Trial Outcomes & Findings for Long Term Safety of Sativex Oromucosal Spray (Sativex®; Nabiximols) as Adjunctive Therapy in Patients With Uncontrolled Persistent Chronic Cancer Related Pain (NCT NCT01337089)
NCT ID: NCT01337089
Last Updated: 2023-04-12
Results Overview
Treatment-emergent Adverse Events (TEAEs) were coded according to the Medical Dictionary for Regulatory Activities (MedDRA) dictionary version 17.0. A TEAE is defined as an adverse event with an onset after the start of study drug treatment. The percent of participants who experienced one or more TEAEs is reported.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
660 participants
Primary outcome timeframe
Baseline, Day 183
Results posted on
2023-04-12
Participant Flow
Participants enrolled in this study included those who had taken part in studies NCT01262651 (GWCA0958), NCT01361607 (GWCA0962), and NCT01424566 (GWCA1103) and who chose to continue treatment by enrolling in this study, as well as new (de novo) participants who met all inclusion criteria and did not meet any of the exclusion criteria.
For the de novo participants enrolled in this study, a screening visit took place 3 to 14 days prior to enrollment.
Participant milestones
| Measure |
Nabiximols
Nabiximols was self-administered by participants as a 100 microliter (μL) oromucosal spray in the morning and evening, up to a maximum of 10 sprays per day, for 6 months. Nabiximols oromucosal spray contained delta-9-tetrahydrocannabinol (THC) (27 milligram \[mg\]/milliliter \[mL\]):cannabidiol (CBD) (25 mg/mL), in ethanol:propylene glycol (50:50) excipients, with peppermint oil (0.05%) flavoring. Each 100 μL actuation delivered 2.7 mg THC and 2.5 mg CBD.
|
|---|---|
|
Overall Study
STARTED
|
660
|
|
Overall Study
Received at Least 1 Dose of Study Drug
|
660
|
|
Overall Study
Safety Population
|
660
|
|
Overall Study
Efficacy Dataset
|
659
|
|
Overall Study
COMPLETED
|
256
|
|
Overall Study
NOT COMPLETED
|
404
|
Reasons for withdrawal
| Measure |
Nabiximols
Nabiximols was self-administered by participants as a 100 microliter (μL) oromucosal spray in the morning and evening, up to a maximum of 10 sprays per day, for 6 months. Nabiximols oromucosal spray contained delta-9-tetrahydrocannabinol (THC) (27 milligram \[mg\]/milliliter \[mL\]):cannabidiol (CBD) (25 mg/mL), in ethanol:propylene glycol (50:50) excipients, with peppermint oil (0.05%) flavoring. Each 100 μL actuation delivered 2.7 mg THC and 2.5 mg CBD.
|
|---|---|
|
Overall Study
Adverse Event
|
237
|
|
Overall Study
Withdrawal by Subject
|
129
|
|
Overall Study
Withdrawal by Investigator
|
33
|
|
Overall Study
Met Withdrawal Criteria
|
3
|
|
Overall Study
Lost to Follow-up
|
2
|
Baseline Characteristics
Long Term Safety of Sativex Oromucosal Spray (Sativex®; Nabiximols) as Adjunctive Therapy in Patients With Uncontrolled Persistent Chronic Cancer Related Pain
Baseline characteristics by cohort
| Measure |
Nabiximols
n=660 Participants
Nabiximols was self-administered by participants as a 100 μL oromucosal spray in the morning and evening, up to a maximum of 10 sprays per day, for 6 months. Nabiximols oromucosal spray contained THC (27 mg/mL):CBD (25 mg/mL), in ethanol:propylene glycol (50:50) excipients, with peppermint oil (0.05%) flavoring. Each 100 μL actuation delivered 2.7 mg THC and 2.5 mg CBD.
|
|---|---|
|
Age, Continuous
|
60.2 years
STANDARD_DEVIATION 11.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
313 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
347 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, Day 183Population: The Safety Population included all participants receiving at least 1 dose of study drug.
