Trial Outcomes & Findings for Comparing the Efficacy of Oral Opioids for Outpatient Acute Pain Management After ED Discharge Discharge (NCT NCT01402375)
NCT ID: NCT01402375
Last Updated: 2018-05-01
Results Overview
Pain intensity is measured on the numerical rating scale (NRS) from 0 ("no pain") to 10 ("worst pain imaginable"). The difference in pain score is calculated by subtracting the average score 2 hours after pain medication is taken from the average pain score immediately before the pain medication is taken.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
720 participants
Primary outcome timeframe
2 hrs
Results posted on
2018-05-01
Participant Flow
Participant milestones
| Measure |
Hydrocodone (First Trial)
Hydrocodone 5mg / Acetaminophen 500mg. Patients instructed to take 1 dose every 4 hrs as needed for pain.
Hydrocodone (first trial): Patients will take 1 dose of Hydrocodone 5mg / Acetaminophen 500mg every 4 hours as needed for pain
|
Codeine (First Trial)
Codeine 30mg / Acetaminophen 300mg. Patients instructed to take 1 dose every 4 hrs as needed for pain.
Codeine (first trial): Patients will take 1 dose of Codeine 30 mg / Acetaminophen 300 mg every 4 hours as needed for pain
|
Oxycodone (for Second Trial)
Oxycodone 5mg / Acetaminophen 325mg. Patients instructed to take 1 dose every 4 hrs as needed for pain.
Oxycodone (for second trial): Patients will take 1 dose of Oxycodone 5 mg / Acetaminophen 325 mg every 4 hours as needed for pain
|
Codeine (for Second Trial)
Codeine 30mg / Acetaminophen 300mg. Patients instructed to take 1 dose every 4 hrs as needed for pain.
Codeine (for second trial): Patients will take 1 dose of Codeine 30 mg / Acetaminophen 300 mg every 4 hours as needed for pain
|
Oxycodone (Third Trial)
Oxycodone 5mg / Acetaminophen 325 mg. Patients instructed to take 1 dose every 4 hours as needed for pain.
Oxycodone (third trial): Patients will take 1 dose of Oxycodone 5mg / Acetaminophen 325 mg every 4 hours as needed for pain
|
Hydrocodone (Third Trial)
Hydrocodone 5mg / Acetaminophen 325 mg. Patients instructed to take 1 dose every 4 hours as needed for pain.
Hydrocodone (third trial): Patients will take 1 dose of Hydrocodone 5 mg / Acetaminophen 325 mg every 4 hours as needed for pain.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
120
|
120
|
120
|
120
|
120
|
120
|
|
Overall Study
COMPLETED
|
120
|
120
|
120
|
120
|
120
|
120
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Comparing the Efficacy of Oral Opioids for Outpatient Acute Pain Management After ED Discharge Discharge
Baseline characteristics by cohort
| Measure |
Hydrocodone (First Trial)
n=88 Participants
Hydrocodone 5mg / Acetaminophen 500mg. Patients instructed to take 1 dose every 4 hrs as needed for pain.
Hydrocodone (first trial): Patients will take 1 dose of Hydrocodone 5mg / Acetaminophen 500mg every 4 hours as needed for pain
|
Codeine (First Trial)
n=93 Participants
Codeine 30mg / Acetaminophen 300mg. Patients instructed to take 1 dose every 4 hrs as needed for pain.
Codeine (first trial): Patients will take 1 dose of Codeine 30 mg / Acetaminophen 300 mg every 4 hours as needed for pain
|
Oxycodone (for Second Trial)
n=111 Participants
Oxycodone 5mg / Acetaminophen 325mg. Patients instructed to take 1 dose every 4 hrs as needed for pain.
Oxycodone (for second trial): Patients will take 1 dose of Oxycodone 5 mg / Acetaminophen 325 mg every 4 hours as needed for pain
|
Codeine (for Second Trial)
n=104 Participants
Codeine 30mg / Acetaminophen 300mg. Patients instructed to take 1 dose every 4 hrs as needed for pain.
Codeine (for second trial): Patients will take 1 dose of Codeine 30 mg / Acetaminophen 300 mg every 4 hours as needed for pain
|
Oxycodone (Third Trial)
n=107 Participants
Oxycodone 5mg / Acetaminophen 325 mg. Patients instructed to take 1 dose every 4 hours as needed for pain.
