Trial Outcomes & Findings for Study of the Safety of BEMA™ Fentanyl Use for Breakthrough Pain in Cancer Subjects on Chronic Opioid Therapy (NCT NCT00293020)
NCT ID: NCT00293020
Last Updated: 2012-10-05
Results Overview
After the first dose of BEMA Fentanyl, all adverse events were recorded and summarized.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
244 participants
Primary outcome timeframe
Participants were followed for the duration of the study, an average of 126 days
Results posted on
2012-10-05
Participant Flow
The enrollment period was 3/14/06 - 6/13/08. Subjects were recruited from academic \& private clinics in the US. Two groups of subjects were eligible for enrollment in this study. Subjects were eligible to enter this study following completion of the placebo-controlled study, FEN-201 or they were enrolled directly into this study.
Participant milestones
| Measure |
Open Label Fentanyl Treatment
BioErodible Muco Adhesive(BEMA) Fentanyl
|
|---|---|
|
Overall Study
STARTED
|
244
|
|
Overall Study
COMPLETED
|
82
|
|
Overall Study
NOT COMPLETED
|
162
|
Reasons for withdrawal
| Measure |
Open Label Fentanyl Treatment
BioErodible Muco Adhesive(BEMA) Fentanyl
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
34
|
|
Overall Study
Adverse Event
|
30
|
|
Overall Study
Death
|
32
|
|
Overall Study
Lack of Efficacy
|
12
|
|
Overall Study
Lost to Follow-up
|
4
|
|
Overall Study
Protocol Violation
|
6
|
|
Overall Study
Physician Decision
|
21
|
|
Overall Study
Other Reason
|
22
|
|
Overall Study
No dose taken
|
1
|
Baseline Characteristics
Study of the Safety of BEMA™ Fentanyl Use for Breakthrough Pain in Cancer Subjects on Chronic Opioid Therapy
Baseline characteristics by cohort
| Measure |
Open Label Fentanyl Treatment
n=243 Participants
BioErodible Muco Adhesive(BEMA) Fentanyl
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
168 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
75 Participants
n=5 Participants
|
|
Age Continuous
|
58.0 years
STANDARD_DEVIATION 12.12 • n=5 Participants
|
|
Sex: Female, Male
Female
|
128 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
115 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
23 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
209 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
9 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
243 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Participants were followed for the duration of the study, an average of 126 daysPopulation: All subjects that received at least 1 dose of study drug were included in the analysis.
After the first dose of BEMA Fentanyl, all adverse events were recorded and summarized.
Outcome measures
| Measure |
Open Label Fentanyl Treatment
n=243 Participants
BioErodible Muco Adhesive(BEMA) Fentanyl
|
|---|---|
|
Percentage of Participants With Adverse Events.
|
88.5 percentage of participants
|
Adverse Events
Open Label Fentanyl Treatment
Serious events: 121 serious events
Other events: 215 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Open Label Fentanyl Treatment
n=243 participants at risk
BioErodible Muco Adhesive(BEMA) Fentanyl
|
|---|---|
|
Blood and lymphatic system disorders
anemia
|
1.2%
3/243 • The duration of a subject's particpation in the trial.
From the start of study drug administration to the final follow-up visit.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.41%
1/243 • The duration of a subject's particpation in the trial.
From the start of study drug administration to the final follow-up visit.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.41%
1/243 • The duration of a subject's particpation in the trial.
From the start of study drug administration to the final follow-up visit.
|
|
Cardiac disorders
Bradycardia
|
0.41%
1/243 • The duration of a subject's particpation in the trial.
From the start of study drug administration to the final follow-up visit.
|
|
Cardiac disorders
Cardiac arrest
|
0.41%
1/243 • The duration of a subject's particpation in the trial.
From the start of study drug administration to the final follow-up visit.
|
|
Cardiac disorders
Cardiomyopathy
|
0.41%
1/243 • The duration of a subject's particpation in the trial.
From the start of study drug administration to the final follow-up visit.
|
|
Cardiac disorders
Myocardial infarction
|
0.41%
1/243 • The duration of a subject's particpation in the trial.
From the start of study drug administration to the final follow-up visit.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.82%
2/243 • The duration of a subject's particpation in the trial.
