Trial Outcomes & Findings for Olanzapine With or Without Fosaprepitant Dimeglumine in Preventing Chemotherapy Induced Nausea and Vomiting in Cancer Patients Receiving Highly Emetogenic Chemotherapy (NCT NCT03578081)
NCT ID: NCT03578081
Last Updated: 2025-04-06
Results Overview
The specific measure will be based on the proportion of patients with a value of 0, as measured by the single nausea item (scale 0-10, 0 is no symptoms, 10 is worst symptoms) of the Questionnaire. A modified intent-to-treat principle will be applied for statistical analysis of efficacy in evaluable patients. The proportions of patients with no nausea during the overall, the acute, and the delayed period will be summarized by treatment arm. They will be tested in a sequential manner, using a Simes gatekeeping procedure to maintain the overall significance level at the specified by the Lan-DeMets family of alpha spending function. The difference in no nausea proportions between arms will be estimated along with a one-sided 95% confidence interval. The tests and the confidence intervals will be constructed using normal approximation of the binomial distribution adjusted for the non-inferiority margin.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
690 participants
Primary outcome timeframe
Up to 120 hours
Results posted on
2025-04-06
Participant Flow
Participant milestones
| Measure |
Arm I (Fosaprepitant Dimeglumine, Olanzapine)
Patients receive palonosetron hydrochloride IV over 30 seconds or ondansetron hydrochloride IV over 2-5 minutes or PO on day 1, dexamethasone PO on days 1-4, fosaprepitant dimeglumine IV over 20-30 minutes on day 1, and olanzapine PO on days 1-4. Treatment may repeat every 4 days for up to 3 courses in the absence of disease progression or unacceptable toxicity.\>\>
\>\> Palonosetron Hydrochloride: Given IV\>\>
\>\> Ondansetron Hydrochloride: Given IV or PO\>\>
\>\> Dexamethasone: Given PO\>\>
\>\> Fosaprepitant Dimeglumine: Given IV\>\>
\>\> Olanzapine: Given PO
|
Arm II (Placebo, Olanzapine)
Patients receive palonosetron hydrochloride IV over 30 seconds or ondansetron hydrochloride IV over 2-5 minutes or PO on day 1, dexamethasone PO on days 1-4, placebo IV over 20-30 minutes on day 1, and olanzapine PO on days 1-4. Treatment (with no placebo) may repeat every 4 days for up to 3 courses in the absence of disease progression or unacceptable toxicity.\>\>
\>\> Palonosetron Hydrochloride: Given IV\>\>
\>\> Ondansetron Hydrochloride: Given IV or PO\>\>
\>\> Dexamethasone: Given PO\>\>
\>\> Olanzapine: Given PO\>\>
\>\> Placebo: Given IV
|
|---|---|---|
|
Overall Study
STARTED
|
346
|
344
|
|
Overall Study
COMPLETED
|
326
|
320
|
|
Overall Study
NOT COMPLETED
|
20
|
24
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Olanzapine With or Without Fosaprepitant Dimeglumine in Preventing Chemotherapy Induced Nausea and Vomiting in Cancer Patients Receiving Highly Emetogenic Chemotherapy
Baseline characteristics by cohort
| Measure |
Arm I (Fosaprepitant Dimeglumine, Olanzapine)
n=346 Participants
Patients receive palonosetron hydrochloride IV over 30 seconds or ondansetron hydrochloride IV over 2-5 minutes or PO on day 1, dexamethasone PO on days 1-4, fosaprepitant dimeglumine IV over 20-30 minutes on day 1, and olanzapine PO on days 1-4. Treatment may repeat every 4 days for up to 3 courses in the absence of disease progression or unacceptable toxicity.\>\>
\>\> Palonosetron Hydrochloride: Given IV\>\>
\>\> Ondansetron Hydrochloride: Given IV or PO\>\>
\>\> Dexamethasone: Given PO\>\>
\>\> Fosaprepitant Dimeglumine: Given IV\>\>
\>\> Olanzapine: Given PO
|
Arm II (Placebo, Olanzapine)
n=344 Participants
Patients receive palonosetron hydrochloride IV over 30 seconds or ondansetron hydrochloride IV over 2-5 minutes or PO on day 1, dexamethasone PO on days 1-4, placebo IV over 20-30 minutes on day 1, and olanzapine PO on days 1-4. Treatment (with no placebo) may repeat every 4 days for up to 3 courses in the absence of disease progression or unacceptable toxicity.\>\>
\>\> Palonosetron Hydrochloride: Given IV\>\>
\>\> Ondansetron Hydrochloride: Given IV or PO\>\>
\>\> Dexamethasone: Given PO\>\>
\>\> Olanzapine: Given PO\>\>
\>\> Placebo: Given IV
|
Total
n=690 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
56.5 years
STANDARD_DEVIATION 11.10 • n=5 Participants
|
56.1 years
STANDARD_DEVIATION 11.58 • n=7 Participants
|
56.3 years
STANDARD_DEVIATION 11.34 • n=5 Participants
|
|
Sex: Female, Male
Female
|
289 Participants
n=5 Participants
|
289 Participants
n=7 Participants
|
578 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
57 Participants
n=5 Participants
|
55 Participants
n=7 Participants
|
112 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
331 Participants
n=5 Participants
|
325 Participants
n=7 Participants
|
656 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
12 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
36 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
76 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
292 Participants
n=5 Participants
|
278 Participants
n=7 Participants
|
570 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
12 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
ECOG Performance Score
0
|
276 Participants
n=5 Participants
|
281 Participants
n=7 Participants
|
557 Participants
n=5 Participants
|
|
ECOG Performance Score
1
|
67 Participants
n=5 Participants
|
59 Participants
n=7 Participants
|
126 Participants
n=5 Participants
|
|
ECOG Performance Score
2
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Chemotherapy Regimen
Anthracycline and cyclophosphamide (AC)
|
267 Participants
n=5 Participants
|
266 Participants
n=7 Participants
|
533 Participants
n=5 Participants
|
|
Chemotherapy Regimen
Cisplatin-containing regimen
|
79 Participants
n=5 Participants
|
78 Participants
n=7 Participants
|
157 Participants
n=5 Participants
|
|
5-HT Receptor Antagonist
Ondansetron
|
90 Participants
n=5 Participants
|
90 Participants
n=7 Participants
|
180 Participants
n=5 Participants
|
|
5-HT Receptor Antagonist
Palonosetron
|
256 Participants
n=5 Participants
|
254 Participants
n=7 Participants
|
510 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 120 hoursThe specific measure will be based on the proportion of patients with a value of 0, as measured by the single nausea item (scale 0-10, 0 is no symptoms, 10 is worst symptoms) of the Questionnaire. A modified intent-to-treat principle will be applied for statistical analysis of efficacy in evaluable patients. The proportions of patients with no nausea during the overall, the acute, and the delayed period will be summarized by treatment arm. They will be tested in a sequential manner, using a Simes gatekeeping procedure to maintain the overall significance level at the specified by the Lan-DeMets family of alpha spending function. The difference in no nausea proportions between arms will be estimated along with a one-sided 95% confidence interval. The tests and the confidence intervals will be constructed using normal approximation of the binomial distribution adjusted for the non-inferiority margin.