Treatment-emergent Adverse Events (TEAEs) were coded according to the Medical Dictionary for Regulatory Activities (MedDRA) dictionary version 17.0. A TEAE is defined as an adverse event with an onset after the start of study drug treatment. The percent of participants who experienced one or more TEAEs is reported.
Outcome measures
| Measure |
Nabiximols
n=660 Participants
Nabiximols was self-administered by participants as a 100 μL oromucosal spray in the morning and evening, up to a maximum of 10 sprays per day, for 6 months. Nabiximols oromucosal spray contained THC (27 mg/mL):CBD (25 mg/mL), in ethanol:propylene glycol (50:50) excipients, with peppermint oil (0.05%) flavoring. Each 100 μL actuation delivered 2.7 mg THC and 2.5 mg CBD.
|
|---|---|
|
Percent Of Participants With Treatment-emergent Adverse Events
|
82.9 percent of participants
|
SECONDARY outcome
Timeframe: Baseline, Last Period (Days 156-183) or last 27 days of treatmentPopulation: The Safety Population included all participants receiving at least 1 dose of study drug.
Participants indicated the level of pain experienced in the last 24 hours on an 11-point Numerical Rating Scale (NRS), where a score of 0 indicated "no pain" and a score of 10 indicated "pain as bad as you can imagine." Change in mean NRS average pain was calculated as: Last Period NRS average pain score - Baseline NRS average pain score. A negative value indicates an improvement in average pain score from Baseline.
Outcome measures
| Measure |
Nabiximols
n=634 Participants
Nabiximols was self-administered by participants as a 100 μL oromucosal spray in the morning and evening, up to a maximum of 10 sprays per day, for 6 months. Nabiximols oromucosal spray contained THC (27 mg/mL):CBD (25 mg/mL), in ethanol:propylene glycol (50:50) excipients, with peppermint oil (0.05%) flavoring. Each 100 μL actuation delivered 2.7 mg THC and 2.5 mg CBD.
|
|---|---|
|
Change From Baseline In Mean NRS Average Pain During The Last Period
|
0.0 units on a scale
Standard Deviation 1.8
|
SECONDARY outcome
Timeframe: Baseline, Last Period (Days 156-183) or last 27 days of treatmentPopulation: The Safety Population included all participants receiving at least 1 dose of study drug.
Participants indicated the level of sleep disruption experienced in the last 24 hours on an 11-point NRS, where a score of 0 indicated "did not disrupt sleep" and a score of 10 indicated "completely disrupted (unable to sleep at all)." Change in mean sleep disruption NRS was calculated as: Last Period sleep disruption NRS score - Baseline sleep disruption NRS score. A negative value indicates an improvement in sleep disruption score from Baseline.
Outcome measures
| Measure |
Nabiximols
n=634 Participants
Nabiximols was self-administered by participants as a 100 μL oromucosal spray in the morning and evening, up to a maximum of 10 sprays per day, for 6 months. Nabiximols oromucosal spray contained THC (27 mg/mL):CBD (25 mg/mL), in ethanol:propylene glycol (50:50) excipients, with peppermint oil (0.05%) flavoring. Each 100 μL actuation delivered 2.7 mg THC and 2.5 mg CBD.
|
|---|---|
|
Change From Baseline In Mean Sleep Disruption NRS During The Last Period
|
0.1 units on a scale
Standard Deviation 1.9
|
SECONDARY outcome
Timeframe: Last Visit (up to Day 183)Population: The Safety Population included all participants receiving at least 1 dose of study drug.
The Patient Satisfaction Questionnaire (PSQ) was used to assess level of satisfaction of the participant with the study drug, with the markers "extremely satisfied, very satisfied, slightly satisfied, neutral, slightly dissatisfied, very dissatisfied, extremely dissatisfied". Last visit refers to the last visit that a participant completed the assessment.
