Trial Outcomes & Findings for Ondissolve in the Prophylaxis/Rescue of Radiation Induced Nausea and Vomiting (NCT NCT02006056)
NCT ID: NCT02006056
Last Updated: 2018-08-16
Results Overview
The primary objectives are to examine the efficacy for the prevention/rescue of Acute and Delayed Phase radiation-induced nausea and vomiting (RINV) in patients undergoing single or multiple fraction, emetogenic palliative radiation therapy for painful bone metastases. Complete control: No increase in emetic episodes or increase in use of rescue medication (for secondary prophylaxis) following radiation treatment, compared to the number of incidences at baseline. Partial control: Increase of 2 or fewer emetic episodes from baseline and no use of rescue antiemetic medication during or after radiotherapy. Uncontrolled: Increase of three or more emetic episodes or use of antiemetic rescue medication.
COMPLETED
PHASE2
30 participants
Day 0 - Day 10
2018-08-16
Participant Flow
Patients attending the Odette Cancer Centre, Toronto, Canada, who satisfy the eligibility criteria were considered for entry into the trial. The last patient was enrolled July 2014.
This prospective phase II trial enrolled patients from November 2013 to July 2014.
Participant milestones
| Measure |
Primary Prophylaxis
Patients have no pre-existing nausea or vomiting 24 hours before radiotherapy
|
Secondary Prophylaxis
Patients already experiencing mild nausea and/or mild vomiting within 24 hours before radiotherapy.
|
|---|---|---|
|
Overall Study
STARTED
|
26
|
4
|
|
Overall Study
COMPLETED
|
26
|
4
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Ondissolve in the Prophylaxis/Rescue of Radiation Induced Nausea and Vomiting
Baseline characteristics by cohort
| Measure |
Primary Prophylaxis
n=26 Participants
Patients had no nausea or vomiting at baseline.
|
Secondary Prophylaxis
n=4 Participants
Patients had nausea or vomiting at baseline.
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
71.6 years
STANDARD_DEVIATION 11.7 • n=99 Participants
|
69.8 years
STANDARD_DEVIATION 5.7 • n=107 Participants
|
71.3 years
STANDARD_DEVIATION 11 • n=206 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
19 Participants
n=206 Participants
|
|
Location
Home
|
24 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
28 Participants
n=206 Participants
|
|
Location
Hospital
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Score on the KPS
|
69.2 units on a scale
STANDARD_DEVIATION 15.2 • n=99 Participants
|
70.0 units on a scale
STANDARD_DEVIATION 14.1 • n=107 Participants
|
69.3 units on a scale
STANDARD_DEVIATION 14.8 • n=206 Participants
|
|
Primary cancer site
Prostate
|
10 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
|
Primary cancer site
Breast
|
8 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Primary cancer site
Lung
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Primary cancer site
Bladder
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Primary cancer site
Other
|
3 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Primary cancer site
Unknown
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Systemic treatment
None
|
13 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
|
Systemic treatment
Chemotherapy
|
7 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Systemic treatment
Hormone therapy
|
4 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Systemic treatment
Bisphosphonate only
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Radiotherapy dose
8 Gy in 1 fraction
|
16 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
20 Participants
n=206 Participants
|
|
Radiotherapy dose
20 Gy in 5 fractions
|
6 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Radiotherapy dose
30 Gy in 10 fractions
|
4 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Day 0 - Day 10Population: The results here encompass the primary outcome measure "the proportion of patients with complete prophylaxis and partial control", which is repeated in the secondary outcome. The secondary outcome "Time to nausea, vomiting and/or use of rescue medication" is unavailable due to the data not being collected/analysed.
The primary objectives are to examine the efficacy for the prevention/rescue of Acute and Delayed Phase radiation-induced nausea and vomiting (RINV) in patients undergoing single or multiple fraction, emetogenic palliative radiation therapy for painful bone metastases. Complete control: No increase in emetic episodes or increase in use of rescue medication (for secondary prophylaxis) following radiation treatment, compared to the number of incidences at baseline. Partial control: Increase of 2 or fewer emetic episodes from baseline and no use of rescue antiemetic medication during or after radiotherapy. Uncontrolled: Increase of three or more emetic episodes or use of antiemetic rescue medication.