Outcome measures
| Measure |
Arm I (Fosaprepitant Dimeglumine, Olanzapine)
n=326 Participants
Patients receive palonosetron hydrochloride IV over 30 seconds or ondansetron hydrochloride IV over 2-5 minutes or PO on day 1, dexamethasone PO on days 1-4, fosaprepitant dimeglumine IV over 20-30 minutes on day 1, and olanzapine PO on days 1-4. Treatment may repeat every 4 days for up to 3 courses in the absence of disease progression or unacceptable toxicity.\>
\>\>
\>
\>\> Palonosetron Hydrochloride: Given IV\>
\>\>
\>
\>\> Ondansetron Hydrochloride: Given IV or PO\>
\>\>
\>
\>\> Dexamethasone: Given PO\>
\>\>
\>
\>\> Fosaprepitant Dimeglumine: Given IV\>
\>\>
\>
\>\> Olanzapine: Given PO
|
Arm II (Placebo, Olanzapine)
n=320 Participants
Patients receive palonosetron hydrochloride IV over 30 seconds or ondansetron hydrochloride IV over 2-5 minutes or PO on day 1, dexamethasone PO on days 1-4, placebo IV over 20-30 minutes on day 1, and olanzapine PO on days 1-4. Treatment (with no placebo) may repeat every 4 days for up to 3 courses in the absence of disease progression or unacceptable toxicity.\>
\>\>
\>
\>\> Palonosetron Hydrochloride: Given IV\>
\>\>
\>
\>\> Ondansetron Hydrochloride: Given IV or PO\>
\>\>
\>
\>\> Dexamethasone: Given PO\>
\>\>
\>
\>\> Olanzapine: Given PO\>
\>\>
\>
\>\> Placebo: Given IV
|
|---|---|---|
|
No Nausea Rate Defined as a Response of 0 in the Nausea Item of Nausea and Vomiting Daily Diary/Questionnaire in the Overall (0-120 Hours), Acute (0-24 Hours), and Delayed (24-120 Hours) Periods
Overall No Nausea
|
123 Participants
|
97 Participants
|
|
No Nausea Rate Defined as a Response of 0 in the Nausea Item of Nausea and Vomiting Daily Diary/Questionnaire in the Overall (0-120 Hours), Acute (0-24 Hours), and Delayed (24-120 Hours) Periods
Overall Any Nausea
|
203 Participants
|
223 Participants
|
|
No Nausea Rate Defined as a Response of 0 in the Nausea Item of Nausea and Vomiting Daily Diary/Questionnaire in the Overall (0-120 Hours), Acute (0-24 Hours), and Delayed (24-120 Hours) Periods
Acute No Nausea
|
202 Participants
|
201 Participants
|
|
No Nausea Rate Defined as a Response of 0 in the Nausea Item of Nausea and Vomiting Daily Diary/Questionnaire in the Overall (0-120 Hours), Acute (0-24 Hours), and Delayed (24-120 Hours) Periods
Acute Any Nausea
|
124 Participants
|
119 Participants
|
|
No Nausea Rate Defined as a Response of 0 in the Nausea Item of Nausea and Vomiting Daily Diary/Questionnaire in the Overall (0-120 Hours), Acute (0-24 Hours), and Delayed (24-120 Hours) Periods
Delayed No Nausea
|
140 Participants
|
114 Participants
|
|
No Nausea Rate Defined as a Response of 0 in the Nausea Item of Nausea and Vomiting Daily Diary/Questionnaire in the Overall (0-120 Hours), Acute (0-24 Hours), and Delayed (24-120 Hours) Periods
Delayed Any Nausea
|
186 Participants
|
206 Participants
|
SECONDARY outcome
Timeframe: Up to 120 hoursThe specific measure will be based on the proportion of patients who answered "None" to both questions concerning Vomiting episode(None, Once, Twice, More than twice) and number of extra nausea/vomiting pills taken (None, One, Two, More than two) in the Nausea and Vomiting Daily Diary/Questionnaire. The CR rate for the overall, the acute, and the delayed period will be summarized by treatment arm and will be compared using a Chi-squared test. The difference in CR rates between arms will be estimated along with a 95% confidence interval.
