Trial Outcomes & Findings for Rolapitant as an Antiemetic in Malignant Glioma Patients Receiving Radiotherapy and Temozolomide (NCT NCT02991456)
NCT ID: NCT02991456
Last Updated: 2023-07-11
Results Overview
The Complete Response rate is defined as the proportion of participants with no emetic episode or the use of rescue medication during the first two weeks of radiation therapy and concomitant Temozolomide. The Complete Response rate will be assessed via the modified Multinational Association of Supportive Care in Cancer (MASCC) Antiemesis Tool (MAT).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
48 participants
Primary outcome timeframe
Weeks 1 and 2
Results posted on
2023-07-11
Participant Flow
Participant milestones
| Measure |
Sequence A
Daily ondansetron alone for 3 weeks, followed by the use of rolapitant (one dose on day 22) plus continued daily ondansetron for 3 weeks.
Rolapitant: single 180 mg dose by mouth
Ondansetron: 8 mg by mouth daily
|
Sequence B
Single dose of rolapitant (one dose on day 1) plus daily ondansetron for 3 weeks, followed by daily ondansetron alone for 3 weeks.
Rolapitant: single 180 mg dose by mouth
Ondansetron: 8 mg by mouth daily
|
|---|---|---|
|
Overall Study
STARTED
|
25
|
23
|
|
Overall Study
COMPLETED
|
22
|
21
|
|
Overall Study
NOT COMPLETED
|
3
|
2
|
Reasons for withdrawal
| Measure |
Sequence A
Daily ondansetron alone for 3 weeks, followed by the use of rolapitant (one dose on day 22) plus continued daily ondansetron for 3 weeks.
Rolapitant: single 180 mg dose by mouth
Ondansetron: 8 mg by mouth daily
|
Sequence B
Single dose of rolapitant (one dose on day 1) plus daily ondansetron for 3 weeks, followed by daily ondansetron alone for 3 weeks.
Rolapitant: single 180 mg dose by mouth
Ondansetron: 8 mg by mouth daily
|
|---|---|---|
|
Overall Study
Adverse Event
|
2
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
2
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
Rolapitant as an Antiemetic in Malignant Glioma Patients Receiving Radiotherapy and Temozolomide
Baseline characteristics by cohort
| Measure |
Sequence A
n=25 Participants
Daily ondansetron alone for 3 weeks, followed by the use of rolapitant (one dose on day 22) plus continued daily ondansetron for 3 weeks.
Rolapitant: single 180 mg dose by mouth
Ondansetron: 8 mg by mouth daily
|
Sequence B
n=23 Participants
Single dose of rolapitant (one dose on day 1) plus daily ondansetron for 3 weeks, followed by daily ondansetron alone for 3 weeks.
Rolapitant: single 180 mg dose by mouth
Ondansetron: 8 mg by mouth daily
|
Total
n=48 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
52.56 years
STANDARD_DEVIATION 13.99 • n=99 Participants
|
52.78 years
STANDARD_DEVIATION 13.95 • n=107 Participants
|
52.67 years
STANDARD_DEVIATION 13.82 • n=206 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
20 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
28 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
24 Participants
n=99 Participants
|
21 Participants
n=107 Participants
|
45 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
24 Participants
n=99 Participants
|
22 Participants
n=107 Participants
|
46 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
25 Participants
n=99 Participants
|
23 Participants
n=107 Participants
|
48 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Weeks 1 and 2Population: Four participants in each group did not complete MATs for the first two weeks.
The Complete Response rate is defined as the proportion of participants with no emetic episode or the use of rescue medication during the first two weeks of radiation therapy and concomitant Temozolomide. The Complete Response rate will be assessed via the modified Multinational Association of Supportive Care in Cancer (MASCC) Antiemesis Tool (MAT).
Outcome measures
| Measure |
Sequence A
n=21 Participants
Daily ondansetron alone for 3 weeks, followed by the use of rolapitant (one dose on day 22) plus continued daily ondansetron for 3 weeks.
Rolapitant: single 180 mg dose by mouth
Ondansetron: 8 mg by mouth daily
|
Sequence B
n=19 Participants
Single dose of rolapitant (one dose on day 1) plus daily ondansetron for 3 weeks, followed by daily ondansetron alone for 3 weeks.
Rolapitant: single 180 mg dose by mouth
Ondansetron: 8 mg by mouth daily
|
|---|---|---|
|
Complete Response (CR) Rate as Measured by Antiemesis Tool (MAT)
|
0.5717 proportion of participants
|
0.7368 proportion of participants
|
PRIMARY outcome
Timeframe: Weeks 1 and 2Population: Forty participants completed MATs; data collected by nurses via telephone on the remaining 8 participants.
The Complete Response rate is defined as the proportion of participants with no emetic episode or the use of rescue medication during the first two weeks of radiation therapy and concomitant Temozolomide. The Complete Response rate will be assessed via the modified Multinational Association of Supportive Care in Cancer (MASCC) MAT and nurse notes if MATs are missing.
Outcome measures
| Measure |
Sequence A
n=25 Participants
Daily ondansetron alone for 3 weeks, followed by the use of rolapitant (one dose on day 22) plus continued daily ondansetron for 3 weeks.
Rolapitant: single 180 mg dose by mouth
Ondansetron: 8 mg by mouth daily
|
Sequence B
n=23 Participants
Single dose of rolapitant (one dose on day 1) plus daily ondansetron for 3 weeks, followed by daily ondansetron alone for 3 weeks.
Rolapitant: single 180 mg dose by mouth
Ondansetron: 8 mg by mouth daily
|
|---|---|---|
|
Complete Response (CR) Rate as Measured by MAT With Supplemental Nurses Notes
|
0.6000 proportion of participants
|
0.6522 proportion of participants
|
SECONDARY outcome
Timeframe: Weeks 1-6Population: Participants who provided treatment preference data.
The number of participants who prefer rolapitant plus ondansetron over ondansetron alone, as determined by response to the question with "Which nausea medication regimen was I most satisfied with?"