From the start of study drug administration to the final follow-up visit.
|
|
Gastrointestinal disorders
Ascites
|
0.41%
1/243 • The duration of a subject's particpation in the trial.
From the start of study drug administration to the final follow-up visit.
|
|
Gastrointestinal disorders
Dysphagia
|
1.2%
3/243 • The duration of a subject's particpation in the trial.
From the start of study drug administration to the final follow-up visit.
|
|
Gastrointestinal disorders
Gastrointestinal fistula
|
0.41%
1/243 • The duration of a subject's particpation in the trial.
From the start of study drug administration to the final follow-up visit.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.82%
2/243 • The duration of a subject's particpation in the trial.
From the start of study drug administration to the final follow-up visit.
|
|
Gastrointestinal disorders
Haematemesis
|
0.41%
1/243 • The duration of a subject's particpation in the trial.
From the start of study drug administration to the final follow-up visit.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.82%
2/243 • The duration of a subject's particpation in the trial.
From the start of study drug administration to the final follow-up visit.
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.41%
1/243 • The duration of a subject's particpation in the trial.
From the start of study drug administration to the final follow-up visit.
|
|
Gastrointestinal disorders
Nausea
|
0.41%
1/243 • The duration of a subject's particpation in the trial.
From the start of study drug administration to the final follow-up visit.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.82%
2/243 • The duration of a subject's particpation in the trial.
From the start of study drug administration to the final follow-up visit.
|
|
Gastrointestinal disorders
Vomiting
|
0.82%
2/243 • The duration of a subject's particpation in the trial.
From the start of study drug administration to the final follow-up visit.
|
|
General disorders
Chest pain
|
0.41%
1/243 • The duration of a subject's particpation in the trial.
From the start of study drug administration to the final follow-up visit.
|
|
General disorders
Disease progression
|
11.1%
27/243 • The duration of a subject's particpation in the trial.
From the start of study drug administration to the final follow-up visit.
|
|
General disorders
Implant site thrombosis
|
0.41%
1/243 • The duration of a subject's particpation in the trial.
From the start of study drug administration to the final follow-up visit.
|
|
General disorders
Mucosal inflammation
|
0.41%
1/243 • The duration of a subject's particpation in the trial.
From the start of study drug administration to the final follow-up visit.
|
|
General disorders
Pain
|
0.82%
2/243 • The duration of a subject's particpation in the trial.
From the start of study drug administration to the final follow-up visit.
|
|
General disorders
Pyrexia
|
0.82%
2/243 • The duration of a subject's particpation in the trial.
From the start of study drug administration to the final follow-up visit.
|
|
Hepatobiliary disorders
Bile duct obstruction
|
0.41%
1/243 • The duration of a subject's particpation in the trial.
From the start of study drug administration to the final follow-up visit.
|
|
Infections and infestations
Arthritis bacterial
|
0.41%
1/243 • The duration of a subject's particpation in the trial.
From the start of study drug administration to the final follow-up visit.
|
|
Infections and infestations
Bronchitis bacterial
|
0.41%
1/243 • The duration of a subject's particpation in the trial.
From the start of study drug administration to the final follow-up visit.
|
|
Infections and infestations
Cellulitis
|
1.2%
3/243 • The duration of a subject's particpation in the trial.
From the start of study drug administration to the final follow-up visit.
|
|
Infections and infestations
Cellulitis orbital
|
0.41%
1/243 • The duration of a subject's particpation in the trial.
From the start of study drug administration to the final follow-up visit.
|
|
Infections and infestations
Central line infection
|
0.41%
1/243 • The duration of a subject's particpation in the trial.
From the start of study drug administration to the final follow-up visit.
|
|
Infections and infestations
Chest wall abscess
|
0.41%
1/243 • The duration of a subject's particpation in the trial.
From the start of study drug administration to the final follow-up visit.
|
|
Infections and infestations
Gastroenteritis
|
0.41%
1/243 • The duration of a subject's particpation in the trial.
From the start of study drug administration to the final follow-up visit.
|
|
Infections and infestations
Infection
|
0.41%
1/243 • The duration of a subject's particpation in the trial.
