Trial Outcomes & Findings for Buprenorphine Sublingual Spray for the Treatment of Moderate to Severe Pain (NCT NCT02310581)
NCT ID: NCT02310581
Last Updated: 2017-08-09
Results Overview
Pain intensity was assessed by the participant using an 11-point NRS from 0=no pain to 10=worst possible pain. Pain intensity scores were collected at Baseline (prior to study drug) and at multiple time points up to 48 hours after Time 0 (administration of first dose of study drug). Pain intensity difference is calculated by subtracting the pain intensity at each time point from the pain intensity at Time 0. The SPID scores are the sum of the differences at each time point multiplied by the duration in hours since the previous time point. Positive numbers indicate a reduction in pain \[maximum (max)=10 at each time point\] and negative numbers indicate an increase in pain \[minimum (min)=-10 at each time point\]. The overall min and max are -10 and 10 times the number of hours specified; SPID-48 range is -480 to 480. The NRS SPID-48 was analyzed using an analysis of covariance (ANCOVA) model, which included treatment and site as main effects and Baseline pain intensity as the covariate.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
40 participants
Primary outcome timeframe
Baseline and 0 to 48 hours after Time 0
Results posted on
2017-08-09
Participant Flow
Participant milestones
| Measure |
Buprenorphine 0.5 mg TID
Participants received buprenorphine 0.5 mg sublingual (under the tongue) spray three times daily (TID) and placebo-matching buprenorphine sublingual spray once daily (QD) for two days.
|
Buprenorphine 1.0 mg BID
Participants received buprenorphine 1.0 mg sublingual spray twice daily (BID) and placebo-matching buprenorphine sublingual spray BID for two days.
|
Buprenorphine 1.0 mg TID
Participants received buprenorphine 1.0 mg sublingual spray TID and placebo-matching buprenorphine sublingual spray QD for two days.
|
Placebo
Participants received placebo-matching buprenorphine sublingual spray four times daily for two days.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
9
|
11
|
10
|
10
|
|
Overall Study
COMPLETED
|
6
|
9
|
9
|
9
|
|
Overall Study
NOT COMPLETED
|
3
|
2
|
1
|
1
|
Reasons for withdrawal
| Measure |
Buprenorphine 0.5 mg TID
Participants received buprenorphine 0.5 mg sublingual (under the tongue) spray three times daily (TID) and placebo-matching buprenorphine sublingual spray once daily (QD) for two days.
|
Buprenorphine 1.0 mg BID
Participants received buprenorphine 1.0 mg sublingual spray twice daily (BID) and placebo-matching buprenorphine sublingual spray BID for two days.
|
Buprenorphine 1.0 mg TID
Participants received buprenorphine 1.0 mg sublingual spray TID and placebo-matching buprenorphine sublingual spray QD for two days.
|
Placebo
Participants received placebo-matching buprenorphine sublingual spray four times daily for two days.
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
1
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
2
|
1
|
0
|
1
|
Baseline Characteristics
Buprenorphine Sublingual Spray for the Treatment of Moderate to Severe Pain
Baseline characteristics by cohort
| Measure |
Buprenorphine 0.5 mg TID
n=9 Participants
Participants received buprenorphine 0.5 mg sublingual spray three times daily (TID) and placebo-matching buprenorphine sublingual spray once daily (QD) for two days.
|
Buprenorphine 1.0 mg BID
n=11 Participants
Participants received buprenorphine 1.0 mg sublingual spray twice daily (BID) and placebo-matching buprenorphine sublingual spray BID for two days.
|
Buprenorphine 1.0 mg TID
n=10 Participants
Participants received buprenorphine 1.0 mg sublingual spray TID and placebo-matching buprenorphine sublingual spray QD for two days.
|
Placebo
n=10 Participants
Participants received placebo-matching buprenorphine sublingual spray four times daily for two days.
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
48.0 years
n=5 Participants
|
43.5 years
n=7 Participants
|
40.8 years
n=5 Participants
|
40.5 years
n=4 Participants
|
43.2 years
n=21 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
32 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Baseline and 0 to 48 hours after Time 0Population: All randomized participants from the Intent-to-Treat (ITT) Population.
Pain intensity was assessed by the participant using an 11-point NRS from 0=no pain to 10=worst possible pain. Pain intensity scores were collected at Baseline (prior to study drug) and at multiple time points up to 48 hours after Time 0 (administration of first dose of study drug). Pain intensity difference is calculated by subtracting the pain intensity at each time point from the pain intensity at Time 0. The SPID scores are the sum of the differences at each time point multiplied by the duration in hours since the previous time point. Positive numbers indicate a reduction in pain \[maximum (max)=10 at each time point\] and negative numbers indicate an increase in pain \[minimum (min)=-10 at each time point\]. The overall min and max are -10 and 10 times the number of hours specified; SPID-48 range is -480 to 480. The NRS SPID-48 was analyzed using an analysis of covariance (ANCOVA) model, which included treatment and site as main effects and Baseline pain intensity as the covariate.
Outcome measures
| Measure |
Buprenorphine 0.5 mg TID
n=9 Participants
Participants received buprenorphine 0.5 mg sublingual spray three times daily (TID) and placebo-matching buprenorphine sublingual spray once daily (QD) for two days.
|
Buprenorphine 1.0 mg BID
n=11 Participants
Participants received buprenorphine 1.0 mg sublingual spray twice daily (BID) and placebo-matching buprenorphine sublingual spray BID for two days.
|
Buprenorphine 1.0 mg TID
n=10 Participants
Participants received buprenorphine 1.0 mg sublingual spray TID and placebo-matching buprenorphine sublingual spray QD for two days.
|
Placebo
n=10 Participants
Participants received placebo-matching buprenorphine sublingual spray four times daily for two days.
|
|---|---|---|---|---|
|
Numeric Rating Scale (NRS) Summed Pain Intensity Difference (SPID) Over 0 to 48 Hours After Time 0 (NRS SPID-48)
|
169.621 units on a scale
Standard Error 29.9942
|
150.964 units on a scale
Standard Error 27.5418
|
129.133 units on a scale
Standard Error 29.3429
|
64.648 units on a scale
Standard Error 29.0597
|
SECONDARY outcome
Timeframe: Baseline and 4, 8, 24 and 48 hours after Time 0Population: All randomized participants from the ITT Population with data available at each timepoint.
Pain intensity was assessed by the participant using an 11-point NRS from 0=no pain to 10=worst possible pain. Pain intensity scores were collected at Baseline (prior to study drug administration) and at multiple time points up to 48 hours after Time 0 (time of administration of the first dose of study drug). NRS PID is defined as the difference in pain at each scheduled timepoint relative to Baseline (PID=pain intensity at baseline - pain intensity at time point). A higher value of NRS PID score indicates a higher decrease in pain from Baseline.
Outcome measures
| Measure |
Buprenorphine 0.5 mg TID
n=9 Participants
Participants received buprenorphine 0.5 mg sublingual spray three times daily (TID) and placebo-matching buprenorphine sublingual spray once daily (QD) for two days.
|
Buprenorphine 1.0 mg BID
n=11 Participants
Participants received buprenorphine 1.0 mg sublingual spray twice daily (BID) and placebo-matching buprenorphine sublingual spray BID for two days.
|
Buprenorphine 1.0 mg TID
n=10 Participants
Participants received buprenorphine 1.0 mg sublingual spray TID and placebo-matching buprenorphine sublingual spray QD for two days.
|
Placebo
n=10 Participants
Participants received placebo-matching buprenorphine sublingual spray four times daily for two days.
|
|---|---|---|---|---|
|
NRS Mean Pain Intensity Difference (PID) at 4, 8, 24 and 48 Hours After Time 0
4 Hours
|
4.7 units on a scale
Standard Deviation 1.73
|
3.4 units on a scale
Standard Deviation 3.01
|
3.8 units on a scale
Standard Deviation 2.94
|
1.6 units on a scale
Standard Deviation 1.33
|
|
NRS Mean Pain Intensity Difference (PID) at 4, 8, 24 and 48 Hours After Time 0
8 Hours
|
3.4 units on a scale
Standard Deviation 1.41
|
4.0 units on a scale
Standard Deviation 2.97
|
3.9 units on a scale
Standard Deviation 2.28
|
1.2 units on a scale
Standard Deviation 1.99
|
|
NRS Mean Pain Intensity Difference (PID) at 4, 8, 24 and 48 Hours After Time 0
24 Hours
|
5.5 units on a scale
Standard Deviation 1.76
|
3.0 units on a scale
Standard Deviation 3.16
|
3.4 units on a scale
Standard Deviation 1.81
|
2.6 units on a scale
Standard Deviation 1.94
|
|
NRS Mean Pain Intensity Difference (PID) at 4, 8, 24 and 48 Hours After Time 0
48 Hours
|
6.3 units on a scale
Standard Deviation 1.03
|
4.2 units on a scale
Standard Deviation 2.39
|
4.1 units on a scale
Standard Deviation 2.80
|
3.2 units on a scale
Standard Deviation 2.64
|
SECONDARY outcome
Timeframe: 4, 8, 24 and 48 hours after Time 0Population: All randomized participants from the ITT Population with data available at each timepoint.