Outcome measures
| Measure |
Nabiximols
n=618 Participants
Nabiximols was self-administered by participants as a 100 μL oromucosal spray in the morning and evening, up to a maximum of 10 sprays per day, for 6 months. Nabiximols oromucosal spray contained THC (27 mg/mL):CBD (25 mg/mL), in ethanol:propylene glycol (50:50) excipients, with peppermint oil (0.05%) flavoring. Each 100 μL actuation delivered 2.7 mg THC and 2.5 mg CBD.
|
|---|---|
|
Patient Satisfaction Questionnaire At Last Visit (Up To Day 183)
Extremely Satisfied
|
56 Participants
|
|
Patient Satisfaction Questionnaire At Last Visit (Up To Day 183)
Very Satisfied
|
230 Participants
|
|
Patient Satisfaction Questionnaire At Last Visit (Up To Day 183)
Slightly Satisfied
|
185 Participants
|
|
Patient Satisfaction Questionnaire At Last Visit (Up To Day 183)
Neutral
|
82 Participants
|
|
Patient Satisfaction Questionnaire At Last Visit (Up To Day 183)
Slightly Dissatisfied
|
33 Participants
|
|
Patient Satisfaction Questionnaire At Last Visit (Up To Day 183)
Very Dissatisfied
|
22 Participants
|
|
Patient Satisfaction Questionnaire At Last Visit (Up To Day 183)
Extremely Dissatisfied
|
10 Participants
|
SECONDARY outcome
Timeframe: Baseline, Last Visit (up to Day 183)Population: The Safety Population included all participants receiving at least 1 dose of study drug.
Participants indicated level of constipation on an 11-point NRS, where a score of 0 was "no constipation", and 10 was "constipation as bad as you can imagine." Last visit refers to the last visit that a participant completed the assessment. Change in NRS constipation score was calculated as: Last Visit NRS constipation score - Baseline NRS constipation score. A negative value indicates improvement in condition from Baseline.
Outcome measures
| Measure |
Nabiximols
n=619 Participants
Nabiximols was self-administered by participants as a 100 μL oromucosal spray in the morning and evening, up to a maximum of 10 sprays per day, for 6 months. Nabiximols oromucosal spray contained THC (27 mg/mL):CBD (25 mg/mL), in ethanol:propylene glycol (50:50) excipients, with peppermint oil (0.05%) flavoring. Each 100 μL actuation delivered 2.7 mg THC and 2.5 mg CBD.
|
|---|---|
|
Change From Baseline In NRS Constipation At Last Visit (Up To Day 183)
|
-0.1 units on a scale
Standard Deviation 2.5
|
Adverse Events
Nabiximols
Serious events: 301 serious events
Other events: 291 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Nabiximols
n=660 participants at risk
Nabiximols was self-administered by participants as a 100 μL oromucosal spray in the morning and evening, up to a maximum of 10 sprays per day, for 6 months. Nabiximols oromucosal spray contained THC (27 mg/mL):CBD (25 mg/mL), in ethanol:propylene glycol (50:50) excipients, with peppermint oil (0.05%) flavoring. Each 100 μL actuation delivered 2.7 mg THC and 2.5 mg CBD.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
1.2%
8/660 • Up to Day 197 post-enrollment
|
|
Blood and lymphatic system disorders
Anaemia Of Malignant Disease
|
0.15%
1/660 • Up to Day 197 post-enrollment
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
0.15%
1/660 • Up to Day 197 post-enrollment
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.15%
1/660 • Up to Day 197 post-enrollment
|
|
Cardiac disorders
Angina Pectoris
|
0.15%
1/660 • Up to Day 197 post-enrollment
|
|
Cardiac disorders
Atrial Fibrillation