Oxycodone (third trial): Patients will take 1 dose of Oxycodone 5mg / Acetaminophen 325 mg every 4 hours as needed for pain
|
Hydrocodone (Third Trial)
n=113 Participants
Hydrocodone 5mg / Acetaminophen 325 mg. Patients instructed to take 1 dose every 4 hours as needed for pain.
Hydrocodone (third trial): Patients will take 1 dose of Hydrocodone 5 mg / Acetaminophen 325 mg every 4 hours as needed for pain.
|
Total
n=616 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
34 years
STANDARD_DEVIATION 12 • n=5 Participants
|
37 years
STANDARD_DEVIATION 11 • n=7 Participants
|
39 years
STANDARD_DEVIATION 12 • n=5 Participants
|
38 years
STANDARD_DEVIATION 11 • n=4 Participants
|
39 years
STANDARD_DEVIATION 12 • n=21 Participants
|
38 years
STANDARD_DEVIATION 13 • n=10 Participants
|
38 years
STANDARD_DEVIATION 12 • n=115 Participants
|
|
Sex: Female, Male
Female
|
38 Participants
n=5 Participants
|
48 Participants
n=7 Participants
|
62 Participants
n=5 Participants
|
58 Participants
n=4 Participants
|
60 Participants
n=21 Participants
|
48 Participants
n=10 Participants
|
314 Participants
n=115 Participants
|
|
Sex: Female, Male
Male
|
50 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
46 Participants
n=4 Participants
|
47 Participants
n=21 Participants
|
65 Participants
n=10 Participants
|
302 Participants
n=115 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
56 Participants
n=5 Participants
|
69 Participants
n=7 Participants
|
66 Participants
n=5 Participants
|
71 Participants
n=4 Participants
|
67 Participants
n=21 Participants
|
73 Participants
n=10 Participants
|
402 Participants
n=115 Participants
|
|
Race/Ethnicity, Customized
African American
|
27 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
27 Participants
n=4 Participants
|
32 Participants
n=21 Participants
|
28 Participants
n=10 Participants
|
167 Participants
n=115 Participants
|
|
Race/Ethnicity, Customized
Other
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
12 Participants
n=10 Participants
|
47 Participants
n=115 Participants
|
|
Region of Enrollment
United States
|
88 Participants
n=5 Participants
|
93 Participants
n=7 Participants
|
111 Participants
n=5 Participants
|
104 Participants
n=4 Participants
|
107 Participants
n=21 Participants
|
113 Participants
n=10 Participants
|
616 Participants
n=115 Participants
|
|
NRS pain intensity score on ED arrival
|
9 units on a scale
n=5 Participants
|
9 units on a scale
n=7 Participants
|
10 units on a scale
n=5 Participants
|
10 units on a scale
n=4 Participants
|
10 units on a scale
n=21 Participants
|
10 units on a scale
n=10 Participants
|
10 units on a scale
n=115 Participants
|
|
NRS pain intensity score on discharge
|
7 units on a scale
n=5 Participants
|
7 units on a scale
n=7 Participants
|
7 units on a scale
n=5 Participants
|
7 units on a scale
n=4 Participants
|
8 units on a scale
n=21 Participants
|
8 units on a scale
n=10 Participants
|
7 units on a scale
n=115 Participants
|
|
Diagnosis
Sprain/strain
|
40 Participants
n=5 Participants
|
54 Participants
n=7 Participants
|
59 Participants
n=5 Participants
|
49 Participants
n=4 Participants
|
39 Participants
n=21 Participants
|
42 Participants
n=10 Participants
|
283 Participants
n=115 Participants
|
|
Diagnosis
Extremity Fracture
|
20 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
37 Participants
n=4 Participants
|
63 Participants
n=21 Participants
|
58 Participants
n=10 Participants
|
228 Participants
n=115 Participants
|
|
Diagnosis
Other
|
28 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
13 Participants
n=10 Participants
|
105 Participants
n=115 Participants
|
|
Took analgesic prior to presentation
No
|
63 Participants
n=5 Participants
|
63 Participants
n=7 Participants
|
72 Participants
n=5 Participants
|
70 Participants
n=4 Participants
|
76 Participants
n=21 Participants
|
74 Participants
n=10 Participants
|
418 Participants
n=115 Participants
|
|
Took analgesic prior to presentation
Yes
|
24 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
33 Participants
n=4 Participants
|
29 Participants
n=21 Participants
|
36 Participants
n=10 Participants
|
186 Participants
n=115 Participants
|
|
Took analgesic prior to presentation
Unknown
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
3 Participants
n=10 Participants
|
12 Participants
n=115 Participants
|
PRIMARY outcome
Timeframe: 2 hrsPain intensity is measured on the numerical rating scale (NRS) from 0 ("no pain") to 10 ("worst pain imaginable"). The difference in pain score is calculated by subtracting the average score 2 hours after pain medication is taken from the average pain score immediately before the pain medication is taken.