Pain intensity was assessed by the participant using an 11-point NRS from 0=no pain to 10=worst possible pain. Pain intensity scores were collected at Baseline (prior to study drug administration) and at multiple time points up to 48 hours after Time 0 (time of administration of the first dose of study drug). A lower value indicates improvement in pain.
Outcome measures
| Measure |
Buprenorphine 0.5 mg TID
n=9 Participants
Participants received buprenorphine 0.5 mg sublingual spray three times daily (TID) and placebo-matching buprenorphine sublingual spray once daily (QD) for two days.
|
Buprenorphine 1.0 mg BID
n=11 Participants
Participants received buprenorphine 1.0 mg sublingual spray twice daily (BID) and placebo-matching buprenorphine sublingual spray BID for two days.
|
Buprenorphine 1.0 mg TID
n=10 Participants
Participants received buprenorphine 1.0 mg sublingual spray TID and placebo-matching buprenorphine sublingual spray QD for two days.
|
Placebo
n=10 Participants
Participants received placebo-matching buprenorphine sublingual spray four times daily for two days.
|
|---|---|---|---|---|
|
NRS Mean Pain Intensity Score at 4, 8, 24 and 48 Hours After Time 0
48 Hours
|
1.0 units on a scale
Standard Deviation 0.89
|
2.1 units on a scale
Standard Deviation 1.76
|
3.9 units on a scale
Standard Deviation 2.42
|
3.2 units on a scale
Standard Deviation 2.11
|
|
NRS Mean Pain Intensity Score at 4, 8, 24 and 48 Hours After Time 0
24 Hours
|
1.8 units on a scale
Standard Deviation 1.47
|
3.3 units on a scale
Standard Deviation 2.55
|
4.6 units on a scale
Standard Deviation 2.07
|
3.9 units on a scale
Standard Deviation 2.80
|
|
NRS Mean Pain Intensity Score at 4, 8, 24 and 48 Hours After Time 0
4 Hours
|
2.2 units on a scale
Standard Deviation 2.49
|
2.9 units on a scale
Standard Deviation 3.08
|
4.0 units on a scale
Standard Deviation 2.87
|
4.9 units on a scale
Standard Deviation 3.14
|
|
NRS Mean Pain Intensity Score at 4, 8, 24 and 48 Hours After Time 0
8 Hours
|
3.5 units on a scale
Standard Deviation 2.14
|
2.3 units on a scale
Standard Deviation 3.00
|
3.9 units on a scale
Standard Deviation 2.42
|
5.2 units on a scale
Standard Deviation 2.64
|
SECONDARY outcome
Timeframe: Baseline and 0 to 4 hours after Time 0Population: ITT Population included all participants who were randomized.
Pain intensity was assessed by the participant using an 11-point NRS from 0=no pain to 10=worst possible pain. Pain intensity scores were collected at Baseline (prior to study drug) and at multiple time points up to 4 hours after Time 0 (administration of first dose of study drug). Pain intensity difference is calculated by subtracting the pain intensity at each time point from the pain intensity at Time 0. The SPID scores are the sum of the differences at each time point multiplied by the duration in hours since the previous time point. Positive numbers indicate a reduction in pain \[maximum (max)=10 at each time point\] and negative numbers indicate an increase in pain \[minimum (min)=-10 at each time point\]. The overall min and max are -10 and 10 times the number of hours specified; SPID-4 range is -40 to 40. The NRS SPID-4 was analyzed using an analysis of covariance (ANCOVA) model, which included treatment and site as main effects and Baseline pain intensity as the covariate.
Outcome measures
| Measure |
Buprenorphine 0.5 mg TID
n=9 Participants
Participants received buprenorphine 0.5 mg sublingual spray three times daily (TID) and placebo-matching buprenorphine sublingual spray once daily (QD) for two days.
|
Buprenorphine 1.0 mg BID
n=11 Participants
Participants received buprenorphine 1.0 mg sublingual spray twice daily (BID) and placebo-matching buprenorphine sublingual spray BID for two days.
|
Buprenorphine 1.0 mg TID
n=10 Participants
Participants received buprenorphine 1.0 mg sublingual spray TID and placebo-matching buprenorphine sublingual spray QD for two days.
|
Placebo
n=10 Participants
Participants received placebo-matching buprenorphine sublingual spray four times daily for two days.
|
|---|---|---|---|---|
|
NRS SPID Over 0 to 4 Hours After Time 0 (NRS SPID-4)
|
11.430 units on a scale
Standard Error 3.6221
|
5.088 units on a scale
Standard Error 3.3259
|
7.095 units on a scale
Standard Error 3.5434
|
-2.968 units on a scale
Standard Error 3.5092
|
SECONDARY outcome
Timeframe: Baseline and 0 to 8 hours after Time 0Population: ITT Population included all randomized participants.
Pain intensity was assessed by the participant using an 11-point NRS from 0=no pain to 10=worst possible pain. Pain intensity scores were collected at Baseline (prior to study drug) and at multiple time points up to 8 hours after Time 0 (administration of first dose of study drug). Pain intensity difference is calculated by subtracting the pain intensity at each time point from the pain intensity at Time 0. The SPID scores are the sum of the differences at each time point multiplied by the duration in hours since the previous time point. Positive numbers indicate a reduction in pain \[maximum (max)=10 at each time point\] and negative numbers indicate an increase in pain \[minimum (min)=-10 at each time point\]. The overall min and max are -10 and 10 times the number of hours specified; SPID-8 range is -80 to 80. The NRS SPID-8 was analyzed using an analysis of covariance (ANCOVA) model, which included treatment and site as main effects and Baseline pain intensity as the covariate.
Outcome measures
| Measure |
Buprenorphine 0.5 mg TID
n=9 Participants
Participants received buprenorphine 0.5 mg sublingual spray three times daily (TID) and placebo-matching buprenorphine sublingual spray once daily (QD) for two days.
|
Buprenorphine 1.0 mg BID
n=11 Participants
Participants received buprenorphine 1.0 mg sublingual spray twice daily (BID) and placebo-matching buprenorphine sublingual spray BID for two days.
|
Buprenorphine 1.0 mg TID
n=10 Participants
Participants received buprenorphine 1.0 mg sublingual spray TID and placebo-matching buprenorphine sublingual spray QD for two days.
|
Placebo
n=10 Participants
Participants received placebo-matching buprenorphine sublingual spray four times daily for two days.
|
|---|---|---|---|---|
|
NRS SPID Over 0 to 8 Hours After Time 0 (NRS SPID-8)
|
24.283 units on a scale
Standard Error 6.2667
|
19.223 units on a scale
Standard Error 5.7543
|
19.761 units on a scale
Standard Error 6.1306
|
-2.382 units on a scale
Standard Error 6.0715
|
SECONDARY outcome
Timeframe: Baseline and 0 to 24 hours after Time 0Population: ITT Population included all participants who were randomized.
Pain intensity was assessed by the participant using an 11-point NRS from 0=no pain to 10=worst possible pain. Pain intensity scores were collected at Baseline (prior to study drug) and at multiple time points up to 24 hours after Time 0 (administration of first dose of study drug). Pain intensity difference is calculated by subtracting the pain intensity at each time point from the pain intensity at Time 0. The SPID scores are the sum of the differences at each time point multiplied by the duration in hours since the previous time point. Positive numbers indicate a reduction in pain \[maximum (max)=10 at each time point\] and negative numbers indicate an increase in pain \[minimum (min)=-10 at each time point\]. The overall min and max are -10 and 10 times the number of hours specified; SPID-24 range is -240 to 240. The NRS SPID-24 was analyzed using an analysis of covariance (ANCOVA) model, which included treatment and site as main effects and Baseline pain intensity as the covariate.
Outcome measures
| Measure |
Buprenorphine 0.5 mg TID
n=9 Participants
Participants received buprenorphine 0.5 mg sublingual spray three times daily (TID) and placebo-matching buprenorphine sublingual spray once daily (QD) for two days.
|
Buprenorphine 1.0 mg BID
n=11 Participants
Participants received buprenorphine 1.0 mg sublingual spray twice daily (BID) and placebo-matching buprenorphine sublingual spray BID for two days.
|
Buprenorphine 1.0 mg TID
n=10 Participants
Participants received buprenorphine 1.0 mg sublingual spray TID and placebo-matching buprenorphine sublingual spray QD for two days.
|
Placebo
n=10 Participants
Participants received placebo-matching buprenorphine sublingual spray four times daily for two days.
|
|---|---|---|---|---|
|
NRS SPID Over 0 to 24 Hours After Time 0 (NRS SPID-24)
|
83.668 units on a scale
Standard Error 14.0612
|
70.071 units on a scale
Standard Error 12.9115
|
76.666 units on a scale
Standard Error 13.7558
|
19.787 units on a scale
Standard Error 13.6231
|
SECONDARY outcome
Timeframe: From Time 0 (first dose of study drug) up to Day 9Population: ITT Population included all participants who were randomized.