Outcome measures
| Measure |
Sequence A
n=35 Participants
Daily ondansetron alone for 3 weeks, followed by the use of rolapitant (one dose on day 22) plus continued daily ondansetron for 3 weeks.
Rolapitant: single 180 mg dose by mouth
Ondansetron: 8 mg by mouth daily
|
Sequence B
Single dose of rolapitant (one dose on day 1) plus daily ondansetron for 3 weeks, followed by daily ondansetron alone for 3 weeks.
Rolapitant: single 180 mg dose by mouth
Ondansetron: 8 mg by mouth daily
|
|---|---|---|
|
Number of Participants Preferring Rolapitant in Combination With Ondansetron Versus Ondansetron Alone
Rolapitant + Ondansetron
|
7 Participants
|
—
|
|
Number of Participants Preferring Rolapitant in Combination With Ondansetron Versus Ondansetron Alone
Ondansetron alone
|
21 Participants
|
—
|
|
Number of Participants Preferring Rolapitant in Combination With Ondansetron Versus Ondansetron Alone
No Preference
|
7 Participants
|
—
|
SECONDARY outcome
Timeframe: Weeks 1-3Population: Participants who responded to at least two of the TSQM-9 questions for the effectiveness subscale at week 3.
Mean effectiveness scores at week 3 using the 9-item Treatment Satisfaction Questionnaire for Medication (TSQM-9) patient satisfaction survey. The effectiveness subscale score was computed from the 3 items corresponding to effectiveness. The resulting effectiveness score is measured from 0-100 with higher scores corresponding to higher effectiveness.
Outcome measures
| Measure |
Sequence A
n=21 Participants
Daily ondansetron alone for 3 weeks, followed by the use of rolapitant (one dose on day 22) plus continued daily ondansetron for 3 weeks.
Rolapitant: single 180 mg dose by mouth
Ondansetron: 8 mg by mouth daily
|
Sequence B
n=19 Participants
Single dose of rolapitant (one dose on day 1) plus daily ondansetron for 3 weeks, followed by daily ondansetron alone for 3 weeks.
Rolapitant: single 180 mg dose by mouth
Ondansetron: 8 mg by mouth daily
|
|---|---|---|
|
Week 3 Patient Satisfaction: Effectiveness
|
83.60 score on a scale
Standard Deviation 20.14
|
94.44 score on a scale
Standard Deviation 11.11
|
SECONDARY outcome
Timeframe: Weeks 1-3Population: Participants who responded to at least two of the TSQM-9 questions for the convenience subscale at week 3.
Mean convenience scores at week 3 using the 9-item Treatment Satisfaction Questionnaire for Medication (TSQM-9) patient satisfaction survey. The convenience subscale score was computed from the 3 items corresponding to convenience. The resulting convenience score is measured from 0-100 with higher scores corresponding to higher convenience.
Outcome measures
| Measure |
Sequence A
n=21 Participants
Daily ondansetron alone for 3 weeks, followed by the use of rolapitant (one dose on day 22) plus continued daily ondansetron for 3 weeks.
Rolapitant: single 180 mg dose by mouth
Ondansetron: 8 mg by mouth daily
|
Sequence B
n=19 Participants
Single dose of rolapitant (one dose on day 1) plus daily ondansetron for 3 weeks, followed by daily ondansetron alone for 3 weeks.
Rolapitant: single 180 mg dose by mouth
Ondansetron: 8 mg by mouth daily
|
|---|---|---|
|
Week 3 Patient Satisfaction: Convenience
|
85.71 score on a scale
Standard Deviation 15.57
|
94.15 score on a scale
Standard Deviation 10.05
|
SECONDARY outcome
Timeframe: Weeks 1-3Population: Participants who responded to at least two of the TSQM-9 questions for the overall satisfaction subscale at week 3.
Mean overall satisfaction scores at week 3 using the 9-item Treatment Satisfaction Questionnaire for Medication (TSQM-9) patient satisfaction survey. The overall satisfaction subscale score was computed from the 3 items corresponding to overall satisfaction. The resulting overall satisfaction score is measured from 0-100 with higher scores corresponding to higher overall satisfaction.
Outcome measures
| Measure |
Sequence A
n=21 Participants
Daily ondansetron alone for 3 weeks, followed by the use of rolapitant (one dose on day 22) plus continued daily ondansetron for 3 weeks.
Rolapitant: single 180 mg dose by mouth
Ondansetron: 8 mg by mouth daily
|
Sequence B
n=19 Participants
Single dose of rolapitant (one dose on day 1) plus daily ondansetron for 3 weeks, followed by daily ondansetron alone for 3 weeks.
Rolapitant: single 180 mg dose by mouth
Ondansetron: 8 mg by mouth daily
|
|---|---|---|
|
Week 3 Patient Satisfaction: Overall Satisfaction
|
81.88 score on a scale
Standard Deviation 17.69
|
90.94 score on a scale
Standard Deviation 13.38
|
SECONDARY outcome
Timeframe: Weeks 4-6Population: Participants who responded to at least two of the TSQM-9 questions for the effectiveness subscale at week 6.
Mean effectiveness scores at week 6 using the 9-item Treatment Satisfaction Questionnaire for Medication (TSQM-9) patient satisfaction survey. The effectiveness subscale score was computed by summing the 3 items corresponding to effectiveness. The resulting effectiveness score is measured from 0-100 with higher scores corresponding to higher effectiveness.
Outcome measures
| Measure |
Sequence A
n=20 Participants
Daily ondansetron alone for 3 weeks, followed by the use of rolapitant (one dose on day 22) plus continued daily ondansetron for 3 weeks.
Rolapitant: single 180 mg dose by mouth
Ondansetron: 8 mg by mouth daily
|
Sequence B
n=18 Participants
Single dose of rolapitant (one dose on day 1) plus daily ondansetron for 3 weeks, followed by daily ondansetron alone for 3 weeks.