Outcome measures
| Measure |
Arm I (Fosaprepitant Dimeglumine, Olanzapine)
n=326 Participants
Patients receive palonosetron hydrochloride IV over 30 seconds or ondansetron hydrochloride IV over 2-5 minutes or PO on day 1, dexamethasone PO on days 1-4, fosaprepitant dimeglumine IV over 20-30 minutes on day 1, and olanzapine PO on days 1-4. Treatment may repeat every 4 days for up to 3 courses in the absence of disease progression or unacceptable toxicity.\>
\>\>
\>
\>\> Palonosetron Hydrochloride: Given IV\>
\>\>
\>
\>\> Ondansetron Hydrochloride: Given IV or PO\>
\>\>
\>
\>\> Dexamethasone: Given PO\>
\>\>
\>
\>\> Fosaprepitant Dimeglumine: Given IV\>
\>\>
\>
\>\> Olanzapine: Given PO
|
Arm II (Placebo, Olanzapine)
n=320 Participants
Patients receive palonosetron hydrochloride IV over 30 seconds or ondansetron hydrochloride IV over 2-5 minutes or PO on day 1, dexamethasone PO on days 1-4, placebo IV over 20-30 minutes on day 1, and olanzapine PO on days 1-4. Treatment (with no placebo) may repeat every 4 days for up to 3 courses in the absence of disease progression or unacceptable toxicity.\>
\>\>
\>
\>\> Palonosetron Hydrochloride: Given IV\>
\>\>
\>
\>\> Ondansetron Hydrochloride: Given IV or PO\>
\>\>
\>
\>\> Dexamethasone: Given PO\>
\>\>
\>
\>\> Olanzapine: Given PO\>
\>\>
\>
\>\> Placebo: Given IV
|
|---|---|---|
|
Complete Response (CR) (no Emetic Episodes and no Use of Rescue Medication) During the Acute, Delayed and the Overall Periods as Measured by the Nausea and Vomiting Daily Diary/Questionnaire
Complete Response - >> Overall
|
179 Participants
|
151 Participants
|
|
Complete Response (CR) (no Emetic Episodes and no Use of Rescue Medication) During the Acute, Delayed and the Overall Periods as Measured by the Nausea and Vomiting Daily Diary/Questionnaire
Complete Response - >> Acute
|
256 Participants
|
247 Participants
|
|
Complete Response (CR) (no Emetic Episodes and no Use of Rescue Medication) During the Acute, Delayed and the Overall Periods as Measured by the Nausea and Vomiting Daily Diary/Questionnaire
Complete Response ->> Delayed
|
193 Participants
|
166 Participants
|
SECONDARY outcome
Timeframe: Up to 120 hoursPotential toxicities includes nausea, undesired sedation, and undesired appetite, measured by three individual items ( nausea, undesired sedation, undesired appetite) of the Nausea and Vomiting Daily Dairy/Questionnaire(scale 0-10, 0 is no symptoms, 10 is worst symptoms). Incidences of toxicities will be summarized by type and by treatment arm. Incidences of toxicities will be compared between arms using a Chi-squared test or the Fisher's exact test as appropriate. In addition, undesired sedation and appetite increase as collected in the Nausea and Vomiting Daily Diary/Questionnaire will be analyzed by repeated measures analyses including descriptive statistics, graphical approaches, and growth curve models to account for the factor of day and time trend.
Outcome measures
| Measure |
Arm I (Fosaprepitant Dimeglumine, Olanzapine)
n=326 Participants
Patients receive palonosetron hydrochloride IV over 30 seconds or ondansetron hydrochloride IV over 2-5 minutes or PO on day 1, dexamethasone PO on days 1-4, fosaprepitant dimeglumine IV over 20-30 minutes on day 1, and olanzapine PO on days 1-4. Treatment may repeat every 4 days for up to 3 courses in the absence of disease progression or unacceptable toxicity.\>
\>\>
\>
\>\> Palonosetron Hydrochloride: Given IV\>
\>\>
\>
\>\> Ondansetron Hydrochloride: Given IV or PO\>
\>\>
\>
\>\> Dexamethasone: Given PO\>
\>\>
\>
\>\> Fosaprepitant Dimeglumine: Given IV\>
\>\>
\>
\>\> Olanzapine: Given PO
|
Arm II (Placebo, Olanzapine)
n=320 Participants
Patients receive palonosetron hydrochloride IV over 30 seconds or ondansetron hydrochloride IV over 2-5 minutes or PO on day 1, dexamethasone PO on days 1-4, placebo IV over 20-30 minutes on day 1, and olanzapine PO on days 1-4. Treatment (with no placebo) may repeat every 4 days for up to 3 courses in the absence of disease progression or unacceptable toxicity.\>
\>\>
\>
\>\> Palonosetron Hydrochloride: Given IV\>
\>\>
\>
\>\> Ondansetron Hydrochloride: Given IV or PO\>
\>\>
\>
\>\> Dexamethasone: Given PO\>
\>\>
\>
\>\> Olanzapine: Given PO\>
\>\>
\>
\>\> Placebo: Given IV
|
|---|---|---|
|
Potential Toxicities as Ascribed to Olanzapine as Measured by the Nausea and Vomiting Daily Diary/Questionnaire
Overall No Appetite Increase
|
140 Participants
|
136 Participants
|
|
Potential Toxicities as Ascribed to Olanzapine as Measured by the Nausea and Vomiting Daily Diary/Questionnaire
Overall Any Appetite Increase
|
186 Participants
|
184 Participants
|
|
Potential Toxicities as Ascribed to Olanzapine as Measured by the Nausea and Vomiting Daily Diary/Questionnaire
Acute No Appetite Increase
|
235 Participants
|
236 Participants
|
|
Potential Toxicities as Ascribed to Olanzapine as Measured by the Nausea and Vomiting Daily Diary/Questionnaire
Acute Any Appetite Increase
|
91 Participants
|
84 Participants
|
|
Potential Toxicities as Ascribed to Olanzapine as Measured by the Nausea and Vomiting Daily Diary/Questionnaire
Delayed No Appetite Increase
|
147 Participants
|
143 Participants
|
|
Potential Toxicities as Ascribed to Olanzapine as Measured by the Nausea and Vomiting Daily Diary/Questionnaire
Delayed Any Appetite Increase
|
179 Participants
|
177 Participants
|
SECONDARY outcome
Timeframe: Up to 1 yearThe specific measure will be based on the by the single nausea item (scale 0-10, 0 is no symptoms, 10 is worst symptoms) of the Nausea and Vomiting Daily Diary/Questionnaire. Nausea scores (0-10) repeatedly measured by the Nausea and Vomiting Daily Diary/Questionnaire will be analyzed using the repeated measures analyses and growth curve models as described above for undesired sedation and increase in appetite.
