Trial Outcomes & Findings for Long-term Safety and Efficacy Study of Fentanyl Sublingual Spray for the Treatment of Breakthrough Cancer Pain (NCT NCT00538863)
NCT ID: NCT00538863
Last Updated: 2013-10-11
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
319 participants
Primary outcome timeframe
Baseline to end of the study (up to 116 days)
Results posted on
2013-10-11
Participant Flow
The number of patients in the fentanyl sublingual spray maintenance group includes 179 patients who completed the fentanyl sublingual spray titration period of the study plus 90 patients who entered the study directly in the maintenance period.
Five patients who completed the titration period did not start the maintenance period due to failure to determine a dose in the titration period (n=1), withdrawal from the study (n=3), and adverse event (n=1).
Participant milestones
| Measure |
Fentanyl Sublingual Spray
In the titration period, patients were titrated upward to a maximum dose of 1600 µg fentanyl sublingual spray. In the maintenance period, patients received a dose of 100 to 1600 µg fentanyl sublingual spray determined in a previous study (INS-05-001, NCT00538850) or in the titration period of the current study.
|
|---|---|
|
Open-label Titration
STARTED
|
229
|
|
Open-label Titration
COMPLETED
|
184
|
|
Open-label Titration
NOT COMPLETED
|
45
|
|
Open-label Maintenance
STARTED
|
269
|
|
Open-label Maintenance
COMPLETED
|
163
|
|
Open-label Maintenance
NOT COMPLETED
|
106
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Long-term Safety and Efficacy Study of Fentanyl Sublingual Spray for the Treatment of Breakthrough Cancer Pain
Baseline characteristics by cohort
| Measure |
Fentanyl Sublingual Spray
n=319 Participants
In the titration period, patients were titrated upward to a maximum dose of 1600 µg fentanyl sublingual spray. In the maintenance period, patients received a dose of 100 to 1600 µg fentanyl sublingual spray determined in a previous study (INS-05-001, NCT00538850) or in the titration period of the current study.
|
|---|---|
|
Age Continuous
Titration Period
|
54.1 years
STANDARD_DEVIATION 12.5 • n=5 Participants
|
|
Age Continuous
Maintenance Period
|
53.6 years
STANDARD_DEVIATION 12.2 • n=5 Participants
|
|
Sex/Gender, Customized
Titration period - Female
|
117 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Titration period - Male
|
112 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Maintenance period - Female
|
141 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Maintenance period - Male
|
128 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to end of the study (up to 116 days)Population: Safety population: All patients who received study medication.
Outcome measures
| Measure |
Fentanyl Sublingual Spray Titration
n=229 Participants
Patients received fentanyl sublingual spray to treat up to a maximum of 4 breakthrough pain episodes per day with a minimum separation of 4 hours between treatments. Patients 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 26 days was reached.
|
Fentanyl Sublingual Spray Maintenance
n=269 Participants
Patients received fentanyl sublingual spray up to a maximum of 4 times per day with a minimum separation of 4 hours between treatments for 90 days. Patients received a dose of 100 to 1600 µg determined in a previous study (INS-05-001, NCT00538850) or in the open-label dose titration period of the current study. The dose administered provided adequate analgesia for breakthrough pain without unacceptable side effects.
|
|---|---|---|
|
Percentage of Patients That Experienced 1 or More Adverse Events
|
59.0 Percentage of patients
|
80.7 Percentage of patients
|
Adverse Events
Fentanyl Sublingual Spray Titration
Serious events: 33 serious events
Other events: 194 other events
Deaths: 0 deaths
Fentanyl Sublingual Spray Maintenance
Serious events: 178 serious events
Other events: 269 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Fentanyl Sublingual Spray Titration
n=229 participants at risk
Patients received fentanyl sublingual spray to treat up to a maximum of 4 breakthrough pain episodes per day with a minimum separation of 4 hours between treatments. Patients 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 26 days was reached.
|
Fentanyl Sublingual Spray Maintenance
n=269 participants at risk
Patients received fentanyl sublingual spray up to a maximum of 4 times per day with a minimum separation of 4 hours between treatments for 90 days. Patients received a dose of 100 to 1600 µg determined in a previous study (INS-05-001, NCT00538850) or in the open-label dose titration period of the current study. The dose administered provided adequate analgesia for breakthrough pain without unacceptable side effects.
|
|---|---|---|
|
Cardiac disorders
Cardiac failure congestive
|
0.44%
1/229 • All adverse events were followed to resolution, an outcome had been reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study (up to 150 days).
Safety population: All patients (n=319) who received study medication. The number of patients in the fentanyl sublingual spray maintenance group includes 179 patients who completed the fentanyl sublingual spray titration period of the study plus 90 patients who entered the study directly in the maintenance period.
|
0.00%
0/269 • All adverse events were followed to resolution, an outcome had been reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study (up to 150 days).
Safety population: All patients (n=319) who received study medication. The number of patients in the fentanyl sublingual spray maintenance group includes 179 patients who completed the fentanyl sublingual spray titration period of the study plus 90 patients who entered the study directly in the maintenance period.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.44%
1/229 • All adverse events were followed to resolution, an outcome had been reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study (up to 150 days).
Safety population: All patients (n=319) who received study medication. The number of patients in the fentanyl sublingual spray maintenance group includes 179 patients who completed the fentanyl sublingual spray titration period of the study plus 90 patients who entered the study directly in the maintenance period.
|
0.74%
2/269 • All adverse events were followed to resolution, an outcome had been reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study (up to 150 days).
Safety population: All patients (n=319) who received study medication. The number of patients in the fentanyl sublingual spray maintenance group includes 179 patients who completed the fentanyl sublingual spray titration period of the study plus 90 patients who entered the study directly in the maintenance period.
|
|
Gastrointestinal disorders
Ascites
|
0.44%
1/229 • All adverse events were followed to resolution, an outcome had been reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study (up to 150 days).
Safety population: All patients (n=319) who received study medication. The number of patients in the fentanyl sublingual spray maintenance group includes 179 patients who completed the fentanyl sublingual spray titration period of the study plus 90 patients who entered the study directly in the maintenance period.
|
0.00%
0/269 • All adverse events were followed to resolution, an outcome had been reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study (up to 150 days).
Safety population: All patients (n=319) who received study medication. The number of patients in the fentanyl sublingual spray maintenance group includes 179 patients who completed the fentanyl sublingual spray titration period of the study plus 90 patients who entered the study directly in the maintenance period.
|
|
Gastrointestinal disorders
Nausea
|
0.44%
1/229 • All adverse events were followed to resolution, an outcome had been reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study (up to 150 days).
Safety population: All patients (n=319) who received study medication. The number of patients in the fentanyl sublingual spray maintenance group includes 179 patients who completed the fentanyl sublingual spray titration period of the study plus 90 patients who entered the study directly in the maintenance period.
|
1.1%
3/269 • All adverse events were followed to resolution, an outcome had been reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study (up to 150 days).
Safety population: All patients (n=319) who received study medication. The number of patients in the fentanyl sublingual spray maintenance group includes 179 patients who completed the fentanyl sublingual spray titration period of the study plus 90 patients who entered the study directly in the maintenance period.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.44%
1/229 • All adverse events were followed to resolution, an outcome had been reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study (up to 150 days).
Safety population: All patients (n=319) who received study medication. The number of patients in the fentanyl sublingual spray maintenance group includes 179 patients who completed the fentanyl sublingual spray titration period of the study plus 90 patients who entered the study directly in the maintenance period.
|
0.00%
0/269 • All adverse events were followed to resolution, an outcome had been reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study (up to 150 days).
Safety population: All patients (n=319) who received study medication. The number of patients in the fentanyl sublingual spray maintenance group includes 179 patients who completed the fentanyl sublingual spray titration period of the study plus 90 patients who entered the study directly in the maintenance period.
|
|
Gastrointestinal disorders
Vomiting
|
0.87%
2/229 • All adverse events were followed to resolution, an outcome had been reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study (up to 150 days).
Safety population: All patients (n=319) who received study medication. The number of patients in the fentanyl sublingual spray maintenance group includes 179 patients who completed the fentanyl sublingual spray titration period of the study plus 90 patients who entered the study directly in the maintenance period.
|
1.1%
3/269 • All adverse events were followed to resolution, an outcome had been reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study (up to 150 days).
Safety population: All patients (n=319) who received study medication. The number of patients in the fentanyl sublingual spray maintenance group includes 179 patients who completed the fentanyl sublingual spray titration period of the study plus 90 patients who entered the study directly in the maintenance period.
|
|
General disorders
Disease progression
|
0.87%
2/229 • All adverse events were followed to resolution, an outcome had been reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study (up to 150 days).
Safety population: All patients (n=319) who received study medication. The number of patients in the fentanyl sublingual spray maintenance group includes 179 patients who completed the fentanyl sublingual spray titration period of the study plus 90 patients who entered the study directly in the maintenance period.
|
1.9%
5/269 • All adverse events were followed to resolution, an outcome had been reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study (up to 150 days).
Safety population: All patients (n=319) who received study medication. The number of patients in the fentanyl sublingual spray maintenance group includes 179 patients who completed the fentanyl sublingual spray titration period of the study plus 90 patients who entered the study directly in the maintenance period.
|
|
Infections and infestations
Bacterial sepsis
|
0.44%
1/229 • All adverse events were followed to resolution, an outcome had been reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study (up to 150 days).
Safety population: All patients (n=319) who received study medication. The number of patients in the fentanyl sublingual spray maintenance group includes 179 patients who completed the fentanyl sublingual spray titration period of the study plus 90 patients who entered the study directly in the maintenance period.
|
0.00%
0/269 • All adverse events were followed to resolution, an outcome had been reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study (up to 150 days).
Safety population: All patients (n=319) who received study medication. The number of patients in the fentanyl sublingual spray maintenance group includes 179 patients who completed the fentanyl sublingual spray titration period of the study plus 90 patients who entered the study directly in the maintenance period.
|
|
Infections and infestations
Breast infection
|
0.44%
1/229 • All adverse events were followed to resolution, an outcome had been reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study (up to 150 days).
Safety population: All patients (n=319) who received study medication. The number of patients in the fentanyl sublingual spray maintenance group includes 179 patients who completed the fentanyl sublingual spray titration period of the study plus 90 patients who entered the study directly in the maintenance period.
|
0.00%
0/269 • All adverse events were followed to resolution, an outcome had been reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study (up to 150 days).
Safety population: All patients (n=319) who received study medication. The number of patients in the fentanyl sublingual spray maintenance group includes 179 patients who completed the fentanyl sublingual spray titration period of the study plus 90 patients who entered the study directly in the maintenance period.
|
|
Infections and infestations
Liver abscess
|
0.44%
1/229 • All adverse events were followed to resolution, an outcome had been reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study (up to 150 days).