|
0.15%
1/660 • Up to Day 197 post-enrollment
|
|
Cardiac disorders
Cardiopulmonary Failure
|
0.15%
1/660 • Up to Day 197 post-enrollment
|
|
Cardiac disorders
Myocardial Infarction
|
0.45%
3/660 • Up to Day 197 post-enrollment
|
|
Congenital, familial and genetic disorders
Pyloric Stenosis
|
0.15%
1/660 • Up to Day 197 post-enrollment
|
|
Ear and labyrinth disorders
Deafness Neurosensory
|
0.15%
1/660 • Up to Day 197 post-enrollment
|
|
Ear and labyrinth disorders
Vertigo
|
0.15%
1/660 • Up to Day 197 post-enrollment
|
|
Endocrine disorders
Adrenal Insufficiency
|
0.15%
1/660 • Up to Day 197 post-enrollment
|
|
Eye disorders
Blindness
|
0.15%
1/660 • Up to Day 197 post-enrollment
|
|
Gastrointestinal disorders
Nausea
|
0.91%
6/660 • Up to Day 197 post-enrollment
|
|
Gastrointestinal disorders
Vomiting
|
1.1%
7/660 • Up to Day 197 post-enrollment
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.61%
4/660 • Up to Day 197 post-enrollment
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
0.15%
1/660 • Up to Day 197 post-enrollment
|
|
Gastrointestinal disorders
Gastritis
|
0.15%
1/660 • Up to Day 197 post-enrollment
|
|
Gastrointestinal disorders
Gastritis Erosive
|
0.15%
1/660 • Up to Day 197 post-enrollment
|
|
Gastrointestinal disorders
Haematemesis
|
0.15%
1/660 • Up to Day 197 post-enrollment
|
|
Gastrointestinal disorders
Ileus
|
0.30%
2/660 • Up to Day 197 post-enrollment
|
|
Gastrointestinal disorders
Intestinal Obstruction
|
0.15%
1/660 • Up to Day 197 post-enrollment
|
|
Gastrointestinal disorders
Mechanical Ileus
|
0.15%
1/660 • Up to Day 197 post-enrollment
|
|
Gastrointestinal disorders
Proctalgia
|
0.15%
1/660 • Up to Day 197 post-enrollment
|
|
Gastrointestinal disorders
Small Intestinal Obstruction
|
0.30%
2/660 • Up to Day 197 post-enrollment
|
|
Gastrointestinal disorders
Tongue Haemorrhage
|
0.15%
1/660 • Up to Day 197 post-enrollment
|
|
General disorders
Chest Pain
|
0.61%
4/660 • Up to Day 197 post-enrollment
|
|
General disorders
Device Occlusion
|
0.15%
1/660 • Up to Day 197 post-enrollment
|
|
General disorders
General Physical Health Deterioration
|
0.15%
1/660 • Up to Day 197 post-enrollment
|
|
General disorders
Local Swelling
|
0.15%
1/660 • Up to Day 197 post-enrollment
|
|
General disorders
Pain
|
0.91%
6/660 • Up to Day 197 post-enrollment
|
|
General disorders
Pyrexia
|
0.45%
3/660 • Up to Day 197 post-enrollment
|
|
Infections and infestations
Gastroenteritis
|
0.30%
2/660 • Up to Day 197 post-enrollment
|
|
Infections and infestations
Urinary Tract Infection
|
0.15%
1/660 • Up to Day 197 post-enrollment
|
|
Infections and infestations
Bacteraemia
|
0.15%
1/660 • Up to Day 197 post-enrollment
|
|
Infections and infestations
Bronchitis
|
0.15%
1/660 • Up to Day 197 post-enrollment
|
|
Infections and infestations
Catheter Site Infection
|
0.15%
1/660 • Up to Day 197 post-enrollment
|
|
Infections and infestations
Cellulitis
|
0.30%
2/660 • Up to Day 197 post-enrollment
|
|
Infections and infestations
Clostridium Difficile Colitis
|
0.15%
1/660 • Up to Day 197 post-enrollment
|
|
Infections and infestations
Diverticulitis
|
0.15%
1/660 • Up to Day 197 post-enrollment
|
|
Infections and infestations
Herpes Zoster
|
0.15%
1/660 • Up to Day 197 post-enrollment
|
|
Infections and infestations
Klebsiella Sepsis
|
0.15%
1/660 • Up to Day 197 post-enrollment
|
|
Infections and infestations
Lobar Pneumonia
