Hematopoietic/Lymphoid Cancer, Nausea and Vomiting, Unspecified Adult Solid Tumor, Protocol Specific
Conditions
Brief summary
This randomized phase III trial studies antiemetic therapy with olanzapine to see how well they work compared to antiemetic therapy alone in preventing chemotherapy-induced nausea and vomiting in patients with cancer receiving highly emetogenic (causes vomiting) chemotherapy. Antiemetic drugs, such as palonosetron hydrochloride, ondansetron, and granisetron hydrochloride, may help lessen or prevent nausea and vomiting in patients treated with chemotherapy. Olanzapine may help prevent chemotherapy-induced nausea and vomiting by blocking brain receptors that appear to be involved in nausea and vomiting.
Detailed description
Patients with cancer may receive chemotherapy that may cause nausea and vomiting. The purpose of this study is to determine if the use of olanzapine in combination with antiemetic therapy can significantly reduce nausea and vomiting in a large number of patients receiving chemotherapy. Patients are randomized to one of two treatment arms. Please see the Arms and Intervention sections for more detailed information. The primary objective is to compare the number of patients with no nausea for the acute (0-24 hours post-chemotherapy), delayed (24-120 hours post-chemotherapy) and overall periods (0-120 hours post-chemotherapy) for patients receiving HEC. The secondary objectives are: 1. To compare the complete response (CR) (no emetic episodes and no use of rescue medication) in the acute, delayed and overall periods 2. To compare the incidences of potential toxicities ascribed to olanzapine Protocol treatment is to begin ≤ 14 days of registration. Patients will receive treatment on Days 1-4. Patients will be permitted to take rescue therapy of the treating investigator's choice for nausea and/or emesis/retching, based on clinical circumstances. After completing treatment, patients will be monitored for side effects.
Interventions
DRUGOlanzapine
oral
DRUGChemotherapy (cisplatin or cyclophosphamide and doxorubicin)
oral or IV
DRUGAntiemetic treatment (ondansetron or granisetron or palonosetron; plus dexamethasone; plus fosaprepitant or aprepitant)
oral or IV
OTHERPlacebo
oral
Sponsors
National Cancer Institute (NCI)
Alliance for Clinical Trials in Oncology
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosis of malignant disease * No prior chemotherapy and scheduled to receive HEC (either cisplatin-containing regimen or anthracycline + cyclophosphamide \[AC\]) * Cisplatin at a dose of ≥70mg/m\^2, with or without other chemotherapy agent(s) OR * Anthracycline (60 mg/m\^2) plus cyclophosphamide(600 mg/m\^2) * Age ≥18 years * Eastern Cooperative Oncology Group (ECOG) Performance Status 0, 1 or 2 * Required Initial Laboratory Values ≤ 120 days prior to registration * Serum Creatinine ≤2.0 mg/dL * Serum glutamic oxaloacetic transaminase (SGOT) or Serum glutamic oxaloacetic transaminase (SGPT) ≤3 x Upper Limit of Normal (ULN) * Absolute neutrophil count (ANC) ≥1500/mm\^3 * No nausea or vomiting ≤ 24 hours prior to registration * Negative pregnancy test (serum or urine) done ≤7 days prior to registration, for women of childbearing potential only (per clinician discretion) * No severe cognitive compromise * No known history of CNS disease (e.g. brain metastases, seizure disorder) * No treatment with another antipsychotic agent such as risperidone, quetiapine, clozapine, phenothiazine or butyrophenone ≤30 days prior to registration or planned during protocol therapy * No chronic phenothiazine administration as an antipsychotic agent (patients may receive prochlorperazine and other phenothiazines as rescue anti-emetic therapy) * No concurrent use of amifostine * No concurrent abdominal radiotherapy * No concurrent use of quinolone antibiotic therapy * No chronic alcoholism (as determined by the investigator) * No