Trial Outcomes & Findings for A Study of the Safety and Tolerability of Pimavanserin (ACP-103) in Patients With Parkinson's Disease Psychosis (NCT NCT00550238)
NCT ID: NCT00550238
Last Updated: 2019-06-24
Results Overview
Number (%) of patients with drug-related treatment-emergent AEs (i.e. AEs reported by the Investigator as possibly, probably, or highly probably related to study drug)
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
459 participants
Primary outcome timeframe
From first to last study drug dose plus 30 days
Results posted on
2019-06-24
Participant Flow
Eligible patients were adult males or females with Parkinson's Disease Psychosis who had completed a prior double blind study with pimavanserin and were determined by the treating physician (Investigator) to benefit from continued treatment. This study did not have a fixed duration. Thus, no patients were considered to have "completed" the study.
Patients could be enrolled in this study as early as the final visit of the previous double-blind study, or up to 28 days following completion of the treatment period of the previous double-blind study.
Participant milestones
| Measure |
Pimavanserin
Pimavanserin tartrate (ACP-103) tablets taken once daily by mouth for as long as the drug is considered to be tolerated and beneficial to patients
|
|---|---|
|
Overall Study
STARTED
|
459
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
459
|
Reasons for withdrawal
| Measure |
Pimavanserin
Pimavanserin tartrate (ACP-103) tablets taken once daily by mouth for as long as the drug is considered to be tolerated and beneficial to patients
|
|---|---|
|
Overall Study
Adverse Event
|
88
|
|
Overall Study
Death
|
34
|
|
Overall Study
Disease progression
|
46
|
|
Overall Study
Withdrawal by Subject
|
167
|
|
Overall Study
Physician Decision
|
31
|
|
Overall Study
Patient noncompliance
|
25
|
|
Overall Study
Lost to Follow-up
|
13
|
|
Overall Study
Sponsor decision
|
55
|
Baseline Characteristics
A Study of the Safety and Tolerability of Pimavanserin (ACP-103) in Patients With Parkinson's Disease Psychosis
Baseline characteristics by cohort
| Measure |
Pimavanserin
n=459 Participants
Pimavanserin tartrate (ACP-103) tablets taken once daily by mouth for as long as the drug is considered to be tolerated and beneficial to patients
|
|---|---|
|
Age, Continuous
|
71.2 years
STANDARD_DEVIATION 8.19 • n=93 Participants
|
|
Sex: Female, Male
Female
|
176 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
283 Participants
n=93 Participants
|
|
Race/Ethnicity, Customized
White
|
423 Participants
n=93 Participants
|
|
Race/Ethnicity, Customized
Black/African American
|
4 Participants
n=93 Participants
|
|
Race/Ethnicity, Customized
Asian
|
19 Participants
n=93 Participants
|
|
Race/Ethnicity, Customized
Other
|
13 Participants
n=93 Participants
|
|
Region of Enrollment
North America
|
321 participants
n=93 Participants
|
|
Region of Enrollment
Europe
|
120 participants
n=93 Participants
|
|
Region of Enrollment
India
|
18 participants
n=93 Participants
|
PRIMARY outcome
Timeframe: From first to last study drug dose plus 30 daysPopulation: Enrolled patients who received at least 1 dose of study drug
Number (%) of patients with drug-related treatment-emergent AEs (i.e. AEs reported by the Investigator as possibly, probably, or highly probably related to study drug)
Outcome measures
| Measure |
Pimavanserin
n=459 Participants
Pimavanserin tartrate (ACP-103) tablets taken once daily by mouth for as long as the drug is considered to be tolerated and beneficial to patients
|
|---|---|
|
Safety: Number (%) of Patients With Drug-related Treatment-emergent Adverse Events (AEs)
|
180 Participants
|
Adverse Events
Pimavanserin
Serious events: 188 serious events
Other events: 328 other events
Deaths: 59 deaths
Serious adverse events
| Measure |
Pimavanserin
n=459 participants at risk
Pimavanserin tartrate (ACP-103) tablets taken once daily by mouth for as long as the drug is considered to be tolerated and beneficial to patients