Rolapitant: single 180 mg dose by mouth
Ondansetron: 8 mg by mouth daily
|
|---|---|---|
|
Week 6 Patient Satisfaction: Effectiveness
|
83.89 score on a scale
Standard Deviation 17.28
|
88.27 score on a scale
Standard Deviation 15.23
|
SECONDARY outcome
Timeframe: Weeks 4-6Population: Participants who responded to at least two of the TSQM-9 questions for the convenience subscale at week 6.
Mean convenience scores at week 6 using the 9-item Treatment Satisfaction Questionnaire for Medication (TSQM-9) patient satisfaction survey. The convenience subscale score was computed from the 3 items corresponding to convenience. The resulting convenience score is measured from 0-100 with higher scores corresponding to higher convenience.
Outcome measures
| Measure |
Sequence A
n=20 Participants
Daily ondansetron alone for 3 weeks, followed by the use of rolapitant (one dose on day 22) plus continued daily ondansetron for 3 weeks.
Rolapitant: single 180 mg dose by mouth
Ondansetron: 8 mg by mouth daily
|
Sequence B
n=18 Participants
Single dose of rolapitant (one dose on day 1) plus daily ondansetron for 3 weeks, followed by daily ondansetron alone for 3 weeks.
Rolapitant: single 180 mg dose by mouth
Ondansetron: 8 mg by mouth daily
|
|---|---|---|
|
Week 6 Patient Satisfaction: Convenience
|
86.11 score on a scale
Standard Deviation 16.07
|
91.98 score on a scale
Standard Deviation 12.53
|
SECONDARY outcome
Timeframe: Weeks 4-6Population: Participants who responded to at least two of the TSQM-9 questions for the overall satisfaction subscale at week 6.
Mean overall satisfaction scores at week 6 using the 9-item Treatment Satisfaction Questionnaire for Medication (TSQM-9) patient satisfaction survey. The overall satisfaction subscale score was computed from the 3 items corresponding to overall satisfaction. The resulting overall satisfaction score is measured from 0-100 with higher scores corresponding to higher overall satisfaction.
Outcome measures
| Measure |
Sequence A
n=20 Participants
Daily ondansetron alone for 3 weeks, followed by the use of rolapitant (one dose on day 22) plus continued daily ondansetron for 3 weeks.
Rolapitant: single 180 mg dose by mouth
Ondansetron: 8 mg by mouth daily
|
Sequence B
n=18 Participants
Single dose of rolapitant (one dose on day 1) plus daily ondansetron for 3 weeks, followed by daily ondansetron alone for 3 weeks.
Rolapitant: single 180 mg dose by mouth
Ondansetron: 8 mg by mouth daily
|
|---|---|---|
|
Week 6 Patient Satisfaction: Overall Satisfaction
|
81.39 score on a scale
Standard Deviation 21.16
|
88.58 score on a scale
Standard Deviation 12.12
|
SECONDARY outcome
Timeframe: Weeks 1 and 2Population: Participants who completed MATs for the first two weeks.
The cRIN-CR rate is defined as the proportion of participants who did not use rescue medication for nausea. The cRIN-CR rates were assessed via the modified Multinational Association of Supportive Care in Cancer (MASCC) Antiemesis Tool (MAT).
Outcome measures
| Measure |
Sequence A
n=21 Participants
Daily ondansetron alone for 3 weeks, followed by the use of rolapitant (one dose on day 22) plus continued daily ondansetron for 3 weeks.
Rolapitant: single 180 mg dose by mouth
Ondansetron: 8 mg by mouth daily
|
Sequence B
n=19 Participants
Single dose of rolapitant (one dose on day 1) plus daily ondansetron for 3 weeks, followed by daily ondansetron alone for 3 weeks.
Rolapitant: single 180 mg dose by mouth
Ondansetron: 8 mg by mouth daily
|
|---|---|---|
|
Chemoradiation-induced Nausea (cRIN) Rate Over First Two Weeks
|
0.6160 proportion of participants
|
0.6842 proportion of participants
|
SECONDARY outcome
Timeframe: Weeks 1 and 2Population: Forty participants completed MATs; data collected by nurses via telephone on the remaining 8 participants.
The cRIN-CR rate is defined as the proportion of participants who did not use rescue medication for nausea. The cRIN-CR rates were assessed via the modified Multinational Association of Supportive Care in Cancer (MASCC) Antiemesis Tool (MAT) and nurses notes if MATs were missing.
Outcome measures
| Measure |
Sequence A
n=25 Participants
Daily ondansetron alone for 3 weeks, followed by the use of rolapitant (one dose on day 22) plus continued daily ondansetron for 3 weeks.
Rolapitant: single 180 mg dose by mouth
Ondansetron: 8 mg by mouth daily
|
Sequence B
n=23 Participants
Single dose of rolapitant (one dose on day 1) plus daily ondansetron for 3 weeks, followed by daily ondansetron alone for 3 weeks.
Rolapitant: single 180 mg dose by mouth
Ondansetron: 8 mg by mouth daily
|
|---|---|---|
|
Chemoradiation-induced Nausea (cRIN) Rate Over First Two Weeks and Supplemented by Nurses Notes
|
0.6000 proportion of participants
|
0.6087 proportion of participants
|
SECONDARY outcome
Timeframe: Weeks 1 and 2Population: Participants who completed MATs for the first two weeks.
The cRIV-CR rate is defined as the proportion of participants without use of rescue medication for vomiting. The cRIV-CR rates were assessed via the modified Multinational Association of Supportive Care in Cancer (MASCC) Antiemesis Tool (MAT).
Outcome measures
| Measure |
Sequence A
n=21 Participants
Daily ondansetron alone for 3 weeks, followed by the use of rolapitant (one dose on day 22) plus continued daily ondansetron for 3 weeks.
Rolapitant: single 180 mg dose by mouth
Ondansetron: 8 mg by mouth daily
|
Sequence B
n=19 Participants
Single dose of rolapitant (one dose on day 1) plus daily ondansetron for 3 weeks, followed by daily ondansetron alone for 3 weeks.