The percentage of participants who needed to take an alternate medication for pain relief during the study.
Outcome measures
| Measure |
Buprenorphine 0.5 mg TID
n=9 Participants
Participants received buprenorphine 0.5 mg sublingual spray three times daily (TID) and placebo-matching buprenorphine sublingual spray once daily (QD) for two days.
|
Buprenorphine 1.0 mg BID
n=11 Participants
Participants received buprenorphine 1.0 mg sublingual spray twice daily (BID) and placebo-matching buprenorphine sublingual spray BID for two days.
|
Buprenorphine 1.0 mg TID
n=10 Participants
Participants received buprenorphine 1.0 mg sublingual spray TID and placebo-matching buprenorphine sublingual spray QD for two days.
|
Placebo
n=10 Participants
Participants received placebo-matching buprenorphine sublingual spray four times daily for two days.
|
|---|---|---|---|---|
|
Percentage of Participants Who Used Rescue Medication for Pain
|
44.4 percentage of participants
|
54.5 percentage of participants
|
60.0 percentage of participants
|
100 percentage of participants
|
Adverse Events
Buprenorphine 0.5 mg TID
Serious events: 1 serious events
Other events: 9 other events
Deaths: 0 deaths
Buprenorphine 1.0 mg BID
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Buprenorphine 1.0 mg TID
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Buprenorphine 0.5 mg TID
n=9 participants at risk
Participants received buprenorphine 0.5 mg sublingual spray three times daily (TID) and placebo-matching buprenorphine sublingual spray once daily (QD) for two days.
|
Buprenorphine 1.0 mg BID
n=11 participants at risk
Participants received buprenorphine 1.0 mg sublingual spray twice daily (BID) and placebo-matching buprenorphine sublingual spray BID for two days.
|
Buprenorphine 1.0 mg TID
n=10 participants at risk
Participants received buprenorphine 1.0 mg sublingual spray TID and placebo-matching buprenorphine sublingual spray QD for two days.
|
Placebo
n=10 participants at risk
Participants received placebo-matching buprenorphine sublingual spray four times daily for two days.
|
|---|---|---|---|---|
|
Cardiac disorders
Atrial fibrillation
|
11.1%
1/9 • Serious Adverse Events: from signing of informed consent to the Follow-up visit (up to 9 days). Non-serious Adverse Events: from the first dose of study drug to the Follow-up visit (up to 9 days).
|
0.00%
0/11 • Serious Adverse Events: from signing of informed consent to the Follow-up visit (up to 9 days). Non-serious Adverse Events: from the first dose of study drug to the Follow-up visit (up to 9 days).
|
0.00%
0/10 • Serious Adverse Events: from signing of informed consent to the Follow-up visit (up to 9 days). Non-serious Adverse Events: from the first dose of study drug to the Follow-up visit (up to 9 days).
|
0.00%
0/10 • Serious Adverse Events: from signing of informed consent to the Follow-up visit (up to 9 days). Non-serious Adverse Events: from the first dose of study drug to the Follow-up visit (up to 9 days).
|
Other adverse events
| Measure |
Buprenorphine 0.5 mg TID
n=9 participants at risk
Participants received buprenorphine 0.5 mg sublingual spray three times daily (TID) and placebo-matching buprenorphine sublingual spray once daily (QD) for two days.
|
Buprenorphine 1.0 mg BID
n=11 participants at risk
Participants received buprenorphine 1.0 mg sublingual spray twice daily (BID) and placebo-matching buprenorphine sublingual spray BID for two days.
|
Buprenorphine 1.0 mg TID
n=10 participants at risk
Participants received buprenorphine 1.0 mg sublingual spray TID and placebo-matching buprenorphine sublingual spray QD for two days.
|
Placebo
n=10 participants at risk
Participants received placebo-matching buprenorphine sublingual spray four times daily for two days.
|
|---|---|---|---|---|
|
Eye disorders
Visual disturbance
|
0.00%
0/9 • Serious Adverse Events: from signing of informed consent to the Follow-up visit (up to 9 days). Non-serious Adverse Events: from the first dose of study drug to the Follow-up visit (up to 9 days).
|
9.1%
1/11 • Serious Adverse Events: from signing of informed consent to the Follow-up visit (up to 9 days). Non-serious Adverse Events: from the first dose of study drug to the Follow-up visit (up to 9 days).
|
0.00%
0/10 • Serious Adverse Events: from signing of informed consent to the Follow-up visit (up to 9 days). Non-serious Adverse Events: from the first dose of study drug to the Follow-up visit (up to 9 days).
|
0.00%
0/10 • Serious Adverse Events: from signing of informed consent to the Follow-up visit (up to 9 days). Non-serious Adverse Events: from the first dose of study drug to the Follow-up visit (up to 9 days).
|
|
Gastrointestinal disorders
Burning mouth
|
0.00%
0/9 • Serious Adverse Events: from signing of informed consent to the Follow-up visit (up to 9 days). Non-serious Adverse Events: from the first dose of study drug to the Follow-up visit (up to 9 days).
|
9.1%
1/11 • Serious Adverse Events: from signing of informed consent to the Follow-up visit (up to 9 days). Non-serious Adverse Events: from the first dose of study drug to the Follow-up visit (up to 9 days).
|
0.00%
0/10 • Serious Adverse Events: from signing of informed consent to the Follow-up visit (up to 9 days). Non-serious Adverse Events: from the first dose of study drug to the Follow-up visit (up to 9 days).
|
0.00%
0/10 • Serious Adverse Events: from signing of informed consent to the Follow-up visit (up to 9 days). Non-serious Adverse Events: from the first dose of study drug to the Follow-up visit (up to 9 days).
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/9 • Serious Adverse Events: from signing of informed consent to the Follow-up visit (up to 9 days). Non-serious Adverse Events: from the first dose of study drug to the Follow-up visit (up to 9 days).
|
27.3%
3/11 • Serious Adverse Events: from signing of informed consent to the Follow-up visit (up to 9 days). Non-serious Adverse Events: from the first dose of study drug to the Follow-up visit (up to 9 days).
|
20.0%
2/10 • Serious Adverse Events: from signing of informed consent to the Follow-up visit (up to 9 days). Non-serious Adverse Events: from the first dose of study drug to the Follow-up visit (up to 9 days).
|
0.00%
0/10 • Serious Adverse Events: from signing of informed consent to the Follow-up visit (up to 9 days). Non-serious Adverse Events: from the first dose of study drug to the Follow-up visit (up to 9 days).
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/9 • Serious Adverse Events: from signing of informed consent to the Follow-up visit (up to 9 days). Non-serious Adverse Events: from the first dose of study drug to the Follow-up visit (up to 9 days).
|
0.00%
0/11 • Serious Adverse Events: from signing of informed consent to the Follow-up visit (up to 9 days). Non-serious Adverse Events: from the first dose of study drug to the Follow-up visit (up to 9 days).
|
0.00%
0/10 • Serious Adverse Events: from signing of informed consent to the Follow-up visit (up to 9 days). Non-serious Adverse Events: from the first dose of study drug to the Follow-up visit (up to 9 days).
|
10.0%
1/10 • Serious Adverse Events: from signing of informed consent to the Follow-up visit (up to 9 days). Non-serious Adverse Events: from the first dose of study drug to the Follow-up visit (up to 9 days).
|
|
Gastrointestinal disorders
Dry mouth
|
11.1%
1/9 • Serious Adverse Events: from signing of informed consent to the Follow-up visit (up to 9 days). Non-serious Adverse Events: from the first dose of study drug to the Follow-up visit (up to 9 days).
|
0.00%
0/11 • Serious Adverse Events: from signing of informed consent to the Follow-up visit (up to 9 days). Non-serious Adverse Events: from the first dose of study drug to the Follow-up visit (up to 9 days).
|
10.0%
1/10 • Serious Adverse Events: from signing of informed consent to the Follow-up visit (up to 9 days). Non-serious Adverse Events: from the first dose of study drug to the Follow-up visit (up to 9 days).
|
0.00%
0/10 • Serious Adverse Events: from signing of informed consent to the Follow-up visit (up to 9 days). Non-serious Adverse Events: from the first dose of study drug to the Follow-up visit (up to 9 days).
|
|
Gastrointestinal disorders
Dysphagia
|
11.1%
1/9 • Serious Adverse Events: from signing of informed consent to the Follow-up visit (up to 9 days). Non-serious Adverse Events: from the first dose of study drug to the Follow-up visit (up to 9 days).
|
9.1%
1/11 • Serious Adverse Events: from signing of informed consent to the Follow-up visit (up to 9 days). Non-serious Adverse Events: from the first dose of study drug to the Follow-up visit (up to 9 days).
|
0.00%
0/10 • Serious Adverse Events: from signing of informed consent to the Follow-up visit (up to 9 days). Non-serious Adverse Events: from the first dose of study drug to the Follow-up visit (up to 9 days).
