922 | Background | Navari RM, Qin R, Ruddy KJ, Liu H, Powell SF, Bajaj M, Dietrich L, Biggs D, Lafky JM, Loprinzi CL. Olanzapine for the Prevention of Chemotherapy-Induced Nausea and Vomiting. N Engl J Med. 2016 Jul 14;375(2):134-42. doi: 10.1056/NEJMoa1515725. |
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A total of ninety-four participants consented and three subjects withdrew their consent, and ninety-one enrolled in the study.
Participants were recruited from 08/18/2020 through 03/17/2022 at 1 cancer center in North Carolina.
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| ID | Title | Description |
|---|---|---|
| FG000 | Usual Care | All subjects received the usual care and did not receive olanzapine. |
| FG001 | Olanzapine | All subjects received both olanzapine and usual care. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Usual Care | All subjects received the usual care and did not receive olanzapine. |
| BG001 | Olanzapine | All subjects received both olanzapine and usual care. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Number of Participants With Complete Response | The number of subjects who completed the study and the overall rate of complete response were assessed. Complete response achievement requires all three of the following criteria for the entire duration of the study assessment period: 1. No emesis, 2. Response to PRO-CTCAE question "In the last 24 hours, how often did you have nausea?" is no higher than rarely and 3. Response to PRO-CTCAE question "In the last 24 hours, what was the severity of your nausea at its worst? a score no higher than "mild". | The participants enrolled in the study and complete responses were assessed. | Posted | Count of Participants | Participants | End of study assessment period, until 5 days after last chemotherapy administration (2- 12 days) |
|
from the first day of the study treatment until end of the treatment (Up to 24 days)
Adverse events were assessed according to the NCI Common Toxicity Criteria for Adverse Events (CTCAE), version 5.0, from the first day of the study to the end of the treatment.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Usual Care | All subjects received the usual care and did not receive olanzapine. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Arrhythmia | Cardiac disorders | CTCAE (5) | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | CTCAE (5) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jonathan Ptachcinski PharmD, BCPS, BCOP | University of North Carolina Lineberger Comprehensive Cancer Center | +1 919-966-9786 | Jonathan.Ptachcinski@unchealth.unc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 16, 2020 | Feb 13, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D014839 | Vomiting |
| D009325 | Nausea |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000077152 | Olanzapine |
| ID | Term |
|---|---|
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| Placebo | Drug | It will be a de-identified pill created by investigational drug services at University of North Carolina |
|
| End of day 1 following last chemotherapy administration. (Up to day 2) |
| Number of Subjects Achieving Minimal Nausea | To determine the number of subjects achieving minimal nausea was defined as the frequency of participants responded to the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) nausea question "In the last 24 hours, how often did you have nausea?" as "rarely or less" Starting with the first dose of chemotherapy and continuing for one day after the last dose of highly or moderately emetogenic conditioning chemotherapy. PRO-CTCAE of nausea scale includes categories: Never, Rarely, Occasionally, Frequently, Almost constantly To meet this endpoint the score reported for the Pro-CTCAE question for nausea frequency cannot exceed "rarely" and the score reported for the Pro-CTCAE question for nausea severity cannot exceed "mild" | Day 2-12 |
| Frequency of Nausea in the Acute Phase | Starting with the first dose of highly or moderately emetogenic conditioning chemotherapy and continuing for one day after the last dose of highly or moderately emetogenic conditioning chemotherapy. Nausea was assessed using subjects' responses to the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) nausea questions. Scale: Never, Rarely, Occasionally, Frequently, Almost constantly. To meet this endpoint the score reported for the Pro-CTCAE question for nausea frequency cannot exceed "rarely" in the first 24 hours following receipt of chemotherapy. | End of day 1 following last chemotherapy administration (Up to day 2) |