Rolapitant: single 180 mg dose by mouth
Ondansetron: 8 mg by mouth daily
|
|---|---|---|
|
Chemoradiation-induced Vomiting (cRIV) Rate Over First Two Weeks
|
0.8095 proportion of participants
|
1.0000 proportion of participants
|
SECONDARY outcome
Timeframe: Weeks 1 and 2Population: Forty participants completed MATs; data collected by nurses via telephone on the remaining 8 participants.
The cRIV-CR rate is defined as the proportion of participants without use of rescue medication for vomiting. The cRIV-CR rates were assessed via the modified Multinational Association of Supportive Care in Cancer (MASCC) Antiemesis Tool (MAT) and nurse notes if MATS are missing.
Outcome measures
| Measure |
Sequence A
n=25 Participants
Daily ondansetron alone for 3 weeks, followed by the use of rolapitant (one dose on day 22) plus continued daily ondansetron for 3 weeks.
Rolapitant: single 180 mg dose by mouth
Ondansetron: 8 mg by mouth daily
|
Sequence B
n=23 Participants
Single dose of rolapitant (one dose on day 1) plus daily ondansetron for 3 weeks, followed by daily ondansetron alone for 3 weeks.
Rolapitant: single 180 mg dose by mouth
Ondansetron: 8 mg by mouth daily
|
|---|---|---|
|
Chemoradiation-induced Vomiting (cRIV) Rate Over First Two Weeks With Supplemental Nurses Notes
|
0.8000 proportion of participants
|
0.9565 proportion of participants
|
SECONDARY outcome
Timeframe: Weeks 1-6Population: Participants who completed MATs for six weeks and complied with treatment.
The cRIN-CR rate is defined as the proportion of participants who did not use rescue medication for nausea. The cRIN-CR rates were assessed via the modified Multinational Association of Supportive Care in Cancer (MASCC) Antiemesis Tool (MAT).
Outcome measures
| Measure |
Sequence A
n=19 Participants
Daily ondansetron alone for 3 weeks, followed by the use of rolapitant (one dose on day 22) plus continued daily ondansetron for 3 weeks.
Rolapitant: single 180 mg dose by mouth
Ondansetron: 8 mg by mouth daily
|
Sequence B
n=19 Participants
Single dose of rolapitant (one dose on day 1) plus daily ondansetron for 3 weeks, followed by daily ondansetron alone for 3 weeks.
Rolapitant: single 180 mg dose by mouth
Ondansetron: 8 mg by mouth daily
|
|---|---|---|
|
Chemoradiation-induced Nausea (cRIN) Rate Over All Six Weeks
|
0.4737 proportion of participants
|
0.4737 proportion of participants
|
SECONDARY outcome
Timeframe: Weeks 1-6Population: Data not collected on 10 participants.
The cRIV-CR rate is defined as the proportion of participants without use of rescue medication for vomiting. The cRIV-CR rates were assessed via the modified Multinational Association of Supportive Care in Cancer (MASCC) Antiemesis Tool (MAT).
Outcome measures
| Measure |
Sequence A
n=19 Participants
Daily ondansetron alone for 3 weeks, followed by the use of rolapitant (one dose on day 22) plus continued daily ondansetron for 3 weeks.
Rolapitant: single 180 mg dose by mouth
Ondansetron: 8 mg by mouth daily
|
Sequence B
n=19 Participants
Single dose of rolapitant (one dose on day 1) plus daily ondansetron for 3 weeks, followed by daily ondansetron alone for 3 weeks.
Rolapitant: single 180 mg dose by mouth
Ondansetron: 8 mg by mouth daily
|
|---|---|---|
|
Chemoradiation-induced Vomiting (cRIV) Rate Over All Six Weeks
|
0.7368 proportion of participants
|
0.8947 proportion of participants
|
SECONDARY outcome
Timeframe: Weeks 1-3Population: Participants who remained on study and returned medication logs.
Percentage of participants who adhered to ondansetron treatment for more than 21 days during weeks 1-3.
Outcome measures
| Measure |
Sequence A
n=23 Participants
Daily ondansetron alone for 3 weeks, followed by the use of rolapitant (one dose on day 22) plus continued daily ondansetron for 3 weeks.
Rolapitant: single 180 mg dose by mouth
Ondansetron: 8 mg by mouth daily
|
Sequence B
n=21 Participants
Single dose of rolapitant (one dose on day 1) plus daily ondansetron for 3 weeks, followed by daily ondansetron alone for 3 weeks.
Rolapitant: single 180 mg dose by mouth
Ondansetron: 8 mg by mouth daily
|
|---|---|---|
|
Ondansetron Medication Compliance Weeks 1-3
|
91.30 percentage of participants
|
100 percentage of participants
|
SECONDARY outcome
Timeframe: Weeks 4-6Population: Participants who remained on study without schedule changes and returned medication logs.
Percentage of participants who adhered to ondansetron treatment for more than 21 days during weeks 4-6.
Outcome measures
| Measure |
Sequence A
n=20 Participants
Daily ondansetron alone for 3 weeks, followed by the use of rolapitant (one dose on day 22) plus continued daily ondansetron for 3 weeks.
Rolapitant: single 180 mg dose by mouth
Ondansetron: 8 mg by mouth daily
|
Sequence B
n=21 Participants
Single dose of rolapitant (one dose on day 1) plus daily ondansetron for 3 weeks, followed by daily ondansetron alone for 3 weeks.
Rolapitant: single 180 mg dose by mouth
Ondansetron: 8 mg by mouth daily
|
|---|---|---|
|
Ondansetron Medication Compliance Weeks 4-6
|
95 percentage of participants
|
95.24 percentage of participants
|
SECONDARY outcome
Timeframe: 8 weeksThe proportion of participants with grade 3, 4 or 5 adverse events (severe, life-threatening, or fatal) possibly, probably or definitely related to administration of Rolapitant or Ondansetron. Adverse events will be collected from start of treatment through the end of the two-week period following chemoradiation (or until 30 days after the last dose of rolapitant is given in Sequence A). CTCAE version 4 was used to grade adverse events.
Outcome measures
| Measure |
Sequence A
n=25 Participants
Daily ondansetron alone for 3 weeks, followed by the use of rolapitant (one dose on day 22) plus continued daily ondansetron for 3 weeks.