|
0.00%
0/10 • Serious Adverse Events: from signing of informed consent to the Follow-up visit (up to 9 days). Non-serious Adverse Events: from the first dose of study drug to the Follow-up visit (up to 9 days).
|
|
Gastrointestinal disorders
Emesis
|
44.4%
4/9 • Serious Adverse Events: from signing of informed consent to the Follow-up visit (up to 9 days). Non-serious Adverse Events: from the first dose of study drug to the Follow-up visit (up to 9 days).
|
45.5%
5/11 • Serious Adverse Events: from signing of informed consent to the Follow-up visit (up to 9 days). Non-serious Adverse Events: from the first dose of study drug to the Follow-up visit (up to 9 days).
|
50.0%
5/10 • Serious Adverse Events: from signing of informed consent to the Follow-up visit (up to 9 days). Non-serious Adverse Events: from the first dose of study drug to the Follow-up visit (up to 9 days).
|
0.00%
0/10 • Serious Adverse Events: from signing of informed consent to the Follow-up visit (up to 9 days). Non-serious Adverse Events: from the first dose of study drug to the Follow-up visit (up to 9 days).
|
|
Gastrointestinal disorders
Heartburn
|
11.1%
1/9 • Serious Adverse Events: from signing of informed consent to the Follow-up visit (up to 9 days). Non-serious Adverse Events: from the first dose of study drug to the Follow-up visit (up to 9 days).
|
0.00%
0/11 • Serious Adverse Events: from signing of informed consent to the Follow-up visit (up to 9 days). Non-serious Adverse Events: from the first dose of study drug to the Follow-up visit (up to 9 days).
|
0.00%
0/10 • Serious Adverse Events: from signing of informed consent to the Follow-up visit (up to 9 days). Non-serious Adverse Events: from the first dose of study drug to the Follow-up visit (up to 9 days).
|
0.00%
0/10 • Serious Adverse Events: from signing of informed consent to the Follow-up visit (up to 9 days). Non-serious Adverse Events: from the first dose of study drug to the Follow-up visit (up to 9 days).
|
|
Gastrointestinal disorders
Loose stools
|
0.00%
0/9 • Serious Adverse Events: from signing of informed consent to the Follow-up visit (up to 9 days). Non-serious Adverse Events: from the first dose of study drug to the Follow-up visit (up to 9 days).
|
0.00%
0/11 • Serious Adverse Events: from signing of informed consent to the Follow-up visit (up to 9 days). Non-serious Adverse Events: from the first dose of study drug to the Follow-up visit (up to 9 days).
|
0.00%
0/10 • Serious Adverse Events: from signing of informed consent to the Follow-up visit (up to 9 days). Non-serious Adverse Events: from the first dose of study drug to the Follow-up visit (up to 9 days).
|
10.0%
1/10 • Serious Adverse Events: from signing of informed consent to the Follow-up visit (up to 9 days). Non-serious Adverse Events: from the first dose of study drug to the Follow-up visit (up to 9 days).
|
|
Gastrointestinal disorders
Nausea
|
77.8%
7/9 • Serious Adverse Events: from signing of informed consent to the Follow-up visit (up to 9 days). Non-serious Adverse Events: from the first dose of study drug to the Follow-up visit (up to 9 days).
|
90.9%
10/11 • Serious Adverse Events: from signing of informed consent to the Follow-up visit (up to 9 days). Non-serious Adverse Events: from the first dose of study drug to the Follow-up visit (up to 9 days).
|
70.0%
7/10 • Serious Adverse Events: from signing of informed consent to the Follow-up visit (up to 9 days). Non-serious Adverse Events: from the first dose of study drug to the Follow-up visit (up to 9 days).
|
30.0%
3/10 • Serious Adverse Events: from signing of informed consent to the Follow-up visit (up to 9 days). Non-serious Adverse Events: from the first dose of study drug to the Follow-up visit (up to 9 days).
|
|
Gastrointestinal disorders
Numbness mouth
|
0.00%
0/9 • Serious Adverse Events: from signing of informed consent to the Follow-up visit (up to 9 days). Non-serious Adverse Events: from the first dose of study drug to the Follow-up visit (up to 9 days).
|
9.1%
1/11 • Serious Adverse Events: from signing of informed consent to the Follow-up visit (up to 9 days). Non-serious Adverse Events: from the first dose of study drug to the Follow-up visit (up to 9 days).
|
0.00%
0/10 • Serious Adverse Events: from signing of informed consent to the Follow-up visit (up to 9 days). Non-serious Adverse Events: from the first dose of study drug to the Follow-up visit (up to 9 days).
|
0.00%
0/10 • Serious Adverse Events: from signing of informed consent to the Follow-up visit (up to 9 days). Non-serious Adverse Events: from the first dose of study drug to the Follow-up visit (up to 9 days).
|
|
Gastrointestinal disorders
Sore mouth
|
0.00%
0/9 • Serious Adverse Events: from signing of informed consent to the Follow-up visit (up to 9 days). Non-serious Adverse Events: from the first dose of study drug to the Follow-up visit (up to 9 days).
|
9.1%
1/11 • Serious Adverse Events: from signing of informed consent to the Follow-up visit (up to 9 days). Non-serious Adverse Events: from the first dose of study drug to the Follow-up visit (up to 9 days).
|
0.00%
0/10 • Serious Adverse Events: from signing of informed consent to the Follow-up visit (up to 9 days). Non-serious Adverse Events: from the first dose of study drug to the Follow-up visit (up to 9 days).
|
0.00%
0/10 • Serious Adverse Events: from signing of informed consent to the Follow-up visit (up to 9 days). Non-serious Adverse Events: from the first dose of study drug to the Follow-up visit (up to 9 days).
|
|
Gastrointestinal disorders
Tingling lips
|
11.1%
1/9 • Serious Adverse Events: from signing of informed consent to the Follow-up visit (up to 9 days). Non-serious Adverse Events: from the first dose of study drug to the Follow-up visit (up to 9 days).
|
0.00%
0/11 • Serious Adverse Events: from signing of informed consent to the Follow-up visit (up to 9 days). Non-serious Adverse Events: from the first dose of study drug to the Follow-up visit (up to 9 days).
|
0.00%
0/10 • Serious Adverse Events: from signing of informed consent to the Follow-up visit (up to 9 days). Non-serious Adverse Events: from the first dose of study drug to the Follow-up visit (up to 9 days).
|
0.00%
0/10 • Serious Adverse Events: from signing of informed consent to the Follow-up visit (up to 9 days). Non-serious Adverse Events: from the first dose of study drug to the Follow-up visit (up to 9 days).
|
|
Gastrointestinal disorders
Tingling tongue
|
0.00%
0/9 • Serious Adverse Events: from signing of informed consent to the Follow-up visit (up to 9 days). Non-serious Adverse Events: from the first dose of study drug to the Follow-up visit (up to 9 days).
|
9.1%
1/11 • Serious Adverse Events: from signing of informed consent to the Follow-up visit (up to 9 days). Non-serious Adverse Events: from the first dose of study drug to the Follow-up visit (up to 9 days).
|
0.00%
0/10 • Serious Adverse Events: from signing of informed consent to the Follow-up visit (up to 9 days). Non-serious Adverse Events: from the first dose of study drug to the Follow-up visit (up to 9 days).
|
0.00%
0/10 • Serious Adverse Events: from signing of informed consent to the Follow-up visit (up to 9 days). Non-serious Adverse Events: from the first dose of study drug to the Follow-up visit (up to 9 days).
|
|
Gastrointestinal disorders
Vomiting
|
22.2%
2/9 • Serious Adverse Events: from signing of informed consent to the Follow-up visit (up to 9 days). Non-serious Adverse Events: from the first dose of study drug to the Follow-up visit (up to 9 days).
|
27.3%
3/11 • Serious Adverse Events: from signing of informed consent to the Follow-up visit (up to 9 days). Non-serious Adverse Events: from the first dose of study drug to the Follow-up visit (up to 9 days).
|
30.0%
3/10 • Serious Adverse Events: from signing of informed consent to the Follow-up visit (up to 9 days). Non-serious Adverse Events: from the first dose of study drug to the Follow-up visit (up to 9 days).
|
0.00%
0/10 • Serious Adverse Events: from signing of informed consent to the Follow-up visit (up to 9 days). Non-serious Adverse Events: from the first dose of study drug to the Follow-up visit (up to 9 days).
|
|
Gastrointestinal disorders
Xerostomia
|
0.00%
0/9 • Serious Adverse Events: from signing of informed consent to the Follow-up visit (up to 9 days). Non-serious Adverse Events: from the first dose of study drug to the Follow-up visit (up to 9 days).
|
18.2%
2/11 • Serious Adverse Events: from signing of informed consent to the Follow-up visit (up to 9 days). Non-serious Adverse Events: from the first dose of study drug to the Follow-up visit (up to 9 days).
|
0.00%
0/10 • Serious Adverse Events: from signing of informed consent to the Follow-up visit (up to 9 days). Non-serious Adverse Events: from the first dose of study drug to the Follow-up visit (up to 9 days).