|
0.15%
1/660 • Up to Day 197 post-enrollment
|
|
Infections and infestations
Lower Respiratory Tract Infection
|
0.61%
4/660 • Up to Day 197 post-enrollment
|
|
Infections and infestations
Pelvic Abscess
|
0.15%
1/660 • Up to Day 197 post-enrollment
|
|
Infections and infestations
Pneumonia
|
0.91%
6/660 • Up to Day 197 post-enrollment
|
|
Infections and infestations
Pseudomembranous Colitis
|
0.15%
1/660 • Up to Day 197 post-enrollment
|
|
Infections and infestations
Respiratory Tract Infection
|
0.15%
1/660 • Up to Day 197 post-enrollment
|
|
Infections and infestations
Sepsis
|
0.45%
3/660 • Up to Day 197 post-enrollment
|
|
Infections and infestations
Sinusitis
|
0.15%
1/660 • Up to Day 197 post-enrollment
|
|
Infections and infestations
Staphylococcal Bacteraemia
|
0.15%
1/660 • Up to Day 197 post-enrollment
|
|
Infections and infestations
Staphylococcal Sepsis
|
0.15%
1/660 • Up to Day 197 post-enrollment
|
|
Infections and infestations
Subacute Endocarditis
|
0.15%
1/660 • Up to Day 197 post-enrollment
|
|
Infections and infestations
Viral Infection
|
0.15%
1/660 • Up to Day 197 post-enrollment
|
|
Injury, poisoning and procedural complications
Accidental Overdose
|
0.15%
1/660 • Up to Day 197 post-enrollment
|
|
Injury, poisoning and procedural complications
Fall
|
0.76%
5/660 • Up to Day 197 post-enrollment
|
|
Injury, poisoning and procedural complications
Femur Fracture
|
0.15%
1/660 • Up to Day 197 post-enrollment
|
|
Injury, poisoning and procedural complications
Gastrointestinal Stoma Complication
|
0.15%
1/660 • Up to Day 197 post-enrollment
|
|
Injury, poisoning and procedural complications
Joint Dislocation
|
0.15%
1/660 • Up to Day 197 post-enrollment
|
|
Injury, poisoning and procedural complications
Procedural Headache
|
0.30%
2/660 • Up to Day 197 post-enrollment
|
|
Injury, poisoning and procedural complications
Radiation Oesophagitis
|
0.15%
1/660 • Up to Day 197 post-enrollment
|
|
Injury, poisoning and procedural complications
Shunt Occlusion
|
0.15%
1/660 • Up to Day 197 post-enrollment
|
|
Injury, poisoning and procedural complications
Stoma Complication
|
0.15%
1/660 • Up to Day 197 post-enrollment
|
|
Metabolism and nutrition disorders
Cachexia
|
0.15%
1/660 • Up to Day 197 post-enrollment
|
|
Metabolism and nutrition disorders
Dehydration
|
0.61%
4/660 • Up to Day 197 post-enrollment
|
|
Metabolism and nutrition disorders
Diabetes Mellitus
|
0.15%
1/660 • Up to Day 197 post-enrollment
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.15%
1/660 • Up to Day 197 post-enrollment
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.15%
1/660 • Up to Day 197 post-enrollment
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.15%
1/660 • Up to Day 197 post-enrollment
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.30%
2/660 • Up to Day 197 post-enrollment
|
|
Musculoskeletal and connective tissue disorders
Muscular Weakness
|
0.15%
1/660 • Up to Day 197 post-enrollment
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
0.15%
1/660 • Up to Day 197 post-enrollment
|
|
Musculoskeletal and connective tissue disorders
Pathological Fracture
|
0.61%
4/660 • Up to Day 197 post-enrollment
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm Progression
|
31.7%
209/660 • Up to Day 197 post-enrollment
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast Cancer Metastatic
|
0.15%
1/660 • Up to Day 197 post-enrollment
