Trial Outcomes & Findings for BEKINDA (Ondansetron 24 mg Bimodal Release Tablets) for Vomiting Due to Presumed Acute Gastroenteritis or Gastritis (NCT NCT02246439)
NCT ID: NCT02246439
Last Updated: 2019-02-20
Results Overview
Number of patients without further vomiting, without rescue medication, and who were not given intravenous hydration from 30 minutes post first dose until 24 hours post dose
COMPLETED
PHASE3
330 participants
24 Hours
2019-02-20
Participant Flow
First patient randomized: 08 December 2014 Last patient completed: 17 February 2017 This study was conducted in Emergency Departments (EDs) and urgent care centers across the United States. Only 2 sites were urgent care centers; the rest were EDs.
Participant milestones
| Measure |
RHB-102
1 tablet containing 6 mg immediate release and 18 mg sustained release ondansetron, once daily for up to 4 days.
|
Placebo
1 tablet of matching placebo, once daily for up to 4 days.
|
|---|---|---|
|
Overall Study
STARTED
|
192
|
129
|
|
Overall Study
Randomized
|
198
|
132
|
|
Overall Study
COMPLETED
|
180
|
118
|
|
Overall Study
NOT COMPLETED
|
12
|
11
|
Reasons for withdrawal
| Measure |
RHB-102
1 tablet containing 6 mg immediate release and 18 mg sustained release ondansetron, once daily for up to 4 days.
|
Placebo
1 tablet of matching placebo, once daily for up to 4 days.
|
|---|---|---|
|
Overall Study
Adverse Event
|
3
|
0
|
|
Overall Study
Lost to Follow-up
|
7
|
5
|
|
Overall Study
Protocol Violation
|
0
|
2
|
|
Overall Study
Physician Decision
|
0
|
1
|
|
Overall Study
Unkonwn
|
1
|
3
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
BEKINDA (Ondansetron 24 mg Bimodal Release Tablets) for Vomiting Due to Presumed Acute Gastroenteritis or Gastritis
Baseline characteristics by cohort
| Measure |
RHB-102
n=192 Participants
1 tablet containing 6 mg immediate release and 18 mg sustained release ondansetron, once daily for up to 4 days.
|
Placebo
n=129 Participants
1 tablet of matching placebo, once daily for up to 4 days.
|
Total
n=321 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
29.5 years
STANDARD_DEVIATION 11.92 • n=99 Participants
|
28.4 years
STANDARD_DEVIATION 9.69 • n=107 Participants
|
29.0 years
STANDARD_DEVIATION 11.08 • n=206 Participants
|
|
Age, Customized
<18 years
|
15 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
26 Participants
n=206 Participants
|
|
Age, Customized
18 years or older
|
177 Participants
n=99 Participants
|
118 Participants
n=107 Participants
|
295 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
122 Participants
n=99 Participants
|
73 Participants
n=107 Participants
|
195 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
70 Participants
n=99 Participants
|
56 Participants
n=107 Participants
|
126 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaskan Native
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Asian
|
13 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
24 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
80 Participants
n=99 Participants
|
56 Participants
n=107 Participants
|
136 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
White
|
77 Participants
n=99 Participants
|
46 Participants
n=107 Participants
|
123 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Other
|
21 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
35 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Hispanic/Latino
|
49 Participants
n=99 Participants
|
28 Participants
n=107 Participants
|
77 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic/Latino
|
140 Participants
n=99 Participants
|
99 Participants
n=107 Participants
|
239 Participants
n=206 Participants
|
|
Nausea
No nausea
|
2 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Nausea
Mild nausea
|
24 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
39 Participants
n=206 Participants
|
|
Nausea
Moderate nausea
|
38 Participants
n=99 Participants
|
40 Participants
n=107 Participants
|
78 Participants
n=206 Participants
|
|
Nausea
Severe nausea
|
70 Participants
n=99 Participants
|
44 Participants
n=107 Participants
|
114 Participants
n=206 Participants
|
|
Nausea
Nausea as bad as could be
|
58 Participants
n=99 Participants
|
27 Participants
n=107 Participants
|
85 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 24 HoursPopulation: The Intent-to-treat (ITT) Population consisted of all patients who received any study medication, even if they vomited shortly after administration or were unable to swallow the medication.