Outcome measures
| Measure |
Arm I (Fosaprepitant Dimeglumine, Olanzapine)
n=326 Participants
Patients receive palonosetron hydrochloride IV over 30 seconds or ondansetron hydrochloride IV over 2-5 minutes or PO on day 1, dexamethasone PO on days 1-4, fosaprepitant dimeglumine IV over 20-30 minutes on day 1, and olanzapine PO on days 1-4. Treatment may repeat every 4 days for up to 3 courses in the absence of disease progression or unacceptable toxicity.\>
\>\>
\>
\>\> Palonosetron Hydrochloride: Given IV\>
\>\>
\>
\>\> Ondansetron Hydrochloride: Given IV or PO\>
\>\>
\>
\>\> Dexamethasone: Given PO\>
\>\>
\>
\>\> Fosaprepitant Dimeglumine: Given IV\>
\>\>
\>
\>\> Olanzapine: Given PO
|
Arm II (Placebo, Olanzapine)
n=320 Participants
Patients receive palonosetron hydrochloride IV over 30 seconds or ondansetron hydrochloride IV over 2-5 minutes or PO on day 1, dexamethasone PO on days 1-4, placebo IV over 20-30 minutes on day 1, and olanzapine PO on days 1-4. Treatment (with no placebo) may repeat every 4 days for up to 3 courses in the absence of disease progression or unacceptable toxicity.\>
\>\>
\>
\>\> Palonosetron Hydrochloride: Given IV\>
\>\>
\>
\>\> Ondansetron Hydrochloride: Given IV or PO\>
\>\>
\>
\>\> Dexamethasone: Given PO\>
\>\>
\>
\>\> Olanzapine: Given PO\>
\>\>
\>
\>\> Placebo: Given IV
|
|---|---|---|
|
Average Nausea Scores (0-10) Repeatedly Measured by the Nausea and Vomiting Daily Diary/Questionnaire
|
0.8211364 score on a scale
Standard Deviation 1.6289005
|
0.9177778 score on a scale
Standard Deviation 1.7821806
|
SECONDARY outcome
Timeframe: Over 5 Days per each of the 4 cyclesThe specific measure will be based on the single item : number of extra nausea/vomiting pills taken (None, One , Twice, More than twice) of the Nausea and Vomiting Daily Diary/Questionnaire.
Outcome measures
| Measure |
Arm I (Fosaprepitant Dimeglumine, Olanzapine)
n=326 Participants
Patients receive palonosetron hydrochloride IV over 30 seconds or ondansetron hydrochloride IV over 2-5 minutes or PO on day 1, dexamethasone PO on days 1-4, fosaprepitant dimeglumine IV over 20-30 minutes on day 1, and olanzapine PO on days 1-4. Treatment may repeat every 4 days for up to 3 courses in the absence of disease progression or unacceptable toxicity.\>
\>\>
\>
\>\> Palonosetron Hydrochloride: Given IV\>
\>\>
\>
\>\> Ondansetron Hydrochloride: Given IV or PO\>
\>\>
\>
\>\> Dexamethasone: Given PO\>
\>\>
\>
\>\> Fosaprepitant Dimeglumine: Given IV\>
\>\>
\>
\>\> Olanzapine: Given PO
|
Arm II (Placebo, Olanzapine)
n=320 Participants
Patients receive palonosetron hydrochloride IV over 30 seconds or ondansetron hydrochloride IV over 2-5 minutes or PO on day 1, dexamethasone PO on days 1-4, placebo IV over 20-30 minutes on day 1, and olanzapine PO on days 1-4. Treatment (with no placebo) may repeat every 4 days for up to 3 courses in the absence of disease progression or unacceptable toxicity.\>
\>\>
\>
\>\> Palonosetron Hydrochloride: Given IV\>
\>\>
\>
\>\> Ondansetron Hydrochloride: Given IV or PO\>
\>\>
\>
\>\> Dexamethasone: Given PO\>
\>\>
\>
\>\> Olanzapine: Given PO\>
\>\>
\>
\>\> Placebo: Given IV
|
|---|---|---|
|
Total Frequency of Rescue Medication as Measured by the Nausea and Vomiting Daily Diary/Questionnaire
Zero
|
3614 episodes
|
3541 episodes
|
|
Total Frequency of Rescue Medication as Measured by the Nausea and Vomiting Daily Diary/Questionnaire
One
|
350 episodes
|
405 episodes
|
|
Total Frequency of Rescue Medication as Measured by the Nausea and Vomiting Daily Diary/Questionnaire
Two
|
170 episodes
|
162 episodes
|
|
Total Frequency of Rescue Medication as Measured by the Nausea and Vomiting Daily Diary/Questionnaire
More than two
|
56 episodes
|
74 episodes
|
Adverse Events
Arm I (Fosaprepitant Dimeglumine, Olanzapine)
Serious events: 51 serious events
Other events: 252 other events
Deaths: 1 deaths
Arm II (Placebo, Olanzapine)
Serious events: 60 serious events
Other events: 248 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Arm I (Fosaprepitant Dimeglumine, Olanzapine)
n=286 participants at risk
Olanzapine: Given PO
|
Arm II (Placebo, Olanzapine)
n=291 participants at risk
Placebo: Given IV
|
|---|---|---|
|
Gastrointestinal disorders
Gastrointestinal disorders - Oth spec
|
0.35%
1/286 • Number of events 1 • Up to 1 year
|
0.00%
0/291 • Up to 1 year
|
|
Gastrointestinal disorders
Nausea
|
0.35%
1/286 • Number of events 1 • Up to 1 year
|
0.00%
0/291 • Up to 1 year
|
|
General disorders
Death NOS
|
0.35%
1/286 • Number of events 1 • Up to 1 year
|
0.00%
0/291 • Up to 1 year
|
|
General disorders
Disease progression
|
0.00%
0/286 • Up to 1 year
|
0.34%
1/291 • Number of events 1 • Up to 1 year
|
|
General disorders
Fever
|
0.00%
0/286 • Up to 1 year
|
0.34%
1/291 • Number of events 1 • Up to 1 year
|
|
General disorders
Gen disord and admin site conds-Oth spec