Rolapitant: single 180 mg dose by mouth
Ondansetron: 8 mg by mouth daily
|
Sequence B
n=23 Participants
Single dose of rolapitant (one dose on day 1) plus daily ondansetron for 3 weeks, followed by daily ondansetron alone for 3 weeks.
Rolapitant: single 180 mg dose by mouth
Ondansetron: 8 mg by mouth daily
|
|---|---|---|
|
Proportion of Participants With Grade 3, 4 or 5 Treatment-related Adverse Events
|
0 proportion of participants
|
0 proportion of participants
|
Adverse Events
Period 1 Rolapitant + Ondansetron
Serious events: 3 serious events
Other events: 22 other events
Deaths: 0 deaths
Period 1 Ondansetron
Serious events: 0 serious events
Other events: 23 other events
Deaths: 0 deaths
Period 2 Rolapitant + Ondansetron
Serious events: 1 serious events
Other events: 18 other events
Deaths: 0 deaths
Period 2 Ondansetron
Serious events: 2 serious events
Other events: 21 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Period 1 Rolapitant + Ondansetron
n=23 participants at risk
Weeks 1-3
Rolapitant: single 180 mg dose by mouth
Ondansetron: 8 mg by mouth daily
|
Period 1 Ondansetron
n=25 participants at risk
Weeks 1-3
Ondansetron: 8 mg by mouth daily
|
Period 2 Rolapitant + Ondansetron
n=22 participants at risk
Weeks 4-6
Rolapitant: single 180 mg dose by mouth
Ondansetron: 8 mg by mouth daily
|
Period 2 Ondansetron
n=23 participants at risk
Weeks 4-6
Ondansetron: 8 mg by mouth daily
|
|---|---|---|---|---|
|
Nervous system disorders
Seizure
|
4.3%
1/23 • Number of events 1 • 8 weeks
|
0.00%
0/25 • 8 weeks
|
4.5%
1/22 • Number of events 1 • 8 weeks
|
4.3%
1/23 • Number of events 1 • 8 weeks
|
|
Psychiatric disorders
Psychosis
|
4.3%
1/23 • Number of events 1 • 8 weeks
|
0.00%
0/25 • 8 weeks
|
0.00%
0/22 • 8 weeks
|
0.00%
0/23 • 8 weeks
|
|
Renal and urinary disorders
Renal calculi
|
4.3%
1/23 • Number of events 1 • 8 weeks
|
0.00%
0/25 • 8 weeks
|
0.00%
0/22 • 8 weeks
|
0.00%
0/23 • 8 weeks
|
|
General disorders
Fatigue
|
0.00%
0/23 • 8 weeks
|
0.00%
0/25 • 8 weeks
|
0.00%
0/22 • 8 weeks
|
4.3%
1/23 • Number of events 1 • 8 weeks
|
|
Vascular disorders
Hypotension
|
0.00%
0/23 • 8 weeks
|
0.00%
0/25 • 8 weeks
|
0.00%
0/22 • 8 weeks
|
4.3%
1/23 • Number of events 1 • 8 weeks
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/23 • 8 weeks
|
0.00%
0/25 • 8 weeks
|
0.00%
0/22 • 8 weeks
|
4.3%
1/23 • Number of events 1 • 8 weeks
|
Other adverse events
| Measure |
Period 1 Rolapitant + Ondansetron
n=23 participants at risk
Weeks 1-3
Rolapitant: single 180 mg dose by mouth
Ondansetron: 8 mg by mouth daily
|
Period 1 Ondansetron
n=25 participants at risk
Weeks 1-3
Ondansetron: 8 mg by mouth daily
|
Period 2 Rolapitant + Ondansetron
n=22 participants at risk
Weeks 4-6
Rolapitant: single 180 mg dose by mouth
Ondansetron: 8 mg by mouth daily
|
Period 2 Ondansetron
n=23 participants at risk
Weeks 4-6
Ondansetron: 8 mg by mouth daily
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal Pain
|
4.3%
1/23 • Number of events 1 • 8 weeks
|
0.00%
0/25 • 8 weeks
|
0.00%
0/22 • 8 weeks
|
0.00%
0/23 • 8 weeks
|
|
Psychiatric disorders
Agitation
|
4.3%
1/23 • Number of events 1 • 8 weeks
|
4.0%
1/25 • Number of events 1 • 8 weeks
|
0.00%
0/22 • 8 weeks
|
0.00%
0/23 • 8 weeks
|
|
Investigations
Alanine Aminotransferase Increased
|
13.0%
3/23 • Number of events 3 • 8 weeks
|
4.0%
1/25 • Number of events 1 • 8 weeks
|
4.5%
1/22 • Number of events 1 • 8 weeks
|
13.0%
3/23 • Number of events 3 • 8 weeks
|
|
Investigations
Alkaline Phosphatase Increased
|
0.00%
0/23 • 8 weeks
|
0.00%
0/25 • 8 weeks
|
4.5%
1/22 • Number of events 2 • 8 weeks
|
0.00%
0/23 • 8 weeks
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
8.7%
2/23 • Number of events 2 • 8 weeks
|
16.0%
4/25 • Number of events 4 • 8 weeks
|
18.2%
4/22 • Number of events 4 • 8 weeks
|
26.1%
6/23 • Number of events 6 • 8 weeks
|
|
Blood and lymphatic system disorders
Anemia
|
8.7%
2/23 • Number of events 2 • 8 weeks
|
16.0%
4/25 • Number of events 4 • 8 weeks
|
27.3%
6/22 • Number of events 6 • 8 weeks
|
0.00%
0/23 • 8 weeks
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/23 • 8 weeks