Number of patients without further vomiting, without rescue medication, and who were not given intravenous hydration from 30 minutes post first dose until 24 hours post dose
Outcome measures
| Measure |
RHB-102
n=192 Participants
1 tablet containing 6 mg immediate release and 18 mg sustained release ondansetron, once daily for up to 4 days.
|
Placebo Oral Tablet
n=129 Participants
1 tablet of matching placebo, once daily for up to 4 days.
|
|---|---|---|
|
Treatment Success From 30 Minutes Through 24 Hours After First Dose of Study Medication - ITT Population
All ages
|
126 Participants
|
70 Participants
|
|
Treatment Success From 30 Minutes Through 24 Hours After First Dose of Study Medication - ITT Population
<18 years of age
|
12 Participants
|
5 Participants
|
|
Treatment Success From 30 Minutes Through 24 Hours After First Dose of Study Medication - ITT Population
18 years of age or older
|
114 Participants
|
65 Participants
|
SECONDARY outcome
Timeframe: 4 DaysPopulation: The Intent-to-treat (ITT) Population consisted of all patients who received any study medication, even if they vomited shortly after administration or were unable to swallow the medication.
Treatment success, as defined in the primary outcome, through 4 days following first dose of study medication.
Outcome measures
| Measure |
RHB-102
n=192 Participants
1 tablet containing 6 mg immediate release and 18 mg sustained release ondansetron, once daily for up to 4 days.
|
Placebo Oral Tablet
n=129 Participants
1 tablet of matching placebo, once daily for up to 4 days.
|
|---|---|---|
|
Responders Through 4 Days After First Dose of Study Medication - ITT Population
|
114 Participants
|
67 Participants
|
SECONDARY outcome
Timeframe: 24 HoursPopulation: The Intent-to-treat (ITT) Population consisted of all patients who received any study medication, even if they vomited shortly after administration or were unable to swallow the medication.
Analysis of vomiting from 30 minutes after first administration of study medication until 24 hours post first dose
Outcome measures
| Measure |
RHB-102
n=192 Participants
1 tablet containing 6 mg immediate release and 18 mg sustained release ondansetron, once daily for up to 4 days.
|
Placebo Oral Tablet
n=129 Participants
1 tablet of matching placebo, once daily for up to 4 days.
|
|---|---|---|
|
Number of Participants Who Vomited - ITT Population
Yes
|
38 Participants
|
33 Participants
|
|
Number of Participants Who Vomited - ITT Population
No
|
131 Participants
|
71 Participants
|
|
Number of Participants Who Vomited - ITT Population
Missing
|
23 Participants
|
25 Participants
|
SECONDARY outcome
Timeframe: 24 HoursPopulation: The Intent-to-treat (ITT) Population consisted of all patients who received any study medication, even if they vomited shortly after administration or were unable to swallow the medication.
Patients receiving rescue antiemetic therapy within 24 hours after the first dose of study medication.
Outcome measures
| Measure |
RHB-102
n=192 Participants
1 tablet containing 6 mg immediate release and 18 mg sustained release ondansetron, once daily for up to 4 days.
|
Placebo Oral Tablet
n=129 Participants
1 tablet of matching placebo, once daily for up to 4 days.
|
|---|---|---|
|
Number of Patients Receiving Rescue Antiemetic Therapy - ITT Population
|
48 Participants
|
43 Participants
|
SECONDARY outcome
Timeframe: 24 HoursPopulation: The Intent-to-treat (ITT) Population consisted of all patients who received any study medication, even if they vomited shortly after administration or were unable to swallow the medication.
Patients receiving parenteral hydration within 24 hours after the first dose of study medication.