From the start of study drug administration to the final follow-up visit.
|
|
Infections and infestations
Intervertebral discitis
|
0.41%
1/243 • The duration of a subject's particpation in the trial.
From the start of study drug administration to the final follow-up visit.
|
|
Infections and infestations
Klebsiella sepsis
|
0.41%
1/243 • The duration of a subject's particpation in the trial.
From the start of study drug administration to the final follow-up visit.
|
|
Infections and infestations
Lung abscess
|
0.41%
1/243 • The duration of a subject's particpation in the trial.
From the start of study drug administration to the final follow-up visit.
|
|
Infections and infestations
Osteomyelitis
|
0.41%
1/243 • The duration of a subject's particpation in the trial.
From the start of study drug administration to the final follow-up visit.
|
|
Infections and infestations
Pneumonia
|
7.0%
17/243 • The duration of a subject's particpation in the trial.
From the start of study drug administration to the final follow-up visit.
|
|
Infections and infestations
Pneumonia viral
|
0.41%
1/243 • The duration of a subject's particpation in the trial.
From the start of study drug administration to the final follow-up visit.
|
|
Infections and infestations
Pseudomonal bacteraemia
|
0.41%
1/243 • The duration of a subject's particpation in the trial.
From the start of study drug administration to the final follow-up visit.
|
|
Infections and infestations
Sepsis
|
2.1%
5/243 • The duration of a subject's particpation in the trial.
From the start of study drug administration to the final follow-up visit.
|
|
Infections and infestations
Sepsis syndrome
|
0.41%
1/243 • The duration of a subject's particpation in the trial.
From the start of study drug administration to the final follow-up visit.
|
|
Infections and infestations
Staphylococcal infection
|
0.41%
1/243 • The duration of a subject's particpation in the trial.
From the start of study drug administration to the final follow-up visit.
|
|
Infections and infestations
Streptococcal sepsis
|
0.41%
1/243 • The duration of a subject's particpation in the trial.
From the start of study drug administration to the final follow-up visit.
|
|
Injury, poisoning and procedural complications
Accidental exposure
|
0.41%
1/243 • The duration of a subject's particpation in the trial.
From the start of study drug administration to the final follow-up visit.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.41%
1/243 • The duration of a subject's particpation in the trial.
From the start of study drug administration to the final follow-up visit.
|
|
Injury, poisoning and procedural complications
Fall
|
0.41%
1/243 • The duration of a subject's particpation in the trial.
From the start of study drug administration to the final follow-up visit.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.82%
2/243 • The duration of a subject's particpation in the trial.
From the start of study drug administration to the final follow-up visit.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.41%
1/243 • The duration of a subject's particpation in the trial.
From the start of study drug administration to the final follow-up visit.
|
|
Metabolism and nutrition disorders
Cachexia
|
0.41%
1/243 • The duration of a subject's particpation in the trial.
From the start of study drug administration to the final follow-up visit.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.82%
2/243 • The duration of a subject's particpation in the trial.
From the start of study drug administration to the final follow-up visit.
|
|
Metabolism and nutrition disorders
Electrolyte imbalance
|
0.41%
1/243 • The duration of a subject's particpation in the trial.
From the start of study drug administration to the final follow-up visit.
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.41%
1/243 • The duration of a subject's particpation in the trial.
From the start of study drug administration to the final follow-up visit.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.41%
1/243 • The duration of a subject's particpation in the trial.
From the start of study drug administration to the final follow-up visit.
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.41%
1/243 • The duration of a subject's particpation in the trial.
From the start of study drug administration to the final follow-up visit.
|
|
Renal and urinary disorders
Arthralgia
|
0.41%
1/243 • The duration of a subject's particpation in the trial.
From the start of study drug administration to the final follow-up visit.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.41%
1/243 • The duration of a subject's particpation in the trial.
From the start of study drug administration to the final follow-up visit.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.41%
1/243 • The duration of a subject's particpation in the trial.
From the start of study drug administration to the final follow-up visit.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.41%
1/243 • The duration of a subject's particpation in the trial.
From the start of study drug administration to the final follow-up visit.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adrenocortical carcinoma
|
0.41%
1/243 • The duration of a subject's particpation in the trial.
From the start of study drug administration to the final follow-up visit.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bone cancer metastatic
|
0.41%
1/243 • The duration of a subject's particpation in the trial.