Safety population: All patients (n=319) who received study medication. The number of patients in the fentanyl sublingual spray maintenance group includes 179 patients who completed the fentanyl sublingual spray titration period of the study plus 90 patients who entered the study directly in the maintenance period.
|
0.00%
0/269 • All adverse events were followed to resolution, an outcome had been reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study (up to 150 days).
Safety population: All patients (n=319) who received study medication. The number of patients in the fentanyl sublingual spray maintenance group includes 179 patients who completed the fentanyl sublingual spray titration period of the study plus 90 patients who entered the study directly in the maintenance period.
|
|
Infections and infestations
Sepsis syndrome
|
0.44%
1/229 • All adverse events were followed to resolution, an outcome had been reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study (up to 150 days).
Safety population: All patients (n=319) who received study medication. The number of patients in the fentanyl sublingual spray maintenance group includes 179 patients who completed the fentanyl sublingual spray titration period of the study plus 90 patients who entered the study directly in the maintenance period.
|
0.37%
1/269 • All adverse events were followed to resolution, an outcome had been reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study (up to 150 days).
Safety population: All patients (n=319) who received study medication. The number of patients in the fentanyl sublingual spray maintenance group includes 179 patients who completed the fentanyl sublingual spray titration period of the study plus 90 patients who entered the study directly in the maintenance period.
|
|
Injury, poisoning and procedural complications
Post procedural complication
|
0.44%
1/229 • All adverse events were followed to resolution, an outcome had been reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study (up to 150 days).
Safety population: All patients (n=319) who received study medication. The number of patients in the fentanyl sublingual spray maintenance group includes 179 patients who completed the fentanyl sublingual spray titration period of the study plus 90 patients who entered the study directly in the maintenance period.
|
0.00%
0/269 • All adverse events were followed to resolution, an outcome had been reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study (up to 150 days).
Safety population: All patients (n=319) who received study medication. The number of patients in the fentanyl sublingual spray maintenance group includes 179 patients who completed the fentanyl sublingual spray titration period of the study plus 90 patients who entered the study directly in the maintenance period.
|
|
Injury, poisoning and procedural complications
Urostomy complication
|
0.44%
1/229 • All adverse events were followed to resolution, an outcome had been reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study (up to 150 days).
Safety population: All patients (n=319) who received study medication. The number of patients in the fentanyl sublingual spray maintenance group includes 179 patients who completed the fentanyl sublingual spray titration period of the study plus 90 patients who entered the study directly in the maintenance period.
|
0.00%
0/269 • All adverse events were followed to resolution, an outcome had been reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study (up to 150 days).
Safety population: All patients (n=319) who received study medication. The number of patients in the fentanyl sublingual spray maintenance group includes 179 patients who completed the fentanyl sublingual spray titration period of the study plus 90 patients who entered the study directly in the maintenance period.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.44%
1/229 • All adverse events were followed to resolution, an outcome had been reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study (up to 150 days).
Safety population: All patients (n=319) who received study medication. The number of patients in the fentanyl sublingual spray maintenance group includes 179 patients who completed the fentanyl sublingual spray titration period of the study plus 90 patients who entered the study directly in the maintenance period.
|
0.37%
1/269 • All adverse events were followed to resolution, an outcome had been reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study (up to 150 days).
Safety population: All patients (n=319) who received study medication. The number of patients in the fentanyl sublingual spray maintenance group includes 179 patients who completed the fentanyl sublingual spray titration period of the study plus 90 patients who entered the study directly in the maintenance period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung cancer metastatic
|
0.44%
1/229 • All adverse events were followed to resolution, an outcome had been reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study (up to 150 days).
Safety population: All patients (n=319) who received study medication. The number of patients in the fentanyl sublingual spray maintenance group includes 179 patients who completed the fentanyl sublingual spray titration period of the study plus 90 patients who entered the study directly in the maintenance period.
|
0.00%
0/269 • All adverse events were followed to resolution, an outcome had been reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study (up to 150 days).
Safety population: All patients (n=319) who received study medication. The number of patients in the fentanyl sublingual spray maintenance group includes 179 patients who completed the fentanyl sublingual spray titration period of the study plus 90 patients who entered the study directly in the maintenance period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant ascites
|
0.44%
1/229 • All adverse events were followed to resolution, an outcome had been reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study (up to 150 days).
Safety population: All patients (n=319) who received study medication. The number of patients in the fentanyl sublingual spray maintenance group includes 179 patients who completed the fentanyl sublingual spray titration period of the study plus 90 patients who entered the study directly in the maintenance period.
|
0.00%
0/269 • All adverse events were followed to resolution, an outcome had been reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study (up to 150 days).
Safety population: All patients (n=319) who received study medication. The number of patients in the fentanyl sublingual spray maintenance group includes 179 patients who completed the fentanyl sublingual spray titration period of the study plus 90 patients who entered the study directly in the maintenance period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
2.2%
5/229 • All adverse events were followed to resolution, an outcome had been reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study (up to 150 days).
Safety population: All patients (n=319) who received study medication. The number of patients in the fentanyl sublingual spray maintenance group includes 179 patients who completed the fentanyl sublingual spray titration period of the study plus 90 patients who entered the study directly in the maintenance period.
|
22.3%
60/269 • All adverse events were followed to resolution, an outcome had been reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study (up to 150 days).
Safety population: All patients (n=319) who received study medication. The number of patients in the fentanyl sublingual spray maintenance group includes 179 patients who completed the fentanyl sublingual spray titration period of the study plus 90 patients who entered the study directly in the maintenance period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic syndrome
|
0.44%
1/229 • All adverse events were followed to resolution, an outcome had been reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study (up to 150 days).
Safety population: All patients (n=319) who received study medication. The number of patients in the fentanyl sublingual spray maintenance group includes 179 patients who completed the fentanyl sublingual spray titration period of the study plus 90 patients who entered the study directly in the maintenance period.
|
0.00%
0/269 • All adverse events were followed to resolution, an outcome had been reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study (up to 150 days).
Safety population: All patients (n=319) who received study medication. The number of patients in the fentanyl sublingual spray maintenance group includes 179 patients who completed the fentanyl sublingual spray titration period of the study plus 90 patients who entered the study directly in the maintenance period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer
|
0.87%
2/229 • All adverse events were followed to resolution, an outcome had been reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study (up to 150 days).
Safety population: All patients (n=319) who received study medication. The number of patients in the fentanyl sublingual spray maintenance group includes 179 patients who completed the fentanyl sublingual spray titration period of the study plus 90 patients who entered the study directly in the maintenance period.
|
1.1%
3/269 • All adverse events were followed to resolution, an outcome had been reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study (up to 150 days).
Safety population: All patients (n=319) who received study medication. The number of patients in the fentanyl sublingual spray maintenance group includes 179 patients who completed the fentanyl sublingual spray titration period of the study plus 90 patients who entered the study directly in the maintenance period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.44%
1/229 • All adverse events were followed to resolution, an outcome had been reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study (up to 150 days).
Safety population: All patients (n=319) who received study medication. The number of patients in the fentanyl sublingual spray maintenance group includes 179 patients who completed the fentanyl sublingual spray titration period of the study plus 90 patients who entered the study directly in the maintenance period.
|
1.1%
3/269 • All adverse events were followed to resolution, an outcome had been reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study (up to 150 days).
Safety population: All patients (n=319) who received study medication. The number of patients in the fentanyl sublingual spray maintenance group includes 179 patients who completed the fentanyl sublingual spray titration period of the study plus 90 patients who entered the study directly in the maintenance period.
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.44%
1/229 • All adverse events were followed to resolution, an outcome had been reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study (up to 150 days).
Safety population: All patients (n=319) who received study medication. The number of patients in the fentanyl sublingual spray maintenance group includes 179 patients who completed the fentanyl sublingual spray titration period of the study plus 90 patients who entered the study directly in the maintenance period.
|
0.00%
0/269 • All adverse events were followed to resolution, an outcome had been reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study (up to 150 days).
Safety population: All patients (n=319) who received study medication. The number of patients in the fentanyl sublingual spray maintenance group includes 179 patients who completed the fentanyl sublingual spray titration period of the study plus 90 patients who entered the study directly in the maintenance period.
|
|
Renal and urinary disorders
Hydronephrosis
|
0.44%
1/229 • All adverse events were followed to resolution, an outcome had been reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study (up to 150 days).
Safety population: All patients (n=319) who received study medication. The number of patients in the fentanyl sublingual spray maintenance group includes 179 patients who completed the fentanyl sublingual spray titration period of the study plus 90 patients who entered the study directly in the maintenance period.
|
0.00%
0/269 • All adverse events were followed to resolution, an outcome had been reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study (up to 150 days).
Safety population: All patients (n=319) who received study medication. The number of patients in the fentanyl sublingual spray maintenance group includes 179 patients who completed the fentanyl sublingual spray titration period of the study plus 90 patients who entered the study directly in the maintenance period.
|
|
Renal and urinary disorders
Renal failure chronic
|
0.44%
1/229 • All adverse events were followed to resolution, an outcome had been reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study (up to 150 days).
Safety population: All patients (n=319) who received study medication. The number of patients in the fentanyl sublingual spray maintenance group includes 179 patients who completed the fentanyl sublingual spray titration period of the study plus 90 patients who entered the study directly in the maintenance period.
|
0.00%
0/269 • All adverse events were followed to resolution, an outcome had been reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study (up to 150 days).
Safety population: All patients (n=319) who received study medication. The number of patients in the fentanyl sublingual spray maintenance group includes 179 patients who completed the fentanyl sublingual spray titration period of the study plus 90 patients who entered the study directly in the maintenance period.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.44%
1/229 • All adverse events were followed to resolution, an outcome had been reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study (up to 150 days).
Safety population: All patients (n=319) who received study medication. The number of patients in the fentanyl sublingual spray maintenance group includes 179 patients who completed the fentanyl sublingual spray titration period of the study plus 90 patients who entered the study directly in the maintenance period.
|
0.37%
1/269 • All adverse events were followed to resolution, an outcome had been reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study (up to 150 days).
Safety population: All patients (n=319) who received study medication. The number of patients in the fentanyl sublingual spray maintenance group includes 179 patients who completed the fentanyl sublingual spray titration period of the study plus 90 patients who entered the study directly in the maintenance period.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.44%
1/229 • All adverse events were followed to resolution, an outcome had been reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study (up to 150 days).