Outcome measures
| Measure |
Primary Prophylaxis
n=28 Participants
Patients had no nausea or vomiting at baseline.
|
Secondary Prophylaxis
n=4 Participants
Patients had nausea or vomiting at baseline.
|
|---|---|---|
|
Efficacy for the Prevention/Rescue of Radiation-induced Nausea and Vomiting.
Acute-Nausea · Partial control
|
2 Participants
|
0 Participants
|
|
Efficacy for the Prevention/Rescue of Radiation-induced Nausea and Vomiting.
Acute-Nausea · Uncontrolled
|
3 Participants
|
0 Participants
|
|
Efficacy for the Prevention/Rescue of Radiation-induced Nausea and Vomiting.
Acute-Vomiting · Complete control
|
25 Participants
|
2 Participants
|
|
Efficacy for the Prevention/Rescue of Radiation-induced Nausea and Vomiting.
Acute-Nausea · Complete control
|
21 Participants
|
4 Participants
|
|
Efficacy for the Prevention/Rescue of Radiation-induced Nausea and Vomiting.
Acute-Vomiting · Partial control
|
1 Participants
|
0 Participants
|
|
Efficacy for the Prevention/Rescue of Radiation-induced Nausea and Vomiting.
Acute-Vomiting · Uncontrolled
|
2 Participants
|
0 Participants
|
|
Efficacy for the Prevention/Rescue of Radiation-induced Nausea and Vomiting.
Delayed-Nausea · Complete control
|
18 Participants
|
2 Participants
|
|
Efficacy for the Prevention/Rescue of Radiation-induced Nausea and Vomiting.
Delayed-Nausea · Partial control
|
1 Participants
|
0 Participants
|
|
Efficacy for the Prevention/Rescue of Radiation-induced Nausea and Vomiting.
Delayed-Nausea · Uncontrolled
|
7 Participants
|
2 Participants
|
|
Efficacy for the Prevention/Rescue of Radiation-induced Nausea and Vomiting.
Delayed-Vomiting · Complete control
|
21 Participants
|
1 Participants
|
|
Efficacy for the Prevention/Rescue of Radiation-induced Nausea and Vomiting.
Delayed-Vomiting · Partial control
|
0 Participants
|
0 Participants
|
|
Efficacy for the Prevention/Rescue of Radiation-induced Nausea and Vomiting.
Delayed-Vomiting · Uncontrolled
|
7 Participants
|
1 Participants
|
|
Efficacy for the Prevention/Rescue of Radiation-induced Nausea and Vomiting.
Combined-Nausea · Complete control
|
17 Participants
|
2 Participants
|
|
Efficacy for the Prevention/Rescue of Radiation-induced Nausea and Vomiting.
Combined-Nausea · Partial control
|
1 Participants
|
0 Participants
|
|
Efficacy for the Prevention/Rescue of Radiation-induced Nausea and Vomiting.
Combined-Nausea · Uncontrolled
|
8 Participants
|
2 Participants
|
|
Efficacy for the Prevention/Rescue of Radiation-induced Nausea and Vomiting.
Combined-Vomiting · Complete control
|
21 Participants
|
1 Participants
|
|
Efficacy for the Prevention/Rescue of Radiation-induced Nausea and Vomiting.
Combined-Vomiting · Partial control
|
0 Participants
|
0 Participants
|
|
Efficacy for the Prevention/Rescue of Radiation-induced Nausea and Vomiting.
Combined-Vomiting · Uncontrolled
|
7 Participants
|
1 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 0-5 during treatmentPopulation: The primary prophylaxis arm and secondary prophylaxis arm patients were combined and analysed together, because the secondary prophylaxis arm had only 4 patients, which was too low to draw any meaningful conclusions.