From the start of study drug administration to the final follow-up visit.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer recurrent
|
0.82%
2/243 • The duration of a subject's particpation in the trial.
From the start of study drug administration to the final follow-up visit.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
1.2%
3/243 • The duration of a subject's particpation in the trial.
From the start of study drug administration to the final follow-up visit.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Carcinoid syndrome
|
0.41%
1/243 • The duration of a subject's particpation in the trial.
From the start of study drug administration to the final follow-up visit.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cervix carcinoma recurrent
|
0.82%
2/243 • The duration of a subject's particpation in the trial.
From the start of study drug administration to the final follow-up visit.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cervix neoplasm
|
0.41%
1/243 • The duration of a subject's particpation in the trial.
From the start of study drug administration to the final follow-up visit.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer metastatic
|
0.41%
1/243 • The duration of a subject's particpation in the trial.
From the start of study drug administration to the final follow-up visit.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hodgkin's disease recurrent
|
0.41%
1/243 • The duration of a subject's particpation in the trial.
From the start of study drug administration to the final follow-up visit.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Leiomyosarcoma
|
0.41%
1/243 • The duration of a subject's particpation in the trial.
From the start of study drug administration to the final follow-up visit.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung carcinoma cell type unspecified recurrent
|
0.41%
1/243 • The duration of a subject's particpation in the trial.
From the start of study drug administration to the final follow-up visit.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
0.82%
2/243 • The duration of a subject's particpation in the trial.
From the start of study drug administration to the final follow-up visit.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant pleural effusion
|
0.41%
1/243 • The duration of a subject's particpation in the trial.
From the start of study drug administration to the final follow-up visit.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
1.2%
3/243 • The duration of a subject's particpation in the trial.
From the start of study drug administration to the final follow-up visit.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to liver
|
0.41%
1/243 • The duration of a subject's particpation in the trial.
From the start of study drug administration to the final follow-up visit.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Multiple myeloma
|
0.41%
1/243 • The duration of a subject's particpation in the trial.
From the start of study drug administration to the final follow-up visit.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm malignant
|
0.41%
1/243 • The duration of a subject's particpation in the trial.
From the start of study drug administration to the final follow-up visit.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm progression
|
1.2%
3/243 • The duration of a subject's particpation in the trial.
From the start of study drug administration to the final follow-up visit.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal cancer metastatic
|
0.41%
1/243 • The duration of a subject's particpation in the trial.
From the start of study drug administration to the final follow-up visit.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian cancer
|
0.41%
1/243 • The duration of a subject's particpation in the trial.
From the start of study drug administration to the final follow-up visit.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian epithelial cancer recurrent
|
0.82%
2/243 • The duration of a subject's particpation in the trial.
From the start of study drug administration to the final follow-up visit.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma metastatic
|
0.41%
1/243 • The duration of a subject's particpation in the trial.
From the start of study drug administration to the final follow-up visit.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma recurrent
|
0.82%
2/243 • The duration of a subject's particpation in the trial.
From the start of study drug administration to the final follow-up visit.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer metastatic
|
0.82%
2/243 • The duration of a subject's particpation in the trial.
From the start of study drug administration to the final follow-up visit.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer recurrent
|
0.41%
1/243 • The duration of a subject's particpation in the trial.
From the start of study drug administration to the final follow-up visit.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal cancer metastatic
|
0.41%
1/243 • The duration of a subject's particpation in the trial.
From the start of study drug administration to the final follow-up visit.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Recurrent cancer
|
0.41%
1/243 • The duration of a subject's particpation in the trial.
From the start of study drug administration to the final follow-up visit.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cell carcinoma recurrent
|
0.41%
1/243 • The duration of a subject's particpation in the trial.
From the start of study drug administration to the final follow-up visit.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Vulval cancer
|
0.41%
1/243 • The duration of a subject's particpation in the trial.
From the start of study drug administration to the final follow-up visit.
|
|
Nervous system disorders
Complicated migraine
|
0.41%
1/243 • The duration of a subject's particpation in the trial.
From the start of study drug administration to the final follow-up visit.
|
|
Nervous system disorders
Headache
|
0.41%
1/243 • The duration of a subject's particpation in the trial.