|
4.0%
1/25 • Number of events 1 • 8 weeks
|
4.5%
1/22 • Number of events 1 • 8 weeks
|
4.3%
1/23 • Number of events 1 • 8 weeks
|
|
Psychiatric disorders
Anxiety
|
4.3%
1/23 • Number of events 1 • 8 weeks
|
0.00%
0/25 • 8 weeks
|
0.00%
0/22 • 8 weeks
|
0.00%
0/23 • 8 weeks
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
4.3%
1/23 • Number of events 1 • 8 weeks
|
0.00%
0/25 • 8 weeks
|
0.00%
0/22 • 8 weeks
|
0.00%
0/23 • 8 weeks
|
|
Investigations
Aspartate Aminotransferase Increased
|
0.00%
0/23 • 8 weeks
|
0.00%
0/25 • 8 weeks
|
4.5%
1/22 • Number of events 1 • 8 weeks
|
4.3%
1/23 • Number of events 1 • 8 weeks
|
|
Gastrointestinal disorders
Bloating
|
4.3%
1/23 • Number of events 1 • 8 weeks
|
0.00%
0/25 • 8 weeks
|
0.00%
0/22 • 8 weeks
|
0.00%
0/23 • 8 weeks
|
|
Investigations
Blood Bilirubin Increased
|
0.00%
0/23 • 8 weeks
|
8.0%
2/25 • Number of events 2 • 8 weeks
|
4.5%
1/22 • Number of events 1 • 8 weeks
|
8.7%
2/23 • Number of events 2 • 8 weeks
|
|
Eye disorders
Blurred Vision
|
0.00%
0/23 • 8 weeks
|
4.0%
1/25 • Number of events 1 • 8 weeks
|
0.00%
0/22 • 8 weeks
|
0.00%
0/23 • 8 weeks
|
|
Skin and subcutaneous tissue disorders
Bullous Dermatitis
|
4.3%
1/23 • Number of events 1 • 8 weeks
|
0.00%
0/25 • 8 weeks
|
0.00%
0/22 • 8 weeks
|
0.00%
0/23 • 8 weeks
|
|
Injury, poisoning and procedural complications
Burn
|
0.00%
0/23 • 8 weeks
|
0.00%
0/25 • 8 weeks
|
0.00%
0/22 • 8 weeks
|
4.3%
1/23 • Number of events 1 • 8 weeks
|
|
Psychiatric disorders
Confusion
|
4.3%
1/23 • Number of events 1 • 8 weeks
|
0.00%
0/25 • 8 weeks
|
4.5%
1/22 • Number of events 1 • 8 weeks
|
0.00%
0/23 • 8 weeks
|
|
Gastrointestinal disorders
Constipation
|
34.8%
8/23 • Number of events 8 • 8 weeks
|
36.0%
9/25 • Number of events 9 • 8 weeks
|
4.5%
1/22 • Number of events 1 • 8 weeks
|
0.00%
0/23 • 8 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/23 • 8 weeks
|
0.00%
0/25 • 8 weeks
|
0.00%
0/22 • 8 weeks
|
8.7%
2/23 • Number of events 2 • 8 weeks
|
|
Investigations
Creatinine Increased
|
0.00%
0/23 • 8 weeks
|
0.00%
0/25 • 8 weeks
|
4.5%
1/22 • Number of events 1 • 8 weeks
|
0.00%
0/23 • 8 weeks
|
|
Psychiatric disorders
Depression
|
0.00%
0/23 • 8 weeks
|
0.00%
0/25 • 8 weeks
|
0.00%
0/22 • 8 weeks
|
4.3%
1/23 • Number of events 1 • 8 weeks
|
|
Injury, poisoning and procedural complications
Dermatitis Radiation
|
0.00%
0/23 • 8 weeks
|
0.00%
0/25 • 8 weeks
|
4.5%
1/22 • Number of events 1 • 8 weeks
|
0.00%
0/23 • 8 weeks
|
|
Gastrointestinal disorders
Diarrhea
|
8.7%
2/23 • Number of events 2 • 8 weeks
|
4.0%
1/25 • Number of events 1 • 8 weeks
|
4.5%
1/22 • Number of events 1 • 8 weeks
|
8.7%
2/23 • Number of events 2 • 8 weeks
|
|
Nervous system disorders
Dizziness
|
0.00%
0/23 • 8 weeks
|
8.0%
2/25 • Number of events 2 • 8 weeks
|
0.00%
0/22 • 8 weeks
|
0.00%
0/23 • 8 weeks
|
|
Nervous system disorders
Dysgeusia
|
4.3%
1/23 • Number of events 1 • 8 weeks
|
0.00%
0/25 • 8 weeks
|
9.1%
2/22 • Number of events 2 • 8 weeks
|
4.3%
1/23 • Number of events 1 • 8 weeks
|
|
Nervous system disorders
Dysphasia
|
0.00%
0/23 • 8 weeks
|
4.0%
1/25 • Number of events 1 • 8 weeks
|
4.5%
1/22 • Number of events 1 • 8 weeks
|
0.00%
0/23 • 8 weeks
|
|
Ear and labyrinth disorders
Other, Specify: "muffling" in right ear
|
0.00%
0/23 • 8 weeks
|
0.00%
0/25 • 8 weeks
|
0.00%
0/22 • 8 weeks
|
4.3%
1/23 • Number of events 1 • 8 weeks
|
|
Ear and labyrinth disorders
Other, Specify: ear fullness/muffling, hard to hear in both ears
|
0.00%
0/23 • 8 weeks
|
0.00%
0/25 • 8 weeks
|
4.5%
1/22 • Number of events 1 • 8 weeks
|
0.00%
0/23 • 8 weeks
|
|
General disorders
Edema Face
|
4.3%
1/23 • Number of events 1 • 8 weeks
|
0.00%
0/25 • 8 weeks
|
0.00%
0/22 • 8 weeks
|
0.00%
0/23 • 8 weeks
|
|
General disorders
Edema Limbs
|
0.00%
0/23 • 8 weeks
|
0.00%
0/25 • 8 weeks
|
4.5%
1/22 • Number of events 1 • 8 weeks
|
0.00%
0/23 • 8 weeks
|
|
Eye disorders
Other, Specify: impaired vision, right eye
|
0.00%
0/23 • 8 weeks
|
4.0%
1/25 • Number of events 1 • 8 weeks
|
0.00%
0/22 • 8 weeks
|
0.00%
0/23 • 8 weeks