Safety population: All patients (n=319) who received study medication. The number of patients in the fentanyl sublingual spray maintenance group includes 179 patients who completed the fentanyl sublingual spray titration period of the study plus 90 patients who entered the study directly in the maintenance period.
|
1.1%
3/269 • All adverse events were followed to resolution, an outcome had been reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study (up to 150 days).
Safety population: All patients (n=319) who received study medication. The number of patients in the fentanyl sublingual spray maintenance group includes 179 patients who completed the fentanyl sublingual spray titration period of the study plus 90 patients who entered the study directly in the maintenance period.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.44%
1/229 • All adverse events were followed to resolution, an outcome had been reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study (up to 150 days).
Safety population: All patients (n=319) who received study medication. The number of patients in the fentanyl sublingual spray maintenance group includes 179 patients who completed the fentanyl sublingual spray titration period of the study plus 90 patients who entered the study directly in the maintenance period.
|
0.37%
1/269 • All adverse events were followed to resolution, an outcome had been reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study (up to 150 days).
Safety population: All patients (n=319) who received study medication. The number of patients in the fentanyl sublingual spray maintenance group includes 179 patients who completed the fentanyl sublingual spray titration period of the study plus 90 patients who entered the study directly in the maintenance period.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/229 • All adverse events were followed to resolution, an outcome had been reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study (up to 150 days).
Safety population: All patients (n=319) who received study medication. The number of patients in the fentanyl sublingual spray maintenance group includes 179 patients who completed the fentanyl sublingual spray titration period of the study plus 90 patients who entered the study directly in the maintenance period.
|
1.5%
4/269 • All adverse events were followed to resolution, an outcome had been reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study (up to 150 days).
Safety population: All patients (n=319) who received study medication. The number of patients in the fentanyl sublingual spray maintenance group includes 179 patients who completed the fentanyl sublingual spray titration period of the study plus 90 patients who entered the study directly in the maintenance period.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/229 • All adverse events were followed to resolution, an outcome had been reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study (up to 150 days).
Safety population: All patients (n=319) who received study medication. The number of patients in the fentanyl sublingual spray maintenance group includes 179 patients who completed the fentanyl sublingual spray titration period of the study plus 90 patients who entered the study directly in the maintenance period.
|
0.37%
1/269 • All adverse events were followed to resolution, an outcome had been reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study (up to 150 days).
Safety population: All patients (n=319) who received study medication. The number of patients in the fentanyl sublingual spray maintenance group includes 179 patients who completed the fentanyl sublingual spray titration period of the study plus 90 patients who entered the study directly in the maintenance period.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.00%
0/229 • All adverse events were followed to resolution, an outcome had been reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study (up to 150 days).
Safety population: All patients (n=319) who received study medication. The number of patients in the fentanyl sublingual spray maintenance group includes 179 patients who completed the fentanyl sublingual spray titration period of the study plus 90 patients who entered the study directly in the maintenance period.
|
0.37%
1/269 • All adverse events were followed to resolution, an outcome had been reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study (up to 150 days).
Safety population: All patients (n=319) who received study medication. The number of patients in the fentanyl sublingual spray maintenance group includes 179 patients who completed the fentanyl sublingual spray titration period of the study plus 90 patients who entered the study directly in the maintenance period.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/229 • All adverse events were followed to resolution, an outcome had been reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study (up to 150 days).
Safety population: All patients (n=319) who received study medication. The number of patients in the fentanyl sublingual spray maintenance group includes 179 patients who completed the fentanyl sublingual spray titration period of the study plus 90 patients who entered the study directly in the maintenance period.
|
0.74%
2/269 • All adverse events were followed to resolution, an outcome had been reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study (up to 150 days).
Safety population: All patients (n=319) who received study medication. The number of patients in the fentanyl sublingual spray maintenance group includes 179 patients who completed the fentanyl sublingual spray titration period of the study plus 90 patients who entered the study directly in the maintenance period.
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/229 • All adverse events were followed to resolution, an outcome had been reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study (up to 150 days).
Safety population: All patients (n=319) who received study medication. The number of patients in the fentanyl sublingual spray maintenance group includes 179 patients who completed the fentanyl sublingual spray titration period of the study plus 90 patients who entered the study directly in the maintenance period.
|
0.37%
1/269 • All adverse events were followed to resolution, an outcome had been reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study (up to 150 days).
Safety population: All patients (n=319) who received study medication. The number of patients in the fentanyl sublingual spray maintenance group includes 179 patients who completed the fentanyl sublingual spray titration period of the study plus 90 patients who entered the study directly in the maintenance period.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/229 • All adverse events were followed to resolution, an outcome had been reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study (up to 150 days).
Safety population: All patients (n=319) who received study medication. The number of patients in the fentanyl sublingual spray maintenance group includes 179 patients who completed the fentanyl sublingual spray titration period of the study plus 90 patients who entered the study directly in the maintenance period.
|
0.37%
1/269 • All adverse events were followed to resolution, an outcome had been reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study (up to 150 days).
Safety population: All patients (n=319) who received study medication. The number of patients in the fentanyl sublingual spray maintenance group includes 179 patients who completed the fentanyl sublingual spray titration period of the study plus 90 patients who entered the study directly in the maintenance period.
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/229 • All adverse events were followed to resolution, an outcome had been reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study (up to 150 days).
Safety population: All patients (n=319) who received study medication. The number of patients in the fentanyl sublingual spray maintenance group includes 179 patients who completed the fentanyl sublingual spray titration period of the study plus 90 patients who entered the study directly in the maintenance period.
|
0.37%
1/269 • All adverse events were followed to resolution, an outcome had been reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study (up to 150 days).
Safety population: All patients (n=319) who received study medication. The number of patients in the fentanyl sublingual spray maintenance group includes 179 patients who completed the fentanyl sublingual spray titration period of the study plus 90 patients who entered the study directly in the maintenance period.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.00%
0/229 • All adverse events were followed to resolution, an outcome had been reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study (up to 150 days).
Safety population: All patients (n=319) who received study medication. The number of patients in the fentanyl sublingual spray maintenance group includes 179 patients who completed the fentanyl sublingual spray titration period of the study plus 90 patients who entered the study directly in the maintenance period.
|
0.37%
1/269 • All adverse events were followed to resolution, an outcome had been reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study (up to 150 days).
Safety population: All patients (n=319) who received study medication. The number of patients in the fentanyl sublingual spray maintenance group includes 179 patients who completed the fentanyl sublingual spray titration period of the study plus 90 patients who entered the study directly in the maintenance period.
|
|
Cardiac disorders
Cardiopulmonary failure
|
0.00%
0/229 • All adverse events were followed to resolution, an outcome had been reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study (up to 150 days).
Safety population: All patients (n=319) who received study medication. The number of patients in the fentanyl sublingual spray maintenance group includes 179 patients who completed the fentanyl sublingual spray titration period of the study plus 90 patients who entered the study directly in the maintenance period.
|
0.37%
1/269 • All adverse events were followed to resolution, an outcome had been reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study (up to 150 days).
Safety population: All patients (n=319) who received study medication. The number of patients in the fentanyl sublingual spray maintenance group includes 179 patients who completed the fentanyl sublingual spray titration period of the study plus 90 patients who entered the study directly in the maintenance period.
|
|
Congenital, familial and genetic disorders
Pyloric stenosis
|
0.00%
0/229 • All adverse events were followed to resolution, an outcome had been reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study (up to 150 days).
Safety population: All patients (n=319) who received study medication. The number of patients in the fentanyl sublingual spray maintenance group includes 179 patients who completed the fentanyl sublingual spray titration period of the study plus 90 patients who entered the study directly in the maintenance period.
|
0.37%
1/269 • All adverse events were followed to resolution, an outcome had been reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study (up to 150 days).
Safety population: All patients (n=319) who received study medication. The number of patients in the fentanyl sublingual spray maintenance group includes 179 patients who completed the fentanyl sublingual spray titration period of the study plus 90 patients who entered the study directly in the maintenance period.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/229 • All adverse events were followed to resolution, an outcome had been reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study (up to 150 days).
Safety population: All patients (n=319) who received study medication. The number of patients in the fentanyl sublingual spray maintenance group includes 179 patients who completed the fentanyl sublingual spray titration period of the study plus 90 patients who entered the study directly in the maintenance period.
|
0.37%
1/269 • All adverse events were followed to resolution, an outcome had been reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study (up to 150 days).
Safety population: All patients (n=319) who received study medication. The number of patients in the fentanyl sublingual spray maintenance group includes 179 patients who completed the fentanyl sublingual spray titration period of the study plus 90 patients who entered the study directly in the maintenance period.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/229 • All adverse events were followed to resolution, an outcome had been reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study (up to 150 days).
Safety population: All patients (n=319) who received study medication. The number of patients in the fentanyl sublingual spray maintenance group includes 179 patients who completed the fentanyl sublingual spray titration period of the study plus 90 patients who entered the study directly in the maintenance period.
|
0.74%
2/269 • All adverse events were followed to resolution, an outcome had been reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study (up to 150 days).
Safety population: All patients (n=319) who received study medication. The number of patients in the fentanyl sublingual spray maintenance group includes 179 patients who completed the fentanyl sublingual spray titration period of the study plus 90 patients who entered the study directly in the maintenance period.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/229 • All adverse events were followed to resolution, an outcome had been reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study (up to 150 days).
Safety population: All patients (n=319) who received study medication. The number of patients in the fentanyl sublingual spray maintenance group includes 179 patients who completed the fentanyl sublingual spray titration period of the study plus 90 patients who entered the study directly in the maintenance period.
|
0.37%
1/269 • All adverse events were followed to resolution, an outcome had been reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study (up to 150 days).
Safety population: All patients (n=319) who received study medication. The number of patients in the fentanyl sublingual spray maintenance group includes 179 patients who completed the fentanyl sublingual spray titration period of the study plus 90 patients who entered the study directly in the maintenance period.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/229 • All adverse events were followed to resolution, an outcome had been reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study (up to 150 days).
Safety population: All patients (n=319) who received study medication. The number of patients in the fentanyl sublingual spray maintenance group includes 179 patients who completed the fentanyl sublingual spray titration period of the study plus 90 patients who entered the study directly in the maintenance period.
|
0.74%
2/269 • All adverse events were followed to resolution, an outcome had been reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study (up to 150 days).
Safety population: All patients (n=319) who received study medication. The number of patients in the fentanyl sublingual spray maintenance group includes 179 patients who completed the fentanyl sublingual spray titration period of the study plus 90 patients who entered the study directly in the maintenance period.
|
|
Gastrointestinal disorders
Gastrointestinal fistula
|
0.00%
0/229 • All adverse events were followed to resolution, an outcome had been reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study (up to 150 days).