| Number of Subjects Achieved Emesis Endpoint in Acute Phase. | : The number of subjects who did not experience emesis, starting from the first dose of highly or moderately emetogenic conditioning chemotherapy and continuing for one day after the last dose of highly or moderately emetogenic conditioning chemotherapy. Met endpoint = 0 emesis. | End of day 1 following last chemotherapy administration. (Up to day 2) |
| Frequency of Somnolence | The frequency of somnolence was determined as the number of patients who experienced somnolence based on Common Terminology Criteria for Adverse Events version 5 (CTCAE v5). The number of subjects has somnolence during the study period was counted. | Day 2-12 |
| Safety Endpoint: Qtc Prolongation | Prolongation of corrected QTc interval graded as defined in Common Terminology Criteria for Adverse Events (CTCAE) v5.0. Corrected QTc was calculated using Fredericia's Formula. Corrected QT interval (QTc) = QT interval / (60/Heart rate)^0.33. | Day 1 to 5 days after end of the chemotherapy (Days 2- 12). |
| Number of Subjects Achieved Nausea Endpoint in the Delayed Phase. | Nausea was assessed using subjects' responses to the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) nausea questions, starting the second day after the completion of highly or moderately emetogenic conditioning chemotherapy and continuing through the fifth day after the completion of highly or moderately emetogenic chemotherapy. Scale: Never, Rarely, Occasionally, Frequently, Almost constantly. The number of subjects who experienced "never" or "rarely" nausea were considered as met the endpoint while those who experienced "occasionally", "frequently" or "almost constantly" were considered as not met the endpoint. | Day 1 to 5 days after end of the chemotherapy (Days 2-12). |
| Severity of Nausea in Delayed Phase | The severity of nausea in the delayed phase was defined as the response of the subject to the PRO- CTCAE nausea question. Starting the second day after the completion of highly or moderately emetogenic conditioning chemotherapy and continuing through the fifth day after the completion of highly or moderately emetogenic chemotherapy (PRO-CTCAE) Scale: Never, Rarely, Occasionally, Frequently, Almost constantly o meet the endpoint, the subject could not have answered a score as higher than "mild" in the period of time starting 24 hours after the last dose of chemotherapy and continuing until the 5th day following receipt of chemotherapy . | Day 2-12 |
| Number of Emesis Episodes in Delayed Phase | The number of emesis episodes in acute phase was defined as the number of subjects with no emesis, 1 emesis, and 2 or more emesis. | Day 1 to 5 days after end of the chemotherapy ( Days 2-12). |
| Total Number of Rescue Medications Needed -Delayed | The total number of rescue medications needed for breakthrough chemotherapy-induced nausea and vomiting were calculated, starting from the second day after the completion of highly or moderately emetogenic conditioning chemotherapy and continuing through the fifth day after the completion of highly or moderately emetogenic chemotherapy. The rescue medication is defined as documented administration of an anti-emetic agent other than those that are scheduled for CINV prophylaxis. | Day 1 to 5 days after end of the chemotherapy ( Days 2-12). |
| 28759346 | Background | Hesketh PJ, Kris MG, Basch E, Bohlke K, Barbour SY, Clark-Snow RA, Danso MA, Dennis K, Dupuis LL, Dusetzina SB, Eng C, Feyer PC, Jordan K, Noonan K, Sparacio D, Somerfield MR, Lyman GH. Antiemetics: American Society of Clinical Oncology Clinical Practice Guideline Update. J Clin Oncol. 2017 Oct 1;35(28):3240-3261. doi: 10.1200/JCO.2017.74.4789. Epub 2017 Jul 31. |
| 28694084 | Background | Trifilio S, Welles C, Seeger K, Mehta S, Fishman M, McGowan K, Strejcek K, Eiten E, Pirotte C, Lucier E, DeFrates S, Mehta J. Olanzapine Reduces Chemotherapy-induced Nausea and Vomiting Compared With Aprepitant in Myeloma Patients Receiving High-dose Melphalan Before Stem Cell Transplantation: A Retrospective Study. Clin Lymphoma Myeloma Leuk. 2017 Sep;17(9):584-589. doi: 10.1016/j.clml.2017.06.012. Epub 2017 Jun 20. |
| 27050207 | Background | Navari RM, Aapro M. Antiemetic Prophylaxis for Chemotherapy-Induced Nausea and Vomiting. N Engl J Med. 2016 Apr 7;374(14):1356-67. doi: 10.1056/NEJMra1515442. No abstract available. |