|
0.00%
0/10 • Serious Adverse Events: from signing of informed consent to the Follow-up visit (up to 9 days). Non-serious Adverse Events: from the first dose of study drug to the Follow-up visit (up to 9 days).
|
|
General disorders
Feeling hot
|
11.1%
1/9 • Serious Adverse Events: from signing of informed consent to the Follow-up visit (up to 9 days). Non-serious Adverse Events: from the first dose of study drug to the Follow-up visit (up to 9 days).
|
0.00%
0/11 • Serious Adverse Events: from signing of informed consent to the Follow-up visit (up to 9 days). Non-serious Adverse Events: from the first dose of study drug to the Follow-up visit (up to 9 days).
|
0.00%
0/10 • Serious Adverse Events: from signing of informed consent to the Follow-up visit (up to 9 days). Non-serious Adverse Events: from the first dose of study drug to the Follow-up visit (up to 9 days).
|
0.00%
0/10 • Serious Adverse Events: from signing of informed consent to the Follow-up visit (up to 9 days). Non-serious Adverse Events: from the first dose of study drug to the Follow-up visit (up to 9 days).
|
|
General disorders
Shivering
|
11.1%
1/9 • Serious Adverse Events: from signing of informed consent to the Follow-up visit (up to 9 days). Non-serious Adverse Events: from the first dose of study drug to the Follow-up visit (up to 9 days).
|
0.00%
0/11 • Serious Adverse Events: from signing of informed consent to the Follow-up visit (up to 9 days). Non-serious Adverse Events: from the first dose of study drug to the Follow-up visit (up to 9 days).
|
0.00%
0/10 • Serious Adverse Events: from signing of informed consent to the Follow-up visit (up to 9 days). Non-serious Adverse Events: from the first dose of study drug to the Follow-up visit (up to 9 days).
|
0.00%
0/10 • Serious Adverse Events: from signing of informed consent to the Follow-up visit (up to 9 days). Non-serious Adverse Events: from the first dose of study drug to the Follow-up visit (up to 9 days).
|
|
Infections and infestations
Cellulitis
|
0.00%
0/9 • Serious Adverse Events: from signing of informed consent to the Follow-up visit (up to 9 days). Non-serious Adverse Events: from the first dose of study drug to the Follow-up visit (up to 9 days).
|
9.1%
1/11 • Serious Adverse Events: from signing of informed consent to the Follow-up visit (up to 9 days). Non-serious Adverse Events: from the first dose of study drug to the Follow-up visit (up to 9 days).
|
0.00%
0/10 • Serious Adverse Events: from signing of informed consent to the Follow-up visit (up to 9 days). Non-serious Adverse Events: from the first dose of study drug to the Follow-up visit (up to 9 days).
|
0.00%
0/10 • Serious Adverse Events: from signing of informed consent to the Follow-up visit (up to 9 days). Non-serious Adverse Events: from the first dose of study drug to the Follow-up visit (up to 9 days).
|
|
Infections and infestations
Post procedural cellulitis
|
0.00%
0/9 • Serious Adverse Events: from signing of informed consent to the Follow-up visit (up to 9 days). Non-serious Adverse Events: from the first dose of study drug to the Follow-up visit (up to 9 days).
|
0.00%
0/11 • Serious Adverse Events: from signing of informed consent to the Follow-up visit (up to 9 days). Non-serious Adverse Events: from the first dose of study drug to the Follow-up visit (up to 9 days).
|
10.0%
1/10 • Serious Adverse Events: from signing of informed consent to the Follow-up visit (up to 9 days). Non-serious Adverse Events: from the first dose of study drug to the Follow-up visit (up to 9 days).
|
0.00%
0/10 • Serious Adverse Events: from signing of informed consent to the Follow-up visit (up to 9 days). Non-serious Adverse Events: from the first dose of study drug to the Follow-up visit (up to 9 days).
|
|
Injury, poisoning and procedural complications
Incision site erythema
|
0.00%
0/9 • Serious Adverse Events: from signing of informed consent to the Follow-up visit (up to 9 days). Non-serious Adverse Events: from the first dose of study drug to the Follow-up visit (up to 9 days).
|
0.00%
0/11 • Serious Adverse Events: from signing of informed consent to the Follow-up visit (up to 9 days). Non-serious Adverse Events: from the first dose of study drug to the Follow-up visit (up to 9 days).
|
20.0%
2/10 • Serious Adverse Events: from signing of informed consent to the Follow-up visit (up to 9 days). Non-serious Adverse Events: from the first dose of study drug to the Follow-up visit (up to 9 days).
|
0.00%
0/10 • Serious Adverse Events: from signing of informed consent to the Follow-up visit (up to 9 days). Non-serious Adverse Events: from the first dose of study drug to the Follow-up visit (up to 9 days).
|
|
Investigations
Oxygen saturation decreased
|
11.1%
1/9 • Serious Adverse Events: from signing of informed consent to the Follow-up visit (up to 9 days). Non-serious Adverse Events: from the first dose of study drug to the Follow-up visit (up to 9 days).
|
0.00%
0/11 • Serious Adverse Events: from signing of informed consent to the Follow-up visit (up to 9 days). Non-serious Adverse Events: from the first dose of study drug to the Follow-up visit (up to 9 days).
|
0.00%
0/10 • Serious Adverse Events: from signing of informed consent to the Follow-up visit (up to 9 days). Non-serious Adverse Events: from the first dose of study drug to the Follow-up visit (up to 9 days).
|
0.00%
0/10 • Serious Adverse Events: from signing of informed consent to the Follow-up visit (up to 9 days). Non-serious Adverse Events: from the first dose of study drug to the Follow-up visit (up to 9 days).
|
|
Investigations
Respiratory rate decreased
|
0.00%
0/9 • Serious Adverse Events: from signing of informed consent to the Follow-up visit (up to 9 days). Non-serious Adverse Events: from the first dose of study drug to the Follow-up visit (up to 9 days).
|
0.00%
0/11 • Serious Adverse Events: from signing of informed consent to the Follow-up visit (up to 9 days). Non-serious Adverse Events: from the first dose of study drug to the Follow-up visit (up to 9 days).
|
10.0%
1/10 • Serious Adverse Events: from signing of informed consent to the Follow-up visit (up to 9 days). Non-serious Adverse Events: from the first dose of study drug to the Follow-up visit (up to 9 days).
|
0.00%
0/10 • Serious Adverse Events: from signing of informed consent to the Follow-up visit (up to 9 days). Non-serious Adverse Events: from the first dose of study drug to the Follow-up visit (up to 9 days).
|
|
Investigations
Temperature elevation
|
11.1%
1/9 • Serious Adverse Events: from signing of informed consent to the Follow-up visit (up to 9 days). Non-serious Adverse Events: from the first dose of study drug to the Follow-up visit (up to 9 days).
|
0.00%
0/11 • Serious Adverse Events: from signing of informed consent to the Follow-up visit (up to 9 days). Non-serious Adverse Events: from the first dose of study drug to the Follow-up visit (up to 9 days).
|
0.00%
0/10 • Serious Adverse Events: from signing of informed consent to the Follow-up visit (up to 9 days). Non-serious Adverse Events: from the first dose of study drug to the Follow-up visit (up to 9 days).
|
0.00%
0/10 • Serious Adverse Events: from signing of informed consent to the Follow-up visit (up to 9 days). Non-serious Adverse Events: from the first dose of study drug to the Follow-up visit (up to 9 days).
|
|
Metabolism and nutrition disorders
Anorexia
|
11.1%
1/9 • Serious Adverse Events: from signing of informed consent to the Follow-up visit (up to 9 days). Non-serious Adverse Events: from the first dose of study drug to the Follow-up visit (up to 9 days).
|
0.00%
0/11 • Serious Adverse Events: from signing of informed consent to the Follow-up visit (up to 9 days). Non-serious Adverse Events: from the first dose of study drug to the Follow-up visit (up to 9 days).
|
0.00%
0/10 • Serious Adverse Events: from signing of informed consent to the Follow-up visit (up to 9 days). Non-serious Adverse Events: from the first dose of study drug to the Follow-up visit (up to 9 days).
|
0.00%
0/10 • Serious Adverse Events: from signing of informed consent to the Follow-up visit (up to 9 days). Non-serious Adverse Events: from the first dose of study drug to the Follow-up visit (up to 9 days).