Outcome measures
| Measure |
RHB-102
n=192 Participants
1 tablet containing 6 mg immediate release and 18 mg sustained release ondansetron, once daily for up to 4 days.
|
Placebo Oral Tablet
n=129 Participants
1 tablet of matching placebo, once daily for up to 4 days.
|
|---|---|---|
|
Number of Patients Receiving Intravenous Fluids - ITT Population
|
34 Participants
|
32 Participants
|
SECONDARY outcome
Timeframe: Day 1 - Baseline through 5 Hours Post DosePopulation: The Intent-to-treat (ITT) Population consisted of all patients who received any study medication, even if they vomited shortly after administration or were unable to swallow the medication.
Severity of nausea was assessed using a 5-point Likert scale: 0=no nausea; 1=mild nausea; 2=moderate nausea; 3=severe nausea; 4=nausea as bad as can be.
Outcome measures
| Measure |
RHB-102
n=192 Participants
1 tablet containing 6 mg immediate release and 18 mg sustained release ondansetron, once daily for up to 4 days.
|
Placebo Oral Tablet
n=129 Participants
1 tablet of matching placebo, once daily for up to 4 days.
|
|---|---|---|
|
Severity of Nausea at Baseline - ITT Population
Baseline
|
2.8 score on a scale
Standard Deviation 1.03
|
2.6 score on a scale
Standard Deviation 1.02
|
|
Severity of Nausea at Baseline - ITT Population
Hour 5 Post Dose
|
0.1 score on a scale
Standard Deviation 0.42
|
0.2 score on a scale
Standard Deviation 0.49
|
|
Severity of Nausea at Baseline - ITT Population
Hour 1 Post Dose
|
1.1 score on a scale
Standard Deviation 1.10
|
1.3 score on a scale
Standard Deviation 1.16
|
|
Severity of Nausea at Baseline - ITT Population
Hour 2 Post Dose
|
0.8 score on a scale
Standard Deviation 0.97
|
0.9 score on a scale
Standard Deviation 1.07
|
|
Severity of Nausea at Baseline - ITT Population
Hour 3 Post Dose
|
0.5 score on a scale
Standard Deviation 0.85
|
0.8 score on a scale
Standard Deviation 1.05
|
|
Severity of Nausea at Baseline - ITT Population
Hour 4 Post Dose
|
0.4 score on a scale
Standard Deviation 0.75
|
0.6 score on a scale
Standard Deviation 1.04
|
SECONDARY outcome
Timeframe: From 30 Minutes Through 24 Hours after First Dose of Study MedicationPopulation: The Intent-to-treat (ITT) Population consisted of all patients who received any study medication, even if they vomited shortly after administration or were unable to swallow the medication.
Severity of diarrhea for patients having bowel movements was assessed using the Bristol Stool Scale ("BSS"), a Likert scale rating bowel movements from 1=separate hard lumps, like nuts, to 7=watery, no solid pieces; entirely liquid. The BSS was added to the emergency room day and follow-up diaries beginning with protocol amendment 3.
Outcome measures
| Measure |
RHB-102
n=95 Participants
1 tablet containing 6 mg immediate release and 18 mg sustained release ondansetron, once daily for up to 4 days.
|
Placebo Oral Tablet
n=62 Participants
1 tablet of matching placebo, once daily for up to 4 days.
|
|---|---|---|
|
Incidence and Severity of Diarrhea - ITT Population
No bowel movement
|
48 Participants
|
29 Participants
|
|
Incidence and Severity of Diarrhea - ITT Population
BSS 1
|
2 Participants
|
2 Participants
|
|
Incidence and Severity of Diarrhea - ITT Population
BSS 3
|
6 Participants
|
2 Participants
|
|
Incidence and Severity of Diarrhea - ITT Population
BSS 5
|
6 Participants
|
2 Participants
|
|
Incidence and Severity of Diarrhea - ITT Population
BSS 2
|
1 Participants
|
2 Participants
|
|
Incidence and Severity of Diarrhea - ITT Population
BSS 4
|
10 Participants
|
5 Participants
|
|
Incidence and Severity of Diarrhea - ITT Population
BSS 6
|
3 Participants
|
7 Participants
|
|
Incidence and Severity of Diarrhea - ITT Population
BSS 7
|
19 Participants
|
13 Participants
|
SECONDARY outcome
Timeframe: Hours from first dose of study medication to discharge from ED, extended observation unit or hospital, whichever comes lastPopulation: Patients were required to stay in the ED for at least 2 hours (first 172 patients) and subsequently, when post-treatment ECGs were introduced, for 4 hours. Since not all patients had prolonged ED stays, a difference in time until patients were clinically eligible for discharge may have been masked.