| 29906570 | Background | Clemmons AB, Orr J, Andrick B, Gandhi A, Sportes C, DeRemer D. Randomized, Placebo-Controlled, Phase III Trial of Fosaprepitant, Ondansetron, Dexamethasone (FOND) Versus FOND Plus Olanzapine (FOND-O) for the Prevention of Chemotherapy-Induced Nausea and Vomiting in Patients with Hematologic Malignancies Receiving Highly Emetogenic Chemotherapy and Hematopoietic Cell Transplantation Regimens: The FOND-O Trial. Biol Blood Marrow Transplant. 2018 Oct;24(10):2065-2071. doi: 10.1016/j.bbmt.2018.06.005. Epub 2018 Jun 13. |
| 30204536 | Background | Basch E, Dueck AC, Rogak LJ, Mitchell SA, Minasian LM, Denicoff AM, Wind JK, Shaw MC, Heon N, Shi Q, Ginos B, Nelson GD, Meyers JP, Chang GJ, Mamon HJ, Weiser MR, Kolevska T, Reeve BB, Bruner DW, Schrag D. Feasibility of Implementing the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events in a Multicenter Trial: NCCTG N1048. J Clin Oncol. 2018 Sep 11;36(31):JCO2018788620. doi: 10.1200/JCO.2018.78.8620. Online ahead of print. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Olanzapine | All subjects received both olanzapine and usual care. |
|
|
| Secondary | Total Number of Rescue Medications Needed Acute | The total number of rescue medications needed acute was calculated, starting from the first dose of highly or moderately emetogenic conditioning chemotherapy and continuing for one day after the last dose of highly or moderately emetogenic conditioning chemotherapy. The rescue medication is defined as documented administration of an anti-emetic agent other than those that are scheduled for chemotherapy-induced nausea and vomiting (CINV) prophylaxis. | The subjects who completed CINV prophylaxis treatment and their rescue medications were counted. | Posted | Mean | Full Range | number of rescue medication | End of day 1 following last chemotherapy administration. (Up to day 2) |
|
|
|
| Secondary | Number of Subjects Achieving Minimal Nausea | To determine the number of subjects achieving minimal nausea was defined as the frequency of participants responded to the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) nausea question "In the last 24 hours, how often did you have nausea?" as "rarely or less" Starting with the first dose of chemotherapy and continuing for one day after the last dose of highly or moderately emetogenic conditioning chemotherapy. PRO-CTCAE of nausea scale includes categories: Never, Rarely, Occasionally, Frequently, Almost constantly To meet this endpoint the score reported for the Pro-CTCAE question for nausea frequency cannot exceed "rarely" and the score reported for the Pro-CTCAE question for nausea severity cannot exceed "mild" | The subjects who completed CINV prophylaxis treatment and responded to PRO-CTCAE questions. | Posted | Count of Participants | Participants | Day 2-12 |
|
|
|
| Secondary | Frequency of Nausea in the Acute Phase | Starting with the first dose of highly or moderately emetogenic conditioning chemotherapy and continuing for one day after the last dose of highly or moderately emetogenic conditioning chemotherapy. Nausea was assessed using subjects' responses to the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) nausea questions. Scale: Never, Rarely, Occasionally, Frequently, Almost constantly. To meet this endpoint the score reported for the Pro-CTCAE question for nausea frequency cannot exceed "rarely" in the first 24 hours following receipt of chemotherapy. | The subjects who completed CINV prophylaxis acute phase and responded to PRO-CTCAE questions. | Posted | Count of Participants | Participants | End of day 1 following last chemotherapy administration (Up to day 2) |
|
|
|
| Secondary | Number of Subjects Achieved Emesis Endpoint in Acute Phase. | : The number of subjects who did not experience emesis, starting from the first dose of highly or moderately emetogenic conditioning chemotherapy and continuing for one day after the last dose of highly or moderately emetogenic conditioning chemotherapy. Met endpoint = 0 emesis. | The subjects who completed CINV prophylaxis acute phase and responded to PRO-CTCAE questions. | Posted | Count of Participants | Participants | End of day 1 following last chemotherapy administration. (Up to day 2) |
|
|
|
| Secondary | Frequency of Somnolence | The frequency of somnolence was determined as the number of patients who experienced somnolence based on Common Terminology Criteria for Adverse Events version 5 (CTCAE v5). The number of subjects has somnolence during the study period was counted. | Posted | Count of Participants | Participants | Day 2-12 |
|
|
|
| Secondary | Safety Endpoint: Qtc Prolongation | Prolongation of corrected QTc interval graded as defined in Common Terminology Criteria for Adverse Events (CTCAE) v5.0. Corrected QTc was calculated using Fredericia's Formula. Corrected QT interval (QTc) = QT interval / (60/Heart rate)^0.33. | Posted | Count of Participants | Participants | Day 1 to 5 days after end of the chemotherapy (Days 2- 12). |