From the start of study drug administration to the final follow-up visit.
|
|
Nervous system disorders
Loss of consciousness
|
0.41%
1/243 • The duration of a subject's particpation in the trial.
From the start of study drug administration to the final follow-up visit.
|
|
Psychiatric disorders
Mental status changes
|
0.82%
2/243 • The duration of a subject's particpation in the trial.
From the start of study drug administration to the final follow-up visit.
|
|
Renal and urinary disorders
Renal failure
|
0.41%
1/243 • The duration of a subject's particpation in the trial.
From the start of study drug administration to the final follow-up visit.
|
|
Renal and urinary disorders
Renal failure acute
|
0.82%
2/243 • The duration of a subject's particpation in the trial.
From the start of study drug administration to the final follow-up visit.
|
|
Renal and urinary disorders
Urinary retention
|
0.82%
2/243 • The duration of a subject's particpation in the trial.
From the start of study drug administration to the final follow-up visit.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.41%
1/243 • The duration of a subject's particpation in the trial.
From the start of study drug administration to the final follow-up visit.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.41%
1/243 • The duration of a subject's particpation in the trial.
From the start of study drug administration to the final follow-up visit.
|
|
Reproductive system and breast disorders
Dyspnoea
|
0.41%
1/243 • The duration of a subject's particpation in the trial.
From the start of study drug administration to the final follow-up visit.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.82%
2/243 • The duration of a subject's particpation in the trial.
From the start of study drug administration to the final follow-up visit.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.82%
2/243 • The duration of a subject's particpation in the trial.
From the start of study drug administration to the final follow-up visit.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.82%
2/243 • The duration of a subject's particpation in the trial.
From the start of study drug administration to the final follow-up visit.
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.41%
1/243 • The duration of a subject's particpation in the trial.
From the start of study drug administration to the final follow-up visit.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.41%
1/243 • The duration of a subject's particpation in the trial.
From the start of study drug administration to the final follow-up visit.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory arrest
|
0.41%
1/243 • The duration of a subject's particpation in the trial.
From the start of study drug administration to the final follow-up visit.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.82%
2/243 • The duration of a subject's particpation in the trial.
From the start of study drug administration to the final follow-up visit.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
1.2%
3/243 • The duration of a subject's particpation in the trial.
From the start of study drug administration to the final follow-up visit.
|
|
Vascular disorders
Deep vein thrombosis
|
2.5%
6/243 • The duration of a subject's particpation in the trial.
From the start of study drug administration to the final follow-up visit.
|
|
Vascular disorders
Haematoma
|
0.82%
2/243 • The duration of a subject's particpation in the trial.
From the start of study drug administration to the final follow-up visit.
|
|
Vascular disorders
Hypertension
|
0.41%
1/243 • The duration of a subject's particpation in the trial.
From the start of study drug administration to the final follow-up visit.
|
Other adverse events
| Measure |
Open Label Fentanyl Treatment
n=243 participants at risk
BioErodible Muco Adhesive(BEMA) Fentanyl
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
12.8%
31/243 • The duration of a subject's particpation in the trial.
From the start of study drug administration to the final follow-up visit.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
6.2%
15/243 • The duration of a subject's particpation in the trial.
From the start of study drug administration to the final follow-up visit.
|
|
Gastrointestinal disorders
Abdominal Pain
|
5.8%
14/243 • The duration of a subject's particpation in the trial.
From the start of study drug administration to the final follow-up visit.
|
|
Gastrointestinal disorders
Constipation
|
10.7%
26/243 • The duration of a subject's particpation in the trial.
From the start of study drug administration to the final follow-up visit.
|
|
Gastrointestinal disorders
Diarrhoea
|
8.6%
21/243 • The duration of a subject's particpation in the trial.
From the start of study drug administration to the final follow-up visit.
|
|
Gastrointestinal disorders
Dry mouth
|
7.4%
18/243 • The duration of a subject's particpation in the trial.
From the start of study drug administration to the final follow-up visit.
|
|
Gastrointestinal disorders
Nausea
|
30.5%
74/243 • The duration of a subject's particpation in the trial.
