Trial Outcomes & Findings for Fentanyl Sublingual Spray in Treating Patients With Breakthrough Cancer Pain (NCT NCT00538850)
NCT ID: NCT00538850
Last Updated: 2014-03-05
Results Overview
Pain intensity was assessed by the participant using a 0-100 mm visual analog scale where 0 represented "no pain" and 100 represented "worst possible pain" at 0 (baseline, beginning of the pain episode), 5, 10, 15, and 30 minutes after each dose of study medication during each breakthrough pain episode. The pain intensity difference was defined as the difference in pain intensity at the various time points versus time 0 (baseline). SPID30 was calculated as the time-weighted sum of the PID scores using the following formula: SPID30=(5\*PID5)+(5\*PID10)+(5\*PID15)+(15\*PID30). The minimum and maximum SPID30 scores were -3000 and 3000. A higher score indicates less pain.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
130 participants
Primary outcome timeframe
Baseline (time 0, beginning of each pain episode) through 30 minutes after dosing for each pain episode
Results posted on
2014-03-05
Participant Flow
As there are dozens, if not hundreds, of cross-over sequences during the double-blind period of this study, instead of reporting participant flow for each of the cross-over sequences, participant flow is reported separately for the fentanyl and placebo groups.
Participant milestones
| Measure |
Fentanyl Sublingual Spray - Titration
In the open-label titration period of the study, participants started at a dose of 100, 200, or 400 µg and titrated upward to a maximum dose of 1600 µg. Titration was stopped when the dose administered provided adequate analgesia for breakthrough pain without unacceptable side effects or the maximum titration period of 21±5 days was reached.
|
Fentanyl Sublingual Spray - Double-blind
Participants received fentanyl sublingual spray 7 times randomly (out of 10 treatments total) to treat up to a maximum of 2 breakthrough pain episodes per day with a minimum separation of 2 hours between treatments. Patients received a dose of 100 to 1600 µg determined in the open-label dose titration period of the current study.
|
Placebo - Double-blind
Participants received placebo 3 times randomly (out of 10 treatments total) to treat up to a maximum of 2 breakthrough pain episodes per day with a minimum separation of 2 hours between treatments. Patients received a dose of 100 to 1600 µg determined in the open-label dose titration period of the current study.
|
|---|---|---|---|
|
Titration Period
STARTED
|
130
|
0
|
0
|
|
Titration Period
COMPLETED
|
98
|
0
|
0
|
|
Titration Period
NOT COMPLETED
|
32
|
0
|
0
|
|
Fentanyl Sublingual Spray - Double-blind
STARTED
|
0
|
98
|
0
|
|
Fentanyl Sublingual Spray - Double-blind
COMPLETED
|
0
|
95
|
0
|
|
Fentanyl Sublingual Spray - Double-blind
NOT COMPLETED
|
0
|
3
|
0
|
|
Placebo - Double-blind
STARTED
|
0
|
0
|
98
|
|
Placebo - Double-blind
COMPLETED
|
0
|
0
|
95
|
|
Placebo - Double-blind
NOT COMPLETED
|
0
|
0
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Fentanyl Sublingual Spray in Treating Patients With Breakthrough Cancer Pain
Baseline characteristics by cohort
| Measure |
Fentanyl Sublingual Spray
n=130 Participants
Participants received fentanyl sublingual spray 7 times or placebo 3 times in random order to treat up to a maximum of 2 breakthrough pain episodes per day with a minimum separation of 2 hours between treatments. Patients received a dose of 100 to 1600 µg determined in the open-label dose titration period of the current study.
|
|---|---|
|
Age, Continuous
|
55.6 years
STANDARD_DEVIATION 12.2 • n=99 Participants
|
|
Sex: Female, Male
Female
|
69 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
61 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Baseline (time 0, beginning of each pain episode) through 30 minutes after dosing for each pain episodePopulation: Intent-to-treat (ITT) population: All participants in the double-blind treatment period who received at least 1 dose of study medication and had at least 1 pain measurement. 4 of the 96 participants in the ITT population were excluded from analysis because they did not have at least 1 dose of study medication and 1 dose of placebo.