known hypersensitivity to olanzapine * No known cardiac arrhythmia, uncontrolled congestive heart failure or acute myocardial infarction within the previous six months. * No history of uncontrolled diabetes mellitus (e.g. on insulin or an oral hypoglycemic agent)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Patients With no Nausea | 0 to 120 hours after chemotherapy | No nausea was defined as a response of 0 in the nausea item of Nausea and Vomiting Daily Diary/Questionnaire in the acute (0-24 hours), delayed (25-120 hours) and overall (0-120 hours) periods after chemotherapy. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Median Nausea Scores | Baseline and Day 2 to Day 6 after chemotherapy | Nausea scores was measured using a visual-analogue scale ranging from 0 (none) to 10 (as bad as it can be). |
| Proportion of Patients With Complete Response | 0 to 120 hours after chemotherapy | Complete response was defined as no emetic episodes and no use of rescue medication during the acute (0-24 hours), delayed (25-120 hours) and overall (0-120 hours) periods as measured by the Nausea and Vomiting Daily Diary/Questionnaire. |
| Mean Scores of Potential Toxicities Related to Olanzapine as Measured by the Nausea and Vomiting Daily Diary/Questionnaire | Baseline and day 2 to 6 days after chemotherapy | Patients were asked to record daily levels of undesired sedation and appetite increase using a visual-analogue scale ranging from 0 (none) to 10 (as bad as it can be). |
| Frequency of Rescue Medication | Day 2 to Day 6 after chemotherapy | Patients were asked to record daily number of extra nausea/vomiting pills taken because they developed nausea/vomiting in the following categories: None, One, Two, More than two in Nausea and Vomiting Daily Diary Questionnaire. |
Countries
United States
Participant flow
Recruitment details
Four-hundred and one (401) participants were enrolled from 46 academic or community practice institutions in the United States between August 2014 and March 2015.
Pre-assignment details
There were eighteen participants withdrew consent (8 Olanzapine; 10 Placebo); and three participants had major violations (2 Olanzapine; 1 Placebo). All of these 21 participants were excluded from all analyses.
Participants by arm
| Arm | Count |
|---|---|
| Olanzapine Patients receive the chemotherapy drugs cisplatin or cyclophosphamide and doxorubicin as well as the following anti-nausea/vomiting drugs:
* Ondansetron (8 mg orally or intravenously) or granisetron (1 mg intravenously or 2 mg orally) or palonosetron (0.25 mg intravenously) on the day of chemotherapy, plus
* Dexamethasone (12 mg orally on the day of chemotherapy and 8 mg orally days 2, 3, 4 post chemotherapy), plus
* Fosaprepitant (150 mg intravenously on the day of chemotherapy) or aprepitant (125 mg orally on the day of chemotherapy and 80 mg orally on days 2 and 3 post chemotherapy), plus
* olanzapine (10 mg orally on the day of chemotherapy and 10 mg orally on days 2, 3, 4 post chemotherapy) | 192 |
| Placebo Patients receive the chemotherapy drugs cisplatin or cyclophosphamide and doxorubicin as well as usual anti-nausea/vomiting drugs:
* Ondansetron (8 mg orally or intravenously) or granisetron (1 mg intravenously or 2 mg orally) or palonosetron (0.25 mg intravenously) on the day of chemotherapy, plus
* Dexamethasone (12 mg orally on the day of chemotherapy and 8 mg orally days 2, 3, 4 post chemotherapy), plus
* Fosaprepitant (150 mg intravenously on the day of chemotherapy) or aprepitant (125 mg orally on the day of chemotherapy and 80 mg orally on days 2 and 3 post chemotherapy), plus
* placebo | 188 |
| Total | 380 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 4 | 0 |
| Overall Study | Lost to Follow-up | 1 | 0 |
| Overall Study | Other Medical Problems | 2 | 2 |
| Overall Study | Physician Decision | 1 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 2 |