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/9 • Serious Adverse Events: from signing of informed consent to the Follow-up visit (up to 9 days). Non-serious Adverse Events: from the first dose of study drug to the Follow-up visit (up to 9 days).
|
9.1%
1/11 • Serious Adverse Events: from signing of informed consent to the Follow-up visit (up to 9 days). Non-serious Adverse Events: from the first dose of study drug to the Follow-up visit (up to 9 days).
|
0.00%
0/10 • Serious Adverse Events: from signing of informed consent to the Follow-up visit (up to 9 days). Non-serious Adverse Events: from the first dose of study drug to the Follow-up visit (up to 9 days).
|
0.00%
0/10 • Serious Adverse Events: from signing of informed consent to the Follow-up visit (up to 9 days). Non-serious Adverse Events: from the first dose of study drug to the Follow-up visit (up to 9 days).
|
|
Musculoskeletal and connective tissue disorders
Cramps in leg
|
11.1%
1/9 • Serious Adverse Events: from signing of informed consent to the Follow-up visit (up to 9 days). Non-serious Adverse Events: from the first dose of study drug to the Follow-up visit (up to 9 days).
|
0.00%
0/11 • Serious Adverse Events: from signing of informed consent to the Follow-up visit (up to 9 days). Non-serious Adverse Events: from the first dose of study drug to the Follow-up visit (up to 9 days).
|
0.00%
0/10 • Serious Adverse Events: from signing of informed consent to the Follow-up visit (up to 9 days). Non-serious Adverse Events: from the first dose of study drug to the Follow-up visit (up to 9 days).
|
0.00%
0/10 • Serious Adverse Events: from signing of informed consent to the Follow-up visit (up to 9 days). Non-serious Adverse Events: from the first dose of study drug to the Follow-up visit (up to 9 days).
|
|
Musculoskeletal and connective tissue disorders
Low back pain
|
0.00%
0/9 • Serious Adverse Events: from signing of informed consent to the Follow-up visit (up to 9 days). Non-serious Adverse Events: from the first dose of study drug to the Follow-up visit (up to 9 days).
|
9.1%
1/11 • Serious Adverse Events: from signing of informed consent to the Follow-up visit (up to 9 days). Non-serious Adverse Events: from the first dose of study drug to the Follow-up visit (up to 9 days).
|
0.00%
0/10 • Serious Adverse Events: from signing of informed consent to the Follow-up visit (up to 9 days). Non-serious Adverse Events: from the first dose of study drug to the Follow-up visit (up to 9 days).
|
0.00%
0/10 • Serious Adverse Events: from signing of informed consent to the Follow-up visit (up to 9 days). Non-serious Adverse Events: from the first dose of study drug to the Follow-up visit (up to 9 days).
|
|
Nervous system disorders
Dizziness
|
55.6%
5/9 • Serious Adverse Events: from signing of informed consent to the Follow-up visit (up to 9 days). Non-serious Adverse Events: from the first dose of study drug to the Follow-up visit (up to 9 days).
|
36.4%
4/11 • Serious Adverse Events: from signing of informed consent to the Follow-up visit (up to 9 days). Non-serious Adverse Events: from the first dose of study drug to the Follow-up visit (up to 9 days).
|
40.0%
4/10 • Serious Adverse Events: from signing of informed consent to the Follow-up visit (up to 9 days). Non-serious Adverse Events: from the first dose of study drug to the Follow-up visit (up to 9 days).
|
0.00%
0/10 • Serious Adverse Events: from signing of informed consent to the Follow-up visit (up to 9 days). Non-serious Adverse Events: from the first dose of study drug to the Follow-up visit (up to 9 days).
|
|
Nervous system disorders
Dizzy
|
0.00%
0/9 • Serious Adverse Events: from signing of informed consent to the Follow-up visit (up to 9 days). Non-serious Adverse Events: from the first dose of study drug to the Follow-up visit (up to 9 days).
|
9.1%
1/11 • Serious Adverse Events: from signing of informed consent to the Follow-up visit (up to 9 days). Non-serious Adverse Events: from the first dose of study drug to the Follow-up visit (up to 9 days).
|
0.00%
0/10 • Serious Adverse Events: from signing of informed consent to the Follow-up visit (up to 9 days). Non-serious Adverse Events: from the first dose of study drug to the Follow-up visit (up to 9 days).
|
0.00%
0/10 • Serious Adverse Events: from signing of informed consent to the Follow-up visit (up to 9 days). Non-serious Adverse Events: from the first dose of study drug to the Follow-up visit (up to 9 days).
|
|
Nervous system disorders
Drowsiness
|
44.4%
4/9 • Serious Adverse Events: from signing of informed consent to the Follow-up visit (up to 9 days). Non-serious Adverse Events: from the first dose of study drug to the Follow-up visit (up to 9 days).
|
27.3%
3/11 • Serious Adverse Events: from signing of informed consent to the Follow-up visit (up to 9 days). Non-serious Adverse Events: from the first dose of study drug to the Follow-up visit (up to 9 days).
|
40.0%
4/10 • Serious Adverse Events: from signing of informed consent to the Follow-up visit (up to 9 days). Non-serious Adverse Events: from the first dose of study drug to the Follow-up visit (up to 9 days).
|
0.00%
0/10 • Serious Adverse Events: from signing of informed consent to the Follow-up visit (up to 9 days). Non-serious Adverse Events: from the first dose of study drug to the Follow-up visit (up to 9 days).
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/9 • Serious Adverse Events: from signing of informed consent to the Follow-up visit (up to 9 days). Non-serious Adverse Events: from the first dose of study drug to the Follow-up visit (up to 9 days).
|
0.00%
0/11 • Serious Adverse Events: from signing of informed consent to the Follow-up visit (up to 9 days). Non-serious Adverse Events: from the first dose of study drug to the Follow-up visit (up to 9 days).
|
10.0%
1/10 • Serious Adverse Events: from signing of informed consent to the Follow-up visit (up to 9 days). Non-serious Adverse Events: from the first dose of study drug to the Follow-up visit (up to 9 days).
|
0.00%
0/10 • Serious Adverse Events: from signing of informed consent to the Follow-up visit (up to 9 days). Non-serious Adverse Events: from the first dose of study drug to the Follow-up visit (up to 9 days).
|
|
Nervous system disorders
Headache
|
11.1%
1/9 • Serious Adverse Events: from signing of informed consent to the Follow-up visit (up to 9 days). Non-serious Adverse Events: from the first dose of study drug to the Follow-up visit (up to 9 days).
|
36.4%
4/11 • Serious Adverse Events: from signing of informed consent to the Follow-up visit (up to 9 days). Non-serious Adverse Events: from the first dose of study drug to the Follow-up visit (up to 9 days).
|
10.0%
1/10 • Serious Adverse Events: from signing of informed consent to the Follow-up visit (up to 9 days). Non-serious Adverse Events: from the first dose of study drug to the Follow-up visit (up to 9 days).
|
20.0%
2/10 • Serious Adverse Events: from signing of informed consent to the Follow-up visit (up to 9 days). Non-serious Adverse Events: from the first dose of study drug to the Follow-up visit (up to 9 days).
|
|
Nervous system disorders
Intermittent headache
|
0.00%
0/9 • Serious Adverse Events: from signing of informed consent to the Follow-up visit (up to 9 days). Non-serious Adverse Events: from the first dose of study drug to the Follow-up visit (up to 9 days).
|
0.00%
0/11 • Serious Adverse Events: from signing of informed consent to the Follow-up visit (up to 9 days). Non-serious Adverse Events: from the first dose of study drug to the Follow-up visit (up to 9 days).
|
0.00%
0/10 • Serious Adverse Events: from signing of informed consent to the Follow-up visit (up to 9 days). Non-serious Adverse Events: from the first dose of study drug to the Follow-up visit (up to 9 days).
|
20.0%
2/10 • Serious Adverse Events: from signing of informed consent to the Follow-up visit (up to 9 days). Non-serious Adverse Events: from the first dose of study drug to the Follow-up visit (up to 9 days).
|
|
Nervous system disorders
Lightheadedness
|
22.2%
2/9 • Serious Adverse Events: from signing of informed consent to the Follow-up visit (up to 9 days). Non-serious Adverse Events: from the first dose of study drug to the Follow-up visit (up to 9 days).
|
9.1%
1/11 • Serious Adverse Events: from signing of informed consent to the Follow-up visit (up to 9 days). Non-serious Adverse Events: from the first dose of study drug to the Follow-up visit (up to 9 days).
|
10.0%
1/10 • Serious Adverse Events: from signing of informed consent to the Follow-up visit (up to 9 days). Non-serious Adverse Events: from the first dose of study drug to the Follow-up visit (up to 9 days).
|
0.00%
0/10 • Serious Adverse Events: from signing of informed consent to the Follow-up visit (up to 9 days). Non-serious Adverse Events: from the first dose of study drug to the Follow-up visit (up to 9 days).
|
|
Nervous system disorders
Paresthesia of fingers
|
11.1%
1/9 • Serious Adverse Events: from signing of informed consent to the Follow-up visit (up to 9 days). Non-serious Adverse Events: from the first dose of study drug to the Follow-up visit (up to 9 days).
|
0.00%
0/11 • Serious Adverse Events: from signing of informed consent to the Follow-up visit (up to 9 days). Non-serious Adverse Events: from the first dose of study drug to the Follow-up visit (up to 9 days).
|
0.00%
0/10 • Serious Adverse Events: from signing of informed consent to the Follow-up visit (up to 9 days). Non-serious Adverse Events: from the first dose of study drug to the Follow-up visit (up to 9 days).
|
0.00%
0/10 • Serious Adverse Events: from signing of informed consent to the Follow-up visit (up to 9 days). Non-serious Adverse Events: from the first dose of study drug to the Follow-up visit (up to 9 days).