Pain intensity was assessed by the participant using a 0-100 mm visual analog scale where 0 represented "no pain" and 100 represented "worst possible pain" at 0 (baseline, beginning of the pain episode), 5, 10, 15, and 30 minutes after each dose of study medication during each breakthrough pain episode. The pain intensity difference was defined as the difference in pain intensity at the various time points versus time 0 (baseline). SPID30 was calculated as the time-weighted sum of the PID scores using the following formula: SPID30=(5\*PID5)+(5\*PID10)+(5\*PID15)+(15\*PID30). The minimum and maximum SPID30 scores were -3000 and 3000. A higher score indicates less pain.
Outcome measures
| Measure |
Fentanyl Sublingual Spray
n=92 Participants
Participants received fentanyl sublingual spray 7 times randomly (out of 10 treatments total) to treat up to a maximum of 2 breakthrough pain episodes per day with a minimum separation of 2 hours between treatments. Patients received a dose of 100 to 1600 µg determined in the open-label dose titration period of the current study.
|
Placebo
n=92 Participants
Participants received placebo 3 times randomly (out of 10 treatments total) to treat up to a maximum of 2 breakthrough pain episodes per day with a minimum separation of 2 hours between treatments. Patients received a dose of 100 to 1600 µg determined in the open-label dose titration period of the current study.
|
|---|---|---|
|
Summed Pain Intensity Differences (SPID) at 30 Minutes After Dosing (SPID30)
|
640.3 Units on a scale
Standard Deviation 458.8
|
399.6 Units on a scale
Standard Deviation 391.2
|
SECONDARY outcome
Timeframe: Baseline (time 0, beginning of each pain episode) through 60 minutes after dosing for each pain episodePopulation: Intent-to-treat (ITT) population: All participants in the double-blind treatment period who received at least 1 dose of study medication and had at least 1 pain measurement. 4 of the 96 participants in the ITT population were excluded from analysis because they did not have at least 1 dose of study medication and 1 dose of placebo.
Pain intensity was assessed by the participant using a 0-100 mm visual analog scale where 0 represented "no pain" and 100 represented "worst possible pain" at 0 (baseline, beginning of the pain episode), 5, 10, 15, 30, 45 and 60 minutes after each dose of study medication during each breakthrough pain episode. The pain intensity difference was defined as the difference in pain intensity at the various time points versus time 0 (baseline). SPID was calculated as the time-weighted sum of the PID scores using the following formulas: SPID5=(5\*PID5), SPID10=(5\*PID5)+(5\*PID10), SPID15=(5\*PID5)+(5\*PID10)+(5\*PID15), SPID30=(5\*PID5)+(5\*PID10)+(5\*PID15)+(15\*PID30), SPID45=(5\*PID5)+(5\*PID10)+(5\*PID15)+(15\*PID30)+(15\*PID45), SPID60=(5\*PID5)+(5\*PID10)+(5\*PID15)+(15\*PID30) +(15\*PID45) +(15\*PID60). The minimum and maximum SPID scores were -500 to 500, -1000 to 1000, -1500 to 1500, -3000 to 3000, -4500 to 4500, and -6000 to 6000, respectively. A higher score indicates less pain.
Outcome measures
| Measure |
Fentanyl Sublingual Spray
n=92 Participants
Participants received fentanyl sublingual spray 7 times randomly (out of 10 treatments total) to treat up to a maximum of 2 breakthrough pain episodes per day with a minimum separation of 2 hours between treatments. Patients received a dose of 100 to 1600 µg determined in the open-label dose titration period of the current study.
|
Placebo
n=92 Participants
Participants received placebo 3 times randomly (out of 10 treatments total) to treat up to a maximum of 2 breakthrough pain episodes per day with a minimum separation of 2 hours between treatments. Patients received a dose of 100 to 1600 µg determined in the open-label dose titration period of the current study.
|
|---|---|---|
|
Summed Pain Intensity Differences (SPID) at 5, 10, 15, 45, and 60 Minutes After Dosing
SPID5
|
40.3 Units on a scale
Standard Deviation 57.7
|
32.0 Units on a scale
Standard Deviation 52.1
|
|
Summed Pain Intensity Differences (SPID) at 5, 10, 15, 45, and 60 Minutes After Dosing
SPID10
|
115.0 Units on a scale
Standard Deviation 130.7
|
81.1 Units on a scale
Standard Deviation 108.0
|
|
Summed Pain Intensity Differences (SPID) at 5, 10, 15, 45, and 60 Minutes After Dosing
SPID15
|
220.6 Units on a scale
Standard Deviation 209.7
|
150.3 Units on a scale
Standard Deviation 172.5
|
|
Summed Pain Intensity Differences (SPID) at 5, 10, 15, 45, and 60 Minutes After Dosing
SPID45
|
1122.0 Units on a scale
Standard Deviation 731.9
|
667.0 Units on a scale
Standard Deviation 614.5
|
|
Summed Pain Intensity Differences (SPID) at 5, 10, 15, 45, and 60 Minutes After Dosing
SPID60
|
1649.0 Units on a scale
Standard Deviation 1016.2
|
965.7 Units on a scale
Standard Deviation 862.1
|
SECONDARY outcome
Timeframe: 5 through 60 minutes after dosing for each pain episodePopulation: Intent-to-treat (ITT) population: All participants in the double-blind treatment period who received at least 1 dose of study medication and had at least 1 pain measurement. 4 of the 96 participants in the ITT population were excluded from analysis because they did not have at least 1 dose of study medication and 1 dose of placebo.