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.44%
2/459 • Number of events 2 • From first to last study drug dose plus 30 days
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.22%
1/459 • Number of events 1 • From first to last study drug dose plus 30 days
|
|
Cardiac disorders
Acute myocardial infarction
|
1.1%
5/459 • Number of events 5 • From first to last study drug dose plus 30 days
|
|
Cardiac disorders
Cardiac arrest
|
0.65%
3/459 • Number of events 3 • From first to last study drug dose plus 30 days
|
|
Cardiac disorders
Cardiac failure congestive
|
0.65%
3/459 • Number of events 3 • From first to last study drug dose plus 30 days
|
|
Cardiac disorders
Angina pectoris
|
0.44%
2/459 • Number of events 2 • From first to last study drug dose plus 30 days
|
|
Cardiac disorders
Cardiac failure
|
0.44%
2/459 • Number of events 2 • From first to last study drug dose plus 30 days
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.44%
2/459 • Number of events 2 • From first to last study drug dose plus 30 days
|
|
Cardiac disorders
Cardiopulmonary failure
|
0.44%
2/459 • Number of events 2 • From first to last study drug dose plus 30 days
|
|
Cardiac disorders
Coronary artery disease
|
0.44%
2/459 • Number of events 2 • From first to last study drug dose plus 30 days
|
|
Cardiac disorders
Myocardial infarction
|
0.44%
2/459 • Number of events 2 • From first to last study drug dose plus 30 days
|
|
Cardiac disorders
Atrial flutter
|
0.22%
1/459 • Number of events 1 • From first to last study drug dose plus 30 days
|
|
Cardiac disorders
Atrioventricular block complete
|
0.22%
1/459 • Number of events 1 • From first to last study drug dose plus 30 days
|
|
Cardiac disorders
Bradycardia
|
0.22%
1/459 • Number of events 1 • From first to last study drug dose plus 30 days
|
|
Cardiac disorders
Cardiomyopathy
|
0.22%
1/459 • Number of events 1 • From first to last study drug dose plus 30 days
|
|
Cardiac disorders
Myocardial ischaemia
|
0.22%
1/459 • Number of events 1 • From first to last study drug dose plus 30 days
|
|
Cardiac disorders
Sick sinus syndrome
|
0.22%
1/459 • Number of events 1 • From first to last study drug dose plus 30 days
|
|
Eye disorders
Visual acuity reduced
|
0.22%
1/459 • Number of events 1 • From first to last study drug dose plus 30 days
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.44%
2/459 • Number of events 2 • From first to last study drug dose plus 30 days
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.44%
2/459 • Number of events 2 • From first to last study drug dose plus 30 days
|
|
Gastrointestinal disorders
Abdominal pain
|
0.22%
1/459 • Number of events 1 • From first to last study drug dose plus 30 days
|
|
Gastrointestinal disorders
Constipation
|
0.22%
1/459 • Number of events 1 • From first to last study drug dose plus 30 days
|
|
Gastrointestinal disorders
Crohn's disease
|
0.22%
1/459 • Number of events 1 • From first to last study drug dose plus 30 days
|
|
Gastrointestinal disorders
Dyschezia
|
0.22%
1/459 • Number of events 1 • From first to last study drug dose plus 30 days
|
|
Gastrointestinal disorders
Faecaloma
|
0.22%
1/459 • Number of events 1 • From first to last study drug dose plus 30 days
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.22%
1/459 • Number of events 1 • From first to last study drug dose plus 30 days
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.22%
1/459 • Number of events 1 • From first to last study drug dose plus 30 days
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.22%
1/459 • Number of events 1 • From first to last study drug dose plus 30 days
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.22%
1/459 • Number of events 1 • From first to last study drug dose plus 30 days
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.22%
1/459 • Number of events 1 • From first to last study drug dose plus 30 days
|
|
Gastrointestinal disorders
Melaena
|
0.22%
1/459 • Number of events 1 • From first to last study drug dose plus 30 days