Quality of life as measured by the EORTC QLQ-C15-PAL. For multiple fractions of radiotherapy, the questionnaire will be administered on Day 5 and 10 during treatment when applicable. Since the number of secondary prophylaxis patients was small (n=4), quality of life (QOL) analysis was done with two arms combined. Questions on the C15-PAL were scored on a scale of 0-100, with 0 representing no symptoms but low level of functioning and 100 representing severe symptoms and high degree of functioning.
Outcome measures
| Measure |
Primary Prophylaxis
n=30 Participants
Patients had no nausea or vomiting at baseline.
|
Secondary Prophylaxis
Patients had nausea or vomiting at baseline.
|
|---|---|---|
|
The European Organization for Research and Treatment of Cancer Quality of LIfe Questionnaire - C15 Palliative (C15-PAL), From Day 1-5 of Treatment.
Pain
|
50.6 units on a scale
Standard Deviation 31.0
|
—
|
|
The European Organization for Research and Treatment of Cancer Quality of LIfe Questionnaire - C15 Palliative (C15-PAL), From Day 1-5 of Treatment.
Dyspnea
|
24.1 units on a scale
Standard Deviation 25.0
|
—
|
|
The European Organization for Research and Treatment of Cancer Quality of LIfe Questionnaire - C15 Palliative (C15-PAL), From Day 1-5 of Treatment.
Insomnia
|
34.5 units on a scale
Standard Deviation 33.9
|
—
|
|
The European Organization for Research and Treatment of Cancer Quality of LIfe Questionnaire - C15 Palliative (C15-PAL), From Day 1-5 of Treatment.
Appetite loss
|
36.8 units on a scale
Standard Deviation 36.0
|
—
|
|
The European Organization for Research and Treatment of Cancer Quality of LIfe Questionnaire - C15 Palliative (C15-PAL), From Day 1-5 of Treatment.
Constipation
|
27.6 units on a scale
Standard Deviation 34.6
|
—
|
|
The European Organization for Research and Treatment of Cancer Quality of LIfe Questionnaire - C15 Palliative (C15-PAL), From Day 1-5 of Treatment.
Overall quality of life
|
47.7 units on a scale
Standard Deviation 24.3
|
—
|
|
The European Organization for Research and Treatment of Cancer Quality of LIfe Questionnaire - C15 Palliative (C15-PAL), From Day 1-5 of Treatment.
Physical functioning
|
49.0 units on a scale
Standard Deviation 36.2
|
—
|
|
The European Organization for Research and Treatment of Cancer Quality of LIfe Questionnaire - C15 Palliative (C15-PAL), From Day 1-5 of Treatment.
Fatigue
|
54.8 units on a scale
Standard Deviation 34.4
|
—
|
|
The European Organization for Research and Treatment of Cancer Quality of LIfe Questionnaire - C15 Palliative (C15-PAL), From Day 1-5 of Treatment.
Nausea/vomiting
|
5.75 units on a scale
Standard Deviation 19.0
|
—
|
|
The European Organization for Research and Treatment of Cancer Quality of LIfe Questionnaire - C15 Palliative (C15-PAL), From Day 1-5 of Treatment.
Emotional functioning
|
69.2 units on a scale
Standard Deviation 25.8
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 6-10 of treatmentPopulation: Combined patients from primary prophylaxis and secondary prophylaxis arms, due to the low number of patients in the secondary prophylaxis arm (n=4).
Quality of life as measured by the EORTC QLQ-C15-PAL. For multiple fractions of radiotherapy, the questionnaire will be administered on Day 5 and 10 during treatment when applicable. Since the number of secondary prophylaxis patients was small (n=4), quality of life (QOL) analysis was done with two arms combined. Questions on the C15-PAL were scored on a scale of 0-100, with 0 representing no symptoms but low level of functioning and 100 representing severe symptoms and high degree of functioning.