Pain relief (PAR) was assessed by the participant on a 5-point scale (1=No relief, 2=A little relief, 3=Moderate relief, 4=A lot of relief, 5=Complete relief) at 5, 10, 15, 30, 45 and 60 minutes after each dose of study medication during each breakthrough pain episode. TOTPAR was calculated as the time-weighted sum of the PAR scores at each time point using the following formulas: TOTPAR5=(5\*PAR5), TOTPAR10=(5\*PAR5)+(5\*PAR10), TOTPAR15=(5\*PAR5)+(5\*PAR10)+(5\*PAR15), TOTPAR30=(5\*PAR5)+(5\*PAR10)+(5\*PAR15)+(15\*PAR30), TOTPAR45=(5\*PAR5)+(5\*PAR10)+(5\*PAR15)+(15\*PAR30)+(15\*PAR45), TOTPAR60=(5\*PAR5)+(5\*PAR10)+(5\*PAR15)+(15\*PAR30) +(15\*PAR45) +(15\*PAR60). The minimum and maximum TOTPAR5, TOTPAR10, TOTPAR15, TOTPAR30, TOTPAR45, and TOTPAR60 scores were 5 to 25, 10 to 50, 15 to 75, 30 to 150, 45 to 225, and 60 to 300, respectively. A higher score indicates more pain relief.
Outcome measures
| Measure |
Fentanyl Sublingual Spray
n=92 Participants
Participants received fentanyl sublingual spray 7 times randomly (out of 10 treatments total) to treat up to a maximum of 2 breakthrough pain episodes per day with a minimum separation of 2 hours between treatments. Patients received a dose of 100 to 1600 µg determined in the open-label dose titration period of the current study.
|
Placebo
n=92 Participants
Participants received placebo 3 times randomly (out of 10 treatments total) to treat up to a maximum of 2 breakthrough pain episodes per day with a minimum separation of 2 hours between treatments. Patients received a dose of 100 to 1600 µg determined in the open-label dose titration period of the current study.
|
|---|---|---|
|
Total Pain Relief (TOTPAR) at 5, 10, 15, 30, 45, and 60 Minutes After Dosing
TOTPAR5
|
8.6 Units on a scale
Standard Deviation 3.5
|
7.6 Units on a scale
Standard Deviation 3.3
|
|
Total Pain Relief (TOTPAR) at 5, 10, 15, 30, 45, and 60 Minutes After Dosing
TOTPAR10
|
19.7 Units on a scale
Standard Deviation 7.0
|
16.7 Units on a scale
Standard Deviation 6.5
|
|
Total Pain Relief (TOTPAR) at 5, 10, 15, 30, 45, and 60 Minutes After Dosing
TOTPAR15
|
32.9 Units on a scale
Standard Deviation 10.3
|
27.1 Units on a scale
Standard Deviation 10.0
|
|
Total Pain Relief (TOTPAR) at 5, 10, 15, 30, 45, and 60 Minutes After Dosing
TOTPAR30
|
78.3 Units on a scale
Standard Deviation 20.4
|
61.0 Units on a scale
Standard Deviation 20.8
|
|
Total Pain Relief (TOTPAR) at 5, 10, 15, 30, 45, and 60 Minutes After Dosing
TOTPAR45
|
126.3 Units on a scale
Standard Deviation 30.9
|
95.5 Units on a scale
Standard Deviation 32.0
|
|
Total Pain Relief (TOTPAR) at 5, 10, 15, 30, 45, and 60 Minutes After Dosing
TOTPAR60
|
176.4 Units on a scale
Standard Deviation 41.5
|
131.2 Units on a scale
Standard Deviation 43.6
|
SECONDARY outcome
Timeframe: 30 through 60 minutes after dosing for each pain episodePopulation: Intent-to-treat (ITT) population: All participants in the double-blind treatment period who received at least 1 dose of study medication and had at least 1 pain measurement. 4 of the 96 participants in the ITT population were excluded from analysis because they did not have at least 1 dose of study medication and 1 dose of placebo.