Outcome measures
| Measure |
Hydrocodone (First Trial)
n=88 Participants
Hydrocodone 5mg / Acetaminophen 500mg. Patients instructed to take 1 dose every 4 hrs as needed for pain.
Hydrocodone (first trial): Patients will take 1 dose of Hydrocodone 5mg / Acetaminophen 500mg every 4 hours as needed for pain
|
Codeine (First Trial)
n=93 Participants
Codeine 30mg / Acetaminophen 300mg. Patients instructed to take 1 dose every 4 hrs as needed for pain.
Codeine (first trial): Patients will take 1 dose of Codeine 30 mg / Acetaminophen 300 mg every 4 hours as needed for pain
|
Oxycodone (for Second Trial)
n=111 Participants
Oxycodone 5mg / Acetaminophen 325mg. Patients instructed to take 1 dose every 4 hrs as needed for pain.
Oxycodone (for second trial): Patients will take 1 dose of Oxycodone 5 mg / Acetaminophen 325 mg every 4 hours as needed for pain
|
Codeine (for Second Trial)
n=104 Participants
Codeine 30mg / Acetaminophen 300mg. Patients instructed to take 1 dose every 4 hrs as needed for pain.
Codeine (for second trial): Patients will take 1 dose of Codeine 30 mg / Acetaminophen 300 mg every 4 hours as needed for pain
|
Oxycodone (Third Trial)
n=107 Participants
Oxycodone 5mg / Acetaminophen 325 mg. Patients instructed to take 1 dose every 4 hours as needed for pain.
Oxycodone (third trial): Patients will take 1 dose of Oxycodone 5mg / Acetaminophen 325 mg every 4 hours as needed for pain
|
Hydrocodone (Third Trial)
n=113 Participants
Hydrocodone 5mg / Acetaminophen 325 mg. Patients instructed to take 1 dose every 4 hours as needed for pain.
Hydrocodone (third trial): Patients will take 1 dose of Hydrocodone 5 mg / Acetaminophen 325 mg every 4 hours as needed for pain.
|
|---|---|---|---|---|---|---|
|
Difference in Pain Intensity Score Before and After Last Dose.
change in NRS before to after most recent dose
|
3.9 units on a scale
Standard Deviation 2.5
|
3.5 units on a scale
Standard Deviation 2.6
|
4.5 units on a scale
Standard Deviation 2.4
|
4.2 units on a scale
Standard Deviation 2.4
|
4.4 units on a scale
Standard Deviation 2.5
|
4.0 units on a scale
Standard Deviation 2.5
|
|
Difference in Pain Intensity Score Before and After Last Dose.
before most recent dose
|
7.6 units on a scale
Standard Deviation 1.7
|
7.6 units on a scale
Standard Deviation 1.8
|
7.9 units on a scale
Standard Deviation 1.5
|
7.9 units on a scale
Standard Deviation 1.7
|
7.8 units on a scale
Standard Deviation 1.5
|
7.6 units on a scale
Standard Deviation 1.6
|
|
Difference in Pain Intensity Score Before and After Last Dose.
2 hours after most recent dose
|
3.6 units on a scale
Standard Deviation 2.8
|
4.1 units on a scale
Standard Deviation 2.9
|
3.4 units on a scale
Standard Deviation 2.5
|
3.6 units on a scale
Standard Deviation 4.2
|
3.3 units on a scale
Standard Deviation 2.7
|
3.6 units on a scale
Standard Deviation 2.6
|
SECONDARY outcome
Timeframe: 24 hrsPopulation: Any number analyzed that does not equal the overall number of participants is due to missing data
Overall satisfaction with the oral opioid pain medication at 24 hours after discharge using a Likert scale. Patients will be asked to describe their overall experience as being very satisfied, satisfied, unsatisfied or very unsatisfied with the study medication.