|
0.35%
1/286 • Number of events 1 • Up to 1 year
|
0.00%
0/291 • Up to 1 year
|
|
Infections and infestations
Catheter related infection
|
0.00%
0/286 • Up to 1 year
|
0.34%
1/291 • Number of events 1 • Up to 1 year
|
|
Infections and infestations
Enterocolitis infectious
|
0.35%
1/286 • Number of events 1 • Up to 1 year
|
0.00%
0/291 • Up to 1 year
|
|
Infections and infestations
Joint infection
|
0.00%
0/286 • Up to 1 year
|
0.34%
1/291 • Number of events 1 • Up to 1 year
|
|
Infections and infestations
Lung infection
|
0.35%
1/286 • Number of events 1 • Up to 1 year
|
0.00%
0/291 • Up to 1 year
|
|
Infections and infestations
Sepsis
|
0.70%
2/286 • Number of events 2 • Up to 1 year
|
1.0%
3/291 • Number of events 3 • Up to 1 year
|
|
Infections and infestations
Skin infection
|
0.35%
1/286 • Number of events 1 • Up to 1 year
|
0.00%
0/291 • Up to 1 year
|
|
Infections and infestations
Urinary tract infection
|
0.35%
1/286 • Number of events 1 • Up to 1 year
|
0.34%
1/291 • Number of events 1 • Up to 1 year
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/286 • Up to 1 year
|
0.34%
1/291 • Number of events 1 • Up to 1 year
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/286 • Up to 1 year
|
0.34%
1/291 • Number of events 1 • Up to 1 year
|
|
Injury, poisoning and procedural complications
Vascular access complication
|
0.00%
0/286 • Up to 1 year
|
0.34%
1/291 • Number of events 1 • Up to 1 year
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/286 • Up to 1 year
|
0.34%
1/291 • Number of events 1 • Up to 1 year
|
|
Investigations
Creatinine increased
|
0.00%
0/286 • Up to 1 year
|
1.0%
3/291 • Number of events 3 • Up to 1 year
|
|
Investigations
Lymphocyte count decreased
|
0.70%
2/286 • Number of events 2 • Up to 1 year
|
0.69%
2/291 • Number of events 2 • Up to 1 year
|
|
Investigations
Neutrophil count decreased
|
3.1%
9/286 • Number of events 9 • Up to 1 year
|
3.4%
10/291 • Number of events 10 • Up to 1 year
|
|
Investigations
Platelet count decreased
|
0.35%
1/286 • Number of events 1 • Up to 1 year
|
0.34%
1/291 • Number of events 1 • Up to 1 year
|
|
Investigations
White blood cell decreased
|
1.7%
5/286 • Number of events 5 • Up to 1 year
|
2.4%
7/291 • Number of events 7 • Up to 1 year
|
|
Metabolism and nutrition disorders
Dehydration
|
0.70%
2/286 • Number of events 2 • Up to 1 year
|
0.69%
2/291 • Number of events 2 • Up to 1 year
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.70%
2/286 • Number of events 2 • Up to 1 year
|
0.00%
0/291 • Up to 1 year
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
0.35%
1/286 • Number of events 1 • Up to 1 year
|
0.34%
1/291 • Number of events 1 • Up to 1 year
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
0.35%
1/286 • Number of events 1 • Up to 1 year
|
0.00%
0/291 • Up to 1 year
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/286 • Up to 1 year
|
1.0%
3/291 • Number of events 3 • Up to 1 year
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
0.35%
1/286 • Number of events 1 • Up to 1 year
|
0.34%
1/291 • Number of events 1 • Up to 1 year
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
0.35%
1/286 • Number of events 1 • Up to 1 year
|
0.00%
0/291 • Up to 1 year
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
0.00%
0/286 • Up to 1 year
|
0.34%
1/291 • Number of events 1 • Up to 1 year
|
|
Nervous system disorders
Dizziness
|
0.35%
1/286 • Number of events 1 • Up to 1 year
|
0.00%
0/291 • Up to 1 year
|
|
Nervous system disorders
Syncope
|
0.35%
1/286 • Number of events 1 • Up to 1 year
|
0.00%
0/291 • Up to 1 year
|
|
Psychiatric disorders
Confusion
|
0.00%
0/286 • Up to 1 year
|
0.34%
1/291 • Number of events 1 • Up to 1 year
|
|
Blood and lymphatic system disorders
Anemia
|
1.4%
4/286 • Number of events 4 • Up to 1 year
|
0.34%
1/291 • Number of events 1 • Up to 1 year
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.70%
2/286 • Number of events 2 • Up to 1 year
|
1.0%
3/291 • Number of events 3 • Up to 1 year
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.35%
1/286 • Number of events 1 • Up to 1 year
|
0.00%
0/291 • Up to 1 year
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/286 • Up to 1 year
|
0.34%
1/291 • Number of events 1 • Up to 1 year
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/286 • Up to 1 year
|
0.34%
1/291 • Number of events 1 • Up to 1 year
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/286 • Up to 1 year
|
0.69%
2/291 • Number of events 2 • Up to 1 year
|
|
Renal and urinary disorders
Acute kidney injury
|
0.35%
1/286 • Number of events 1 • Up to 1 year
|
0.00%
0/291 • Up to 1 year
|
|
Renal and urinary disorders
Cystitis noninfective
|
0.00%
0/286 • Up to 1 year
|
0.34%
1/291 • Number of events 1 • Up to 1 year
|
|
Renal and urinary disorders
Hematuria
|
0.00%
0/286 • Up to 1 year
|
0.34%
1/291 • Number of events 1 • Up to 1 year