Safety population: All patients (n=319) who received study medication. The number of patients in the fentanyl sublingual spray maintenance group includes 179 patients who completed the fentanyl sublingual spray titration period of the study plus 90 patients who entered the study directly in the maintenance period.
|
0.37%
1/269 • All adverse events were followed to resolution, an outcome had been reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study (up to 150 days).
Safety population: All patients (n=319) who received study medication. The number of patients in the fentanyl sublingual spray maintenance group includes 179 patients who completed the fentanyl sublingual spray titration period of the study plus 90 patients who entered the study directly in the maintenance period.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/229 • All adverse events were followed to resolution, an outcome had been reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study (up to 150 days).
Safety population: All patients (n=319) who received study medication. The number of patients in the fentanyl sublingual spray maintenance group includes 179 patients who completed the fentanyl sublingual spray titration period of the study plus 90 patients who entered the study directly in the maintenance period.
|
0.37%
1/269 • All adverse events were followed to resolution, an outcome had been reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study (up to 150 days).
Safety population: All patients (n=319) who received study medication. The number of patients in the fentanyl sublingual spray maintenance group includes 179 patients who completed the fentanyl sublingual spray titration period of the study plus 90 patients who entered the study directly in the maintenance period.
|
|
Gastrointestinal disorders
Glossitis
|
0.00%
0/229 • All adverse events were followed to resolution, an outcome had been reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study (up to 150 days).
Safety population: All patients (n=319) who received study medication. The number of patients in the fentanyl sublingual spray maintenance group includes 179 patients who completed the fentanyl sublingual spray titration period of the study plus 90 patients who entered the study directly in the maintenance period.
|
0.37%
1/269 • All adverse events were followed to resolution, an outcome had been reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study (up to 150 days).
Safety population: All patients (n=319) who received study medication. The number of patients in the fentanyl sublingual spray maintenance group includes 179 patients who completed the fentanyl sublingual spray titration period of the study plus 90 patients who entered the study directly in the maintenance period.
|
|
Gastrointestinal disorders
Neutropenic colitis
|
0.00%
0/229 • All adverse events were followed to resolution, an outcome had been reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study (up to 150 days).
Safety population: All patients (n=319) who received study medication. The number of patients in the fentanyl sublingual spray maintenance group includes 179 patients who completed the fentanyl sublingual spray titration period of the study plus 90 patients who entered the study directly in the maintenance period.
|
1.1%
3/269 • All adverse events were followed to resolution, an outcome had been reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study (up to 150 days).
Safety population: All patients (n=319) who received study medication. The number of patients in the fentanyl sublingual spray maintenance group includes 179 patients who completed the fentanyl sublingual spray titration period of the study plus 90 patients who entered the study directly in the maintenance period.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/229 • All adverse events were followed to resolution, an outcome had been reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study (up to 150 days).
Safety population: All patients (n=319) who received study medication. The number of patients in the fentanyl sublingual spray maintenance group includes 179 patients who completed the fentanyl sublingual spray titration period of the study plus 90 patients who entered the study directly in the maintenance period.
|
0.37%
1/269 • All adverse events were followed to resolution, an outcome had been reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study (up to 150 days).
Safety population: All patients (n=319) who received study medication. The number of patients in the fentanyl sublingual spray maintenance group includes 179 patients who completed the fentanyl sublingual spray titration period of the study plus 90 patients who entered the study directly in the maintenance period.
|
|
General disorders
Asthenia
|
0.00%
0/229 • All adverse events were followed to resolution, an outcome had been reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study (up to 150 days).
Safety population: All patients (n=319) who received study medication. The number of patients in the fentanyl sublingual spray maintenance group includes 179 patients who completed the fentanyl sublingual spray titration period of the study plus 90 patients who entered the study directly in the maintenance period.
|
0.37%
1/269 • All adverse events were followed to resolution, an outcome had been reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study (up to 150 days).
Safety population: All patients (n=319) who received study medication. The number of patients in the fentanyl sublingual spray maintenance group includes 179 patients who completed the fentanyl sublingual spray titration period of the study plus 90 patients who entered the study directly in the maintenance period.
|
|
General disorders
Chest pain
|
0.00%
0/229 • All adverse events were followed to resolution, an outcome had been reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study (up to 150 days).
Safety population: All patients (n=319) who received study medication. The number of patients in the fentanyl sublingual spray maintenance group includes 179 patients who completed the fentanyl sublingual spray titration period of the study plus 90 patients who entered the study directly in the maintenance period.
|
0.37%
1/269 • All adverse events were followed to resolution, an outcome had been reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study (up to 150 days).
Safety population: All patients (n=319) who received study medication. The number of patients in the fentanyl sublingual spray maintenance group includes 179 patients who completed the fentanyl sublingual spray titration period of the study plus 90 patients who entered the study directly in the maintenance period.
|
|
General disorders
Drug withdrawal syndrome
|
0.00%
0/229 • All adverse events were followed to resolution, an outcome had been reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study (up to 150 days).
Safety population: All patients (n=319) who received study medication. The number of patients in the fentanyl sublingual spray maintenance group includes 179 patients who completed the fentanyl sublingual spray titration period of the study plus 90 patients who entered the study directly in the maintenance period.
|
0.37%
1/269 • All adverse events were followed to resolution, an outcome had been reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study (up to 150 days).
Safety population: All patients (n=319) who received study medication. The number of patients in the fentanyl sublingual spray maintenance group includes 179 patients who completed the fentanyl sublingual spray titration period of the study plus 90 patients who entered the study directly in the maintenance period.
|
|
General disorders
Fatigue
|
0.00%
0/229 • All adverse events were followed to resolution, an outcome had been reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study (up to 150 days).
Safety population: All patients (n=319) who received study medication. The number of patients in the fentanyl sublingual spray maintenance group includes 179 patients who completed the fentanyl sublingual spray titration period of the study plus 90 patients who entered the study directly in the maintenance period.
|
0.74%
2/269 • All adverse events were followed to resolution, an outcome had been reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study (up to 150 days).
Safety population: All patients (n=319) who received study medication. The number of patients in the fentanyl sublingual spray maintenance group includes 179 patients who completed the fentanyl sublingual spray titration period of the study plus 90 patients who entered the study directly in the maintenance period.
|
|
General disorders
Oedema peripheral
|
0.00%
0/229 • All adverse events were followed to resolution, an outcome had been reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study (up to 150 days).
Safety population: All patients (n=319) who received study medication. The number of patients in the fentanyl sublingual spray maintenance group includes 179 patients who completed the fentanyl sublingual spray titration period of the study plus 90 patients who entered the study directly in the maintenance period.
|
0.74%
2/269 • All adverse events were followed to resolution, an outcome had been reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study (up to 150 days).
Safety population: All patients (n=319) who received study medication. The number of patients in the fentanyl sublingual spray maintenance group includes 179 patients who completed the fentanyl sublingual spray titration period of the study plus 90 patients who entered the study directly in the maintenance period.
|
|
General disorders
Pain
|
0.00%
0/229 • All adverse events were followed to resolution, an outcome had been reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study (up to 150 days).
Safety population: All patients (n=319) who received study medication. The number of patients in the fentanyl sublingual spray maintenance group includes 179 patients who completed the fentanyl sublingual spray titration period of the study plus 90 patients who entered the study directly in the maintenance period.
|
0.37%
1/269 • All adverse events were followed to resolution, an outcome had been reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study (up to 150 days).
Safety population: All patients (n=319) who received study medication. The number of patients in the fentanyl sublingual spray maintenance group includes 179 patients who completed the fentanyl sublingual spray titration period of the study plus 90 patients who entered the study directly in the maintenance period.
|
|
General disorders
Pyrexia
|
0.00%
0/229 • All adverse events were followed to resolution, an outcome had been reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study (up to 150 days).
Safety population: All patients (n=319) who received study medication. The number of patients in the fentanyl sublingual spray maintenance group includes 179 patients who completed the fentanyl sublingual spray titration period of the study plus 90 patients who entered the study directly in the maintenance period.
|
0.37%
1/269 • All adverse events were followed to resolution, an outcome had been reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study (up to 150 days).
Safety population: All patients (n=319) who received study medication. The number of patients in the fentanyl sublingual spray maintenance group includes 179 patients who completed the fentanyl sublingual spray titration period of the study plus 90 patients who entered the study directly in the maintenance period.
|
|
Infections and infestations
Abscess
|
0.00%
0/229 • All adverse events were followed to resolution, an outcome had been reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study (up to 150 days).
Safety population: All patients (n=319) who received study medication. The number of patients in the fentanyl sublingual spray maintenance group includes 179 patients who completed the fentanyl sublingual spray titration period of the study plus 90 patients who entered the study directly in the maintenance period.
|
0.37%
1/269 • All adverse events were followed to resolution, an outcome had been reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study (up to 150 days).
Safety population: All patients (n=319) who received study medication. The number of patients in the fentanyl sublingual spray maintenance group includes 179 patients who completed the fentanyl sublingual spray titration period of the study plus 90 patients who entered the study directly in the maintenance period.
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/229 • All adverse events were followed to resolution, an outcome had been reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study (up to 150 days).
Safety population: All patients (n=319) who received study medication. The number of patients in the fentanyl sublingual spray maintenance group includes 179 patients who completed the fentanyl sublingual spray titration period of the study plus 90 patients who entered the study directly in the maintenance period.
|
0.37%
1/269 • All adverse events were followed to resolution, an outcome had been reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study (up to 150 days).
Safety population: All patients (n=319) who received study medication. The number of patients in the fentanyl sublingual spray maintenance group includes 179 patients who completed the fentanyl sublingual spray titration period of the study plus 90 patients who entered the study directly in the maintenance period.
|
|
Infections and infestations
Catheter related infection
|
0.00%
0/229 • All adverse events were followed to resolution, an outcome had been reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study (up to 150 days).
Safety population: All patients (n=319) who received study medication. The number of patients in the fentanyl sublingual spray maintenance group includes 179 patients who completed the fentanyl sublingual spray titration period of the study plus 90 patients who entered the study directly in the maintenance period.
|
0.37%
1/269 • All adverse events were followed to resolution, an outcome had been reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study (up to 150 days).
Safety population: All patients (n=319) who received study medication. The number of patients in the fentanyl sublingual spray maintenance group includes 179 patients who completed the fentanyl sublingual spray titration period of the study plus 90 patients who entered the study directly in the maintenance period.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/229 • All adverse events were followed to resolution, an outcome had been reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study (up to 150 days).
Safety population: All patients (n=319) who received study medication. The number of patients in the fentanyl sublingual spray maintenance group includes 179 patients who completed the fentanyl sublingual spray titration period of the study plus 90 patients who entered the study directly in the maintenance period.
|
1.1%
3/269 • All adverse events were followed to resolution, an outcome had been reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study (up to 150 days).