Time from first dose of study medication to discharge from ED, extended observation unit or hospital, whichever comes last, and when clinically appropriate.
Outcome measures
| Measure |
RHB-102
n=192 Participants
1 tablet containing 6 mg immediate release and 18 mg sustained release ondansetron, once daily for up to 4 days.
|
Placebo Oral Tablet
n=129 Participants
1 tablet of matching placebo, once daily for up to 4 days.
|
|---|---|---|
|
Time to Discharge From Emergency Department (ED), Extended Observation Unit, or Hospital - ITT Population
All ages
|
4.3 Hours
Interval 4.1 to 4.5
|
4.3 Hours
Interval 4.0 to 4.6
|
|
Time to Discharge From Emergency Department (ED), Extended Observation Unit, or Hospital - ITT Population
< 18 years of age
|
4.3 Hours
Interval 2.9 to 4.7
|
4.8 Hours
Interval 3.0 to 6.8
|
|
Time to Discharge From Emergency Department (ED), Extended Observation Unit, or Hospital - ITT Population
18 years of age or older
|
4.3 Hours
Interval 4.1 to 4.5
|
4.2 Hours
Interval 4.0 to 4.6
|
SECONDARY outcome
Timeframe: Hours from first dose of study medication to resumption of normal activitiesPopulation: The Intent-to-treat (ITT) Population consisted of all patients who received any study medication, even if they vomited shortly after administration or were unable to swallow the medication.
Time from first dose of study medication to resumption of normal activities (work/school/household).
Outcome measures
| Measure |
RHB-102
n=192 Participants
1 tablet containing 6 mg immediate release and 18 mg sustained release ondansetron, once daily for up to 4 days.
|
Placebo Oral Tablet
n=129 Participants
1 tablet of matching placebo, once daily for up to 4 days.
|
|---|---|---|
|
Time to Resumption of Normal Activities (Work/School/Household) - ITT Population
< 18 years of age
|
2 Hours
Interval 1.0 to 4.0
|
4 Hours
Interval 2.0 to 5.0
|
|
Time to Resumption of Normal Activities (Work/School/Household) - ITT Population
18 years of age or older
|
3 Hours
Interval 3.0 to 4.0
|
3 Hours
|
|
Time to Resumption of Normal Activities (Work/School/Household) - ITT Population
All ages
|
3 Hours
Interval 3.0 to 4.0
|
3 Hours
Interval 3.0 to 4.0
|
SECONDARY outcome
Timeframe: Day 1 of Study - Day 5 of StudyPopulation: The number of treated patients requiring hospitalization was low in this study (14 patients). In the RHB-102 group, 11 patients (5.7%) were hospitalized, including one who returned to the ED for gastrointestinal symptoms 2 days after initial treatment. In the placebo treatment group, 3 patients (2.3%) were hospitalized.
Number of patients requiring hospitalization. 4 patients in the RHB-102 treatment group and 1 patient in the placebo treatment group were hospitalized due to lack of efficacy. The remaining patients hospitalized were admitted for reasons other than gastroenteritis.
Outcome measures
| Measure |
RHB-102
n=192 Participants
1 tablet containing 6 mg immediate release and 18 mg sustained release ondansetron, once daily for up to 4 days.
|
Placebo Oral Tablet
n=129 Participants
1 tablet of matching placebo, once daily for up to 4 days.
|
|---|---|---|
|
Number of Patients Requiring Hospitalization - ITT Population
|
11 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Day 1 of Study - Day 5 of StudyProportion of patients returning to emergency department for gastrointestinal symptoms within 4 days of initial discharge
Outcome measures
| Measure |
RHB-102
n=192 Participants
1 tablet containing 6 mg immediate release and 18 mg sustained release ondansetron, once daily for up to 4 days.
|
Placebo Oral Tablet
n=129 Participants
1 tablet of matching placebo, once daily for up to 4 days.
|
|---|---|---|
|
Number of Patients Returning to Emergency Department - ITT Population
|
4 Participants
|
4 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 24 HoursPopulation: The Intent-to-treat (ITT) Population consisted of all patients who received any study medication, even if they vomited shortly after administration or were unable to swallow the medication.