Baseline characteristics
| Characteristic | Total | Olanzapine | Placebo |
|---|---|---|---|
| 5-hydroxytryptamine type 3 receptor antagonist Granisetron | 2 Participants | 1 Participants | 1 Participants |
| 5-hydroxytryptamine type 3 receptor antagonist Ondansetron | 90 Participants | 46 Participants | 44 Participants |
| 5-hydroxytryptamine type 3 receptor antagonist Palonosetron | 288 Participants | 145 Participants | 143 Participants |
| Age, Continuous | 57 years | 58 years | 56 years |
| Chemotherapy regimen Anthracyline and cyclophosphamide | 244 Participants | 121 Participants | 123 Participants |
| Chemotherapy regimen Cisplatin-containing regimen | 136 Participants | 71 Participants | 65 Participants |
| Eastern Cooperative Oncology Group (ECOG) Performance Status 0=Asymptomatic and fully active | 293 Participants | 149 Participants | 144 Participants |
| Eastern Cooperative Oncology Group (ECOG) Performance Status 1=Symptomatic and fully ambulatory | 81 Participants | 40 Participants | 41 Participants |
| Eastern Cooperative Oncology Group (ECOG) Performance Status 2=Symptomatic, <50% in bed during the day | 5 Participants | 2 Participants | 3 Participants |
| Eastern Cooperative Oncology Group (ECOG) Performance Status Not assessed | 1 Participants | 1 Participants | 0 Participants |
| Primary site of disease Breast | 242 Participants | 120 Participants | 122 Participants |
| Primary site of disease Lung | 49 Participants | 27 Participants | 22 Participants |
| Primary site of disease Other | 89 Participants | 45 Participants | 44 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 4 Participants | 3 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 9 Participants | 5 Participants | 4 Participants |
| Race (NIH/OMB) Black or African American | 18 Participants | 9 Participants | 9 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 6 Participants | 3 Participants | 3 Participants |
| Race (NIH/OMB) White | 343 Participants | 172 Participants | 171 Participants |
| Region of Enrollment United States | 380 participants | 192 participants | 188 participants |
| Sex: Female, Male Female | 275 Participants | 139 Participants | 136 Participants |
| Sex: Female, Male Male | 105 Participants | 53 Participants | 52 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 44 / 188 | 36 / 185 |
| serious Total, serious adverse events | 3 / 188 | 0 / 185 |
Outcome results
Primary
Proportion of Patients With no Nausea
No nausea was defined as a response of 0 in the nausea item of Nausea and Vomiting Daily Diary/Questionnaire in the acute (0-24 hours), delayed (25-120 hours) and overall (0-120 hours) periods after chemotherapy.
Time frame: 0 to 120 hours after chemotherapy
Population: All participants who met eligibility criteria, did not cancel prior to receiving treatment, had no major violations and had Nausea data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Olanzapine | Proportion of Patients With no Nausea | 0-24 hours after chemotherapy | 73.8 percentage of participants |
| Olanzapine | Proportion of Patients With no Nausea | 25-120 hours after chemotherapy | 42.4 percentage of participants |
| Olanzapine | Proportion of Patients With no Nausea | 0-120 hours after chemotherapy | 37.3 percentage of participants |
| Placebo | Proportion of Patients With no Nausea | 0-24 hours after chemotherapy | 45.3 percentage of participants |
| Placebo | Proportion of Patients With no Nausea | 25-120 hours after chemotherapy | 25.4 percentage of participants |
| Placebo | Proportion of Patients With no Nausea | 0-120 hours after chemotherapy | 21.9 percentage of participants |
Secondary
Frequency of Rescue Medication
Patients were asked to record daily number of extra nausea/vomiting pills taken because they developed nausea/vomiting in the following categories: None, One, Two, More than two in Nausea and Vomiting Daily Diary Questionnaire.