|
|
|
| Secondary | Number of Subjects Achieved Nausea Endpoint in the Delayed Phase. | Nausea was assessed using subjects' responses to the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) nausea questions, starting the second day after the completion of highly or moderately emetogenic conditioning chemotherapy and continuing through the fifth day after the completion of highly or moderately emetogenic chemotherapy. Scale: Never, Rarely, Occasionally, Frequently, Almost constantly. The number of subjects who experienced "never" or "rarely" nausea were considered as met the endpoint while those who experienced "occasionally", "frequently" or "almost constantly" were considered as not met the endpoint. | The subjects who completed the treatment and responded to PRO-CTCAE questions. | Posted | Count of Participants | Participants | Day 1 to 5 days after end of the chemotherapy (Days 2-12). |
|
|
|
| Secondary | Severity of Nausea in Delayed Phase | The severity of nausea in the delayed phase was defined as the response of the subject to the PRO- CTCAE nausea question. Starting the second day after the completion of highly or moderately emetogenic conditioning chemotherapy and continuing through the fifth day after the completion of highly or moderately emetogenic chemotherapy (PRO-CTCAE) Scale: Never, Rarely, Occasionally, Frequently, Almost constantly o meet the endpoint, the subject could not have answered a score as higher than "mild" in the period of time starting 24 hours after the last dose of chemotherapy and continuing until the 5th day following receipt of chemotherapy . | The subjects who completed the treatment and responded to PRO-CTCAE questions. | Posted | Count of Participants | Participants | Day 2-12 |
|
|
|
| Secondary | Number of Emesis Episodes in Delayed Phase | The number of emesis episodes in acute phase was defined as the number of subjects with no emesis, 1 emesis, and 2 or more emesis. | The subjects who completed the treatment and responded to PRO-CTCAE questions. | Posted | Count of Participants | Participants | Day 1 to 5 days after end of the chemotherapy ( Days 2-12). |
|
|
|
| Secondary | Total Number of Rescue Medications Needed -Delayed | The total number of rescue medications needed for breakthrough chemotherapy-induced nausea and vomiting were calculated, starting from the second day after the completion of highly or moderately emetogenic conditioning chemotherapy and continuing through the fifth day after the completion of highly or moderately emetogenic chemotherapy. The rescue medication is defined as documented administration of an anti-emetic agent other than those that are scheduled for CINV prophylaxis. | The subjects who completed CINV prophylaxis treatment and their rescue medications were counted. | Posted | Mean | Full Range | number of rescue medication | Day 1 to 5 days after end of the chemotherapy ( Days 2-12). |
|
|
|
| 0 |
| 46 |
| 3 |
| 46 |
| 46 |
| 46 |
| EG001 | Olanzapine | All subjects received both olanzapine and usual care. | 0 | 45 | 8 | 45 | 45 | 45 |
| engraftment syndrome | Immune system disorders | CTCAE (5) | Non-systematic Assessment |
|
| Encephalopathy | Nervous system disorders | CTCAE (5) | Non-systematic Assessment |
|
| cytokine release syndrome | Immune system disorders | CTCAE (5) | Non-systematic Assessment |
|
| Syncopal episode | General disorders | CTCAE (5) | Non-systematic Assessment |
|
| Tumor Lysis Syndrome | Metabolism and nutrition disorders | CTCAE (5) | Non-systematic Assessment |
|
| Activated partial thromboplastin time prolonged | Investigations | CTCAE (5) | Non-systematic Assessment |
|
| Akathisia | Nervous system disorders | CTCAE (5) | Non-systematic Assessment |
|
| pain in extremity | Musculoskeletal and connective tissue disorders | CTCAE (5) | Non-systematic Assessment |
|
| Blurred vision | Eye disorders | CTCAE (5) | Non-systematic Assessment |
|
| Bradycardia | Cardiac disorders | CTCAE (5) | Non-systematic Assessment |
|
| Chest pain | General disorders | CTCAE (5) | Non-systematic Assessment |
|
| Confusion | Nervous system disorders | CTCAE (5) | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | CTCAE (5) | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE (5) | Non-systematic Assessment |
|
| Creatinine increase | Investigations | CTCAE (5) | Non-systematic Assessment |
|