Proportion of patients without further vomiting, without rescue medication, and who were not given intravenous hydration from 30 minutes post first dose until 24 hours post dose
Outcome measures
| Measure |
RHB-102
n=192 Participants
1 tablet containing 6 mg immediate release and 18 mg sustained release ondansetron, once daily for up to 4 days.
|
Placebo Oral Tablet
n=129 Participants
1 tablet of matching placebo, once daily for up to 4 days.
|
|---|---|---|
|
Treatment Success From 30 Minutes Through 24 Hours After First Dose of Study Medication by Baseline Nausea Severity - ITT Population, All Ages
No nausea or mild nausea
|
22 Participants
|
13 Participants
|
|
Treatment Success From 30 Minutes Through 24 Hours After First Dose of Study Medication by Baseline Nausea Severity - ITT Population, All Ages
Moderate nausea
|
26 Participants
|
24 Participants
|
|
Treatment Success From 30 Minutes Through 24 Hours After First Dose of Study Medication by Baseline Nausea Severity - ITT Population, All Ages
Severe nausea
|
47 Participants
|
22 Participants
|
|
Treatment Success From 30 Minutes Through 24 Hours After First Dose of Study Medication by Baseline Nausea Severity - ITT Population, All Ages
Nausea as bad as it could have been
|
31 Participants
|
11 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 24 HoursPopulation: The Per Protocol Population contained all patients who met all inclusion/exclusion criteria, received a second dose of study medication if they vomited within 15 minutes of receiving the first dose, \& did not have a primary diagnosis upon discharge from ED (or, if admitted, discharge from the hospital) other than acute gastroenteritis/gastritis.
Proportion of patients without further vomiting, without rescue medication, and who were not given intravenous hydration from 30 minutes post first dose until 24 hours post dose
Outcome measures
| Measure |
RHB-102
n=177 Participants
1 tablet containing 6 mg immediate release and 18 mg sustained release ondansetron, once daily for up to 4 days.
|
Placebo Oral Tablet
n=122 Participants
1 tablet of matching placebo, once daily for up to 4 days.
|
|---|---|---|
|
Treatment Success From 30 Minutes Through 24 Hours After First Dose of Study Medication - PP Population
All ages
|
123 Participants
|
67 Participants
|
|
Treatment Success From 30 Minutes Through 24 Hours After First Dose of Study Medication - PP Population
<18 years of age
|
11 Participants
|
5 Participants
|
|
Treatment Success From 30 Minutes Through 24 Hours After First Dose of Study Medication - PP Population
18 years of age or older
|
112 Participants
|
62 Participants
|
POST_HOC outcome
Timeframe: 24 HoursPopulation: The Per Protocol (PP) Population contained all patients who met all inclusion/exclusion criteria, received a second dose of medication if they vomited within 15 minutes of receiving first dose, and did not have a primary diagnosis upon discharge from the ED (or, if admitted, discharge from the hospital) other than acute gastroenteritis/gastritis.
Examination of treatment success rates by age (\<18 and ≥18 years).
Outcome measures
| Measure |
RHB-102
n=177 Participants
1 tablet containing 6 mg immediate release and 18 mg sustained release ondansetron, once daily for up to 4 days.
|
Placebo Oral Tablet
n=122 Participants
1 tablet of matching placebo, once daily for up to 4 days.
|
|---|---|---|
|
Primary Endpoint Subgroup Analysis - PP Population
< 18 years of age
|
11 Participants
|
5 Participants
|
|
Primary Endpoint Subgroup Analysis - PP Population
18 years of age or older
|
112 Participants
|
62 Participants
|
POST_HOC outcome
Timeframe: 24 HoursPopulation: The Intent-to-treat (ITT) Population consisted of all patients who received any study medication, even if they vomited shortly after administration or were unable to swallow the medication. The primary efficacy analysis was conducted using the ITT Population.