From the start of study drug administration to the final follow-up visit.
|
|
Gastrointestinal disorders
Vomiting
|
21.4%
52/243 • The duration of a subject's particpation in the trial.
From the start of study drug administration to the final follow-up visit.
|
|
General disorders
Asthenia
|
10.3%
25/243 • The duration of a subject's particpation in the trial.
From the start of study drug administration to the final follow-up visit.
|
|
General disorders
Disease progression
|
11.5%
28/243 • The duration of a subject's particpation in the trial.
From the start of study drug administration to the final follow-up visit.
|
|
General disorders
Fatique
|
10.3%
25/243 • The duration of a subject's particpation in the trial.
From the start of study drug administration to the final follow-up visit.
|
|
General disorders
Edema peripheral
|
11.9%
29/243 • The duration of a subject's particpation in the trial.
From the start of study drug administration to the final follow-up visit.
|
|
General disorders
Pain
|
9.1%
22/243 • The duration of a subject's particpation in the trial.
From the start of study drug administration to the final follow-up visit.
|
|
General disorders
Pyrexia
|
10.3%
25/243 • The duration of a subject's particpation in the trial.
From the start of study drug administration to the final follow-up visit.
|
|
General disorders
Bronchitis
|
5.3%
13/243 • The duration of a subject's particpation in the trial.
From the start of study drug administration to the final follow-up visit.
|
|
Infections and infestations
Pheumonia
|
9.5%
23/243 • The duration of a subject's particpation in the trial.
From the start of study drug administration to the final follow-up visit.
|
|
Infections and infestations
Urinary tract infection
|
6.6%
16/243 • The duration of a subject's particpation in the trial.
From the start of study drug administration to the final follow-up visit.
|
|
Investigations
Weight decreased
|
6.2%
15/243 • The duration of a subject's particpation in the trial.
From the start of study drug administration to the final follow-up visit.
|
|
Metabolism and nutrition disorders
Anorexia
|
6.6%
16/243 • The duration of a subject's particpation in the trial.
From the start of study drug administration to the final follow-up visit.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
7.4%
18/243 • The duration of a subject's particpation in the trial.
From the start of study drug administration to the final follow-up visit.
|
|
Metabolism and nutrition disorders
Dehydration
|
11.9%
29/243 • The duration of a subject's particpation in the trial.
From the start of study drug administration to the final follow-up visit.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.3%
13/243 • The duration of a subject's particpation in the trial.
From the start of study drug administration to the final follow-up visit.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
9.9%
24/243 • The duration of a subject's particpation in the trial.
From the start of study drug administration to the final follow-up visit.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
6.6%
16/243 • The duration of a subject's particpation in the trial.
From the start of study drug administration to the final follow-up visit.
|
|
Nervous system disorders
Dizziness
|
14.4%
35/243 • The duration of a subject's particpation in the trial.
From the start of study drug administration to the final follow-up visit.
|
|
Nervous system disorders
Headache
|
9.9%
24/243 • The duration of a subject's particpation in the trial.
From the start of study drug administration to the final follow-up visit.
|
|
Nervous system disorders
Somnolence
|
9.5%
23/243 • The duration of a subject's particpation in the trial.
From the start of study drug administration to the final follow-up visit.
|
|
Psychiatric disorders
Anxiety
|
5.3%
13/243 • The duration of a subject's particpation in the trial.
From the start of study drug administration to the final follow-up visit.
|
|
Psychiatric disorders
Confusional state
|
8.2%
20/243 • The duration of a subject's particpation in the trial.
From the start of study drug administration to the final follow-up visit.
|
|
Psychiatric disorders
Depression
|
7.8%
19/243 • The duration of a subject's particpation in the trial.
From the start of study drug administration to the final follow-up visit.
|
|
Psychiatric disorders
Insomnia
|
5.8%
14/243 • The duration of a subject's particpation in the trial.
From the start of study drug administration to the final follow-up visit.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
6.6%
16/243 • The duration of a subject's particpation in the trial.
From the start of study drug administration to the final follow-up visit.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
11.5%
28/243 • The duration of a subject's particpation in the trial.
From the start of study drug administration to the final follow-up visit.
|
Additional Information
Andrew Finn, Pharm.D.
BioDelivery Sciences International
Phone: 919-582-9050
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60