Time frame: Day 2 to Day 6 after chemotherapy
Population: All participants who met eligibility criteria, did not cancel prior to receiving treatment, had no major violations and had rescue medication data at each time point.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Olanzapine | Frequency of Rescue Medication | Day 2 | Twice | 3 Participants |
| Olanzapine | Frequency of Rescue Medication | Day 4 | Twice | 10 Participants |
| Olanzapine | Frequency of Rescue Medication | Day 3 | Once | 11 Participants |
| Olanzapine | Frequency of Rescue Medication | Day 4 | More than twice | 3 Participants |
| Olanzapine | Frequency of Rescue Medication | Day 2 | Once | 21 Participants |
| Olanzapine | Frequency of Rescue Medication | Day 5 | None | 145 Participants |
| Olanzapine | Frequency of Rescue Medication | Day 3 | Twice | 7 Participants |
| Olanzapine | Frequency of Rescue Medication | Day 5 | Once | 19 Participants |
| Olanzapine | Frequency of Rescue Medication | Day 2 | More than twice | 2 Participants |
| Olanzapine | Frequency of Rescue Medication | Day 5 | Twice | 5 Participants |
| Olanzapine | Frequency of Rescue Medication | Day 3 | More than twice | 4 Participants |
| Olanzapine | Frequency of Rescue Medication | Day 5 | More than twice | 4 Participants |
| Olanzapine | Frequency of Rescue Medication | Day 2 | None | 156 Participants |
| Olanzapine | Frequency of Rescue Medication | Day 6 | None | 143 Participants |
| Olanzapine | Frequency of Rescue Medication | Day 4 | None | 141 Participants |
| Olanzapine | Frequency of Rescue Medication | Day 6 | Once | 12 Participants |
| Olanzapine | Frequency of Rescue Medication | Day 3 | None | 158 Participants |
| Olanzapine | Frequency of Rescue Medication | Day 4 | Once | 16 Participants |
| Olanzapine | Frequency of Rescue Medication | Day 6 | More than twice | 4 Participants |
| Olanzapine | Frequency of Rescue Medication | Day 6 | Twice | 12 Participants |
| Placebo | Frequency of Rescue Medication | Day 6 | More than twice | 14 Participants |
| Placebo | Frequency of Rescue Medication | Day 2 | None | 117 Participants |
| Placebo | Frequency of Rescue Medication | Day 2 | Once | 35 Participants |
| Placebo | Frequency of Rescue Medication | Day 2 | Twice | 19 Participants |
| Placebo | Frequency of Rescue Medication | Day 2 | More than twice | 10 Participants |
| Placebo | Frequency of Rescue Medication | Day 3 | None | 124 Participants |
| Placebo | Frequency of Rescue Medication | Day 3 | Once | 24 Participants |
| Placebo | Frequency of Rescue Medication | Day 3 | Twice | 20 Participants |
| Placebo | Frequency of Rescue Medication | Day 3 | More than twice | 10 Participants |
| Placebo | Frequency of Rescue Medication | Day 4 | None | 124 Participants |
| Placebo | Frequency of Rescue Medication | Day 4 | Once | 24 Participants |
| Placebo | Frequency of Rescue Medication | Day 4 | Twice | 17 Participants |
| Placebo | Frequency of Rescue Medication | Day 4 | More than twice | 11 Participants |
| Placebo | Frequency of Rescue Medication | Day 5 | None | 131 Participants |
| Placebo | Frequency of Rescue Medication | Day 5 | Once | 23 Participants |
| Placebo | Frequency of Rescue Medication | Day 5 | Twice | 7 Participants |
| Placebo | Frequency of Rescue Medication | Day 5 | More than twice | 10 Participants |
| Placebo | Frequency of Rescue Medication | Day 6 | None | 130 Participants |
| Placebo | Frequency of Rescue Medication | Day 6 | Once | 16 Participants |
| Placebo | Frequency of Rescue Medication | Day 6 | Twice | 11 Participants |
Secondary
Mean Scores of Potential Toxicities Related to Olanzapine as Measured by the Nausea and Vomiting Daily Diary/Questionnaire
Patients were asked to record daily levels of undesired sedation and appetite increase using a visual-analogue scale ranging from 0 (none) to 10 (as bad as it can be).