Global evaluation of the study medication was assessed by the participant on a 5-point scale (1=Poor, 2=Fair, 3=Good, 4=Very good, 5=Excellent) at 30 and 60 minutes after each dose of study medication during each breakthrough pain episode. A higher score indicates a better evaluation.
Outcome measures
| Measure |
Fentanyl Sublingual Spray
n=92 Participants
Participants received fentanyl sublingual spray 7 times randomly (out of 10 treatments total) to treat up to a maximum of 2 breakthrough pain episodes per day with a minimum separation of 2 hours between treatments. Patients received a dose of 100 to 1600 µg determined in the open-label dose titration period of the current study.
|
Placebo
n=92 Participants
Participants received placebo 3 times randomly (out of 10 treatments total) to treat up to a maximum of 2 breakthrough pain episodes per day with a minimum separation of 2 hours between treatments. Patients received a dose of 100 to 1600 µg determined in the open-label dose titration period of the current study.
|
|---|---|---|
|
Global Evaluation of the Study Medication at 30 and 60 Minutes After Dosing
30 minutes
|
2.8 Units on a scale
Standard Deviation 0.8
|
2.0 Units on a scale
Standard Deviation 0.8
|
|
Global Evaluation of the Study Medication at 30 and 60 Minutes After Dosing
60 minutes
|
3.1 Units on a scale
Standard Deviation 0.8
|
2.2 Units on a scale
Standard Deviation 0.8
|
Adverse Events
Fentanyl Sublingual Spray - Titration
Serious events: 7 serious events
Other events: 78 other events
Deaths: 0 deaths
Fentanyl Sublingual Spray - Double-blind
Serious events: 6 serious events
Other events: 47 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Fentanyl Sublingual Spray - Titration
n=130 participants at risk
In the open-label titration period of the study, participants started at a dose of 100, 200, or 400 µg and titrated upward to a maximum dose of 1600 µg. Titration was stopped when the dose administered provided adequate analgesia for breakthrough pain without unacceptable side effects or the maximum titration period of 21±5 days was reached.
|
Fentanyl Sublingual Spray - Double-blind
n=98 participants at risk
Participants received fentanyl sublingual spray 7 times or placebo 3 times in random order to treat up to a maximum of 2 breakthrough pain episodes per day with a minimum separation of 2 hours between treatments. Patients received a dose of 100 to 1600 µg determined in the open-label dose titration period of the current study.
|
|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung cancer metastatic
|
0.77%
1/130 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
0.00%
0/98 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
0.77%
1/130 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
1.0%
1/98 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to bone
|
0.77%
1/130 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
0.00%
0/98 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Spinal cord neoplasm
|
0.77%
1/130 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
0.00%
0/98 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.77%
1/130 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
1.0%
1/98 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
|
Gastrointestinal disorders
Nausea
|
0.77%
1/130 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
1.0%
1/98 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
|
Gastrointestinal disorders
Vomiting
|
0.77%
1/130 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
1.0%
1/98 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.77%
1/130 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
0.00%
0/98 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
|
Infections and infestations
Cellulitis
|
0.77%
1/130 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
1.0%
1/98 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.77%
1/130 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
0.00%
0/98 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
|
Musculoskeletal and connective tissue disorders
Fistula
|
0.77%
1/130 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
0.00%
0/98 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
|
Infections and infestations
Gastroenteritis Viral
|
0.00%
0/130 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
1.0%
1/98 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/130 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
1.0%
1/98 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
|
Nervous system disorders
Paraplegia
|
0.00%
0/130 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
1.0%
1/98 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
Other adverse events
| Measure |
Fentanyl Sublingual Spray - Titration
n=130 participants at risk
In the open-label titration period of the study, participants started at a dose of 100, 200, or 400 µg and titrated upward to a maximum dose of 1600 µg. Titration was stopped when the dose administered provided adequate analgesia for breakthrough pain without unacceptable side effects or the maximum titration period of 21±5 days was reached.
|
Fentanyl Sublingual Spray - Double-blind
n=98 participants at risk
Participants received fentanyl sublingual spray 7 times or placebo 3 times in random order to treat up to a maximum of 2 breakthrough pain episodes per day with a minimum separation of 2 hours between treatments. Patients received a dose of 100 to 1600 µg determined in the open-label dose titration period of the current study.
