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Antiemetic Therapy With or Without Olanzapine in Preventing Chemotherapy-Induced Nausea and Vomiting in Patients With Cancer Receiving Highly Emetogenic Chemotherapy

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ClinicalTrials.gov Identifier: NCT02116530
Recruitment Status : Completed
First Posted : April 17, 2014
Results First Posted : April 10, 2017
Last Update Posted : May 7, 2020
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Supportive Care
Conditions Hematopoietic/Lymphoid Cancer
Nausea and Vomiting
Unspecified Adult Solid Tumor, Protocol Specific
Interventions Drug: Olanzapine
Drug: Chemotherapy (cisplatin or cyclophosphamide and doxorubicin)
Drug: Antiemetic treatment (ondansetron or granisetron or palonosetron; plus dexamethasone; plus fosaprepitant or aprepitant)
Other: Placebo
Enrollment 401
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.
Arm/Group Title Olanzapine Placebo
Hide Arm/Group Description

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)

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
Period Title: Overall Study
Started 192 188
Completed 183 184
Not Completed 9 4
Reason Not Completed
Withdrawal by Subject             1             2
Adverse Event             4             0
Physician Decision             1             0
Lost to Follow-up             1             0
Other Medical Problems             2             2
Arm/Group Title Olanzapine Placebo Total
Hide Arm/Group Description

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)

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
Total of all reporting groups
Overall Number of Baseline Participants 192 188 380
Hide Baseline Analysis Population Description
All participants who started the treatment.
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 192 participants 188 participants 380 participants
58
(29 to 86)
56
(28 to 89)
57
(28 to 89)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 192 participants 188 participants 380 participants
Female
139
  72.4%
136
  72.3%
275
  72.4%
Male
53
  27.6%
52
  27.7%
105
  27.6%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 192 participants 188 participants 380 participants
American Indian or Alaska Native
3
   1.6%
1
   0.5%
4
   1.1%
Asian
5
   2.6%
4
   2.1%
9
   2.4%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
9
   4.7%
9
   4.8%
18
   4.7%
White
172
  89.6%
171
  91.0%
343
  90.3%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
3
   1.6%
3
   1.6%
6
   1.6%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 192 participants 188 participants 380 participants
192 188 380
5-hydroxytryptamine type 3 receptor antagonist  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 192 participants 188 participants 380 participants
Palonosetron
145
  75.5%
143
  76.1%
288
  75.8%
Ondansetron
46
  24.0%
44
  23.4%
90
  23.7%
Granisetron
1
   0.5%
1
   0.5%
2
   0.5%
Chemotherapy regimen  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 192 participants 188 participants 380 participants
Cisplatin-containing regimen
71
  37.0%
65
  34.6%
136
  35.8%
Anthracyline and cyclophosphamide
121
  63.0%
123
  65.4%
244
  64.2%
Primary site of disease  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 192 participants 188 participants 380 participants
Breast
120
  62.5%
122
  64.9%
242
  63.7%
Lung
27
  14.1%
22
  11.7%
49
  12.9%
Other
45
  23.4%
44
  23.4%
89
  23.4%
Eastern Cooperative Oncology Group (ECOG) Performance Status  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 192 participants 188 participants 380 participants
0=Asymptomatic and fully active 149 144 293
1=Symptomatic and fully ambulatory 40 41 81
2=Symptomatic, <50% in bed during the day 2 3 5
Not assessed 1 0 1
1.Primary Outcome
Title Proportion of Patients With no Nausea
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who met eligibility criteria, did not cancel prior to receiving treatment, had no major violations and had Nausea data.
Arm/Group Title Olanzapine Placebo
Hide Arm/Group Description:

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)

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
Overall Number of Participants Analyzed 183 181
Measure Type: Number
Unit of Measure: percentage of participants
0-24 hours after chemotherapy Number Analyzed 183 participants 181 participants
73.8 45.3
25-120 hours after chemotherapy Number Analyzed 177 participants 177 participants
42.4 25.4
0-120 hours after chemotherapy Number Analyzed 177 participants 178 participants
37.3 21.9
2.Secondary Outcome
Title Median Nausea Scores
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Olanzapine Placebo
Hide Arm/Group Description:

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)

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
Overall Number of Participants Analyzed 190 188
Median (Full Range)
Unit of Measure: units on a scale
Baseline Number Analyzed 190 participants 188 participants
0
(0 to 7)
0
(0 to 9)
Day 2 Number Analyzed 183 participants 181 participants
0
(0 to 10)
1
(0 to 10)
Day 3 Number Analyzed 182 participants 180 participants
0
(0 to 9)
1
(0 to 10)
Day 4 Number Analyzed 179 participants 179 participants
0
(0 to 8)
1
(0 to 9)
Day 5 Number Analyzed 179 participants 174 participants
0
(0 to 10)
1
(0 to 10)
Day 6 Number Analyzed 176 participants 174 participants
0
(0 to 9)
1
(0 to 10)
3.Secondary Outcome
Title Proportion of Patients With Complete Response
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Olanzapine Placebo
Hide Arm/Group Description:

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)

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
Overall Number of Participants Analyzed 182 181
Measure Type: Number
Unit of Measure: percentage of participants
0-24 hours after chemotherapy Number Analyzed 182 participants 181 participants
85.7 64.6
25-120 hours after chemotherapy Number Analyzed 163 participants 168 participants
66.9 52.4
0-120 hours after chemotherapy Number Analyzed 162 participants 170 participants
63.6 40.6
4.Secondary Outcome
Title Mean Scores of Potential Toxicities Related to Olanzapine as Measured by the Nausea and Vomiting Daily Diary/Questionnaire
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Olanzapine Placebo
Hide Arm/Group Description:

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)

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
Overall Number of Participants Analyzed 190 188
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline Undesired Sedation Number Analyzed 190 participants 188 participants
0.4  (1.2) 0.5  (1.5)
Day 2 Undesired Sedation Number Analyzed 181 participants 181 participants
2.3  (3.2) 1.2  (2.2)
Day 3 Undesired Sedation Number Analyzed 182 participants 180 participants
1.6  (2.5) 1.4  (2.3)
Day 4 Undesired Sedation Number Analyzed 179 participants 179 participants
1.5  (2.3) 1.4  (2.3)
Day 5 Undesired Sedation Number Analyzed 179 participants 173 participants
1.2  (2.1) 1.2  (2.1)
Day 6 Undesired Sedation Number Analyzed 175 participants 174 participants
0.9  (1.8) 1.3  (2.2)
Baseline Appetite Increase Number Analyzed 190 participants 187 participants
0.6  (1.7) 0.3  (0.9)
Day 2 Appetite Increase Number Analyzed 183 participants 181 participants
0.7  (1.6) 0.5  (1.5)
Day 3 Appetite Increase Number Analyzed 182 participants 180 participants
0.7  (1.5) 0.6  (1.7)
Day 4 Appetite Increase Number Analyzed 179 participants 179 participants
1.0  (1.8) 0.7  (1.7)
Day 5 Appetite Increase Number Analyzed 179 participants 174 participants
1.0  (1.8) 0.7  (1.7)
Day 6 Appetite Increase Number Analyzed 176 participants 174 participants
1.1  (2.0) 0.7  (1.7)
5.Secondary Outcome
Title Frequency of Rescue Medication
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Olanzapine Placebo
Hide Arm/Group Description:

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)

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
Overall Number of Participants Analyzed 182 181
Measure Type: Count of Participants
Unit of Measure: Participants
Day 2 Number Analyzed 182 participants 181 participants
None
156
  85.7%
117
  64.6%
Once
21
  11.5%
35
  19.3%
Twice
3
   1.6%
19
  10.5%
More than twice
2
   1.1%
10
   5.5%
Day 3 Number Analyzed 180 participants 178 participants
None
158
  87.8%
124
  69.7%
Once
11
   6.1%
24
  13.5%
Twice
7
   3.9%
20
  11.2%
More than twice
4
   2.2%
10
   5.6%
Day 4 Number Analyzed 170 participants 176 participants
None
141
  82.9%
124
  70.5%
Once
16
   9.4%
24
  13.6%
Twice
10
   5.9%
17
   9.7%
More than twice
3
   1.8%
11
   6.3%
Day 5 Number Analyzed 173 participants 171 participants
None
145
  83.8%
131
  76.6%
Once
19
  11.0%
23
  13.5%
Twice
5
   2.9%
7
   4.1%
More than twice
4
   2.3%
10
   5.8%
Day 6 Number Analyzed 171 participants 171 participants
None
143
  83.6%
130
  76.0%
Once
12
   7.0%
16
   9.4%
Twice
12
   7.0%
11
   6.4%
More than twice
4
   2.3%
14
   8.2%
Time Frame Day 2 to Day 4 after chemotherapy
Adverse Event Reporting Description All participants who met eligibility criteria, did not cancel prior to receiving treatment, had no major violations. Adverse events were not assessed on seven participants due to participants went off treatment on day 1 of chemotherapy (3 Olanzapine, 3 Placebo) or nurse was not able to reach one Olanzapine participant for the assessment.
 