Outcome measures
| Measure |
Primary Prophylaxis
n=30 Participants
Patients had no nausea or vomiting at baseline.
|
Secondary Prophylaxis
Patients had nausea or vomiting at baseline.
|
|---|---|---|
|
The European Organization for Research and Treatment of Cancer Quality of LIfe Questionnaire - C15 Palliative (C15-PAL) on Day 6-10 of Treatment.
Overall quality of life
|
47.7 units on a scale
Standard Deviation 24.3
|
—
|
|
The European Organization for Research and Treatment of Cancer Quality of LIfe Questionnaire - C15 Palliative (C15-PAL) on Day 6-10 of Treatment.
Pain
|
49.4 units on a scale
Standard Deviation 32.5
|
—
|
|
The European Organization for Research and Treatment of Cancer Quality of LIfe Questionnaire - C15 Palliative (C15-PAL) on Day 6-10 of Treatment.
Dyspnea
|
25.9 units on a scale
Standard Deviation 31.1
|
—
|
|
The European Organization for Research and Treatment of Cancer Quality of LIfe Questionnaire - C15 Palliative (C15-PAL) on Day 6-10 of Treatment.
Insomnia
|
44.4 units on a scale
Standard Deviation 33.3
|
—
|
|
The European Organization for Research and Treatment of Cancer Quality of LIfe Questionnaire - C15 Palliative (C15-PAL) on Day 6-10 of Treatment.
Appetite loss
|
38.3 units on a scale
Standard Deviation 36.6
|
—
|
|
The European Organization for Research and Treatment of Cancer Quality of LIfe Questionnaire - C15 Palliative (C15-PAL) on Day 6-10 of Treatment.
Constipation
|
27.1 units on a scale
Standard Deviation 34.6
|
—
|
|
The European Organization for Research and Treatment of Cancer Quality of LIfe Questionnaire - C15 Palliative (C15-PAL) on Day 6-10 of Treatment.
Physical functioning
|
49.0 units on a scale
Standard Deviation 36.2
|
—
|
|
The European Organization for Research and Treatment of Cancer Quality of LIfe Questionnaire - C15 Palliative (C15-PAL) on Day 6-10 of Treatment.
Fatigue
|
54.8 units on a scale
Standard Deviation 34.4
|
—
|
|
The European Organization for Research and Treatment of Cancer Quality of LIfe Questionnaire - C15 Palliative (C15-PAL) on Day 6-10 of Treatment.
Nausea/vomiting
|
5.75 units on a scale
Standard Deviation 19.0
|
—
|
|
The European Organization for Research and Treatment of Cancer Quality of LIfe Questionnaire - C15 Palliative (C15-PAL) on Day 6-10 of Treatment.
Emotional functioning
|
69.2 units on a scale
Standard Deviation 25.8
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 3Population: Since the number of secondary prophylaxis patients was small (n=4), quality of life (QOL) analysis was done with two arms combined.
Since the number of secondary prophylaxis patients was small (n=4), quality of life (QOL) analysis was done with two arms combined. Questions on the FLIE are reported from 1-7, with "1" being no symptoms and "not at all" for interference with life, and "7" being "a great deal" of symptom and interference with life. Q1-9 are for nausea (N). Q 10-18 are for vomiting (V). All questions refer to "during the past 3 days". Q1/10: How much N/V have you had? Q2/11: Has N/V affected your ability to maintain usual recreation or leisure activities? Q3/12: Has N/V affected your ability to make a meal or do minor household repairs? Q4/13: How much has N/V affected your ability to enjoy a meal? Q5/14: How much has N/V affected your ability to enjoy liquid refreshment? Q6/15: How much has N/V affected your willingness to see and spend time with family/friends? Q7/16: Has N/V affected your daily functioning? Q8/17: Degree your N/V imposed hardship on you? Q9/18: Degree on your family?