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer Pain
|
0.61%
4/660 • Up to Day 197 post-enrollment
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung Adenocarcinoma
|
0.15%
1/660 • Up to Day 197 post-enrollment
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung Neoplasm Malignant
|
0.15%
1/660 • Up to Day 197 post-enrollment
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases To Bone
|
0.15%
1/660 • Up to Day 197 post-enrollment
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases To Central Nervous System
|
0.45%
3/660 • Up to Day 197 post-enrollment
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases To Liver
|
0.15%
1/660 • Up to Day 197 post-enrollment
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases To Spine
|
0.15%
1/660 • Up to Day 197 post-enrollment
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic Neoplasm
|
0.15%
1/660 • Up to Day 197 post-enrollment
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian Cancer
|
0.32%
1/313 • Up to Day 197 post-enrollment
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Plasma Cell Myeloma
|
0.30%
2/660 • Up to Day 197 post-enrollment
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous Cell Carcinoma Of Skin
|
0.15%
1/660 • Up to Day 197 post-enrollment
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour Haemorrhage
|
0.15%
1/660 • Up to Day 197 post-enrollment
|
|
Nervous system disorders
Spinal Cord Compression
|
0.45%
3/660 • Up to Day 197 post-enrollment
|
|
Nervous system disorders
Altered State Of Consciousness
|
0.15%
1/660 • Up to Day 197 post-enrollment
|
|
Nervous system disorders
Balance Disorder
|
0.15%
1/660 • Up to Day 197 post-enrollment
|
|
Nervous system disorders
Carotid Artery Stenosis
|
0.15%
1/660 • Up to Day 197 post-enrollment
|
|
Nervous system disorders
Cerebral Infarction
|
0.15%
1/660 • Up to Day 197 post-enrollment
|
|
Nervous system disorders
Cerebrovascular Accident
|
0.45%
3/660 • Up to Day 197 post-enrollment
|
|
Nervous system disorders
Grand Mal Convulsion
|
0.15%
1/660 • Up to Day 197 post-enrollment
|
|
Nervous system disorders
Dementia With Lewy Bodies
|
0.15%
1/660 • Up to Day 197 post-enrollment
|
|
Nervous system disorders
Dizziness
|
0.30%
2/660 • Up to Day 197 post-enrollment
|
|
Nervous system disorders
Encephalopathy
|
0.15%
1/660 • Up to Day 197 post-enrollment
|
|
Nervous system disorders
Epilepsy
|
0.15%
1/660 • Up to Day 197 post-enrollment
|
|
Nervous system disorders
Posterior Reversible Encephalopathy Syndrome
|
0.30%
2/660 • Up to Day 197 post-enrollment
|
|
Nervous system disorders
Syncope
|
0.15%
1/660 • Up to Day 197 post-enrollment
|
|
Nervous system disorders
Tremor
|
0.15%
1/660 • Up to Day 197 post-enrollment
|
|
Psychiatric disorders
Agitation
|
0.15%
1/660 • Up to Day 197 post-enrollment
|
|
Psychiatric disorders
Completed Suicide
|
0.15%
1/660 • Up to Day 197 post-enrollment
|
|
Psychiatric disorders
Depression
|
0.15%
1/660 • Up to Day 197 post-enrollment
|
|
Psychiatric disorders
Disorientation
|
0.61%
4/660 • Up to Day 197 post-enrollment
|
|
Psychiatric disorders
Mental Status Changes
|
0.30%
2/660 • Up to Day 197 post-enrollment
|
|
Psychiatric disorders
Suicide Attempt
|
0.15%
1/660 • Up to Day 197 post-enrollment
|
|
Renal and urinary disorders
Renal Failure Acute
|
0.15%
1/660 • Up to Day 197 post-enrollment
|
|
Renal and urinary disorders
Urinary Retention
|