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
13.1%
17/130 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
7.1%
7/98 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
|
Gastrointestinal disorders
Vomiting
|
7.7%
10/130 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
4.1%
4/98 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
|
Gastrointestinal disorders
Diarrhoea
|
5.4%
7/130 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
3.1%
3/98 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
|
Gastrointestinal disorders
Constipation
|
3.8%
5/130 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
0.00%
0/98 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
|
Gastrointestinal disorders
Stomatitis
|
3.8%
5/130 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
1.0%
1/98 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
|
Gastrointestinal disorders
Dry mouth
|
1.5%
2/130 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
2.0%
2/98 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.77%
1/130 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
0.00%
0/98 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.77%
1/130 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
0.00%
0/98 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.77%
1/130 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
1.0%
1/98 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.77%
1/130 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
0.00%
0/98 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
|
Gastrointestinal disorders
Dysphagia
|
0.77%
1/130 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
0.00%
0/98 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
|
Gastrointestinal disorders
Flatulence
|
0.77%
1/130 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
1.0%
1/98 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.77%
1/130 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
0.00%
0/98 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
|
Gastrointestinal disorders
Gastrointestinal motility disorder
|
0.77%
1/130 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
0.00%
0/98 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
|
Gastrointestinal disorders
Gingival hyperplasia
|
0.77%
1/130 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
0.00%
0/98 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
|
Gastrointestinal disorders
Glossitis
|
0.77%
1/130 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
0.00%
0/98 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
|
Gastrointestinal disorders
Hyperchlorhydria
|
0.77%
1/130 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
0.00%
0/98 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
|
Gastrointestinal disorders
Hypoaesthesia oral
|
0.77%
1/130 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
0.00%
0/98 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
|
Gastrointestinal disorders
Odynophagia
|
0.77%
1/130 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
0.00%
0/98 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
|
Gastrointestinal disorders
Oral pain
|
0.77%
1/130 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
0.00%
0/98 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
|
Gastrointestinal disorders
Retching
|
0.77%
1/130 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
1.0%
1/98 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
|
Gastrointestinal disorders
Tongue ulceration
|
0.77%
1/130 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
0.00%
0/98 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
|
Nervous system disorders
Somnolence
|
8.5%
11/130 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
2.0%
2/98 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
|
Nervous system disorders
Dizziness
|
7.7%
10/130 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
2.0%
2/98 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
|
Nervous system disorders
Headache
|
3.8%
5/130 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
3.1%
3/98 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
|
Nervous system disorders
Sedation
|
3.1%
4/130 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
0.00%
0/98 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
|
Nervous system disorders
Dysgeusia
|
2.3%
3/130 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
0.00%
0/98 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
|
Nervous system disorders
Lethargy
|
1.5%
2/130 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
0.00%
0/98 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
|
Nervous system disorders
Areflexia
|
0.77%
1/130 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
0.00%
0/98 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
|
Nervous system disorders
Balance disorder
|
0.77%
1/130 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
0.00%
0/98 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
|
Nervous system disorders
Burning sensation
|
0.77%
1/130 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
0.00%
0/98 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
|
Nervous system disorders
Disturbance In attention
|
0.77%
1/130 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
0.00%
0/98 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
|
Nervous system disorders
Dyskinesia
|
0.77%
1/130 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
0.00%
0/98 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
|
Nervous system disorders
Facial palsy
|
0.77%
1/130 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
0.00%
0/98 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
|
Nervous system disorders
Hyperreflexia
|
0.77%
1/130 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
0.00%
0/98 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
|
Nervous system disorders
Hypoaesthesia
|
0.77%
1/130 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
0.00%
0/98 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
|
Nervous system disorders
Paraesthesia
|
0.77%
1/130 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
0.00%
0/98 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
|
General disorders
Pyrexia
|
6.2%
8/130 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
1.0%
1/98 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
|
General disorders
Oedema peripheral
|
5.4%
7/130 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
5.1%
5/98 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
|
General disorders
Asthenia
|
3.1%
4/130 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
2.0%
2/98 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
|
General disorders
Fatigue
|
3.1%
4/130 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
2.0%
2/98 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
|
General disorders
Application site irritation
|
2.3%
3/130 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
0.00%
0/98 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
|
General disorders
Adverse drug reaction
|
0.77%
1/130 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
0.00%
0/98 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
|
General disorders
Catheter related complication
|
0.77%
1/130 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
0.00%
0/98 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
|
General disorders
Catheter site erythema
|
0.77%
1/130 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
0.00%
0/98 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
|
General disorders
Chest discomfort
|
0.77%
1/130 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
1.0%
1/98 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
|