Outcome measures
| Measure |
Hydrocodone (First Trial)
n=88 Participants
Hydrocodone 5mg / Acetaminophen 500mg. Patients instructed to take 1 dose every 4 hrs as needed for pain.
Hydrocodone (first trial): Patients will take 1 dose of Hydrocodone 5mg / Acetaminophen 500mg every 4 hours as needed for pain
|
Codeine (First Trial)
n=93 Participants
Codeine 30mg / Acetaminophen 300mg. Patients instructed to take 1 dose every 4 hrs as needed for pain.
Codeine (first trial): Patients will take 1 dose of Codeine 30 mg / Acetaminophen 300 mg every 4 hours as needed for pain
|
Oxycodone (for Second Trial)
n=111 Participants
Oxycodone 5mg / Acetaminophen 325mg. Patients instructed to take 1 dose every 4 hrs as needed for pain.
Oxycodone (for second trial): Patients will take 1 dose of Oxycodone 5 mg / Acetaminophen 325 mg every 4 hours as needed for pain
|
Codeine (for Second Trial)
n=104 Participants
Codeine 30mg / Acetaminophen 300mg. Patients instructed to take 1 dose every 4 hrs as needed for pain.
Codeine (for second trial): Patients will take 1 dose of Codeine 30 mg / Acetaminophen 300 mg every 4 hours as needed for pain
|
Oxycodone (Third Trial)
n=107 Participants
Oxycodone 5mg / Acetaminophen 325 mg. Patients instructed to take 1 dose every 4 hours as needed for pain.
Oxycodone (third trial): Patients will take 1 dose of Oxycodone 5mg / Acetaminophen 325 mg every 4 hours as needed for pain
|
Hydrocodone (Third Trial)
n=113 Participants
Hydrocodone 5mg / Acetaminophen 325 mg. Patients instructed to take 1 dose every 4 hours as needed for pain.
Hydrocodone (third trial): Patients will take 1 dose of Hydrocodone 5 mg / Acetaminophen 325 mg every 4 hours as needed for pain.
|
|---|---|---|---|---|---|---|
|
Overall Satisfaction With the Pain Medicine
participants would want the same analgesic again
|
59 Participants
|
66 Participants
|
91 Participants
|
85 Participants
|
86 Participants
|
90 Participants
|
|
Overall Satisfaction With the Pain Medicine
Number of participants satisfied with analgesic
|
72 Participants
|
66 Participants
|
99 Participants
|
91 Participants
|
93 Participants
|
97 Participants
|
POST_HOC outcome
Timeframe: 2 hoursOutcome measures
| Measure |
Hydrocodone (First Trial)
n=88 Participants
Hydrocodone 5mg / Acetaminophen 500mg. Patients instructed to take 1 dose every 4 hrs as needed for pain.
Hydrocodone (first trial): Patients will take 1 dose of Hydrocodone 5mg / Acetaminophen 500mg every 4 hours as needed for pain
|
Codeine (First Trial)
n=93 Participants
Codeine 30mg / Acetaminophen 300mg. Patients instructed to take 1 dose every 4 hrs as needed for pain.
Codeine (first trial): Patients will take 1 dose of Codeine 30 mg / Acetaminophen 300 mg every 4 hours as needed for pain
|
Oxycodone (for Second Trial)
n=111 Participants
Oxycodone 5mg / Acetaminophen 325mg. Patients instructed to take 1 dose every 4 hrs as needed for pain.
Oxycodone (for second trial): Patients will take 1 dose of Oxycodone 5 mg / Acetaminophen 325 mg every 4 hours as needed for pain
|
Codeine (for Second Trial)
n=104 Participants
Codeine 30mg / Acetaminophen 300mg. Patients instructed to take 1 dose every 4 hrs as needed for pain.
Codeine (for second trial): Patients will take 1 dose of Codeine 30 mg / Acetaminophen 300 mg every 4 hours as needed for pain
|
Oxycodone (Third Trial)
n=107 Participants
Oxycodone 5mg / Acetaminophen 325 mg. Patients instructed to take 1 dose every 4 hours as needed for pain.
Oxycodone (third trial): Patients will take 1 dose of Oxycodone 5mg / Acetaminophen 325 mg every 4 hours as needed for pain
|
Hydrocodone (Third Trial)
n=113 Participants
Hydrocodone 5mg / Acetaminophen 325 mg. Patients instructed to take 1 dose every 4 hours as needed for pain.