|
|
Renal and urinary disorders
Renal and urinary disorders - Oth spec
|
0.35%
1/286 • Number of events 1 • Up to 1 year
|
0.00%
0/291 • Up to 1 year
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/286 • Up to 1 year
|
0.34%
1/291 • Number of events 1 • Up to 1 year
|
|
Renal and urinary disorders
Urinary retention
|
0.35%
1/286 • Number of events 1 • Up to 1 year
|
0.00%
0/291 • Up to 1 year
|
|
Reproductive system and breast disorders
Irregular menstruation
|
0.35%
1/286 • Number of events 1 • Up to 1 year
|
0.00%
0/291 • Up to 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Adult respiratory distress syndrome
|
0.00%
0/286 • Up to 1 year
|
0.34%
1/291 • Number of events 1 • Up to 1 year
|
|
Vascular disorders
Hypotension
|
0.70%
2/286 • Number of events 2 • Up to 1 year
|
1.0%
3/291 • Number of events 3 • Up to 1 year
|
|
Vascular disorders
Thromboembolic event
|
0.35%
1/286 • Number of events 1 • Up to 1 year
|
0.34%
1/291 • Number of events 1 • Up to 1 year
|
Other adverse events
| Measure |
Arm I (Fosaprepitant Dimeglumine, Olanzapine)
n=286 participants at risk
Olanzapine: Given PO
|
Arm II (Placebo, Olanzapine)
n=291 participants at risk
Placebo: Given IV
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
4.5%
13/286 • Number of events 13 • Up to 1 year
|
6.2%
18/291 • Number of events 18 • Up to 1 year
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/286 • Up to 1 year
|
0.34%
1/291 • Number of events 1 • Up to 1 year
|
|
Gastrointestinal disorders
Abdominal pain
|
0.70%
2/286 • Number of events 2 • Up to 1 year
|
0.34%
1/291 • Number of events 1 • Up to 1 year
|
|
Gastrointestinal disorders
Belching
|
0.00%
0/286 • Up to 1 year
|
0.34%
1/291 • Number of events 1 • Up to 1 year
|
|
Gastrointestinal disorders
Constipation
|
1.7%
5/286 • Number of events 5 • Up to 1 year
|
1.4%
4/291 • Number of events 4 • Up to 1 year
|
|
Gastrointestinal disorders
Diarrhea
|
1.0%
3/286 • Number of events 3 • Up to 1 year
|
1.4%
4/291 • Number of events 4 • Up to 1 year
|
|
Gastrointestinal disorders
Dry mouth
|
0.70%
2/286 • Number of events 2 • Up to 1 year
|
0.00%
0/291 • Up to 1 year
|
|
Gastrointestinal disorders
Dyspepsia
|
0.70%
2/286 • Number of events 2 • Up to 1 year
|
0.34%
1/291 • Number of events 1 • Up to 1 year
|
|
Gastrointestinal disorders
Dysphagia
|
0.70%
2/286 • Number of events 2 • Up to 1 year
|
0.34%
1/291 • Number of events 1 • Up to 1 year
|
|
Gastrointestinal disorders
Gastritis
|
0.35%
1/286 • Number of events 1 • Up to 1 year
|
0.00%
0/291 • Up to 1 year
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
2.1%
6/286 • Number of events 6 • Up to 1 year
|
0.69%
2/291 • Number of events 2 • Up to 1 year
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Oth spec
|
0.35%
1/286 • Number of events 1 • Up to 1 year
|
0.00%
0/291 • Up to 1 year
|
|
Gastrointestinal disorders
Mucositis oral
|
0.70%
2/286 • Number of events 2 • Up to 1 year
|
1.7%
5/291 • Number of events 5 • Up to 1 year
|
|
Gastrointestinal disorders
Nausea
|
2.1%
6/286 • Number of events 6 • Up to 1 year
|
1.7%
5/291 • Number of events 5 • Up to 1 year
|
|
Gastrointestinal disorders
Oral dysesthesia
|
0.00%
0/286 • Up to 1 year
|
0.34%
1/291 • Number of events 1 • Up to 1 year
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/286 • Up to 1 year
|
0.34%
1/291 • Number of events 1 • Up to 1 year
|
|
Gastrointestinal disorders
Vomiting
|
1.0%
3/286 • Number of events 3 • Up to 1 year
|
0.34%
1/291 • Number of events 1 • Up to 1 year
|
|
General disorders
Edema limbs
|
0.35%
1/286 • Number of events 1 • Up to 1 year
|
1.0%
3/291 • Number of events 3 • Up to 1 year
|
|
General disorders
Fatigue
|
6.6%
19/286 • Number of events 19 • Up to 1 year
|
7.6%
22/291 • Number of events 22 • Up to 1 year
|
|
General disorders
Malaise
|
0.35%
1/286 • Number of events 1 • Up to 1 year
|
0.00%
0/291 • Up to 1 year
|
|
General disorders
Non-cardiac chest pain
|
0.70%
2/286 • Number of events 2 • Up to 1 year
|
0.34%
1/291 • Number of events 1 • Up to 1 year
|
|
Immune system disorders
Allergic reaction
|
0.35%
1/286 • Number of events 1 • Up to 1 year
|
0.00%
0/291 • Up to 1 year
|
|
Infections and infestations
Bladder infection
|
0.00%
0/286 • Up to 1 year
|
0.34%
1/291 • Number of events 1 • Up to 1 year
|
|
Infections and infestations
Catheter related infection
|
0.00%
0/286 • Up to 1 year
|
0.34%
1/291 • Number of events 1 • Up to 1 year
|
|
Infections and infestations
Folliculitis
|
0.35%
1/286 • Number of events 1 • Up to 1 year
|
0.34%
1/291 • Number of events 1 • Up to 1 year
|
|
Infections and infestations
Infections and infestations - Oth spec
|
1.0%
3/286 • Number of events 3 • Up to 1 year
|
1.7%
5/291 • Number of events 5 • Up to 1 year
|
|
Infections and infestations
Lung infection
|
0.35%
1/286 • Number of events 1 • Up to 1 year
|
0.34%