|
|
Eye disorders
Other, Specify: right eye inflammation
|
0.00%
0/23 • 8 weeks
|
4.0%
1/25 • Number of events 1 • 8 weeks
|
0.00%
0/22 • 8 weeks
|
0.00%
0/23 • 8 weeks
|
|
Eye disorders
Eye Pain
|
0.00%
0/23 • 8 weeks
|
4.0%
1/25 • Number of events 1 • 8 weeks
|
0.00%
0/22 • 8 weeks
|
0.00%
0/23 • 8 weeks
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/23 • 8 weeks
|
0.00%
0/25 • 8 weeks
|
0.00%
0/22 • 8 weeks
|
4.3%
1/23 • Number of events 1 • 8 weeks
|
|
General disorders
Fatigue
|
34.8%
8/23 • Number of events 8 • 8 weeks
|
48.0%
12/25 • Number of events 12 • 8 weeks
|
18.2%
4/22 • Number of events 4 • 8 weeks
|
13.0%
3/23 • Number of events 4 • 8 weeks
|
|
Eye disorders
Floaters
|
4.3%
1/23 • Number of events 1 • 8 weeks
|
0.00%
0/25 • 8 weeks
|
0.00%
0/22 • 8 weeks
|
0.00%
0/23 • 8 weeks
|
|
General disorders
Other, Unspecified
|
0.00%
0/23 • 8 weeks
|
0.00%
0/25 • 8 weeks
|
0.00%
0/22 • 8 weeks
|
4.3%
1/23 • Number of events 3 • 8 weeks
|
|
General disorders
Other, Specify: constant feeling of being cold
|
0.00%
0/23 • 8 weeks
|
0.00%
0/25 • 8 weeks
|
4.5%
1/22 • Number of events 1 • 8 weeks
|
0.00%
0/23 • 8 weeks
|
|
Nervous system disorders
Headache
|
4.3%
1/23 • Number of events 1 • 8 weeks
|
0.00%
0/25 • 8 weeks
|
4.5%
1/22 • Number of events 1 • 8 weeks
|
0.00%
0/23 • 8 weeks
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
30.4%
7/23 • Number of events 7 • 8 weeks
|
16.0%
4/25 • Number of events 4 • 8 weeks
|
18.2%
4/22 • Number of events 6 • 8 weeks
|
17.4%
4/23 • Number of events 7 • 8 weeks
|
|
Metabolism and nutrition disorders
Hypernatremia
|
4.3%
1/23 • Number of events 1 • 8 weeks
|
0.00%
0/25 • 8 weeks
|
0.00%
0/22 • 8 weeks
|
0.00%
0/23 • 8 weeks
|
|
Vascular disorders
Hypertension
|
4.3%
1/23 • Number of events 1 • 8 weeks
|
0.00%
0/25 • 8 weeks
|
9.1%
2/22 • Number of events 2 • 8 weeks
|
4.3%
1/23 • Number of events 1 • 8 weeks
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
4.3%
1/23 • Number of events 1 • 8 weeks
|
4.0%
1/25 • Number of events 1 • 8 weeks
|
0.00%
0/22 • 8 weeks
|
4.3%
1/23 • Number of events 1 • 8 weeks
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
0.00%
0/23 • 8 weeks
|
0.00%
0/25 • 8 weeks
|
4.5%
1/22 • Number of events 2 • 8 weeks
|
8.7%
2/23 • Number of events 2 • 8 weeks
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
4.3%
1/23 • Number of events 1 • 8 weeks
|
0.00%
0/25 • 8 weeks
|
0.00%
0/22 • 8 weeks
|
0.00%
0/23 • 8 weeks
|
|
Metabolism and nutrition disorders
Hypokalemia
|
4.3%
1/23 • Number of events 1 • 8 weeks
|
8.0%
2/25 • Number of events 2 • 8 weeks
|
9.1%
2/22 • Number of events 2 • 8 weeks
|
8.7%
2/23 • Number of events 2 • 8 weeks
|
|
Metabolism and nutrition disorders
Hyponatremia
|
4.3%
1/23 • Number of events 2 • 8 weeks
|
0.00%
0/25 • 8 weeks
|
0.00%
0/22 • 8 weeks
|
4.3%
1/23 • Number of events 1 • 8 weeks
|
|
Infections and infestations
Other, Specify: oral fungal infection on tongue
|
0.00%
0/23 • 8 weeks
|
4.0%
1/25 • Number of events 1 • 8 weeks
|
0.00%
0/22 • 8 weeks
|
0.00%
0/23 • 8 weeks
|
|
General disorders
Injection Site Reaction
|
4.3%
1/23 • Number of events 7 • 8 weeks
|
4.0%
1/25 • Number of events 1 • 8 weeks
|
0.00%
0/22 • 8 weeks
|
4.3%
1/23 • Number of events 6 • 8 weeks
|
|
Injury, poisoning and procedural complications
Other, Specify: blurred vision preventing reading, d/t radiation mask placement
|
0.00%
0/23 • 8 weeks
|
4.0%
1/25 • Number of events 1 • 8 weeks
|
0.00%
0/22 • 8 weeks
|
0.00%
0/23 • 8 weeks
|
|
Injury, poisoning and procedural complications
Other, Specify: dermatitis radiation
|
0.00%
0/23 • 8 weeks
|
4.0%
1/25 • Number of events 1 • 8 weeks
|
0.00%
0/22 • 8 weeks
|
0.00%
0/23 • 8 weeks
|
|
Injury, poisoning and procedural complications
Other, Specify: swollen eyelids impeding eye opening, d/t radiation mask placement
|
0.00%
0/23 • 8 weeks
|
4.0%
1/25 • Number of events 1 • 8 weeks
|
0.00%
0/22 • 8 weeks
|
0.00%
0/23 • 8 weeks
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/23 • 8 weeks
|
4.0%
1/25 • Number of events 1 • 8 weeks
|
4.5%
1/22 • Number of events 1 • 8 weeks