Time frame: Baseline and day 2 to 6 days after chemotherapy
Population: All participants who met eligibility criteria, did not cancel prior to receiving treatment, had no major violations and had toxicities data at each time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Olanzapine | Mean Scores of Potential Toxicities Related to Olanzapine as Measured by the Nausea and Vomiting Daily Diary/Questionnaire | Baseline Undesired Sedation | 0.4 units on a scale | Standard Deviation 1.2 |
| Olanzapine | Mean Scores of Potential Toxicities Related to Olanzapine as Measured by the Nausea and Vomiting Daily Diary/Questionnaire | Day 2 Undesired Sedation | 2.3 units on a scale | Standard Deviation 3.2 |
| Olanzapine | Mean Scores of Potential Toxicities Related to Olanzapine as Measured by the Nausea and Vomiting Daily Diary/Questionnaire | Day 3 Undesired Sedation | 1.6 units on a scale | Standard Deviation 2.5 |
| Olanzapine | Mean Scores of Potential Toxicities Related to Olanzapine as Measured by the Nausea and Vomiting Daily Diary/Questionnaire | Day 4 Undesired Sedation | 1.5 units on a scale | Standard Deviation 2.3 |
| Olanzapine | Mean Scores of Potential Toxicities Related to Olanzapine as Measured by the Nausea and Vomiting Daily Diary/Questionnaire | Day 5 Undesired Sedation | 1.2 units on a scale | Standard Deviation 2.1 |
| Olanzapine | Mean Scores of Potential Toxicities Related to Olanzapine as Measured by the Nausea and Vomiting Daily Diary/Questionnaire | Day 6 Undesired Sedation | 0.9 units on a scale | Standard Deviation 1.8 |
| Olanzapine | Mean Scores of Potential Toxicities Related to Olanzapine as Measured by the Nausea and Vomiting Daily Diary/Questionnaire | Baseline Appetite Increase | 0.6 units on a scale | Standard Deviation 1.7 |
| Olanzapine | Mean Scores of Potential Toxicities Related to Olanzapine as Measured by the Nausea and Vomiting Daily Diary/Questionnaire | Day 2 Appetite Increase | 0.7 units on a scale | Standard Deviation 1.6 |
| Olanzapine | Mean Scores of Potential Toxicities Related to Olanzapine as Measured by the Nausea and Vomiting Daily Diary/Questionnaire | Day 3 Appetite Increase | 0.7 units on a scale | Standard Deviation 1.5 |
| Olanzapine | Mean Scores of Potential Toxicities Related to Olanzapine as Measured by the Nausea and Vomiting Daily Diary/Questionnaire | Day 4 Appetite Increase | 1.0 units on a scale | Standard Deviation 1.8 |
| Olanzapine | Mean Scores of Potential Toxicities Related to Olanzapine as Measured by the Nausea and Vomiting Daily Diary/Questionnaire | Day 5 Appetite Increase | 1.0 units on a scale | Standard Deviation 1.8 |
| Olanzapine | Mean Scores of Potential Toxicities Related to Olanzapine as Measured by the Nausea and Vomiting Daily Diary/Questionnaire | Day 6 Appetite Increase | 1.1 units on a scale | Standard Deviation 2 |
| Placebo | Mean Scores of Potential Toxicities Related to Olanzapine as Measured by the Nausea and Vomiting Daily Diary/Questionnaire | Day 5 Appetite Increase | 0.7 units on a scale | Standard Deviation 1.7 |
| Placebo | Mean Scores of Potential Toxicities Related to Olanzapine as Measured by the Nausea and Vomiting Daily Diary/Questionnaire | Baseline Undesired Sedation | 0.5 units on a scale | Standard Deviation 1.5 |
| Placebo | Mean Scores of Potential Toxicities Related to Olanzapine as Measured by the Nausea and Vomiting Daily Diary/Questionnaire | Baseline Appetite Increase | 0.3 units on a scale | Standard Deviation 0.9 |
| Placebo | Mean Scores of Potential Toxicities Related to Olanzapine as Measured by the Nausea and Vomiting Daily Diary/Questionnaire | Day 2 Undesired Sedation | 1.2 units on a scale | Standard Deviation 2.2 |
| Placebo | Mean Scores of Potential Toxicities Related to Olanzapine as Measured by the Nausea and Vomiting Daily Diary/Questionnaire | Day 4 Appetite Increase | 0.7 units on a scale | Standard Deviation 1.7 |