General disorders
Feeling abnormal
|
0.77%
1/130 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
0.00%
0/98 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
|
General disorders
Localised oedema
|
0.77%
1/130 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
0.00%
0/98 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
|
General disorders
Mucosal inflammation
|
0.77%
1/130 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
0.00%
0/98 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
|
General disorders
Pain
|
0.77%
1/130 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
1.0%
1/98 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
|
General disorders
Thirst
|
0.77%
1/130 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
0.00%
0/98 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
|
Infections and infestations
Urinary tract infection
|
3.8%
5/130 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
3.1%
3/98 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
|
Infections and infestations
Cellulitis
|
1.5%
2/130 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
1.0%
1/98 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
|
Infections and infestations
Gastroenteritis viral
|
0.77%
1/130 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
1.0%
1/98 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
|
Infections and infestations
Oral herpes
|
0.77%
1/130 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
0.00%
0/98 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
|
Infections and infestations
Pneumonia
|
0.77%
1/130 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
1.0%
1/98 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
|
Infections and infestations
Pyelonephritis
|
0.77%
1/130 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
0.00%
0/98 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.77%
1/130 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
0.00%
0/98 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.77%
1/130 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
0.00%
0/98 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
3.1%
4/130 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
0.00%
0/98 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.3%
3/130 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
3.1%
3/98 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
|
Respiratory, thoracic and mediastinal disorders
Increased bronchial secretion
|
2.3%
3/130 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
0.00%
0/98 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.77%
1/130 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
0.00%
0/98 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.77%
1/130 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
1.0%
1/98 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.77%
1/130 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
0.00%
0/98 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
|
Respiratory, thoracic and mediastinal disorders
Increased upper airway secretion
|
0.77%
1/130 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
0.00%
0/98 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
0.77%
1/130 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
0.00%
0/98 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary congestion
|
0.77%
1/130 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
0.00%
0/98 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract congestion
|
0.77%
1/130 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
0.00%
0/98 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
0.77%
1/130 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
0.00%
0/98 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.77%
1/130 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
1.0%
1/98 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
|
Psychiatric disorders
Confusional state
|
3.1%
4/130 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
0.00%
0/98 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
|
Psychiatric disorders
Insomnia
|
3.1%
4/130 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
1.0%
1/98 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
|
Psychiatric disorders
Agitation
|
1.5%
2/130 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
0.00%
0/98 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
|
Psychiatric disorders
Hallucination
|
1.5%
2/130 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
0.00%
0/98 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
|
Psychiatric disorders
Anxiety
|
0.77%
1/130 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
1.0%
1/98 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
|
Psychiatric disorders
Depression
|
0.77%
1/130 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
0.00%
0/98 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
|
Psychiatric disorders
Disorientation
|
0.77%
1/130 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
0.00%
0/98 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
|
Psychiatric disorders
Mood swings
|
0.77%
1/130 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
0.00%
0/98 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
|
Psychiatric disorders
Paranoia
|
0.77%
1/130 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
0.00%
0/98 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
|
Psychiatric disorders
Restlessness
|
0.77%
1/130 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
0.00%
0/98 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
1.5%
2/130 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
5.1%
5/98 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.77%
1/130 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
0.00%
0/98 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
|
Skin and subcutaneous tissue disorders
Blister
|
0.77%
1/130 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
0.00%
0/98 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.77%
1/130 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
0.00%
0/98 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.77%
1/130 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
0.00%
0/98 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.77%
1/130 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
0.00%
0/98 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
0.77%
1/130 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
0.00%
0/98 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.77%
1/130 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
0.00%
0/98 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.77%
1/130 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
0.00%
0/98 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.77%
1/130 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
0.00%
0/98 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.3%
3/130 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
1.0%
1/98 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.5%
2/130 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
1.0%
1/98 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
|
Musculoskeletal and connective tissue disorders
Fistula
|
1.5%
2/130 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
0.00%
0/98 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
1.5%
2/130 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
0.00%
0/98 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
|
Musculoskeletal and connective tissue disorders
Limb discomfort
|
0.77%
1/130 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
0.00%
0/98 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
|
Musculoskeletal and connective tissue disorders