Outcome measures
| Measure |
Primary Prophylaxis
n=30 Participants
Patients had no nausea or vomiting at baseline.
|
Secondary Prophylaxis
Patients had nausea or vomiting at baseline.
|
|---|---|---|
|
Functional Living Index-emesis (FLIE) at Day 3, Using Questions 2-9, 11-18 (Q1/Q10 Refer to Nausea/Vomiting and Therefore Are Part of Primary Objectives)
Q2 nausea affecting leisure activities
|
1.31 units on a scale
Standard Error 0.43
|
—
|
|
Functional Living Index-emesis (FLIE) at Day 3, Using Questions 2-9, 11-18 (Q1/Q10 Refer to Nausea/Vomiting and Therefore Are Part of Primary Objectives)
Q3 nausea affecting ability to do house work
|
1.21 units on a scale
Standard Error 0.81
|
—
|
|
Functional Living Index-emesis (FLIE) at Day 3, Using Questions 2-9, 11-18 (Q1/Q10 Refer to Nausea/Vomiting and Therefore Are Part of Primary Objectives)
Q4 nausea affecting enjoyment of meals
|
1.40 units on a scale
Standard Error 1.19
|
—
|
|
Functional Living Index-emesis (FLIE) at Day 3, Using Questions 2-9, 11-18 (Q1/Q10 Refer to Nausea/Vomiting and Therefore Are Part of Primary Objectives)
Q5 nausea affecting enjoyment of refreshments
|
1.17 units on a scale
Standard Error 0.46
|
—
|
|
Functional Living Index-emesis (FLIE) at Day 3, Using Questions 2-9, 11-18 (Q1/Q10 Refer to Nausea/Vomiting and Therefore Are Part of Primary Objectives)
Q6 nausea affecting spending time with loved ones
|
1.10 units on a scale
Standard Error 0.40
|
—
|
|
Functional Living Index-emesis (FLIE) at Day 3, Using Questions 2-9, 11-18 (Q1/Q10 Refer to Nausea/Vomiting and Therefore Are Part of Primary Objectives)
Q7 nausea affecting daily functioning
|
1.13 units on a scale
Standard Error 0.43
|
—
|
|
Functional Living Index-emesis (FLIE) at Day 3, Using Questions 2-9, 11-18 (Q1/Q10 Refer to Nausea/Vomiting and Therefore Are Part of Primary Objectives)
Q8 nausea imposing personal hardship
|
1.20 units on a scale
Standard Error 0.55
|
—
|
|
Functional Living Index-emesis (FLIE) at Day 3, Using Questions 2-9, 11-18 (Q1/Q10 Refer to Nausea/Vomiting and Therefore Are Part of Primary Objectives)
Q9 nausea imposing hardship on others
|
1.13 units on a scale
Standard Error 0.51
|
—
|
|
Functional Living Index-emesis (FLIE) at Day 3, Using Questions 2-9, 11-18 (Q1/Q10 Refer to Nausea/Vomiting and Therefore Are Part of Primary Objectives)
Q11 vomiting affecting leisure activities
|
1.03 units on a scale
Standard Error 0.18
|
—
|
|
Functional Living Index-emesis (FLIE) at Day 3, Using Questions 2-9, 11-18 (Q1/Q10 Refer to Nausea/Vomiting and Therefore Are Part of Primary Objectives)
Q12 vomiting affecting ability to do house work
|
1 units on a scale
Standard Error 0
|
—
|
|
Functional Living Index-emesis (FLIE) at Day 3, Using Questions 2-9, 11-18 (Q1/Q10 Refer to Nausea/Vomiting and Therefore Are Part of Primary Objectives)
Q13 vomiting affecting enjoyment of meals
|
1.03 units on a scale
Standard Error 0.18
|
—
|
|
Functional Living Index-emesis (FLIE) at Day 3, Using Questions 2-9, 11-18 (Q1/Q10 Refer to Nausea/Vomiting and Therefore Are Part of Primary Objectives)
Q14 vomiting affecting enjoyment of refreshments
|
1.03 units on a scale
Standard Error 0.18
|
—
|
|
Functional Living Index-emesis (FLIE) at Day 3, Using Questions 2-9, 11-18 (Q1/Q10 Refer to Nausea/Vomiting and Therefore Are Part of Primary Objectives)