|
|
Nervous system disorders
Shakiness
|
0.00%
0/9 • Serious Adverse Events: from signing of informed consent to the Follow-up visit (up to 9 days). Non-serious Adverse Events: from the first dose of study drug to the Follow-up visit (up to 9 days).
|
0.00%
0/11 • Serious Adverse Events: from signing of informed consent to the Follow-up visit (up to 9 days). Non-serious Adverse Events: from the first dose of study drug to the Follow-up visit (up to 9 days).
|
10.0%
1/10 • Serious Adverse Events: from signing of informed consent to the Follow-up visit (up to 9 days). Non-serious Adverse Events: from the first dose of study drug to the Follow-up visit (up to 9 days).
|
0.00%
0/10 • Serious Adverse Events: from signing of informed consent to the Follow-up visit (up to 9 days). Non-serious Adverse Events: from the first dose of study drug to the Follow-up visit (up to 9 days).
|
|
Nervous system disorders
Trembling
|
0.00%
0/9 • Serious Adverse Events: from signing of informed consent to the Follow-up visit (up to 9 days). Non-serious Adverse Events: from the first dose of study drug to the Follow-up visit (up to 9 days).
|
9.1%
1/11 • Serious Adverse Events: from signing of informed consent to the Follow-up visit (up to 9 days). Non-serious Adverse Events: from the first dose of study drug to the Follow-up visit (up to 9 days).
|
0.00%
0/10 • Serious Adverse Events: from signing of informed consent to the Follow-up visit (up to 9 days). Non-serious Adverse Events: from the first dose of study drug to the Follow-up visit (up to 9 days).
|
0.00%
0/10 • Serious Adverse Events: from signing of informed consent to the Follow-up visit (up to 9 days). Non-serious Adverse Events: from the first dose of study drug to the Follow-up visit (up to 9 days).
|
|
Psychiatric disorders
Confusion
|
11.1%
1/9 • Serious Adverse Events: from signing of informed consent to the Follow-up visit (up to 9 days). Non-serious Adverse Events: from the first dose of study drug to the Follow-up visit (up to 9 days).
|
0.00%
0/11 • Serious Adverse Events: from signing of informed consent to the Follow-up visit (up to 9 days). Non-serious Adverse Events: from the first dose of study drug to the Follow-up visit (up to 9 days).
|
0.00%
0/10 • Serious Adverse Events: from signing of informed consent to the Follow-up visit (up to 9 days). Non-serious Adverse Events: from the first dose of study drug to the Follow-up visit (up to 9 days).
|
0.00%
0/10 • Serious Adverse Events: from signing of informed consent to the Follow-up visit (up to 9 days). Non-serious Adverse Events: from the first dose of study drug to the Follow-up visit (up to 9 days).
|
|
Psychiatric disorders
Euphoria
|
0.00%
0/9 • Serious Adverse Events: from signing of informed consent to the Follow-up visit (up to 9 days). Non-serious Adverse Events: from the first dose of study drug to the Follow-up visit (up to 9 days).
|
9.1%
1/11 • Serious Adverse Events: from signing of informed consent to the Follow-up visit (up to 9 days). Non-serious Adverse Events: from the first dose of study drug to the Follow-up visit (up to 9 days).
|
0.00%
0/10 • Serious Adverse Events: from signing of informed consent to the Follow-up visit (up to 9 days). Non-serious Adverse Events: from the first dose of study drug to the Follow-up visit (up to 9 days).
|
0.00%
0/10 • Serious Adverse Events: from signing of informed consent to the Follow-up visit (up to 9 days). Non-serious Adverse Events: from the first dose of study drug to the Follow-up visit (up to 9 days).
|
|
Psychiatric disorders
Vivid dreams
|
0.00%
0/9 • Serious Adverse Events: from signing of informed consent to the Follow-up visit (up to 9 days). Non-serious Adverse Events: from the first dose of study drug to the Follow-up visit (up to 9 days).
|
9.1%
1/11 • Serious Adverse Events: from signing of informed consent to the Follow-up visit (up to 9 days). Non-serious Adverse Events: from the first dose of study drug to the Follow-up visit (up to 9 days).
|
0.00%
0/10 • Serious Adverse Events: from signing of informed consent to the Follow-up visit (up to 9 days). Non-serious Adverse Events: from the first dose of study drug to the Follow-up visit (up to 9 days).
|
0.00%
0/10 • Serious Adverse Events: from signing of informed consent to the Follow-up visit (up to 9 days). Non-serious Adverse Events: from the first dose of study drug to the Follow-up visit (up to 9 days).
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/9 • Serious Adverse Events: from signing of informed consent to the Follow-up visit (up to 9 days). Non-serious Adverse Events: from the first dose of study drug to the Follow-up visit (up to 9 days).
|
0.00%
0/11 • Serious Adverse Events: from signing of informed consent to the Follow-up visit (up to 9 days). Non-serious Adverse Events: from the first dose of study drug to the Follow-up visit (up to 9 days).
|
10.0%
1/10 • Serious Adverse Events: from signing of informed consent to the Follow-up visit (up to 9 days). Non-serious Adverse Events: from the first dose of study drug to the Follow-up visit (up to 9 days).
|
0.00%
0/10 • Serious Adverse Events: from signing of informed consent to the Follow-up visit (up to 9 days). Non-serious Adverse Events: from the first dose of study drug to the Follow-up visit (up to 9 days).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/9 • Serious Adverse Events: from signing of informed consent to the Follow-up visit (up to 9 days). Non-serious Adverse Events: from the first dose of study drug to the Follow-up visit (up to 9 days).
|
0.00%
0/11 • Serious Adverse Events: from signing of informed consent to the Follow-up visit (up to 9 days). Non-serious Adverse Events: from the first dose of study drug to the Follow-up visit (up to 9 days).
|
0.00%
0/10 • Serious Adverse Events: from signing of informed consent to the Follow-up visit (up to 9 days). Non-serious Adverse Events: from the first dose of study drug to the Follow-up visit (up to 9 days).
|
10.0%
1/10 • Serious Adverse Events: from signing of informed consent to the Follow-up visit (up to 9 days). Non-serious Adverse Events: from the first dose of study drug to the Follow-up visit (up to 9 days).
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/9 • Serious Adverse Events: from signing of informed consent to the Follow-up visit (up to 9 days). Non-serious Adverse Events: from the first dose of study drug to the Follow-up visit (up to 9 days).
|
9.1%
1/11 • Serious Adverse Events: from signing of informed consent to the Follow-up visit (up to 9 days). Non-serious Adverse Events: from the first dose of study drug to the Follow-up visit (up to 9 days).
|
0.00%
0/10 • Serious Adverse Events: from signing of informed consent to the Follow-up visit (up to 9 days). Non-serious Adverse Events: from the first dose of study drug to the Follow-up visit (up to 9 days).
|
0.00%
0/10 • Serious Adverse Events: from signing of informed consent to the Follow-up visit (up to 9 days). Non-serious Adverse Events: from the first dose of study drug to the Follow-up visit (up to 9 days).
|
|
Respiratory, thoracic and mediastinal disorders
Singultus
|
11.1%
1/9 • Serious Adverse Events: from signing of informed consent to the Follow-up visit (up to 9 days). Non-serious Adverse Events: from the first dose of study drug to the Follow-up visit (up to 9 days).
|
0.00%
0/11 • Serious Adverse Events: from signing of informed consent to the Follow-up visit (up to 9 days). Non-serious Adverse Events: from the first dose of study drug to the Follow-up visit (up to 9 days).
|
0.00%
0/10 • Serious Adverse Events: from signing of informed consent to the Follow-up visit (up to 9 days). Non-serious Adverse Events: from the first dose of study drug to the Follow-up visit (up to 9 days).
|
0.00%
0/10 • Serious Adverse Events: from signing of informed consent to the Follow-up visit (up to 9 days). Non-serious Adverse Events: from the first dose of study drug to the Follow-up visit (up to 9 days).
|
|
Skin and subcutaneous tissue disorders
Adhesive tape allergy
|
0.00%
0/9 • Serious Adverse Events: from signing of informed consent to the Follow-up visit (up to 9 days). Non-serious Adverse Events: from the first dose of study drug to the Follow-up visit (up to 9 days).
|
0.00%
0/11 • Serious Adverse Events: from signing of informed consent to the Follow-up visit (up to 9 days). Non-serious Adverse Events: from the first dose of study drug to the Follow-up visit (up to 9 days).
|
0.00%
0/10 • Serious Adverse Events: from signing of informed consent to the Follow-up visit (up to 9 days). Non-serious Adverse Events: from the first dose of study drug to the Follow-up visit (up to 9 days).
|
10.0%
1/10 • Serious Adverse Events: from signing of informed consent to the Follow-up visit (up to 9 days). Non-serious Adverse Events: from the first dose of study drug to the Follow-up visit (up to 9 days).