Mobility decreased
|
0.77%
1/130 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
0.00%
0/98 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.77%
1/130 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
0.00%
0/98 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
|
Metabolism and nutrition disorders
Anorexia
|
1.5%
2/130 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
0.00%
0/98 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
|
Metabolism and nutrition disorders
Dehydration
|
1.5%
2/130 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
0.00%
0/98 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.77%
1/130 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
0.00%
0/98 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.77%
1/130 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
0.00%
0/98 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.77%
1/130 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
0.00%
0/98 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
|
Metabolism and nutrition disorders
Increased appetite
|
0.77%
1/130 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
0.00%
0/98 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.77%
1/130 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
0.00%
0/98 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
2.3%
3/130 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
1.0%
1/98 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
0.77%
1/130 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
0.00%
0/98 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung cancer metastatic
|
0.77%
1/130 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
0.00%
0/98 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to bone
|
0.77%
1/130 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
0.00%
0/98 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Spinal cord neoplasm
|
0.77%
1/130 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
0.00%
0/98 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
|
Renal and urinary disorders
Urinary retention
|
2.3%
3/130 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
0.00%
0/98 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
|
Renal and urinary disorders
Bladder distension
|
0.77%
1/130 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
0.00%
0/98 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
|
Renal and urinary disorders
Bladder spasm
|
0.77%
1/130 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
0.00%
0/98 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
|
Renal and urinary disorders
Haematuria
|
0.77%
1/130 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
0.00%
0/98 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
|
Renal and urinary disorders
Micturition urgency
|
0.77%
1/130 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
0.00%
0/98 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
|
Vascular disorders
Deep vein thrombosis
|
0.77%
1/130 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
1.0%
1/98 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
|
Vascular disorders
Hypertension
|
0.77%
1/130 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
2.0%
2/98 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
|
Vascular disorders
Hypotension
|
0.77%
1/130 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
0.00%
0/98 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
|
Vascular disorders
Venous stasis
|
0.77%
1/130 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
0.00%
0/98 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.77%
1/130 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
2.0%
2/98 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.77%
1/130 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
0.00%
0/98 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.77%
1/130 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
0.00%
0/98 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
|
Injury, poisoning and procedural complications
Fall
|
1.5%
2/130 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
0.00%
0/98 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.77%
1/130 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
0.00%
0/98 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
|
Injury, poisoning and procedural complications
Device breakage
|
0.77%
1/130 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
0.00%
0/98 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
|
Injury, poisoning and procedural complications
Excoriation
|
0.77%
1/130 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
0.00%
0/98 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
|
Injury, poisoning and procedural complications
Radiation injury
|
0.77%
1/130 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
1.0%
1/98 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
|
Investigations
Blood bilirubin increased
|
0.77%
1/130 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
0.00%
0/98 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
|
Investigations
Blood creatinine increased
|
0.77%
1/130 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
0.00%
0/98 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
|
Investigations
Blood glucose increased
|
0.77%
1/130 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
0.00%
0/98 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
|
Investigations
Blood potassium decreased
|
0.77%
1/130 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
1.0%
1/98 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
|
Investigations
Blood urea increased
|
0.77%
1/130 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
0.00%
0/98 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
|
Investigations
International normalised ratio increased
|
0.77%
1/130 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
0.00%
0/98 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
|
Investigations
Prothrombin time prolonged
|
0.77%
1/130 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
0.00%
0/98 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
|
Reproductive system and breast disorders
Amenorrhoea
|
1.4%
1/69 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
0.00%
0/98 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
|
Reproductive system and breast disorders
Epididymitis
|
1.6%
1/61 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
0.00%
0/98 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
1.4%
1/69 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
0.00%
0/98 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
|
Ear and labyrinth disorders
Ear pain
|
0.77%
1/130 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
0.00%
0/98 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
|
Ear and labyrinth disorders
Vertigo
|
0.77%
1/130 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
0.00%
0/98 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
|
Cardiac disorders
Tachycardia
|
0.77%
1/130 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
1.0%
1/98 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
|
Eye disorders
Dry eye
|
0.77%
1/130 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
0.00%
0/98 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
|
Hepatobiliary disorders
Jaundice cholestatic
|
0.77%
1/130 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
0.00%
0/98 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/130 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
2.0%
2/98 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
|
Gastrointestinal disorders
Aphthous stomatitis
|
0.00%
0/130 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
1.0%