Arm/Group Title Olanzapine Placebo
Hide Arm/Group Description

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)

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
All-Cause Mortality
Olanzapine Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
Olanzapine Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/188 (1.60%)      0/185 (0.00%)    
Investigations     
Neutrophil count decreased  1  2/188 (1.06%)  2 0/185 (0.00%)  0
White blood cell decreased  1  1/188 (0.53%)  1 0/185 (0.00%)  0
Vascular disorders     
Thromboembolic event  1  1/188 (0.53%)  1 0/185 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAEV4.0
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Olanzapine Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   44/188 (23.40%)      36/185 (19.46%)    
Cardiac disorders     
Palpitations  1  0/188 (0.00%)  0 1/185 (0.54%)  3
Eye disorders     
Blurred vision  1  1/188 (0.53%)  1 1/185 (0.54%)  1
Dry eye  1  0/188 (0.00%)  0 1/185 (0.54%)  1
Gastrointestinal disorders     
Abdominal pain  1  1/188 (0.53%)  2 1/185 (0.54%)  1
Bloating  1  1/188 (0.53%)  1 2/185 (1.08%)  2
Constipation  1  4/188 (2.13%)  5 2/185 (1.08%)  2
Diarrhea  1  0/188 (0.00%)  0 2/185 (1.08%)  3
Dry mouth  1  3/188 (1.60%)  4 1/185 (0.54%)  2
Dyspepsia  1  0/188 (0.00%)  0 6/185 (3.24%)  8
Flatulence  1  1/188 (0.53%)  1 0/185 (0.00%)  0
Gastroesophageal reflux disease  1  2/188 (1.06%)  3 0/185 (0.00%)  0
Gastrointestinal disorders - Other, specify  1  2/188 (1.06%)  4 1/185 (0.54%)  1
Nausea  1  5/188 (2.66%)  8 9/185 (4.86%)  17
Stomach pain  1  0/188 (0.00%)  0 1/185 (0.54%)  1
Vomiting  1  1/188 (0.53%)  1 2/185 (1.08%)  4
General disorders     
Edema limbs  1  1/188 (0.53%)  1 0/185 (0.00%)  0
Fatigue  1  11/188 (5.85%)  13 9/185 (4.86%)  12
General disorders and administration site conditions - Other, specify  1  1/188 (0.53%)  2 1/185 (0.54%)  1
Investigations     
Platelet count decreased  1  1/188 (0.53%)  1 0/185 (0.00%)  0
White blood cell decreased  1  1/188 (0.53%)  1 0/185 (0.00%)  0
Metabolism and nutrition disorders     
Anorexia  1  0/188 (0.00%)  0 4/185 (2.16%)  5
Hyperglycemia  1  1/188 (0.53%)  2 1/185 (0.54%)  1
Musculoskeletal and connective tissue disorders     
Myalgia  1  0/188 (0.00%)  0 1/185 (0.54%)  1
Nervous system disorders     
Akathisia  1  1/188 (0.53%)  1 0/185 (0.00%)  0
Dizziness  1  5/188 (2.66%)  6 3/185 (1.62%)  3
Dysgeusia  1  0/188 (0.00%)  0 1/185 (0.54%)  2
Headache  1  3/188 (1.60%)  5 11/185 (5.95%)  13
Somnolence  1  20/188 (10.64%)  29 3/185 (1.62%)  3
Psychiatric disorders     
Anxiety  1  1/188 (0.53%)  2 0/185 (0.00%)  0
Insomnia  1  0/188 (0.00%)  0 2/185 (1.08%)  3
Restlessness  1  1/188 (0.53%)  1 0/185 (0.00%)  0
Renal and urinary disorders     
Renal calculi  1  0/188 (0.00%)  0 1/185 (0.54%)  1
Renal colic  1  0/188 (0.00%)  0 1/185 (0.54%)  1
Urinary incontinence  1  1/188 (0.53%)  1 0/185 (0.00%)  0
Urinary retention  1  1/188 (0.53%)  2 0/185 (0.00%)  0
Reproductive system and breast disorders     
Breast pain  1  1/188 (0.53%)  1 0/185 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Dyspnea  1  0/188 (0.00%)  0 1/185 (0.54%)  1
Hiccups  1  1/188 (0.53%)  1 3/185 (1.62%)  6
Sore throat  1  0/188 (0.00%)  0 1/185 (0.54%)  1
Skin and subcutaneous tissue disorders     
Urticaria  1  0/188 (0.00%)  0 1/185 (0.54%)  1
Vascular disorders     
Hypertension  1  0/188 (0.00%)  0 1/185 (0.54%)  2
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAEV4.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Rudolph M. Navari, MD, PhD, FACP
Organization: Indiana University School of Medicine South Bend
Phone: 574-252-7225
EMail: rmnavari@gmail.com
Layout table for additonal information
Responsible Party: Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier: NCT02116530    
Other Study ID Numbers: A221301
NCI-2014-00446 ( Other Identifier: NCI Clinical Trial Reporting Program )
U10CA031946 ( U.S. NIH Grant/Contract )
First Submitted: April 15, 2014
First Posted: April 17, 2014
Results First Submitted: December 7, 2016
Results First Posted: April 10, 2017
Last Update Posted: May 7, 2020