| Placebo | Mean Scores of Potential Toxicities Related to Olanzapine as Measured by the Nausea and Vomiting Daily Diary/Questionnaire | Day 3 Undesired Sedation | 1.4 units on a scale | Standard Deviation 2.3 |
| Placebo | Mean Scores of Potential Toxicities Related to Olanzapine as Measured by the Nausea and Vomiting Daily Diary/Questionnaire | Day 2 Appetite Increase | 0.5 units on a scale | Standard Deviation 1.5 |
| Placebo | Mean Scores of Potential Toxicities Related to Olanzapine as Measured by the Nausea and Vomiting Daily Diary/Questionnaire | Day 4 Undesired Sedation | 1.4 units on a scale | Standard Deviation 2.3 |
| Placebo | Mean Scores of Potential Toxicities Related to Olanzapine as Measured by the Nausea and Vomiting Daily Diary/Questionnaire | Day 6 Appetite Increase | 0.7 units on a scale | Standard Deviation 1.7 |
| Placebo | Mean Scores of Potential Toxicities Related to Olanzapine as Measured by the Nausea and Vomiting Daily Diary/Questionnaire | Day 5 Undesired Sedation | 1.2 units on a scale | Standard Deviation 2.1 |
| Placebo | Mean Scores of Potential Toxicities Related to Olanzapine as Measured by the Nausea and Vomiting Daily Diary/Questionnaire | Day 3 Appetite Increase | 0.6 units on a scale | Standard Deviation 1.7 |
| Placebo | Mean Scores of Potential Toxicities Related to Olanzapine as Measured by the Nausea and Vomiting Daily Diary/Questionnaire | Day 6 Undesired Sedation | 1.3 units on a scale | Standard Deviation 2.2 |
Secondary
Median Nausea Scores
Nausea scores was measured using a visual-analogue scale ranging from 0 (none) to 10 (as bad as it can be).
Time frame: Baseline and Day 2 to Day 6 after chemotherapy
Population: All participants who met eligibility criteria, did not cancel prior to receiving treatment, had no major violations and had Nausea data at each time point.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Olanzapine | Median Nausea Scores | Baseline | 0 units on a scale |
| Olanzapine | Median Nausea Scores | Day 2 | 0 units on a scale |
| Olanzapine | Median Nausea Scores | Day 3 | 0 units on a scale |
| Olanzapine | Median Nausea Scores | Day 4 | 0 units on a scale |
| Olanzapine | Median Nausea Scores | Day 5 | 0 units on a scale |
| Olanzapine | Median Nausea Scores | Day 6 | 0 units on a scale |
| Placebo | Median Nausea Scores | Day 5 | 1 units on a scale |
| Placebo | Median Nausea Scores | Baseline | 0 units on a scale |
| Placebo | Median Nausea Scores | Day 4 | 1 units on a scale |
| Placebo | Median Nausea Scores | Day 2 | 1 units on a scale |
| Placebo | Median Nausea Scores | Day 6 | 1 units on a scale |
| Placebo | Median Nausea Scores | Day 3 | 1 units on a scale |
Secondary
Proportion of Patients With Complete Response
Complete response was defined as no emetic episodes and no use of rescue medication during the acute (0-24 hours), delayed (25-120 hours) and overall (0-120 hours) periods as measured by the Nausea and Vomiting Daily Diary/Questionnaire.
Time frame: 0 to 120 hours after chemotherapy
Population: All participants who met eligibility criteria, did not cancel prior to receiving treatment, had no major violations and had data on emetic and use of rescue medication questions.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Olanzapine | Proportion of Patients With Complete Response | 0-24 hours after chemotherapy | 85.7 percentage of participants |
| Olanzapine | Proportion of Patients With Complete Response | 25-120 hours after chemotherapy | 66.9 percentage of participants |
| Olanzapine | Proportion of Patients With Complete Response | 0-120 hours after chemotherapy | 63.6 percentage of participants |
| Placebo | Proportion of Patients With Complete Response | 0-24 hours after chemotherapy | 64.6 percentage of participants |
| Placebo | Proportion of Patients With Complete Response | 25-120 hours after chemotherapy | 52.4 percentage of participants |
| Placebo | Proportion of Patients With Complete Response | 0-120 hours after chemotherapy | 40.6 percentage of participants |