|
|
Gastrointestinal disorders
Pancreatitis
|
0.22%
1/459 • Number of events 1 • From first to last study drug dose plus 30 days
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.22%
1/459 • Number of events 1 • From first to last study drug dose plus 30 days
|
|
Gastrointestinal disorders
Presbyoesophagus
|
0.22%
1/459 • Number of events 1 • From first to last study drug dose plus 30 days
|
|
Gastrointestinal disorders
Rectal prolapse
|
0.22%
1/459 • Number of events 1 • From first to last study drug dose plus 30 days
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.22%
1/459 • Number of events 1 • From first to last study drug dose plus 30 days
|
|
General disorders
Chest pain
|
1.3%
6/459 • Number of events 6 • From first to last study drug dose plus 30 days
|
|
General disorders
Death
|
0.44%
2/459 • Number of events 2 • From first to last study drug dose plus 30 days
|
|
General disorders
Asthenia
|
0.22%
1/459 • Number of events 1 • From first to last study drug dose plus 30 days
|
|
General disorders
Axillary pain
|
0.22%
1/459 • Number of events 1 • From first to last study drug dose plus 30 days
|
|
General disorders
Inflammation
|
0.22%
1/459 • Number of events 1 • From first to last study drug dose plus 30 days
|
|
General disorders
Non-cardiac chest pain
|
0.22%
1/459 • Number of events 1 • From first to last study drug dose plus 30 days
|
|
General disorders
Pyrexia
|
0.22%
1/459 • Number of events 1 • From first to last study drug dose plus 30 days
|
|
Hepatobiliary disorders
Cholecystitis
|
0.44%
2/459 • Number of events 2 • From first to last study drug dose plus 30 days
|
|
Hepatobiliary disorders
Bile duct obstruction
|
0.22%
1/459 • Number of events 1 • From first to last study drug dose plus 30 days
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.22%
1/459 • Number of events 1 • From first to last study drug dose plus 30 days
|
|
Infections and infestations
Pneumonia
|
4.6%
21/459 • Number of events 23 • From first to last study drug dose plus 30 days
|
|
Infections and infestations
Urinary tract infection
|
3.7%
17/459 • Number of events 19 • From first to last study drug dose plus 30 days
|
|
Infections and infestations
Sepsis
|
1.5%
7/459 • Number of events 7 • From first to last study drug dose plus 30 days
|
|
Infections and infestations
Cellulitis
|
0.87%
4/459 • Number of events 5 • From first to last study drug dose plus 30 days
|
|
Infections and infestations
Clostridium difficile colitis
|
0.65%
3/459 • Number of events 3 • From first to last study drug dose plus 30 days
|
|
Infections and infestations
Diverticulitis
|
0.65%
3/459 • Number of events 3 • From first to last study drug dose plus 30 days
|
|
Infections and infestations
Respiratory tract infection
|
0.65%
3/459 • Number of events 3 • From first to last study drug dose plus 30 days
|
|
Infections and infestations
Bacterial sepsis
|
0.44%
2/459 • Number of events 2 • From first to last study drug dose plus 30 days
|
|
Infections and infestations
Candiduria
|
0.44%
2/459 • Number of events 2 • From first to last study drug dose plus 30 days
|
|
Infections and infestations
Coccidioidomycosis
|
0.44%
2/459 • Number of events 2 • From first to last study drug dose plus 30 days
|
|
Infections and infestations
Septic shock
|
0.44%
2/459 • Number of events 2 • From first to last study drug dose plus 30 days
|
|
Infections and infestations
Urosepsis
|
0.44%
2/459 • Number of events 2 • From first to last study drug dose plus 30 days
|
|
Infections and infestations
Abscess limb
|
0.22%
1/459 • Number of events 1 • From first to last study drug dose plus 30 days
|
|
Infections and infestations
Bacteraemia
|
0.22%
1/459 • Number of events 1 • From first to last study drug dose plus 30 days
|
|
Infections and infestations
Enterococcal sepsis
|
0.22%
1/459 • Number of events 1 • From first to last study drug dose plus 30 days
|
|
Infections and infestations
Escherichia bacteraemia
|
0.22%
1/459 • Number of events 1 • From first to last study drug dose plus 30 days