| Depression | Nervous system disorders | CTCAE (5) | Non-systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | CTCAE (5) | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | CTCAE (5) | Non-systematic Assessment |
|
| Dry skin | Nervous system disorders | CTCAE (5) | Non-systematic Assessment |
|
| Dysgeusia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (5) | Non-systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | CTCAE (5) | Non-systematic Assessment |
|
| Ear and labrynth disorder | Ear and labyrinth disorders | CTCAE (5) | Non-systematic Assessment |
|
| Elevated alkaline phosphatase | Investigations | CTCAE (5) | Non-systematic Assessment |
|
| Alanine transaminase elevated | Investigations | CTCAE (5) | Non-systematic Assessment |
|
| aspartate aminotransferase elevated | Investigations | CTCAE (5) | Non-systematic Assessment |
|
| hyperglycemia | Metabolism and nutrition disorders | CTCAE (5) | Non-systematic Assessment |
|
| blood bilirubin increased | Investigations | CTCAE (5) | Non-systematic Assessment |
|
| Extrapyramidal symptom | Nervous system disorders | CTCAE (5) | Non-systematic Assessment |
|
| Fatigue | General disorders | CTCAE (5) | Non-systematic Assessment |
|
| Gastroesophageal reflux disease | Gastrointestinal disorders | CTCAE (5) | Non-systematic Assessment |
|
| fever | General disorders | CTCAE (5) | Non-systematic Assessment |
|
| Headache | Nervous system disorders | CTCAE (5) | Non-systematic Assessment |
|
| Hemorrhoids | Gastrointestinal disorders | CTCAE (5) | Non-systematic Assessment |
|
| Hiccups | Respiratory, thoracic and mediastinal disorders | CTCAE (5) | Non-systematic Assessment |
|
| hot flashes | Vascular disorders | CTCAE (5) | Non-systematic Assessment |
|
| Respiratory, thoracic and mediastinal disorders - Other, specify | Respiratory, thoracic and mediastinal disorders | CTCAE (5) | Non-systematic Assessment |
|
| Hypertension | Vascular disorders | CTCAE (5) | Non-systematic Assessment |
|
| Hyperuricemia | Renal and urinary disorders | CTCAE (5) | Non-systematic Assessment |
|
| Hypoalbuminemia | Metabolism and nutrition disorders | CTCAE (5) | Non-systematic Assessment |
|
| Hypocalcemia | Metabolism and nutrition disorders | CTCAE (5) | Non-systematic Assessment |
|
| Hyponatremia | Metabolism and nutrition disorders | CTCAE (5) | Non-systematic Assessment |
|
| Hypotension | Vascular disorders | CTCAE (5) | Non-systematic Assessment |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | CTCAE (5) | Non-systematic Assessment |
|
| anxiety | Psychiatric disorders | CTCAE (5) | Non-systematic Assessment |
|
| Infection | Infections and infestations | CTCAE (5) | Non-systematic Assessment |
|
| Insomnia | Psychiatric disorders | CTCAE (5) | Non-systematic Assessment |
|
| Leukocytosis | Blood and lymphatic system disorders | CTCAE (5) | Non-systematic Assessment |
|
| Agitation | Psychiatric disorders | CTCAE (5) | Non-systematic Assessment | mood change |
|
| Mucositis | Gastrointestinal disorders | CTCAE (5) | Non-systematic Assessment |
|
| Muscle spasm | Musculoskeletal and connective tissue disorders | CTCAE (5) | Non-systematic Assessment |
|
| Neuropathy | Nervous system disorders | CTCAE (5) | Non-systematic Assessment |
|
| Non-cardiac chest pain | General disorders | CTCAE (5) | Non-systematic Assessment |
|
| Renal and urinary disorders - Other, specify | Renal and urinary disorders | CTCAE (5) | Non-systematic Assessment | Other electrolyte abnormality |
|
| Pain | General disorders | CTCAE (5) | Non-systematic Assessment |
|
| Parkinsonian symptom | Nervous system disorders | CTCAE (5) | Non-systematic Assessment |
|
| Pruritis | Skin and subcutaneous tissue disorders | CTCAE (5) | Non-systematic Assessment |
|
| Rash maculo-papular | Skin and subcutaneous tissue disorders | CTCAE (5) | Non-systematic Assessment |
|
| subconjunctival hemorrhage | Eye disorders | CTCAE (5) | Non-systematic Assessment |
|
| Edema limbs | General disorders | CTCAE (5) | Non-systematic Assessment |
|
| Tachycardia | Cardiac disorders | CTCAE (5) | Non-systematic Assessment |
|
| Syncope | Cardiac disorders | CTCAE (5) | Non-systematic Assessment |
|
| Tachypnea | Respiratory, thoracic and mediastinal disorders | CTCAE (5) | Non-systematic Assessment |
|
| Thromboembolic event | Blood and lymphatic system disorders | CTCAE (5) | Non-systematic Assessment |
|
| Tremor | Nervous system disorders | CTCAE (5) | Non-systematic Assessment |
|
| Xerostomia | Endocrine disorders | CTCAE (5) | Non-systematic Assessment |
|
Not provided
Not provided
Not provided
| D006571 | Heterocyclic Compounds |
| Grade 2 |
|
| Grade 3 |
|
| Grade 4 |
|
| Grade 5 |
|
| None |
|
| 2 or more emesis episodes |
|