|
0.00%
0/23 • 8 weeks
|
|
Investigations
Lymphocyte Count Decreased
|
13.0%
3/23 • Number of events 3 • 8 weeks
|
8.0%
2/25 • Number of events 3 • 8 weeks
|
40.9%
9/22 • Number of events 16 • 8 weeks
|
30.4%
7/23 • Number of events 10 • 8 weeks
|
|
Nervous system disorders
Memory Impairment
|
4.3%
1/23 • Number of events 1 • 8 weeks
|
0.00%
0/25 • 8 weeks
|
0.00%
0/22 • 8 weeks
|
0.00%
0/23 • 8 weeks
|
|
Infections and infestations
Mucosal Infection
|
0.00%
0/23 • 8 weeks
|
0.00%
0/25 • 8 weeks
|
0.00%
0/22 • 8 weeks
|
4.3%
1/23 • Number of events 1 • 8 weeks
|
|
Musculoskeletal and connective tissue disorders
Other, Specify: temporomandibular joint inflammation causing nausea while chewing
|
0.00%
0/23 • 8 weeks
|
0.00%
0/25 • 8 weeks
|
4.5%
1/22 • Number of events 1 • 8 weeks
|
0.00%
0/23 • 8 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
0.00%
0/23 • 8 weeks
|
0.00%
0/25 • 8 weeks
|
4.5%
1/22 • Number of events 1 • 8 weeks
|
0.00%
0/23 • 8 weeks
|
|
Gastrointestinal disorders
Nausea
|
39.1%
9/23 • Number of events 11 • 8 weeks
|
44.0%
11/25 • Number of events 11 • 8 weeks
|
9.1%
2/22 • Number of events 2 • 8 weeks
|
30.4%
7/23 • Number of events 8 • 8 weeks
|
|
General disorders
Neck Edema
|
0.00%
0/23 • 8 weeks
|
0.00%
0/25 • 8 weeks
|
0.00%
0/22 • 8 weeks
|
4.3%
1/23 • Number of events 1 • 8 weeks
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
4.3%
1/23 • Number of events 1 • 8 weeks
|
0.00%
0/25 • 8 weeks
|
0.00%
0/22 • 8 weeks
|
0.00%
0/23 • 8 weeks
|
|
Investigations
Neutrophil Count Decreased
|
4.3%
1/23 • Number of events 1 • 8 weeks
|
4.0%
1/25 • Number of events 1 • 8 weeks
|
13.6%
3/22 • Number of events 3 • 8 weeks
|
4.3%
1/23 • Number of events 1 • 8 weeks
|
|
Infections and infestations
Otitis Externa
|
0.00%
0/23 • 8 weeks
|
0.00%
0/25 • 8 weeks
|
4.5%
1/22 • Number of events 1 • 8 weeks
|
0.00%
0/23 • 8 weeks
|
|
General disorders
Pain
|
0.00%
0/23 • 8 weeks
|
4.0%
1/25 • Number of events 1 • 8 weeks
|
0.00%
0/22 • 8 weeks
|
4.3%
1/23 • Number of events 1 • 8 weeks
|
|
Investigations
Platelet Count Decreased
|
4.3%
1/23 • Number of events 1 • 8 weeks
|
8.0%
2/25 • Number of events 2 • 8 weeks
|
27.3%
6/22 • Number of events 11 • 8 weeks
|
21.7%
5/23 • Number of events 11 • 8 weeks
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
4.3%
1/23 • Number of events 1 • 8 weeks
|
4.0%
1/25 • Number of events 1 • 8 weeks
|
0.00%
0/22 • 8 weeks
|
0.00%
0/23 • 8 weeks
|
|
Nervous system disorders
Pyramidal Tract Syndrome
|
0.00%
0/23 • 8 weeks
|
0.00%
0/25 • 8 weeks
|
4.5%
1/22 • Number of events 1 • 8 weeks
|
0.00%
0/23 • 8 weeks
|
|
Skin and subcutaneous tissue disorders
Rash Maculo-Papular
|
0.00%
0/23 • 8 weeks
|
0.00%
0/25 • 8 weeks
|
9.1%
2/22 • Number of events 2 • 8 weeks
|
0.00%
0/23 • 8 weeks
|
|
Nervous system disorders
Seizure
|
4.3%
1/23 • Number of events 1 • 8 weeks
|
0.00%
0/25 • 8 weeks
|
0.00%
0/22 • 8 weeks
|
0.00%
0/23 • 8 weeks
|
|
Cardiac disorders
Sinus Tachycardia
|
4.3%
1/23 • Number of events 1 • 8 weeks
|
4.0%
1/25 • Number of events 1 • 8 weeks
|
4.5%
1/22 • Number of events 1 • 8 weeks
|
0.00%
0/23 • 8 weeks
|
|
Skin and subcutaneous tissue disorders
Other, Specify: "bruising left hand from fall"
|
0.00%
0/23 • 8 weeks
|
0.00%
0/25 • 8 weeks
|
0.00%
0/22 • 8 weeks
|
4.3%
1/23 • Number of events 1 • 8 weeks
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/23 • 8 weeks
|
0.00%
0/25 • 8 weeks
|
0.00%
0/22 • 8 weeks
|
8.7%
2/23 • Number of events 2 • 8 weeks
|
|
Nervous system disorders
Tremor
|
0.00%
0/23 • 8 weeks
|
4.0%
1/25 • Number of events 1 • 8 weeks
|
0.00%
0/22 • 8 weeks
|
0.00%
0/23 • 8 weeks
|
|
Gastrointestinal disorders
Vomiting
|
4.3%
1/23 • Number of events 1 • 8 weeks
|
4.0%
1/25 • Number of events 1 • 8 weeks
|
0.00%
0/22 • 8 weeks
|
4.3%
1/23 • Number of events 1 • 8 weeks
|
|
Investigations
White Blood Cell Decreased
|
8.7%
2/23 • Number of events 2 • 8 weeks
|
0.00%
0/25 • 8 weeks
|
13.6%
3/22 • Number of events 5 • 8 weeks
|
8.7%
2/23 • Number of events 2 • 8 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place