|
|
Infections and infestations
Escherichia urinary tract infection
|
0.22%
1/459 • Number of events 1 • From first to last study drug dose plus 30 days
|
|
Infections and infestations
Fungal infection
|
0.22%
1/459 • Number of events 1 • From first to last study drug dose plus 30 days
|
|
Infections and infestations
Gangrene
|
0.22%
1/459 • Number of events 1 • From first to last study drug dose plus 30 days
|
|
Infections and infestations
Gastroenteritis viral
|
0.22%
1/459 • Number of events 1 • From first to last study drug dose plus 30 days
|
|
Infections and infestations
Gastrointestinal infection
|
0.22%
1/459 • Number of events 1 • From first to last study drug dose plus 30 days
|
|
Infections and infestations
Pneumonia viral
|
0.22%
1/459 • Number of events 1 • From first to last study drug dose plus 30 days
|
|
Injury, poisoning and procedural complications
Hip fracture
|
2.2%
10/459 • Number of events 10 • From first to last study drug dose plus 30 days
|
|
Injury, poisoning and procedural complications
Fall
|
1.3%
6/459 • Number of events 8 • From first to last study drug dose plus 30 days
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.87%
4/459 • Number of events 4 • From first to last study drug dose plus 30 days
|
|
Injury, poisoning and procedural complications
Femure fracture
|
0.87%
4/459 • Number of events 5 • From first to last study drug dose plus 30 days
|
|
Injury, poisoning and procedural complications
Contusion
|
0.44%
2/459 • Number of events 2 • From first to last study drug dose plus 30 days
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.44%
2/459 • Number of events 2 • From first to last study drug dose plus 30 days
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.44%
2/459 • Number of events 2 • From first to last study drug dose plus 30 days
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
0.22%
1/459 • Number of events 1 • From first to last study drug dose plus 30 days
|
|
Injury, poisoning and procedural complications
Craniocerebral injury
|
0.22%
1/459 • Number of events 1 • From first to last study drug dose plus 30 days
|
|
Injury, poisoning and procedural complications
Head injury
|
0.22%
1/459 • Number of events 1 • From first to last study drug dose plus 30 days
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.22%
1/459 • Number of events 1 • From first to last study drug dose plus 30 days
|
|
Injury, poisoning and procedural complications
Laceration
|
0.22%
1/459 • Number of events 1 • From first to last study drug dose plus 30 days
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.22%
1/459 • Number of events 1 • From first to last study drug dose plus 30 days
|
|
Injury, poisoning and procedural complications
Overdose
|
0.22%
1/459 • Number of events 1 • From first to last study drug dose plus 30 days
|
|
Injury, poisoning and procedural complications
Post procedural complication
|
0.22%
1/459 • Number of events 1 • From first to last study drug dose plus 30 days
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.22%
1/459 • Number of events 1 • From first to last study drug dose plus 30 days
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.22%
1/459 • Number of events 1 • From first to last study drug dose plus 30 days
|
|
Injury, poisoning and procedural complications
Soft tissue injury
|
0.22%
1/459 • Number of events 1 • From first to last study drug dose plus 30 days
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.22%
1/459 • Number of events 1 • From first to last study drug dose plus 30 days
|
|
Injury, poisoning and procedural complications
Stress fracture
|
0.22%
1/459 • Number of events 1 • From first to last study drug dose plus 30 days
|
|
Injury, poisoning and procedural complications
Subdural haemorrhage
|
0.22%
1/459 • Number of events 1 • From first to last study drug dose plus 30 days
|
|
Injury, poisoning and procedural complications
Thoracic vertebral fracture
|
0.22%
1/459 • Number of events 1 • From first to last study drug dose plus 30 days