Hydrocodone (third trial): Patients will take 1 dose of Hydrocodone 5 mg / Acetaminophen 325 mg every 4 hours as needed for pain.
|
|---|---|---|---|---|---|---|
|
50% or Greater Decrease in Numerical Rating Scale (NRS) Pain Score
|
50 Participants
|
45 Participants
|
73 Participants
|
64 Participants
|
68 Participants
|
66 Participants
|
POST_HOC outcome
Timeframe: up to 48 hoursMedian time to contact patients for data collection, measured from discharge to time contacted
Outcome measures
| Measure |
Hydrocodone (First Trial)
n=88 Participants
Hydrocodone 5mg / Acetaminophen 500mg. Patients instructed to take 1 dose every 4 hrs as needed for pain.
Hydrocodone (first trial): Patients will take 1 dose of Hydrocodone 5mg / Acetaminophen 500mg every 4 hours as needed for pain
|
Codeine (First Trial)
n=93 Participants
Codeine 30mg / Acetaminophen 300mg. Patients instructed to take 1 dose every 4 hrs as needed for pain.
Codeine (first trial): Patients will take 1 dose of Codeine 30 mg / Acetaminophen 300 mg every 4 hours as needed for pain
|
Oxycodone (for Second Trial)
n=111 Participants
Oxycodone 5mg / Acetaminophen 325mg. Patients instructed to take 1 dose every 4 hrs as needed for pain.
Oxycodone (for second trial): Patients will take 1 dose of Oxycodone 5 mg / Acetaminophen 325 mg every 4 hours as needed for pain
|
Codeine (for Second Trial)
n=104 Participants
Codeine 30mg / Acetaminophen 300mg. Patients instructed to take 1 dose every 4 hrs as needed for pain.
Codeine (for second trial): Patients will take 1 dose of Codeine 30 mg / Acetaminophen 300 mg every 4 hours as needed for pain
|
Oxycodone (Third Trial)
n=107 Participants
Oxycodone 5mg / Acetaminophen 325 mg. Patients instructed to take 1 dose every 4 hours as needed for pain.
Oxycodone (third trial): Patients will take 1 dose of Oxycodone 5mg / Acetaminophen 325 mg every 4 hours as needed for pain
|
Hydrocodone (Third Trial)
n=113 Participants
Hydrocodone 5mg / Acetaminophen 325 mg. Patients instructed to take 1 dose every 4 hours as needed for pain.
Hydrocodone (third trial): Patients will take 1 dose of Hydrocodone 5 mg / Acetaminophen 325 mg every 4 hours as needed for pain.
|
|---|---|---|---|---|---|---|
|
Time to Follow up
|
27 hours
Interval 24.0 to 42.0
|
25 hours
Interval 24.0 to 36.0
|
26 hours
Interval 24.0 to 37.0
|
28 hours
Interval 25.0 to 36.0
|
27 hours
Interval 25.0 to 42.0
|
28 hours
Interval 25.0 to 41.0
|
Adverse Events
Hydrocodone (First Trial)
Serious events: 0 serious events
Other events: 54 other events
Deaths: 0 deaths
Codeine (First Trial)
Serious events: 0 serious events
Other events: 51 other events
Deaths: 0 deaths
Oxycodone (for Second Trial)
Serious events: 0 serious events
Other events: 68 other events
Deaths: 0 deaths
Codeine (for Second Trial)
Serious events: 0 serious events
Other events: 61 other events
Deaths: 0 deaths
Oxycodone (Third Trial)
Serious events: 0 serious events
Other events: 74 other events
Deaths: 0 deaths
Hydrocodone (Third Trial)
Serious events: 0 serious events
Other events: 51 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Hydrocodone (First Trial)
n=88 participants at risk
Hydrocodone 5mg / Acetaminophen 500mg. Patients instructed to take 1 dose every 4 hrs as needed for pain.
Hydrocodone (first trial): Patients will take 1 dose of Hydrocodone 5mg / Acetaminophen 500mg every 4 hours as needed for pain
|
Codeine (First Trial)
n=93 participants at risk
Codeine 30mg / Acetaminophen 300mg. Patients instructed to take 1 dose every 4 hrs as needed for pain.