Safety population: All patients (n=319) who received study medication. The number of patients in the fentanyl sublingual spray maintenance group includes 179 patients who completed the fentanyl sublingual spray titration period of the study plus 90 patients who entered the study directly in the maintenance period.
|
|
Infections and infestations
Lobar pneumonia
|
0.00%
0/229 • All adverse events were followed to resolution, an outcome had been reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study (up to 150 days).
Safety population: All patients (n=319) who received study medication. The number of patients in the fentanyl sublingual spray maintenance group includes 179 patients who completed the fentanyl sublingual spray titration period of the study plus 90 patients who entered the study directly in the maintenance period.
|
0.37%
1/269 • All adverse events were followed to resolution, an outcome had been reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study (up to 150 days).
Safety population: All patients (n=319) who received study medication. The number of patients in the fentanyl sublingual spray maintenance group includes 179 patients who completed the fentanyl sublingual spray titration period of the study plus 90 patients who entered the study directly in the maintenance period.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/229 • All adverse events were followed to resolution, an outcome had been reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study (up to 150 days).
Safety population: All patients (n=319) who received study medication. The number of patients in the fentanyl sublingual spray maintenance group includes 179 patients who completed the fentanyl sublingual spray titration period of the study plus 90 patients who entered the study directly in the maintenance period.
|
0.37%
1/269 • All adverse events were followed to resolution, an outcome had been reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study (up to 150 days).
Safety population: All patients (n=319) who received study medication. The number of patients in the fentanyl sublingual spray maintenance group includes 179 patients who completed the fentanyl sublingual spray titration period of the study plus 90 patients who entered the study directly in the maintenance period.
|
|
Infections and infestations
Oesophageal candidiasis
|
0.00%
0/229 • All adverse events were followed to resolution, an outcome had been reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study (up to 150 days).
Safety population: All patients (n=319) who received study medication. The number of patients in the fentanyl sublingual spray maintenance group includes 179 patients who completed the fentanyl sublingual spray titration period of the study plus 90 patients who entered the study directly in the maintenance period.
|
0.37%
1/269 • All adverse events were followed to resolution, an outcome had been reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study (up to 150 days).
Safety population: All patients (n=319) who received study medication. The number of patients in the fentanyl sublingual spray maintenance group includes 179 patients who completed the fentanyl sublingual spray titration period of the study plus 90 patients who entered the study directly in the maintenance period.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/229 • All adverse events were followed to resolution, an outcome had been reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study (up to 150 days).
Safety population: All patients (n=319) who received study medication. The number of patients in the fentanyl sublingual spray maintenance group includes 179 patients who completed the fentanyl sublingual spray titration period of the study plus 90 patients who entered the study directly in the maintenance period.
|
1.5%
4/269 • All adverse events were followed to resolution, an outcome had been reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study (up to 150 days).
Safety population: All patients (n=319) who received study medication. The number of patients in the fentanyl sublingual spray maintenance group includes 179 patients who completed the fentanyl sublingual spray titration period of the study plus 90 patients who entered the study directly in the maintenance period.
|
|
Infections and infestations
Sepsis
|
0.00%
0/229 • All adverse events were followed to resolution, an outcome had been reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study (up to 150 days).
Safety population: All patients (n=319) who received study medication. The number of patients in the fentanyl sublingual spray maintenance group includes 179 patients who completed the fentanyl sublingual spray titration period of the study plus 90 patients who entered the study directly in the maintenance period.
|
0.37%
1/269 • All adverse events were followed to resolution, an outcome had been reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study (up to 150 days).
Safety population: All patients (n=319) who received study medication. The number of patients in the fentanyl sublingual spray maintenance group includes 179 patients who completed the fentanyl sublingual spray titration period of the study plus 90 patients who entered the study directly in the maintenance period.
|
|
Infections and infestations
Septic shock
|
0.00%
0/229 • All adverse events were followed to resolution, an outcome had been reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study (up to 150 days).
Safety population: All patients (n=319) who received study medication. The number of patients in the fentanyl sublingual spray maintenance group includes 179 patients who completed the fentanyl sublingual spray titration period of the study plus 90 patients who entered the study directly in the maintenance period.
|
0.37%
1/269 • All adverse events were followed to resolution, an outcome had been reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study (up to 150 days).
Safety population: All patients (n=319) who received study medication. The number of patients in the fentanyl sublingual spray maintenance group includes 179 patients who completed the fentanyl sublingual spray titration period of the study plus 90 patients who entered the study directly in the maintenance period.
|
|
Infections and infestations
Streptococcal bacteraemia
|
0.00%
0/229 • All adverse events were followed to resolution, an outcome had been reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study (up to 150 days).
Safety population: All patients (n=319) who received study medication. The number of patients in the fentanyl sublingual spray maintenance group includes 179 patients who completed the fentanyl sublingual spray titration period of the study plus 90 patients who entered the study directly in the maintenance period.
|
0.37%
1/269 • All adverse events were followed to resolution, an outcome had been reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study (up to 150 days).
Safety population: All patients (n=319) who received study medication. The number of patients in the fentanyl sublingual spray maintenance group includes 179 patients who completed the fentanyl sublingual spray titration period of the study plus 90 patients who entered the study directly in the maintenance period.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/229 • All adverse events were followed to resolution, an outcome had been reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study (up to 150 days).
Safety population: All patients (n=319) who received study medication. The number of patients in the fentanyl sublingual spray maintenance group includes 179 patients who completed the fentanyl sublingual spray titration period of the study plus 90 patients who entered the study directly in the maintenance period.
|
0.37%
1/269 • All adverse events were followed to resolution, an outcome had been reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study (up to 150 days).
Safety population: All patients (n=319) who received study medication. The number of patients in the fentanyl sublingual spray maintenance group includes 179 patients who completed the fentanyl sublingual spray titration period of the study plus 90 patients who entered the study directly in the maintenance period.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.00%
0/229 • All adverse events were followed to resolution, an outcome had been reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study (up to 150 days).
Safety population: All patients (n=319) who received study medication. The number of patients in the fentanyl sublingual spray maintenance group includes 179 patients who completed the fentanyl sublingual spray titration period of the study plus 90 patients who entered the study directly in the maintenance period.
|
0.37%
1/269 • All adverse events were followed to resolution, an outcome had been reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study (up to 150 days).
Safety population: All patients (n=319) who received study medication. The number of patients in the fentanyl sublingual spray maintenance group includes 179 patients who completed the fentanyl sublingual spray titration period of the study plus 90 patients who entered the study directly in the maintenance period.
|
|
Injury, poisoning and procedural complications
Fibula fracture
|
0.00%
0/229 • All adverse events were followed to resolution, an outcome had been reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study (up to 150 days).
Safety population: All patients (n=319) who received study medication. The number of patients in the fentanyl sublingual spray maintenance group includes 179 patients who completed the fentanyl sublingual spray titration period of the study plus 90 patients who entered the study directly in the maintenance period.
|
0.37%
1/269 • All adverse events were followed to resolution, an outcome had been reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study (up to 150 days).
Safety population: All patients (n=319) who received study medication. The number of patients in the fentanyl sublingual spray maintenance group includes 179 patients who completed the fentanyl sublingual spray titration period of the study plus 90 patients who entered the study directly in the maintenance period.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/229 • All adverse events were followed to resolution, an outcome had been reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study (up to 150 days).
Safety population: All patients (n=319) who received study medication. The number of patients in the fentanyl sublingual spray maintenance group includes 179 patients who completed the fentanyl sublingual spray titration period of the study plus 90 patients who entered the study directly in the maintenance period.
|
0.37%
1/269 • All adverse events were followed to resolution, an outcome had been reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study (up to 150 days).
Safety population: All patients (n=319) who received study medication. The number of patients in the fentanyl sublingual spray maintenance group includes 179 patients who completed the fentanyl sublingual spray titration period of the study plus 90 patients who entered the study directly in the maintenance period.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.00%
0/229 • All adverse events were followed to resolution, an outcome had been reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study (up to 150 days).
Safety population: All patients (n=319) who received study medication. The number of patients in the fentanyl sublingual spray maintenance group includes 179 patients who completed the fentanyl sublingual spray titration period of the study plus 90 patients who entered the study directly in the maintenance period.
|
0.37%
1/269 • All adverse events were followed to resolution, an outcome had been reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study (up to 150 days).
Safety population: All patients (n=319) who received study medication. The number of patients in the fentanyl sublingual spray maintenance group includes 179 patients who completed the fentanyl sublingual spray titration period of the study plus 90 patients who entered the study directly in the maintenance period.
|
|
Injury, poisoning and procedural complications
Open wound
|
0.00%
0/229 • All adverse events were followed to resolution, an outcome had been reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study (up to 150 days).
Safety population: All patients (n=319) who received study medication. The number of patients in the fentanyl sublingual spray maintenance group includes 179 patients who completed the fentanyl sublingual spray titration period of the study plus 90 patients who entered the study directly in the maintenance period.
|
0.37%
1/269 • All adverse events were followed to resolution, an outcome had been reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study (up to 150 days).
Safety population: All patients (n=319) who received study medication. The number of patients in the fentanyl sublingual spray maintenance group includes 179 patients who completed the fentanyl sublingual spray titration period of the study plus 90 patients who entered the study directly in the maintenance period.
|
|
Injury, poisoning and procedural complications
Wound
|
0.00%
0/229 • All adverse events were followed to resolution, an outcome had been reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study (up to 150 days).
Safety population: All patients (n=319) who received study medication. The number of patients in the fentanyl sublingual spray maintenance group includes 179 patients who completed the fentanyl sublingual spray titration period of the study plus 90 patients who entered the study directly in the maintenance period.
|
0.37%
1/269 • All adverse events were followed to resolution, an outcome had been reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study (up to 150 days).
Safety population: All patients (n=319) who received study medication. The number of patients in the fentanyl sublingual spray maintenance group includes 179 patients who completed the fentanyl sublingual spray titration period of the study plus 90 patients who entered the study directly in the maintenance period.
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/229 • All adverse events were followed to resolution, an outcome had been reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study (up to 150 days).
Safety population: All patients (n=319) who received study medication. The number of patients in the fentanyl sublingual spray maintenance group includes 179 patients who completed the fentanyl sublingual spray titration period of the study plus 90 patients who entered the study directly in the maintenance period.
|
0.37%
1/269 • All adverse events were followed to resolution, an outcome had been reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study (up to 150 days).