Q15 vomiting affecting spending time with loved on
|
1.03 units on a scale
Standard Error 0.18
|
—
|
|
Functional Living Index-emesis (FLIE) at Day 3, Using Questions 2-9, 11-18 (Q1/Q10 Refer to Nausea/Vomiting and Therefore Are Part of Primary Objectives)
Q16 vomiting affecting daily functioning
|
1.03 units on a scale
Standard Error 0.19
|
—
|
|
Functional Living Index-emesis (FLIE) at Day 3, Using Questions 2-9, 11-18 (Q1/Q10 Refer to Nausea/Vomiting and Therefore Are Part of Primary Objectives)
Q17 vomiting imposing personal hardship
|
1.07 units on a scale
Standard Error 0.25
|
—
|
|
Functional Living Index-emesis (FLIE) at Day 3, Using Questions 2-9, 11-18 (Q1/Q10 Refer to Nausea/Vomiting and Therefore Are Part of Primary Objectives)
Q18 vomiting imposing hardship on others
|
1.03 units on a scale
Standard Error 0.18
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 7Population: Since the number of secondary prophylaxis patients was small (n=4), quality of life (QOL) analysis was done with two arms combined.
Since the number of secondary prophylaxis patients was small (n=4), quality of life (QOL) analysis was done with two arms combined. Questions on the FLIE are reported from 1-7, with "1" being no symptoms and "not at all" for interference with life, and "7" being "a great deal" of symptom and interference with life. Q1-9 are for nausea (N). Q 10-18 are for vomiting (V). All questions refer to "during the past 3 days". Q1/10: How much N/V have you had? Q2/11: Has N/V affected your ability to maintain usual recreation or leisure activities? Q3/12: Has N/V affected your ability to make a meal or do minor household repairs? Q4/13: How much has N/V affected your ability to enjoy a meal? Q5/14: How much has N/V affected your ability to enjoy liquid refreshment? Q6/15: How much has N/V affected your willingness to see and spend time with family/friends? Q7/16: Has N/V affected your daily functioning? Q8/17: Degree your N/V imposed hardship on you? Q9/18: Degree on your family?
Outcome measures
| Measure |
Primary Prophylaxis
n=30 Participants
Patients had no nausea or vomiting at baseline.
|
Secondary Prophylaxis
Patients had nausea or vomiting at baseline.
|
|---|---|---|
|
Functional Living Index-emesis (FLIE) at Day 7, Using Questions 2-9, 11-18 (Q1/Q10 Refer to Nausea/Vomiting and Therefore Are Part of Primary Objectives)
Q2 nausea affecting leisure activities
|
1.23 units on a scale
Standard Error 0.82
|
—
|
|
Functional Living Index-emesis (FLIE) at Day 7, Using Questions 2-9, 11-18 (Q1/Q10 Refer to Nausea/Vomiting and Therefore Are Part of Primary Objectives)
Q3 nausea affecting ability to do house work
|
1.19 units on a scale
Standard Error 0.69
|
—
|
|
Functional Living Index-emesis (FLIE) at Day 7, Using Questions 2-9, 11-18 (Q1/Q10 Refer to Nausea/Vomiting and Therefore Are Part of Primary Objectives)
Q4 nausea affecting enjoyment of meals
|
1.37 units on a scale
Standard Error 1.01
|
—
|
|
Functional Living Index-emesis (FLIE) at Day 7, Using Questions 2-9, 11-18 (Q1/Q10 Refer to Nausea/Vomiting and Therefore Are Part of Primary Objectives)
Q5 nausea affecting enjoyment of refreshments
|
1.15 units on a scale
Standard Error 0.60
|
—
|
|
Functional Living Index-emesis (FLIE) at Day 7, Using Questions 2-9, 11-18 (Q1/Q10 Refer to Nausea/Vomiting and Therefore Are Part of Primary Objectives)