Codeine (first trial): Patients will take 1 dose of Codeine 30 mg / Acetaminophen 300 mg every 4 hours as needed for pain
|
Oxycodone (for Second Trial)
n=111 participants at risk
Oxycodone 5mg / Acetaminophen 325mg. Patients instructed to take 1 dose every 4 hrs as needed for pain.
Oxycodone (for second trial): Patients will take 1 dose of Oxycodone 5 mg / Acetaminophen 325 mg every 4 hours as needed for pain
|
Codeine (for Second Trial)
n=104 participants at risk
Codeine 30mg / Acetaminophen 300mg. Patients instructed to take 1 dose every 4 hrs as needed for pain.
Codeine (for second trial): Patients will take 1 dose of Codeine 30 mg / Acetaminophen 300 mg every 4 hours as needed for pain
|
Oxycodone (Third Trial)
n=106 participants at risk；n=107 participants at risk
Oxycodone 5mg / Acetaminophen 325 mg. Patients instructed to take 1 dose every 4 hours as needed for pain.
Oxycodone (third trial): Patients will take 1 dose of Oxycodone 5mg / Acetaminophen 325 mg every 4 hours as needed for pain
|
Hydrocodone (Third Trial)
n=112 participants at risk；n=113 participants at risk
Hydrocodone 5mg / Acetaminophen 325 mg. Patients instructed to take 1 dose every 4 hours as needed for pain.
Hydrocodone (third trial): Patients will take 1 dose of Hydrocodone 5 mg / Acetaminophen 325 mg every 4 hours as needed for pain.
|
|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
10.3%
9/87 • follow up period, 24-48 hours
In adverse events, any change in total participants at risk from overall number reflects missing data
|
9.8%
9/92 • follow up period, 24-48 hours
In adverse events, any change in total participants at risk from overall number reflects missing data
|
11.7%
13/111 • follow up period, 24-48 hours
In adverse events, any change in total participants at risk from overall number reflects missing data
|
11.5%
12/104 • follow up period, 24-48 hours
In adverse events, any change in total participants at risk from overall number reflects missing data
|
17.1%
18/105 • follow up period, 24-48 hours
In adverse events, any change in total participants at risk from overall number reflects missing data
|
7.1%
8/112 • follow up period, 24-48 hours
In adverse events, any change in total participants at risk from overall number reflects missing data
|
|
Gastrointestinal disorders
Vomiting
|
2.3%
2/87 • follow up period, 24-48 hours
In adverse events, any change in total participants at risk from overall number reflects missing data
|
1.1%
1/92 • follow up period, 24-48 hours
In adverse events, any change in total participants at risk from overall number reflects missing data
|
3.6%
4/111 • follow up period, 24-48 hours
In adverse events, any change in total participants at risk from overall number reflects missing data
|
1.9%
2/104 • follow up period, 24-48 hours
In adverse events, any change in total participants at risk from overall number reflects missing data
|
4.8%
5/105 • follow up period, 24-48 hours
In adverse events, any change in total participants at risk from overall number reflects missing data
|
0.89%
1/112 • follow up period, 24-48 hours
In adverse events, any change in total participants at risk from overall number reflects missing data
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/88 • follow up period, 24-48 hours
In adverse events, any change in total participants at risk from overall number reflects missing data
|
0.00%
0/93 • follow up period, 24-48 hours
In adverse events, any change in total participants at risk from overall number reflects missing data
|
0.00%
0/111 • follow up period, 24-48 hours
In adverse events, any change in total participants at risk from overall number reflects missing data
|
0.00%
0/104 • follow up period, 24-48 hours
In adverse events, any change in total participants at risk from overall number reflects missing data
|
0.00%
0/106 • follow up period, 24-48 hours
In adverse events, any change in total participants at risk from overall number reflects missing data
|
1.8%
2/110 • follow up period, 24-48 hours
In adverse events, any change in total participants at risk from overall number reflects missing data
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/87 • follow up period, 24-48 hours
In adverse events, any change in total participants at risk from overall number reflects missing data
|
5.4%
5/93 • follow up period, 24-48 hours
In adverse events, any change in total participants at risk from overall number reflects missing data
|
0.90%
1/111 • follow up period, 24-48 hours
In adverse events, any change in total participants at risk from overall number reflects missing data
|
2.9%
3/104 • follow up period, 24-48 hours
In adverse events, any change in total participants at risk from overall number reflects missing data
|
2.8%
3/106 • follow up period, 24-48 hours
In adverse events, any change in total participants at risk from overall number reflects missing data
|
1.8%
2/110 • follow up period, 24-48 hours