1/98 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/130 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
1.0%
1/98 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/130 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
1.0%
1/98 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
|
Gastrointestinal disorders
Lip disorder
|
0.00%
0/130 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
1.0%
1/98 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
|
Gastrointestinal disorders
Oral mucosal discolouration
|
0.00%
0/130 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
1.0%
1/98 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
|
Gastrointestinal disorders
Salivary gland enlargement
|
0.00%
0/130 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
1.0%
1/98 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
|
General disorders
Chills
|
0.00%
0/130 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
1.0%
1/98 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
|
General disorders
Malaise
|
0.00%
0/130 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
1.0%
1/98 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
|
General disorders
Mass
|
0.00%
0/130 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
1.0%
1/98 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
|
Infections and infestations
Candidiasis
|
0.00%
0/130 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
1.0%
1/98 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
|
Infections and infestations
Extradural abscess
|
0.00%
0/130 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
1.0%
1/98 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
|
Infections and infestations
Fungal infection
|
0.00%
0/130 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
1.0%
1/98 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/130 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
1.0%
1/98 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
|
Infections and infestations
Oral viral infection
|
0.00%
0/130 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
1.0%
1/98 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/130 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
1.0%
1/98 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/130 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
1.0%
1/98 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/130 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
1.0%
1/98 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
|
Nervous system disorders
Paraplegia
|
0.00%
0/130 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
1.0%
1/98 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
|
Nervous system disorders
Spinal cord disorder
|
0.00%
0/130 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
1.0%
1/98 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/130 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
1.0%
1/98 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
0.00%
0/130 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
1.0%
1/98 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
0.00%
0/130 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
1.0%
1/98 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
|
Skin and subcutaneous tissue disorders
Stasis dermatitis
|
0.00%
0/130 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
1.0%
1/98 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal inflammation
|
0.00%
0/130 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
1.0%
1/98 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/130 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
1.0%
1/98 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/130 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
2.0%
2/98 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/130 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
1.0%
1/98 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/130 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
1.0%
1/98 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/130 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
1.0%
1/98 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/130 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
1.0%
1/98 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
|
Vascular disorders
Flushing
|
0.00%
0/130 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
2.0%
2/98 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
|
Investigations
Breath sounds abnormal
|
0.00%
0/130 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
1.0%
1/98 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
|
Investigations
Electrocardiogram Qrs complex abnormal
|
0.00%
0/130 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
1.0%
1/98 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
|
Investigations
Weight decreased
|
0.00%
0/130 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
1.0%
1/98 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
|
Investigations
Weight increased
|
0.00%
0/130 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
1.0%
1/98 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
|
Psychiatric disorders
Euphoric mood
|
0.00%
0/130 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
1.0%
1/98 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
|
Psychiatric disorders
Nervousness
|
0.00%
0/130 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
1.0%
1/98 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.00%
0/130 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
1.0%
1/98 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm
|
0.00%
0/130 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
1.0%
1/98 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Polycythaemia vera
|
0.00%
0/130 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
1.0%
1/98 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
|
Cardiac disorders
Right ventricular hypertrophy
|
0.00%
0/130 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
1.0%
1/98 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/130 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
1.0%
1/98 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
|
Injury, poisoning and procedural complications
Radiation mucositis
|
0.00%
0/130 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
1.0%
1/98 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
|
Metabolism and nutrition disorders
Glucose tolerance impaired
|
0.00%
0/130 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
1.0%
1/98 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/130 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
1.0%
1/98 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
|
Renal and urinary disorders
Renal impairment
|
0.00%
0/130 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
1.0%
1/98 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/130 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
1.0%
1/98 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
|
Reproductive system and breast disorders
Vaginal ulceration
|
0.00%
0/130 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
1.0%
1/98 • All adverse events were followed to resolution, an outcome was reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study.
Safety population: All enrolled subjects who took at least 1 dose of fentanyl sublingual spray. As subjects may have taken both treatments on the same day and adverse events were only collected once each day, it is not possible to report adverse events separately for the 2 treatments.
|
Additional Information
Larry Dillaha, M.D., Chief Medical Officer
Insys Therapeutics, Inc.
Phone: 602 910-2617
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place