1/291 • Number of events 1 • Up to 1 year
|
|
Infections and infestations
Mucosal infection
|
0.00%
0/286 • Up to 1 year
|
0.34%
1/291 • Number of events 1 • Up to 1 year
|
|
Infections and infestations
Sinusitis
|
0.35%
1/286 • Number of events 1 • Up to 1 year
|
0.34%
1/291 • Number of events 1 • Up to 1 year
|
|
Infections and infestations
Skin infection
|
0.70%
2/286 • Number of events 2 • Up to 1 year
|
0.69%
2/291 • Number of events 2 • Up to 1 year
|
|
Infections and infestations
Thrush
|
0.35%
1/286 • Number of events 1 • Up to 1 year
|
0.34%
1/291 • Number of events 1 • Up to 1 year
|
|
Infections and infestations
Upper respiratory infection
|
0.35%
1/286 • Number of events 1 • Up to 1 year
|
0.00%
0/291 • Up to 1 year
|
|
Infections and infestations
Urinary tract infection
|
0.35%
1/286 • Number of events 1 • Up to 1 year
|
0.69%
2/291 • Number of events 2 • Up to 1 year
|
|
Injury, poisoning and procedural complications
Fall
|
0.35%
1/286 • Number of events 1 • Up to 1 year
|
0.00%
0/291 • Up to 1 year
|
|
Injury, poisoning and procedural complications
Seroma
|
0.35%
1/286 • Number of events 1 • Up to 1 year
|
0.00%
0/291 • Up to 1 year
|
|
Investigations
Alanine aminotransferase increased
|
0.35%
1/286 • Number of events 1 • Up to 1 year
|
0.00%
0/291 • Up to 1 year
|
|
Investigations
Alkaline phosphatase increased
|
0.70%
2/286 • Number of events 2 • Up to 1 year
|
0.00%
0/291 • Up to 1 year
|
|
Investigations
Aspartate aminotransferase increased
|
0.35%
1/286 • Number of events 1 • Up to 1 year
|
0.00%
0/291 • Up to 1 year
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/286 • Up to 1 year
|
0.34%
1/291 • Number of events 1 • Up to 1 year
|
|
Investigations
Creatinine increased
|
0.70%
2/286 • Number of events 2 • Up to 1 year
|
0.00%
0/291 • Up to 1 year
|
|
Investigations
INR increased
|
0.35%
1/286 • Number of events 1 • Up to 1 year
|
0.00%
0/291 • Up to 1 year
|
|
Investigations
Lymphocyte count decreased
|
7.0%
20/286 • Number of events 20 • Up to 1 year
|
5.8%
17/291 • Number of events 17 • Up to 1 year
|
|
Investigations
Lymphocyte count increased
|
0.35%
1/286 • Number of events 1 • Up to 1 year
|
0.00%
0/291 • Up to 1 year
|
|
Investigations
Neutrophil count decreased
|
7.0%
20/286 • Number of events 20 • Up to 1 year
|
6.5%
19/291 • Number of events 19 • Up to 1 year
|
|
Investigations
Platelet count decreased
|
1.0%
3/286 • Number of events 3 • Up to 1 year
|
2.4%
7/291 • Number of events 7 • Up to 1 year
|
|
Investigations
Weight loss
|
0.00%
0/286 • Up to 1 year
|
0.34%
1/291 • Number of events 1 • Up to 1 year
|
|
Investigations
White blood cell decreased
|
3.8%
11/286 • Number of events 11 • Up to 1 year
|
5.8%
17/291 • Number of events 17 • Up to 1 year
|
|
Metabolism and nutrition disorders
Anorexia
|
0.70%
2/286 • Number of events 2 • Up to 1 year
|
0.34%
1/291 • Number of events 1 • Up to 1 year
|
|
Metabolism and nutrition disorders
Dehydration
|
0.70%
2/286 • Number of events 2 • Up to 1 year
|
1.4%
4/291 • Number of events 4 • Up to 1 year
|
|
Metabolism and nutrition disorders
Glucose intolerance
|
0.35%
1/286 • Number of events 1 • Up to 1 year
|
0.00%
0/291 • Up to 1 year
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
1.0%
3/286 • Number of events 3 • Up to 1 year
|
0.69%
2/291 • Number of events 2 • Up to 1 year
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
2.4%
7/286 • Number of events 7 • Up to 1 year
|
0.34%
1/291 • Number of events 1 • Up to 1 year
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
0.35%
1/286 • Number of events 1 • Up to 1 year
|
0.34%
1/291 • Number of events 1 • Up to 1 year
|
|
Metabolism and nutrition disorders
Hypokalemia
|
1.7%
5/286 • Number of events 5 • Up to 1 year
|
1.7%
5/291 • Number of events 5 • Up to 1 year
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
0.00%
0/286 • Up to 1 year
|
0.69%
2/291 • Number of events 2 • Up to 1 year
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.70%
2/286 • Number of events 2 • Up to 1 year
|
0.34%
1/291 • Number of events 1 • Up to 1 year
|
|
Metabolism and nutrition disorders
Metabolism, nutrition disord - Oth spec
|
0.00%
0/286 • Up to 1 year
|
0.34%
1/291 • Number of events 1 • Up to 1 year
|
|
Metabolism and nutrition disorders
Obesity
|
1.0%
3/286 • Number of events 3 • Up to 1 year
|
0.34%
1/291 • Number of events 1 • Up to 1 year
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.4%
4/286 • Number of events 4 • Up to 1 year
|
0.34%
1/291 • Number of events 1 • Up to 1 year
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.35%
1/286 • Number of events 1 • Up to 1 year
|
0.34%
1/291 • Number of events 1 • Up to 1 year
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
0.70%
2/286 • Number of events 2 • Up to 1 year
|
0.00%
0/291 • Up to 1 year
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.35%
1/286 • Number of events 1 • Up to 1 year