In adverse events, any change in total participants at risk from overall number reflects missing data
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
3.4%
3/87 • follow up period, 24-48 hours
In adverse events, any change in total participants at risk from overall number reflects missing data
|
3.2%
3/93 • follow up period, 24-48 hours
In adverse events, any change in total participants at risk from overall number reflects missing data
|
5.4%
6/111 • follow up period, 24-48 hours
In adverse events, any change in total participants at risk from overall number reflects missing data
|
3.8%
4/104 • follow up period, 24-48 hours
In adverse events, any change in total participants at risk from overall number reflects missing data
|
2.8%
3/106 • follow up period, 24-48 hours
In adverse events, any change in total participants at risk from overall number reflects missing data
|
3.6%
4/110 • follow up period, 24-48 hours
In adverse events, any change in total participants at risk from overall number reflects missing data
|
|
Skin and subcutaneous tissue disorders
Rash
|
1.1%
1/87 • follow up period, 24-48 hours
In adverse events, any change in total participants at risk from overall number reflects missing data
|
0.00%
0/92 • follow up period, 24-48 hours
In adverse events, any change in total participants at risk from overall number reflects missing data
|
1.8%
2/111 • follow up period, 24-48 hours
In adverse events, any change in total participants at risk from overall number reflects missing data
|
2.9%
3/104 • follow up period, 24-48 hours
In adverse events, any change in total participants at risk from overall number reflects missing data
|
1.9%
2/106 • follow up period, 24-48 hours
In adverse events, any change in total participants at risk from overall number reflects missing data
|
1.8%
2/111 • follow up period, 24-48 hours
In adverse events, any change in total participants at risk from overall number reflects missing data
|
|
Nervous system disorders
Dizziness
|
13.8%
12/87 • follow up period, 24-48 hours
In adverse events, any change in total participants at risk from overall number reflects missing data
|
5.4%
5/93 • follow up period, 24-48 hours
In adverse events, any change in total participants at risk from overall number reflects missing data
|
9.9%
11/111 • follow up period, 24-48 hours
In adverse events, any change in total participants at risk from overall number reflects missing data
|
12.5%
13/104 • follow up period, 24-48 hours
In adverse events, any change in total participants at risk from overall number reflects missing data
|
17.0%
18/106 • follow up period, 24-48 hours
In adverse events, any change in total participants at risk from overall number reflects missing data
|
7.2%
8/111 • follow up period, 24-48 hours
In adverse events, any change in total participants at risk from overall number reflects missing data
|
|
Nervous system disorders
Drowsiness
|
28.4%
25/88 • follow up period, 24-48 hours
In adverse events, any change in total participants at risk from overall number reflects missing data
|
29.0%
27/93 • follow up period, 24-48 hours
In adverse events, any change in total participants at risk from overall number reflects missing data
|
27.0%
30/111 • follow up period, 24-48 hours
In adverse events, any change in total participants at risk from overall number reflects missing data
|
22.1%
23/104 • follow up period, 24-48 hours
In adverse events, any change in total participants at risk from overall number reflects missing data
|
22.9%
24/105 • follow up period, 24-48 hours
In adverse events, any change in total participants at risk from overall number reflects missing data
|
20.5%
23/112 • follow up period, 24-48 hours
In adverse events, any change in total participants at risk from overall number reflects missing data
|
|
Nervous system disorders
Confusion
|
2.3%
2/86 • follow up period, 24-48 hours
In adverse events, any change in total participants at risk from overall number reflects missing data
|
1.1%
1/93 • follow up period, 24-48 hours
In adverse events, any change in total participants at risk from overall number reflects missing data
|
0.90%
1/111 • follow up period, 24-48 hours
In adverse events, any change in total participants at risk from overall number reflects missing data
|
0.96%
1/104 • follow up period, 24-48 hours
In adverse events, any change in total participants at risk from overall number reflects missing data
|
0.96%
1/104 • follow up period, 24-48 hours
In adverse events, any change in total participants at risk from overall number reflects missing data
|
0.92%
1/109 • follow up period, 24-48 hours
In adverse events, any change in total participants at risk from overall number reflects missing data
|
Additional Information
Andrew Chang, MD, MS
Department of Emergency Medicine, Albert Einstein College of Medicine, Montefiore Medical Center
Phone: 718-920-6626
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place