Number of patients without further vomiting, without rescue medication, and who were not given intravenous hydration from 30 minutes post first dose until 24 hours post dose (analyzed using logistic regression with treatment as a factor and baseline nausea severity as a continuous variable)
Outcome measures
| Measure |
RHB-102
n=192 Participants
1 tablet containing 6 mg immediate release and 18 mg sustained release ondansetron, once daily for up to 4 days.
|
Placebo Oral Tablet
n=129 Participants
1 tablet of matching placebo, once daily for up to 4 days.
|
|---|---|---|
|
Treatment Success From 30 Minutes Through 24 Hours After First Dose of Study Medication - ITT Population (Logistic Regression Adjusted by Baseline Nausea Severity)
|
126 Participants
|
70 Participants
|
POST_HOC outcome
Timeframe: 24 HoursPopulation: The Per Protocol Population contained all patients who met all inclusion/exclusion criteria, received a second dose of medication if they vomited within 15 minutes of receiving the first dose, and did not have a primary diagnosis upon discharge from the ED (or, if admitted, discharge from the hospital) other than acute gastroenteritis/gastritis.
Number of patients without further vomiting, without rescue medication, and who were not given intravenous hydration from 30 minutes post first dose until 24 hours post dose (analyzed using logistic regression with treatment as a factor and baseline nausea severity as a continuous variable)
Outcome measures
| Measure |
RHB-102
n=177 Participants
1 tablet containing 6 mg immediate release and 18 mg sustained release ondansetron, once daily for up to 4 days.
|
Placebo Oral Tablet
n=122 Participants
1 tablet of matching placebo, once daily for up to 4 days.
|
|---|---|---|
|
Treatment Success From 30 Minutes Through 24 Hours After First Dose of Study Medication - PP Population (Logistic Regression Adjusted by Baseline Nausea Severity)
|
123 Participants
|
67 Participants
|
Adverse Events
RHB-102
Placebo
Serious adverse events
| Measure |
RHB-102
n=193 participants at risk
1 tablet containing 6 mg immediate release and 18 mg sustained release ondansetron, once daily for up to 4 days.
|
Placebo
n=128 participants at risk
1 tablet of matching placebo, once daily for up to 4 days.
|
|---|---|---|
|
Hepatobiliary disorders
Bile Duct Stone
|
0.52%
1/193 • 2 years, 3 months
A treatment-emergent adverse event (TEAE) is an adverse event occurring from the start of study medication.
|
0.00%
0/128 • 2 years, 3 months
A treatment-emergent adverse event (TEAE) is an adverse event occurring from the start of study medication.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.52%
1/193 • 2 years, 3 months
A treatment-emergent adverse event (TEAE) is an adverse event occurring from the start of study medication.
|
0.00%
0/128 • 2 years, 3 months
A treatment-emergent adverse event (TEAE) is an adverse event occurring from the start of study medication.
|
|
Blood and lymphatic system disorders
Sideroblastic Anaemia
|
0.52%
1/193 • 2 years, 3 months
A treatment-emergent adverse event (TEAE) is an adverse event occurring from the start of study medication.
|
0.00%
0/128 • 2 years, 3 months
A treatment-emergent adverse event (TEAE) is an adverse event occurring from the start of study medication.
|
|
Investigations
Hospitalization for further diagnosis
|
0.52%
1/193 • 2 years, 3 months
A treatment-emergent adverse event (TEAE) is an adverse event occurring from the start of study medication.
|
0.00%
0/128 • 2 years, 3 months
A treatment-emergent adverse event (TEAE) is an adverse event occurring from the start of study medication.
|
|
Gastrointestinal disorders
Small Intestinal Obstruction
|
0.52%
1/193 • 2 years, 3 months
A treatment-emergent adverse event (TEAE) is an adverse event occurring from the start of study medication.
|
0.78%
1/128 • 2 years, 3 months
A treatment-emergent adverse event (TEAE) is an adverse event occurring from the start of study medication.