Safety population: All patients (n=319) who received study medication. The number of patients in the fentanyl sublingual spray maintenance group includes 179 patients who completed the fentanyl sublingual spray titration period of the study plus 90 patients who entered the study directly in the maintenance period.
|
|
Investigations
International normalised ratio decreased
|
0.00%
0/229 • All adverse events were followed to resolution, an outcome had been reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study (up to 150 days).
Safety population: All patients (n=319) who received study medication. The number of patients in the fentanyl sublingual spray maintenance group includes 179 patients who completed the fentanyl sublingual spray titration period of the study plus 90 patients who entered the study directly in the maintenance period.
|
0.37%
1/269 • All adverse events were followed to resolution, an outcome had been reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study (up to 150 days).
Safety population: All patients (n=319) who received study medication. The number of patients in the fentanyl sublingual spray maintenance group includes 179 patients who completed the fentanyl sublingual spray titration period of the study plus 90 patients who entered the study directly in the maintenance period.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/229 • All adverse events were followed to resolution, an outcome had been reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study (up to 150 days).
Safety population: All patients (n=319) who received study medication. The number of patients in the fentanyl sublingual spray maintenance group includes 179 patients who completed the fentanyl sublingual spray titration period of the study plus 90 patients who entered the study directly in the maintenance period.
|
0.37%
1/269 • All adverse events were followed to resolution, an outcome had been reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study (up to 150 days).
Safety population: All patients (n=319) who received study medication. The number of patients in the fentanyl sublingual spray maintenance group includes 179 patients who completed the fentanyl sublingual spray titration period of the study plus 90 patients who entered the study directly in the maintenance period.
|
|
Metabolism and nutrition disorders
Electrolyte imbalance
|
0.00%
0/229 • All adverse events were followed to resolution, an outcome had been reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study (up to 150 days).
Safety population: All patients (n=319) who received study medication. The number of patients in the fentanyl sublingual spray maintenance group includes 179 patients who completed the fentanyl sublingual spray titration period of the study plus 90 patients who entered the study directly in the maintenance period.
|
0.74%
2/269 • All adverse events were followed to resolution, an outcome had been reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study (up to 150 days).
Safety population: All patients (n=319) who received study medication. The number of patients in the fentanyl sublingual spray maintenance group includes 179 patients who completed the fentanyl sublingual spray titration period of the study plus 90 patients who entered the study directly in the maintenance period.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/229 • All adverse events were followed to resolution, an outcome had been reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study (up to 150 days).
Safety population: All patients (n=319) who received study medication. The number of patients in the fentanyl sublingual spray maintenance group includes 179 patients who completed the fentanyl sublingual spray titration period of the study plus 90 patients who entered the study directly in the maintenance period.
|
0.37%
1/269 • All adverse events were followed to resolution, an outcome had been reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study (up to 150 days).
Safety population: All patients (n=319) who received study medication. The number of patients in the fentanyl sublingual spray maintenance group includes 179 patients who completed the fentanyl sublingual spray titration period of the study plus 90 patients who entered the study directly in the maintenance period.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/229 • All adverse events were followed to resolution, an outcome had been reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study (up to 150 days).
Safety population: All patients (n=319) who received study medication. The number of patients in the fentanyl sublingual spray maintenance group includes 179 patients who completed the fentanyl sublingual spray titration period of the study plus 90 patients who entered the study directly in the maintenance period.
|
0.37%
1/269 • All adverse events were followed to resolution, an outcome had been reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study (up to 150 days).
Safety population: All patients (n=319) who received study medication. The number of patients in the fentanyl sublingual spray maintenance group includes 179 patients who completed the fentanyl sublingual spray titration period of the study plus 90 patients who entered the study directly in the maintenance period.
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
0.00%
0/229 • All adverse events were followed to resolution, an outcome had been reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study (up to 150 days).
Safety population: All patients (n=319) who received study medication. The number of patients in the fentanyl sublingual spray maintenance group includes 179 patients who completed the fentanyl sublingual spray titration period of the study plus 90 patients who entered the study directly in the maintenance period.
|
0.37%
1/269 • All adverse events were followed to resolution, an outcome had been reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study (up to 150 days).
Safety population: All patients (n=319) who received study medication. The number of patients in the fentanyl sublingual spray maintenance group includes 179 patients who completed the fentanyl sublingual spray titration period of the study plus 90 patients who entered the study directly in the maintenance period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.00%
0/229 • All adverse events were followed to resolution, an outcome had been reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study (up to 150 days).
Safety population: All patients (n=319) who received study medication. The number of patients in the fentanyl sublingual spray maintenance group includes 179 patients who completed the fentanyl sublingual spray titration period of the study plus 90 patients who entered the study directly in the maintenance period.
|
0.37%
1/269 • All adverse events were followed to resolution, an outcome had been reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study (up to 150 days).
Safety population: All patients (n=319) who received study medication. The number of patients in the fentanyl sublingual spray maintenance group includes 179 patients who completed the fentanyl sublingual spray titration period of the study plus 90 patients who entered the study directly in the maintenance period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer metastatic
|
0.00%
0/229 • All adverse events were followed to resolution, an outcome had been reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study (up to 150 days).
Safety population: All patients (n=319) who received study medication. The number of patients in the fentanyl sublingual spray maintenance group includes 179 patients who completed the fentanyl sublingual spray titration period of the study plus 90 patients who entered the study directly in the maintenance period.
|
0.37%
1/269 • All adverse events were followed to resolution, an outcome had been reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study (up to 150 days).
Safety population: All patients (n=319) who received study medication. The number of patients in the fentanyl sublingual spray maintenance group includes 179 patients who completed the fentanyl sublingual spray titration period of the study plus 90 patients who entered the study directly in the maintenance period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
0.00%
0/229 • All adverse events were followed to resolution, an outcome had been reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study (up to 150 days).
Safety population: All patients (n=319) who received study medication. The number of patients in the fentanyl sublingual spray maintenance group includes 179 patients who completed the fentanyl sublingual spray titration period of the study plus 90 patients who entered the study directly in the maintenance period.
|
1.5%
4/269 • All adverse events were followed to resolution, an outcome had been reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study (up to 150 days).
Safety population: All patients (n=319) who received study medication. The number of patients in the fentanyl sublingual spray maintenance group includes 179 patients who completed the fentanyl sublingual spray titration period of the study plus 90 patients who entered the study directly in the maintenance period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer metastatic
|
0.00%
0/229 • All adverse events were followed to resolution, an outcome had been reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study (up to 150 days).
Safety population: All patients (n=319) who received study medication. The number of patients in the fentanyl sublingual spray maintenance group includes 179 patients who completed the fentanyl sublingual spray titration period of the study plus 90 patients who entered the study directly in the maintenance period.
|
0.37%
1/269 • All adverse events were followed to resolution, an outcome had been reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study (up to 150 days).
Safety population: All patients (n=319) who received study medication. The number of patients in the fentanyl sublingual spray maintenance group includes 179 patients who completed the fentanyl sublingual spray titration period of the study plus 90 patients who entered the study directly in the maintenance period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Laryngeal cancer
|
0.00%
0/229 • All adverse events were followed to resolution, an outcome had been reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study (up to 150 days).
Safety population: All patients (n=319) who received study medication. The number of patients in the fentanyl sublingual spray maintenance group includes 179 patients who completed the fentanyl sublingual spray titration period of the study plus 90 patients who entered the study directly in the maintenance period.
|
0.37%
1/269 • All adverse events were followed to resolution, an outcome had been reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study (up to 150 days).
Safety population: All patients (n=319) who received study medication. The number of patients in the fentanyl sublingual spray maintenance group includes 179 patients who completed the fentanyl sublingual spray titration period of the study plus 90 patients who entered the study directly in the maintenance period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lip and/or oral cavity cancer
|
0.00%
0/229 • All adverse events were followed to resolution, an outcome had been reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study (up to 150 days).
Safety population: All patients (n=319) who received study medication. The number of patients in the fentanyl sublingual spray maintenance group includes 179 patients who completed the fentanyl sublingual spray titration period of the study plus 90 patients who entered the study directly in the maintenance period.
|
0.37%
1/269 • All adverse events were followed to resolution, an outcome had been reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study (up to 150 days).
Safety population: All patients (n=319) who received study medication. The number of patients in the fentanyl sublingual spray maintenance group includes 179 patients who completed the fentanyl sublingual spray titration period of the study plus 90 patients who entered the study directly in the maintenance period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.00%
0/229 • All adverse events were followed to resolution, an outcome had been reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study (up to 150 days).
Safety population: All patients (n=319) who received study medication. The number of patients in the fentanyl sublingual spray maintenance group includes 179 patients who completed the fentanyl sublingual spray titration period of the study plus 90 patients who entered the study directly in the maintenance period.
|
0.37%
1/269 • All adverse events were followed to resolution, an outcome had been reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study (up to 150 days).
Safety population: All patients (n=319) who received study medication. The number of patients in the fentanyl sublingual spray maintenance group includes 179 patients who completed the fentanyl sublingual spray titration period of the study plus 90 patients who entered the study directly in the maintenance period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to bone
|
0.00%
0/229 • All adverse events were followed to resolution, an outcome had been reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study (up to 150 days).
Safety population: All patients (n=319) who received study medication. The number of patients in the fentanyl sublingual spray maintenance group includes 179 patients who completed the fentanyl sublingual spray titration period of the study plus 90 patients who entered the study directly in the maintenance period.
|
0.37%
1/269 • All adverse events were followed to resolution, an outcome had been reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study (up to 150 days).
Safety population: All patients (n=319) who received study medication. The number of patients in the fentanyl sublingual spray maintenance group includes 179 patients who completed the fentanyl sublingual spray titration period of the study plus 90 patients who entered the study directly in the maintenance period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to spine
|
0.00%
0/229 • All adverse events were followed to resolution, an outcome had been reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study (up to 150 days).
Safety population: All patients (n=319) who received study medication. The number of patients in the fentanyl sublingual spray maintenance group includes 179 patients who completed the fentanyl sublingual spray titration period of the study plus 90 patients who entered the study directly in the maintenance period.
|
0.37%
1/269 • All adverse events were followed to resolution, an outcome had been reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study (up to 150 days).
Safety population: All patients (n=319) who received study medication. The number of patients in the fentanyl sublingual spray maintenance group includes 179 patients who completed the fentanyl sublingual spray titration period of the study plus 90 patients who entered the study directly in the maintenance period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Multiple myeloma
|
0.00%
0/229 • All adverse events were followed to resolution, an outcome had been reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study (up to 150 days).
Safety population: All patients (n=319) who received study medication. The number of patients in the fentanyl sublingual spray maintenance group includes 179 patients who completed the fentanyl sublingual spray titration period of the study plus 90 patients who entered the study directly in the maintenance period.
|
0.37%
1/269 • All adverse events were followed to resolution, an outcome had been reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study (up to 150 days).