0.76%
5/660 • Up to Day 197 post-enrollment
|
|
Renal and urinary disorders
Urinary Tract Obstruction
|
0.15%
1/660 • Up to Day 197 post-enrollment
|
|
Reproductive system and breast disorders
Genital Haemorrhage
|
0.15%
1/660 • Up to Day 197 post-enrollment
|
|
Reproductive system and breast disorders
Vaginal Fistula
|
0.32%
1/313 • Up to Day 197 post-enrollment
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.76%
5/660 • Up to Day 197 post-enrollment
|
|
Respiratory, thoracic and mediastinal disorders
Chronic Obstructive Pulmonary Disease
|
0.45%
3/660 • Up to Day 197 post-enrollment
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.15%
1/660 • Up to Day 197 post-enrollment
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
0.30%
2/660 • Up to Day 197 post-enrollment
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
0.15%
1/660 • Up to Day 197 post-enrollment
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
0.45%
3/660 • Up to Day 197 post-enrollment
|
|
Skin and subcutaneous tissue disorders
Acute Febrile Neutrophilic Dermatosis
|
0.15%
1/660 • Up to Day 197 post-enrollment
|
|
Skin and subcutaneous tissue disorders
Dry Gangrene
|
0.15%
1/660 • Up to Day 197 post-enrollment
|
|
Vascular disorders
Deep Vein Thrombosis
|
0.61%
4/660 • Up to Day 197 post-enrollment
|
|
Vascular disorders
Haemorrhage
|
0.15%
1/660 • Up to Day 197 post-enrollment
|
|
Vascular disorders
Hypertension
|
0.15%
1/660 • Up to Day 197 post-enrollment
|
|
Vascular disorders
Hypotension
|
0.15%
1/660 • Up to Day 197 post-enrollment
|
|
Vascular disorders
Inferior Vena Caval Occlusion
|
0.15%
1/660 • Up to Day 197 post-enrollment
|
|
Vascular disorders
Venous Thrombosis Limb
|
0.15%
1/660 • Up to Day 197 post-enrollment
|
|
Nervous system disorders
Convulsion
|
0.30%
2/660 • Up to Day 197 post-enrollment
|
Other adverse events
| Measure |
Nabiximols
n=660 participants at risk
Nabiximols was self-administered by participants as a 100 μL oromucosal spray in the morning and evening, up to a maximum of 10 sprays per day, for 6 months. Nabiximols oromucosal spray contained THC (27 mg/mL):CBD (25 mg/mL), in ethanol:propylene glycol (50:50) excipients, with peppermint oil (0.05%) flavoring. Each 100 μL actuation delivered 2.7 mg THC and 2.5 mg CBD.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
5.9%
39/660 • Up to Day 197 post-enrollment
|
|
Gastrointestinal disorders
Nausea
|
13.0%
86/660 • Up to Day 197 post-enrollment
|
|
Gastrointestinal disorders
Vomiting
|
8.9%
59/660 • Up to Day 197 post-enrollment
|
|
Gastrointestinal disorders
Constipation
|
6.7%
44/660 • Up to Day 197 post-enrollment
|
|
Gastrointestinal disorders
Diarrhoea
|
6.2%
41/660 • Up to Day 197 post-enrollment
|
|
General disorders
Fatigue
|
5.3%
35/660 • Up to Day 197 post-enrollment
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
7.4%
49/660 • Up to Day 197 post-enrollment
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm Progression
|
6.2%
41/660 • Up to Day 197 post-enrollment
|
|
Nervous system disorders
Dizziness
|
7.7%
51/660 • Up to Day 197 post-enrollment
|
|
Nervous system disorders
Somnolence
|
5.8%
38/660 • Up to Day 197 post-enrollment
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
5.6%
37/660 • Up to Day 197 post-enrollment
|
|
General disorders
Asthenia
|
7.6%
50/660 • Up to Day 197 post-enrollment
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60