|
0.00%
0/291 • Up to 1 year
|
|
Nervous system disorders
Akathisia
|
0.35%
1/286 • Number of events 1 • Up to 1 year
|
0.00%
0/291 • Up to 1 year
|
|
Nervous system disorders
Depressed level of consciousness
|
0.35%
1/286 • Number of events 1 • Up to 1 year
|
0.00%
0/291 • Up to 1 year
|
|
Nervous system disorders
Dizziness
|
1.7%
5/286 • Number of events 5 • Up to 1 year
|
0.34%
1/291 • Number of events 1 • Up to 1 year
|
|
Nervous system disorders
Dysgeusia
|
0.35%
1/286 • Number of events 1 • Up to 1 year
|
0.34%
1/291 • Number of events 1 • Up to 1 year
|
|
Nervous system disorders
Extrapyramidal disorder
|
0.00%
0/286 • Up to 1 year
|
0.34%
1/291 • Number of events 1 • Up to 1 year
|
|
Nervous system disorders
Headache
|
0.35%
1/286 • Number of events 1 • Up to 1 year
|
1.4%
4/291 • Number of events 4 • Up to 1 year
|
|
Nervous system disorders
Movements involuntary
|
0.00%
0/286 • Up to 1 year
|
0.34%
1/291 • Number of events 1 • Up to 1 year
|
|
Nervous system disorders
Nervous system disorders - Oth spec
|
0.00%
0/286 • Up to 1 year
|
0.34%
1/291 • Number of events 1 • Up to 1 year
|
|
Nervous system disorders
Paresthesia
|
0.00%
0/286 • Up to 1 year
|
0.34%
1/291 • Number of events 1 • Up to 1 year
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
1.0%
3/286 • Number of events 3 • Up to 1 year
|
0.00%
0/291 • Up to 1 year
|
|
Nervous system disorders
Somnolence
|
3.8%
11/286 • Number of events 11 • Up to 1 year
|
5.2%
15/291 • Number of events 15 • Up to 1 year
|
|
Nervous system disorders
Syncope
|
0.35%
1/286 • Number of events 1 • Up to 1 year
|
0.00%
0/291 • Up to 1 year
|
|
Nervous system disorders
Tremor
|
0.70%
2/286 • Number of events 2 • Up to 1 year
|
0.00%
0/291 • Up to 1 year
|
|
Psychiatric disorders
Agitation
|
0.35%
1/286 • Number of events 1 • Up to 1 year
|
0.34%
1/291 • Number of events 1 • Up to 1 year
|
|
Psychiatric disorders
Insomnia
|
1.7%
5/286 • Number of events 5 • Up to 1 year
|
2.1%
6/291 • Number of events 6 • Up to 1 year
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.35%
1/286 • Number of events 1 • Up to 1 year
|
1.0%
3/291 • Number of events 3 • Up to 1 year
|
|
Renal and urinary disorders
Renal and urinary disorders - Oth spec
|
0.35%
1/286 • Number of events 1 • Up to 1 year
|
0.00%
0/291 • Up to 1 year
|
|
Reproductive system and breast disorders
Irregular menstruation
|
0.35%
1/286 • Number of events 1 • Up to 1 year
|
0.00%
0/291 • Up to 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.70%
2/286 • Number of events 2 • Up to 1 year
|
1.0%
3/291 • Number of events 3 • Up to 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.70%
2/286 • Number of events 2 • Up to 1 year
|
0.69%
2/291 • Number of events 2 • Up to 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/286 • Up to 1 year
|
0.34%
1/291 • Number of events 1 • Up to 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal mucositis
|
1.4%
4/286 • Number of events 4 • Up to 1 year
|
0.34%
1/291 • Number of events 1 • Up to 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/286 • Up to 1 year
|
0.34%
1/291 • Number of events 1 • Up to 1 year
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
4.9%
14/286 • Number of events 14 • Up to 1 year
|
6.9%
20/291 • Number of events 20 • Up to 1 year
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.35%
1/286 • Number of events 1 • Up to 1 year
|
0.00%
0/291 • Up to 1 year
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.35%
1/286 • Number of events 1 • Up to 1 year
|
0.34%
1/291 • Number of events 1 • Up to 1 year
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysesthesia syndrm
|
0.70%
2/286 • Number of events 2 • Up to 1 year
|
0.34%
1/291 • Number of events 1 • Up to 1 year
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.35%
1/286 • Number of events 1 • Up to 1 year
|
0.00%
0/291 • Up to 1 year
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.35%
1/286 • Number of events 1 • Up to 1 year
|
0.34%
1/291 • Number of events 1 • Up to 1 year
|
|
Skin and subcutaneous tissue disorders
Skin and subcut tissue disord - Oth spec
|
0.35%
1/286 • Number of events 1 • Up to 1 year
|
0.69%
2/291 • Number of events 2 • Up to 1 year
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
0.00%
0/286 • Up to 1 year
|
0.69%
2/291 • Number of events 2 • Up to 1 year
|
|
Vascular disorders
Hot flashes
|
0.70%
2/286 • Number of events 2 • Up to 1 year
|
0.00%
0/291 • Up to 1 year
|
|
Vascular disorders
Hypertension
|
1.7%
5/286 • Number of events 5 • Up to 1 year
|
1.0%
3/291 • Number of events 3 • Up to 1 year
|
|
Vascular disorders
Thromboembolic event
|
0.00%
0/286 • Up to 1 year
|
1.4%
4/291 • Number of events 4 • Up to 1 year
|
Additional Information
Dr Rudolph M. Navari
University of Alabama at Birmingham
Phone: 205-975-2833
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place