Q6 nausea affecting spending time with loved ones
|
1.19 units on a scale
Standard Error 0.56
|
—
|
|
Functional Living Index-emesis (FLIE) at Day 7, Using Questions 2-9, 11-18 (Q1/Q10 Refer to Nausea/Vomiting and Therefore Are Part of Primary Objectives)
Q7 nausea affecting daily functioning
|
1.19 units on a scale
Standard Error 0.56
|
—
|
|
Functional Living Index-emesis (FLIE) at Day 7, Using Questions 2-9, 11-18 (Q1/Q10 Refer to Nausea/Vomiting and Therefore Are Part of Primary Objectives)
Q8 nausea imposing personal hardship
|
1.26 units on a scale
Standard Error 0.71
|
—
|
|
Functional Living Index-emesis (FLIE) at Day 7, Using Questions 2-9, 11-18 (Q1/Q10 Refer to Nausea/Vomiting and Therefore Are Part of Primary Objectives)
Q9 nausea imposing hardship on others
|
1.22 units on a scale
Standard Error 0.80
|
—
|
|
Functional Living Index-emesis (FLIE) at Day 7, Using Questions 2-9, 11-18 (Q1/Q10 Refer to Nausea/Vomiting and Therefore Are Part of Primary Objectives)
Q11 vomiting affecting leisure activities
|
1.19 units on a scale
Standard Error 0.68
|
—
|
|
Functional Living Index-emesis (FLIE) at Day 7, Using Questions 2-9, 11-18 (Q1/Q10 Refer to Nausea/Vomiting and Therefore Are Part of Primary Objectives)
Q12 vomiting affecting ability to do house work
|
1.19 units on a scale
Standard Error 0.68
|
—
|
|
Functional Living Index-emesis (FLIE) at Day 7, Using Questions 2-9, 11-18 (Q1/Q10 Refer to Nausea/Vomiting and Therefore Are Part of Primary Objectives)
Q13 vomiting affecting enjoyment of meals
|
1.30 units on a scale
Standard Error 1.2
|
—
|
|
Functional Living Index-emesis (FLIE) at Day 7, Using Questions 2-9, 11-18 (Q1/Q10 Refer to Nausea/Vomiting and Therefore Are Part of Primary Objectives)
Q14 vomiting affecting enjoyment of refreshments
|
1.30 units on a scale
Standard Error 1.2
|
—
|
|
Functional Living Index-emesis (FLIE) at Day 7, Using Questions 2-9, 11-18 (Q1/Q10 Refer to Nausea/Vomiting and Therefore Are Part of Primary Objectives)
Q15 vomiting affecting spending time with loved on
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1.15 units on a scale
Standard Error 0.60
|
—
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Functional Living Index-emesis (FLIE) at Day 7, Using Questions 2-9, 11-18 (Q1/Q10 Refer to Nausea/Vomiting and Therefore Are Part of Primary Objectives)
Q16 vomiting affecting daily functioning
|
1.19 units on a scale
Standard Error 0.68
|
—
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Functional Living Index-emesis (FLIE) at Day 7, Using Questions 2-9, 11-18 (Q1/Q10 Refer to Nausea/Vomiting and Therefore Are Part of Primary Objectives)
Q17 vomiting imposing personal hardship
|
1.19 units on a scale
Standard Error 0.56
|
—
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Functional Living Index-emesis (FLIE) at Day 7, Using Questions 2-9, 11-18 (Q1/Q10 Refer to Nausea/Vomiting and Therefore Are Part of Primary Objectives)
Q18 vomiting imposing hardship on others
|
1.12 units on a scale
Standard Error 0.43
|
—
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Adverse Events
Ondissolve
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Edward Chow
Odette Cancer Centre, Sunnybrook Health Sciences Centre, University of Toronto
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place