Safety population: All patients (n=319) who received study medication. The number of patients in the fentanyl sublingual spray maintenance group includes 179 patients who completed the fentanyl sublingual spray titration period of the study plus 90 patients who entered the study directly in the maintenance period.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/229 • All adverse events were followed to resolution, an outcome had been reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study (up to 150 days).
Safety population: All patients (n=319) who received study medication. The number of patients in the fentanyl sublingual spray maintenance group includes 179 patients who completed the fentanyl sublingual spray titration period of the study plus 90 patients who entered the study directly in the maintenance period.
|
0.37%
1/269 • All adverse events were followed to resolution, an outcome had been reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study (up to 150 days).
Safety population: All patients (n=319) who received study medication. The number of patients in the fentanyl sublingual spray maintenance group includes 179 patients who completed the fentanyl sublingual spray titration period of the study plus 90 patients who entered the study directly in the maintenance period.
|
|
Renal and urinary disorders
Real failure acute
|
0.00%
0/229 • All adverse events were followed to resolution, an outcome had been reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study (up to 150 days).
Safety population: All patients (n=319) who received study medication. The number of patients in the fentanyl sublingual spray maintenance group includes 179 patients who completed the fentanyl sublingual spray titration period of the study plus 90 patients who entered the study directly in the maintenance period.
|
0.37%
1/269 • All adverse events were followed to resolution, an outcome had been reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study (up to 150 days).
Safety population: All patients (n=319) who received study medication. The number of patients in the fentanyl sublingual spray maintenance group includes 179 patients who completed the fentanyl sublingual spray titration period of the study plus 90 patients who entered the study directly in the maintenance period.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/229 • All adverse events were followed to resolution, an outcome had been reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study (up to 150 days).
Safety population: All patients (n=319) who received study medication. The number of patients in the fentanyl sublingual spray maintenance group includes 179 patients who completed the fentanyl sublingual spray titration period of the study plus 90 patients who entered the study directly in the maintenance period.
|
0.37%
1/269 • All adverse events were followed to resolution, an outcome had been reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study (up to 150 days).
Safety population: All patients (n=319) who received study medication. The number of patients in the fentanyl sublingual spray maintenance group includes 179 patients who completed the fentanyl sublingual spray titration period of the study plus 90 patients who entered the study directly in the maintenance period.
|
|
Respiratory, thoracic and mediastinal disorders
Emphysema
|
0.00%
0/229 • All adverse events were followed to resolution, an outcome had been reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study (up to 150 days).
Safety population: All patients (n=319) who received study medication. The number of patients in the fentanyl sublingual spray maintenance group includes 179 patients who completed the fentanyl sublingual spray titration period of the study plus 90 patients who entered the study directly in the maintenance period.
|
0.37%
1/269 • All adverse events were followed to resolution, an outcome had been reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study (up to 150 days).
Safety population: All patients (n=319) who received study medication. The number of patients in the fentanyl sublingual spray maintenance group includes 179 patients who completed the fentanyl sublingual spray titration period of the study plus 90 patients who entered the study directly in the maintenance period.
|
|
Skin and subcutaneous tissue disorders
Blister
|
0.00%
0/229 • All adverse events were followed to resolution, an outcome had been reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study (up to 150 days).
Safety population: All patients (n=319) who received study medication. The number of patients in the fentanyl sublingual spray maintenance group includes 179 patients who completed the fentanyl sublingual spray titration period of the study plus 90 patients who entered the study directly in the maintenance period.
|
0.37%
1/269 • All adverse events were followed to resolution, an outcome had been reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study (up to 150 days).
Safety population: All patients (n=319) who received study medication. The number of patients in the fentanyl sublingual spray maintenance group includes 179 patients who completed the fentanyl sublingual spray titration period of the study plus 90 patients who entered the study directly in the maintenance period.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/229 • All adverse events were followed to resolution, an outcome had been reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study (up to 150 days).
Safety population: All patients (n=319) who received study medication. The number of patients in the fentanyl sublingual spray maintenance group includes 179 patients who completed the fentanyl sublingual spray titration period of the study plus 90 patients who entered the study directly in the maintenance period.
|
0.74%
2/269 • All adverse events were followed to resolution, an outcome had been reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study (up to 150 days).
Safety population: All patients (n=319) who received study medication. The number of patients in the fentanyl sublingual spray maintenance group includes 179 patients who completed the fentanyl sublingual spray titration period of the study plus 90 patients who entered the study directly in the maintenance period.
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/229 • All adverse events were followed to resolution, an outcome had been reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study (up to 150 days).
Safety population: All patients (n=319) who received study medication. The number of patients in the fentanyl sublingual spray maintenance group includes 179 patients who completed the fentanyl sublingual spray titration period of the study plus 90 patients who entered the study directly in the maintenance period.
|
0.37%
1/269 • All adverse events were followed to resolution, an outcome had been reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study (up to 150 days).
Safety population: All patients (n=319) who received study medication. The number of patients in the fentanyl sublingual spray maintenance group includes 179 patients who completed the fentanyl sublingual spray titration period of the study plus 90 patients who entered the study directly in the maintenance period.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/229 • All adverse events were followed to resolution, an outcome had been reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study (up to 150 days).
Safety population: All patients (n=319) who received study medication. The number of patients in the fentanyl sublingual spray maintenance group includes 179 patients who completed the fentanyl sublingual spray titration period of the study plus 90 patients who entered the study directly in the maintenance period.
|
1.1%
3/269 • All adverse events were followed to resolution, an outcome had been reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study (up to 150 days).
Safety population: All patients (n=319) who received study medication. The number of patients in the fentanyl sublingual spray maintenance group includes 179 patients who completed the fentanyl sublingual spray titration period of the study plus 90 patients who entered the study directly in the maintenance period.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/229 • All adverse events were followed to resolution, an outcome had been reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study (up to 150 days).
Safety population: All patients (n=319) who received study medication. The number of patients in the fentanyl sublingual spray maintenance group includes 179 patients who completed the fentanyl sublingual spray titration period of the study plus 90 patients who entered the study directly in the maintenance period.
|
0.37%
1/269 • All adverse events were followed to resolution, an outcome had been reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study (up to 150 days).
Safety population: All patients (n=319) who received study medication. The number of patients in the fentanyl sublingual spray maintenance group includes 179 patients who completed the fentanyl sublingual spray titration period of the study plus 90 patients who entered the study directly in the maintenance period.
|
Other adverse events
| Measure |
Fentanyl Sublingual Spray Titration
n=229 participants at risk
Patients received fentanyl sublingual spray to treat up to a maximum of 4 breakthrough pain episodes per day with a minimum separation of 4 hours between treatments. Patients 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 26 days was reached.
|
Fentanyl Sublingual Spray Maintenance
n=269 participants at risk
Patients received fentanyl sublingual spray up to a maximum of 4 times per day with a minimum separation of 4 hours between treatments for 90 days. Patients received a dose of 100 to 1600 µg determined in a previous study (INS-05-001, NCT00538850) or in the open-label dose titration period of the current study. The dose administered provided adequate analgesia for breakthrough pain without unacceptable side effects.
|
|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
3.1%
7/229 • All adverse events were followed to resolution, an outcome had been reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study (up to 150 days).
Safety population: All patients (n=319) who received study medication. The number of patients in the fentanyl sublingual spray maintenance group includes 179 patients who completed the fentanyl sublingual spray titration period of the study plus 90 patients who entered the study directly in the maintenance period.
|
24.2%
65/269 • All adverse events were followed to resolution, an outcome had been reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study (up to 150 days).
Safety population: All patients (n=319) who received study medication. The number of patients in the fentanyl sublingual spray maintenance group includes 179 patients who completed the fentanyl sublingual spray titration period of the study plus 90 patients who entered the study directly in the maintenance period.
|
|
Gastrointestinal disorders
Vomiting
|
11.8%
27/229 • All adverse events were followed to resolution, an outcome had been reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study (up to 150 days).
Safety population: All patients (n=319) who received study medication. The number of patients in the fentanyl sublingual spray maintenance group includes 179 patients who completed the fentanyl sublingual spray titration period of the study plus 90 patients who entered the study directly in the maintenance period.
|
16.0%
43/269 • All adverse events were followed to resolution, an outcome had been reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study (up to 150 days).
Safety population: All patients (n=319) who received study medication. The number of patients in the fentanyl sublingual spray maintenance group includes 179 patients who completed the fentanyl sublingual spray titration period of the study plus 90 patients who entered the study directly in the maintenance period.
|
|
Gastrointestinal disorders
Nausea
|
13.1%
30/229 • All adverse events were followed to resolution, an outcome had been reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study (up to 150 days).
Safety population: All patients (n=319) who received study medication. The number of patients in the fentanyl sublingual spray maintenance group includes 179 patients who completed the fentanyl sublingual spray titration period of the study plus 90 patients who entered the study directly in the maintenance period.
|
10.4%
28/269 • All adverse events were followed to resolution, an outcome had been reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study (up to 150 days).
Safety population: All patients (n=319) who received study medication. The number of patients in the fentanyl sublingual spray maintenance group includes 179 patients who completed the fentanyl sublingual spray titration period of the study plus 90 patients who entered the study directly in the maintenance period.
|
|
Nervous system disorders
Somnolence
|
10.0%
23/229 • All adverse events were followed to resolution, an outcome had been reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study (up to 150 days).
Safety population: All patients (n=319) who received study medication. The number of patients in the fentanyl sublingual spray maintenance group includes 179 patients who completed the fentanyl sublingual spray titration period of the study plus 90 patients who entered the study directly in the maintenance period.
|
3.7%
10/269 • All adverse events were followed to resolution, an outcome had been reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study (up to 150 days).
Safety population: All patients (n=319) who received study medication. The number of patients in the fentanyl sublingual spray maintenance group includes 179 patients who completed the fentanyl sublingual spray titration period of the study plus 90 patients who entered the study directly in the maintenance period.
|
|
General disorders
Oedema peripheral
|
3.1%
7/229 • All adverse events were followed to resolution, an outcome had been reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study (up to 150 days).
Safety population: All patients (n=319) who received study medication. The number of patients in the fentanyl sublingual spray maintenance group includes 179 patients who completed the fentanyl sublingual spray titration period of the study plus 90 patients who entered the study directly in the maintenance period.
|
11.5%
31/269 • All adverse events were followed to resolution, an outcome had been reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study (up to 150 days).