|
|
Renal and urinary disorders
Renal Failure Acute
|
0.52%
1/193 • 2 years, 3 months
A treatment-emergent adverse event (TEAE) is an adverse event occurring from the start of study medication.
|
0.00%
0/128 • 2 years, 3 months
A treatment-emergent adverse event (TEAE) is an adverse event occurring from the start of study medication.
|
|
Gastrointestinal disorders
Diverticulitis Intestinal Haemorrhagic
|
0.52%
1/193 • 2 years, 3 months
A treatment-emergent adverse event (TEAE) is an adverse event occurring from the start of study medication.
|
0.00%
0/128 • 2 years, 3 months
A treatment-emergent adverse event (TEAE) is an adverse event occurring from the start of study medication.
|
|
Metabolism and nutrition disorders
Diabetic Ketoacidosis
|
0.00%
0/193 • 2 years, 3 months
A treatment-emergent adverse event (TEAE) is an adverse event occurring from the start of study medication.
|
0.78%
1/128 • 2 years, 3 months
A treatment-emergent adverse event (TEAE) is an adverse event occurring from the start of study medication.
|
Other adverse events
| Measure |
RHB-102
n=193 participants at risk
1 tablet containing 6 mg immediate release and 18 mg sustained release ondansetron, once daily for up to 4 days.
|
Placebo
n=128 participants at risk
1 tablet of matching placebo, once daily for up to 4 days.
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal Distension
|
1.6%
3/193 • 2 years, 3 months
A treatment-emergent adverse event (TEAE) is an adverse event occurring from the start of study medication.
|
0.78%
1/128 • 2 years, 3 months
A treatment-emergent adverse event (TEAE) is an adverse event occurring from the start of study medication.
|
|
Gastrointestinal disorders
Abdominal Pain
|
1.6%
3/193 • 2 years, 3 months
A treatment-emergent adverse event (TEAE) is an adverse event occurring from the start of study medication.
|
0.78%
1/128 • 2 years, 3 months
A treatment-emergent adverse event (TEAE) is an adverse event occurring from the start of study medication.
|
|
Gastrointestinal disorders
Constipation
|
4.7%
9/193 • 2 years, 3 months
A treatment-emergent adverse event (TEAE) is an adverse event occurring from the start of study medication.
|
0.78%
1/128 • 2 years, 3 months
A treatment-emergent adverse event (TEAE) is an adverse event occurring from the start of study medication.
|
|
General disorders
Chest Pain
|
1.0%
2/193 • 2 years, 3 months
A treatment-emergent adverse event (TEAE) is an adverse event occurring from the start of study medication.
|
1.6%
2/128 • 2 years, 3 months
A treatment-emergent adverse event (TEAE) is an adverse event occurring from the start of study medication.
|
|
General disorders
Pyrexia
|
1.6%
3/193 • 2 years, 3 months
A treatment-emergent adverse event (TEAE) is an adverse event occurring from the start of study medication.
|
3.9%
5/128 • 2 years, 3 months
A treatment-emergent adverse event (TEAE) is an adverse event occurring from the start of study medication.
|
|
Nervous system disorders
Dizziness
|
1.0%
2/193 • 2 years, 3 months
A treatment-emergent adverse event (TEAE) is an adverse event occurring from the start of study medication.
|
1.6%
2/128 • 2 years, 3 months
A treatment-emergent adverse event (TEAE) is an adverse event occurring from the start of study medication.
|
|
Nervous system disorders
Headache
|
11.4%
22/193 • 2 years, 3 months
A treatment-emergent adverse event (TEAE) is an adverse event occurring from the start of study medication.
|
5.5%
7/128 • 2 years, 3 months
A treatment-emergent adverse event (TEAE) is an adverse event occurring from the start of study medication.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Institution will provide to Sponsor, for review and comment, all manuscripts or other material prior to such publication. Sponsor shall have 30 days to review any such publication. The Sponsor can require changes to the communication and such confidential information shall be deleted and/or the submission of the proposed publication shall be delayed for an additional 60 days.
- Publication restrictions are in place
Restriction type: OTHER