|
|
Skin and subcutaneous tissue disorders
Diaphoresis
|
22.2%
2/9 • Serious Adverse Events: from signing of informed consent to the Follow-up visit (up to 9 days). Non-serious Adverse Events: from the first dose of study drug to the Follow-up visit (up to 9 days).
|
18.2%
2/11 • Serious Adverse Events: from signing of informed consent to the Follow-up visit (up to 9 days). Non-serious Adverse Events: from the first dose of study drug to the Follow-up visit (up to 9 days).
|
10.0%
1/10 • Serious Adverse Events: from signing of informed consent to the Follow-up visit (up to 9 days). Non-serious Adverse Events: from the first dose of study drug to the Follow-up visit (up to 9 days).
|
0.00%
0/10 • Serious Adverse Events: from signing of informed consent to the Follow-up visit (up to 9 days). Non-serious Adverse Events: from the first dose of study drug to the Follow-up visit (up to 9 days).
|
|
Skin and subcutaneous tissue disorders
Itching
|
11.1%
1/9 • Serious Adverse Events: from signing of informed consent to the Follow-up visit (up to 9 days). Non-serious Adverse Events: from the first dose of study drug to the Follow-up visit (up to 9 days).
|
9.1%
1/11 • Serious Adverse Events: from signing of informed consent to the Follow-up visit (up to 9 days). Non-serious Adverse Events: from the first dose of study drug to the Follow-up visit (up to 9 days).
|
0.00%
0/10 • Serious Adverse Events: from signing of informed consent to the Follow-up visit (up to 9 days). Non-serious Adverse Events: from the first dose of study drug to the Follow-up visit (up to 9 days).
|
0.00%
0/10 • Serious Adverse Events: from signing of informed consent to the Follow-up visit (up to 9 days). Non-serious Adverse Events: from the first dose of study drug to the Follow-up visit (up to 9 days).
|
|
Skin and subcutaneous tissue disorders
Localised rash
|
0.00%
0/9 • Serious Adverse Events: from signing of informed consent to the Follow-up visit (up to 9 days). Non-serious Adverse Events: from the first dose of study drug to the Follow-up visit (up to 9 days).
|
0.00%
0/11 • Serious Adverse Events: from signing of informed consent to the Follow-up visit (up to 9 days). Non-serious Adverse Events: from the first dose of study drug to the Follow-up visit (up to 9 days).
|
10.0%
1/10 • Serious Adverse Events: from signing of informed consent to the Follow-up visit (up to 9 days). Non-serious Adverse Events: from the first dose of study drug to the Follow-up visit (up to 9 days).
|
10.0%
1/10 • Serious Adverse Events: from signing of informed consent to the Follow-up visit (up to 9 days). Non-serious Adverse Events: from the first dose of study drug to the Follow-up visit (up to 9 days).
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
11.1%
1/9 • Serious Adverse Events: from signing of informed consent to the Follow-up visit (up to 9 days). Non-serious Adverse Events: from the first dose of study drug to the Follow-up visit (up to 9 days).
|
9.1%
1/11 • Serious Adverse Events: from signing of informed consent to the Follow-up visit (up to 9 days). Non-serious Adverse Events: from the first dose of study drug to the Follow-up visit (up to 9 days).
|
10.0%
1/10 • Serious Adverse Events: from signing of informed consent to the Follow-up visit (up to 9 days). Non-serious Adverse Events: from the first dose of study drug to the Follow-up visit (up to 9 days).
|
0.00%
0/10 • Serious Adverse Events: from signing of informed consent to the Follow-up visit (up to 9 days). Non-serious Adverse Events: from the first dose of study drug to the Follow-up visit (up to 9 days).
|
|
Skin and subcutaneous tissue disorders
Pruritus facial
|
11.1%
1/9 • Serious Adverse Events: from signing of informed consent to the Follow-up visit (up to 9 days). Non-serious Adverse Events: from the first dose of study drug to the Follow-up visit (up to 9 days).
|
9.1%
1/11 • Serious Adverse Events: from signing of informed consent to the Follow-up visit (up to 9 days). Non-serious Adverse Events: from the first dose of study drug to the Follow-up visit (up to 9 days).
|
0.00%
0/10 • Serious Adverse Events: from signing of informed consent to the Follow-up visit (up to 9 days). Non-serious Adverse Events: from the first dose of study drug to the Follow-up visit (up to 9 days).
|
0.00%
0/10 • Serious Adverse Events: from signing of informed consent to the Follow-up visit (up to 9 days). Non-serious Adverse Events: from the first dose of study drug to the Follow-up visit (up to 9 days).
|
|
Skin and subcutaneous tissue disorders
Wheals
|
0.00%
0/9 • Serious Adverse Events: from signing of informed consent to the Follow-up visit (up to 9 days). Non-serious Adverse Events: from the first dose of study drug to the Follow-up visit (up to 9 days).
|
9.1%
1/11 • Serious Adverse Events: from signing of informed consent to the Follow-up visit (up to 9 days). Non-serious Adverse Events: from the first dose of study drug to the Follow-up visit (up to 9 days).
|
0.00%
0/10 • Serious Adverse Events: from signing of informed consent to the Follow-up visit (up to 9 days). Non-serious Adverse Events: from the first dose of study drug to the Follow-up visit (up to 9 days).
|
0.00%
0/10 • Serious Adverse Events: from signing of informed consent to the Follow-up visit (up to 9 days). Non-serious Adverse Events: from the first dose of study drug to the Follow-up visit (up to 9 days).
|
|
Vascular disorders
Flushing
|
0.00%
0/9 • Serious Adverse Events: from signing of informed consent to the Follow-up visit (up to 9 days). Non-serious Adverse Events: from the first dose of study drug to the Follow-up visit (up to 9 days).
|
9.1%
1/11 • Serious Adverse Events: from signing of informed consent to the Follow-up visit (up to 9 days). Non-serious Adverse Events: from the first dose of study drug to the Follow-up visit (up to 9 days).
|
0.00%
0/10 • Serious Adverse Events: from signing of informed consent to the Follow-up visit (up to 9 days). Non-serious Adverse Events: from the first dose of study drug to the Follow-up visit (up to 9 days).
|
0.00%
0/10 • Serious Adverse Events: from signing of informed consent to the Follow-up visit (up to 9 days). Non-serious Adverse Events: from the first dose of study drug to the Follow-up visit (up to 9 days).
|
|
Vascular disorders
Hot flush
|
11.1%
1/9 • Serious Adverse Events: from signing of informed consent to the Follow-up visit (up to 9 days). Non-serious Adverse Events: from the first dose of study drug to the Follow-up visit (up to 9 days).
|
18.2%
2/11 • Serious Adverse Events: from signing of informed consent to the Follow-up visit (up to 9 days). Non-serious Adverse Events: from the first dose of study drug to the Follow-up visit (up to 9 days).
|
0.00%
0/10 • Serious Adverse Events: from signing of informed consent to the Follow-up visit (up to 9 days). Non-serious Adverse Events: from the first dose of study drug to the Follow-up visit (up to 9 days).
|
0.00%
0/10 • Serious Adverse Events: from signing of informed consent to the Follow-up visit (up to 9 days). Non-serious Adverse Events: from the first dose of study drug to the Follow-up visit (up to 9 days).
|
|
Vascular disorders
Hypertension
|
0.00%
0/9 • Serious Adverse Events: from signing of informed consent to the Follow-up visit (up to 9 days). Non-serious Adverse Events: from the first dose of study drug to the Follow-up visit (up to 9 days).
|
0.00%
0/11 • Serious Adverse Events: from signing of informed consent to the Follow-up visit (up to 9 days). Non-serious Adverse Events: from the first dose of study drug to the Follow-up visit (up to 9 days).
|
0.00%
0/10 • Serious Adverse Events: from signing of informed consent to the Follow-up visit (up to 9 days). Non-serious Adverse Events: from the first dose of study drug to the Follow-up visit (up to 9 days).
|
10.0%
1/10 • Serious Adverse Events: from signing of informed consent to the Follow-up visit (up to 9 days). Non-serious Adverse Events: from the first dose of study drug to the Follow-up visit (up to 9 days).
|
|
Vascular disorders
Pallor
|
11.1%
1/9 • Serious Adverse Events: from signing of informed consent to the Follow-up visit (up to 9 days). Non-serious Adverse Events: from the first dose of study drug to the Follow-up visit (up to 9 days).
|
0.00%
0/11 • Serious Adverse Events: from signing of informed consent to the Follow-up visit (up to 9 days). Non-serious Adverse Events: from the first dose of study drug to the Follow-up visit (up to 9 days).
|
0.00%
0/10 • Serious Adverse Events: from signing of informed consent to the Follow-up visit (up to 9 days). Non-serious Adverse Events: from the first dose of study drug to the Follow-up visit (up to 9 days).
|
0.00%
0/10 • Serious Adverse Events: from signing of informed consent to the Follow-up visit (up to 9 days). Non-serious Adverse Events: from the first dose of study drug to the Follow-up visit (up to 9 days).
|
Additional Information
Director, Clinical Development
Insys Therapeutics, Inc.
Phone: 480-500-3105
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place