Safety population: All patients (n=319) who received study medication. The number of patients in the fentanyl sublingual spray maintenance group includes 179 patients who completed the fentanyl sublingual spray titration period of the study plus 90 patients who entered the study directly in the maintenance period.
|
|
Gastrointestinal disorders
Constipation
|
5.7%
13/229 • All adverse events were followed to resolution, an outcome had been reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study (up to 150 days).
Safety population: All patients (n=319) who received study medication. The number of patients in the fentanyl sublingual spray maintenance group includes 179 patients who completed the fentanyl sublingual spray titration period of the study plus 90 patients who entered the study directly in the maintenance period.
|
10.4%
28/269 • All adverse events were followed to resolution, an outcome had been reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study (up to 150 days).
Safety population: All patients (n=319) who received study medication. The number of patients in the fentanyl sublingual spray maintenance group includes 179 patients who completed the fentanyl sublingual spray titration period of the study plus 90 patients who entered the study directly in the maintenance period.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
3.1%
7/229 • All adverse events were followed to resolution, an outcome had been reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study (up to 150 days).
Safety population: All patients (n=319) who received study medication. The number of patients in the fentanyl sublingual spray maintenance group includes 179 patients who completed the fentanyl sublingual spray titration period of the study plus 90 patients who entered the study directly in the maintenance period.
|
10.4%
28/269 • All adverse events were followed to resolution, an outcome had been reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study (up to 150 days).
Safety population: All patients (n=319) who received study medication. The number of patients in the fentanyl sublingual spray maintenance group includes 179 patients who completed the fentanyl sublingual spray titration period of the study plus 90 patients who entered the study directly in the maintenance period.
|
|
General disorders
Asthenia
|
1.7%
4/229 • All adverse events were followed to resolution, an outcome had been reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study (up to 150 days).
Safety population: All patients (n=319) who received study medication. The number of patients in the fentanyl sublingual spray maintenance group includes 179 patients who completed the fentanyl sublingual spray titration period of the study plus 90 patients who entered the study directly in the maintenance period.
|
9.7%
26/269 • All adverse events were followed to resolution, an outcome had been reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study (up to 150 days).
Safety population: All patients (n=319) who received study medication. The number of patients in the fentanyl sublingual spray maintenance group includes 179 patients who completed the fentanyl sublingual spray titration period of the study plus 90 patients who entered the study directly in the maintenance period.
|
|
General disorders
Fatigue
|
3.1%
7/229 • All adverse events were followed to resolution, an outcome had been reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study (up to 150 days).
Safety population: All patients (n=319) who received study medication. The number of patients in the fentanyl sublingual spray maintenance group includes 179 patients who completed the fentanyl sublingual spray titration period of the study plus 90 patients who entered the study directly in the maintenance period.
|
8.6%
23/269 • All adverse events were followed to resolution, an outcome had been reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study (up to 150 days).
Safety population: All patients (n=319) who received study medication. The number of patients in the fentanyl sublingual spray maintenance group includes 179 patients who completed the fentanyl sublingual spray titration period of the study plus 90 patients who entered the study directly in the maintenance period.
|
|
General disorders
Application site irritation
|
7.4%
17/229 • All adverse events were followed to resolution, an outcome had been reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study (up to 150 days).
Safety population: All patients (n=319) who received study medication. The number of patients in the fentanyl sublingual spray maintenance group includes 179 patients who completed the fentanyl sublingual spray titration period of the study plus 90 patients who entered the study directly in the maintenance period.
|
1.1%
3/269 • All adverse events were followed to resolution, an outcome had been reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study (up to 150 days).
Safety population: All patients (n=319) who received study medication. The number of patients in the fentanyl sublingual spray maintenance group includes 179 patients who completed the fentanyl sublingual spray titration period of the study plus 90 patients who entered the study directly in the maintenance period.
|
|
Gastrointestinal disorders
Diarrhoea
|
3.5%
8/229 • All adverse events were followed to resolution, an outcome had been reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study (up to 150 days).
Safety population: All patients (n=319) who received study medication. The number of patients in the fentanyl sublingual spray maintenance group includes 179 patients who completed the fentanyl sublingual spray titration period of the study plus 90 patients who entered the study directly in the maintenance period.
|
7.4%
20/269 • All adverse events were followed to resolution, an outcome had been reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study (up to 150 days).
Safety population: All patients (n=319) who received study medication. The number of patients in the fentanyl sublingual spray maintenance group includes 179 patients who completed the fentanyl sublingual spray titration period of the study plus 90 patients who entered the study directly in the maintenance period.
|
|
Nervous system disorders
Dizziness
|
7.0%
16/229 • All adverse events were followed to resolution, an outcome had been reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study (up to 150 days).
Safety population: All patients (n=319) who received study medication. The number of patients in the fentanyl sublingual spray maintenance group includes 179 patients who completed the fentanyl sublingual spray titration period of the study plus 90 patients who entered the study directly in the maintenance period.
|
1.1%
3/269 • All adverse events were followed to resolution, an outcome had been reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study (up to 150 days).
Safety population: All patients (n=319) who received study medication. The number of patients in the fentanyl sublingual spray maintenance group includes 179 patients who completed the fentanyl sublingual spray titration period of the study plus 90 patients who entered the study directly in the maintenance period.
|
|
General disorders
Pyrexia
|
4.8%
11/229 • All adverse events were followed to resolution, an outcome had been reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study (up to 150 days).
Safety population: All patients (n=319) who received study medication. The number of patients in the fentanyl sublingual spray maintenance group includes 179 patients who completed the fentanyl sublingual spray titration period of the study plus 90 patients who entered the study directly in the maintenance period.
|
6.7%
18/269 • All adverse events were followed to resolution, an outcome had been reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study (up to 150 days).
Safety population: All patients (n=319) who received study medication. The number of patients in the fentanyl sublingual spray maintenance group includes 179 patients who completed the fentanyl sublingual spray titration period of the study plus 90 patients who entered the study directly in the maintenance period.
|
|
Blood and lymphatic system disorders
Anaemia
|
1.3%
3/229 • All adverse events were followed to resolution, an outcome had been reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study (up to 150 days).
Safety population: All patients (n=319) who received study medication. The number of patients in the fentanyl sublingual spray maintenance group includes 179 patients who completed the fentanyl sublingual spray titration period of the study plus 90 patients who entered the study directly in the maintenance period.
|
6.3%
17/269 • All adverse events were followed to resolution, an outcome had been reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study (up to 150 days).
Safety population: All patients (n=319) who received study medication. The number of patients in the fentanyl sublingual spray maintenance group includes 179 patients who completed the fentanyl sublingual spray titration period of the study plus 90 patients who entered the study directly in the maintenance period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
2.6%
6/229 • All adverse events were followed to resolution, an outcome had been reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study (up to 150 days).
Safety population: All patients (n=319) who received study medication. The number of patients in the fentanyl sublingual spray maintenance group includes 179 patients who completed the fentanyl sublingual spray titration period of the study plus 90 patients who entered the study directly in the maintenance period.
|
6.3%
17/269 • All adverse events were followed to resolution, an outcome had been reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study (up to 150 days).
Safety population: All patients (n=319) who received study medication. The number of patients in the fentanyl sublingual spray maintenance group includes 179 patients who completed the fentanyl sublingual spray titration period of the study plus 90 patients who entered the study directly in the maintenance period.
|
|
Psychiatric disorders
Anxiety
|
1.3%
3/229 • All adverse events were followed to resolution, an outcome had been reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study (up to 150 days).
Safety population: All patients (n=319) who received study medication. The number of patients in the fentanyl sublingual spray maintenance group includes 179 patients who completed the fentanyl sublingual spray titration period of the study plus 90 patients who entered the study directly in the maintenance period.
|
5.9%
16/269 • All adverse events were followed to resolution, an outcome had been reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study (up to 150 days).
Safety population: All patients (n=319) who received study medication. The number of patients in the fentanyl sublingual spray maintenance group includes 179 patients who completed the fentanyl sublingual spray titration period of the study plus 90 patients who entered the study directly in the maintenance period.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.87%
2/229 • All adverse events were followed to resolution, an outcome had been reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study (up to 150 days).
Safety population: All patients (n=319) who received study medication. The number of patients in the fentanyl sublingual spray maintenance group includes 179 patients who completed the fentanyl sublingual spray titration period of the study plus 90 patients who entered the study directly in the maintenance period.
|
5.6%
15/269 • All adverse events were followed to resolution, an outcome had been reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study (up to 150 days).
Safety population: All patients (n=319) who received study medication. The number of patients in the fentanyl sublingual spray maintenance group includes 179 patients who completed the fentanyl sublingual spray titration period of the study plus 90 patients who entered the study directly in the maintenance period.
|
|
Metabolism and nutrition disorders
Anorexia
|
0.87%
2/229 • All adverse events were followed to resolution, an outcome had been reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study (up to 150 days).
Safety population: All patients (n=319) who received study medication. The number of patients in the fentanyl sublingual spray maintenance group includes 179 patients who completed the fentanyl sublingual spray titration period of the study plus 90 patients who entered the study directly in the maintenance period.
|
5.2%
14/269 • All adverse events were followed to resolution, an outcome had been reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study (up to 150 days).
Safety population: All patients (n=319) who received study medication. The number of patients in the fentanyl sublingual spray maintenance group includes 179 patients who completed the fentanyl sublingual spray titration period of the study plus 90 patients who entered the study directly in the maintenance period.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.44%
1/229 • All adverse events were followed to resolution, an outcome had been reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study (up to 150 days).
Safety population: All patients (n=319) who received study medication. The number of patients in the fentanyl sublingual spray maintenance group includes 179 patients who completed the fentanyl sublingual spray titration period of the study plus 90 patients who entered the study directly in the maintenance period.
|
5.2%
14/269 • All adverse events were followed to resolution, an outcome had been reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study (up to 150 days).
Safety population: All patients (n=319) who received study medication. The number of patients in the fentanyl sublingual spray maintenance group includes 179 patients who completed the fentanyl sublingual spray titration period of the study plus 90 patients who entered the study directly in the maintenance period.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/229 • All adverse events were followed to resolution, an outcome had been reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study (up to 150 days).
Safety population: All patients (n=319) who received study medication. The number of patients in the fentanyl sublingual spray maintenance group includes 179 patients who completed the fentanyl sublingual spray titration period of the study plus 90 patients who entered the study directly in the maintenance period.
|
5.2%
14/269 • All adverse events were followed to resolution, an outcome had been reached, stabilization, or the event was otherwise explained regardless of whether the subject was still participating in the study (up to 150 days).
Safety population: All patients (n=319) who received study medication. The number of patients in the fentanyl sublingual spray maintenance group includes 179 patients who completed the fentanyl sublingual spray titration period of the study plus 90 patients who entered the study directly in the maintenance period.
|
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