|
|
Injury, poisoning and procedural complications
Toxicity to various agents
|
0.22%
1/459 • Number of events 1 • From first to last study drug dose plus 30 days
|
|
Investigations
Nuclear magnetic resonance imaging
|
0.22%
1/459 • Number of events 1 • From first to last study drug dose plus 30 days
|
|
Metabolism and nutrition disorders
Dehydration
|
2.0%
9/459 • Number of events 9 • From first to last study drug dose plus 30 days
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.87%
4/459 • Number of events 4 • From first to last study drug dose plus 30 days
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.65%
3/459 • Number of events 4 • From first to last study drug dose plus 30 days
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc disorder
|
0.44%
2/459 • Number of events 2 • From first to last study drug dose plus 30 days
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.22%
1/459 • Number of events 1 • From first to last study drug dose plus 30 days
|
|
Musculoskeletal and connective tissue disorders
Exostosis
|
0.22%
1/459 • Number of events 1 • From first to last study drug dose plus 30 days
|
|
Musculoskeletal and connective tissue disorders
Osteochondrosis
|
0.22%
1/459 • Number of events 1 • From first to last study drug dose plus 30 days
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.22%
1/459 • Number of events 1 • From first to last study drug dose plus 30 days
|
|
Musculoskeletal and connective tissue disorders
Scoliosis
|
0.22%
1/459 • Number of events 1 • From first to last study drug dose plus 30 days
|
|
Musculoskeletal and connective tissue disorders
Spinal column stenosis
|
0.22%
1/459 • Number of events 1 • From first to last study drug dose plus 30 days
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.22%
1/459 • Number of events 1 • From first to last study drug dose plus 30 days
|
|
Musculoskeletal and connective tissue disorders
Spondylolysis
|
0.22%
1/459 • Number of events 1 • From first to last study drug dose plus 30 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.65%
3/459 • Number of events 3 • From first to last study drug dose plus 30 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.22%
1/459 • Number of events 1 • From first to last study drug dose plus 30 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain neoplasm
|
0.22%
1/459 • Number of events 1 • From first to last study drug dose plus 30 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer stage III
|
0.22%
1/459 • Number of events 1 • From first to last study drug dose plus 30 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic neoplasm malignant
|
0.22%
1/459 • Number of events 1 • From first to last study drug dose plus 30 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Meningioma benign
|
0.22%
1/459 • Number of events 1 • From first to last study drug dose plus 30 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Multiple myeloma
|
0.22%
1/459 • Number of events 1 • From first to last study drug dose plus 30 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Paraproteinaemia
|
0.22%
1/459 • Number of events 1 • From first to last study drug dose plus 30 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Recurrent cancer
|
0.22%
1/459 • Number of events 1 • From first to last study drug dose plus 30 days
|
|
Nervous system disorders
Parkinson's disease
|
2.2%
10/459 • Number of events 10 • From first to last study drug dose plus 30 days
|
|
Nervous system disorders
Syncope
|
1.7%
8/459 • Number of events 9 • From first to last study drug dose plus 30 days
|
|
Nervous system disorders
Dementia
|
1.5%
7/459 • Number of events 7 • From first to last study drug dose plus 30 days
|
|
Nervous system disorders
Cerebrovascular accident
|
1.1%
5/459 • Number of events 6 • From first to last study drug dose plus 30 days
|
|
Nervous system disorders
Transient ischaemic attack
|
0.87%
4/459 • Number of events 4 • From first to last study drug dose plus 30 days
|
|
Nervous system disorders
Convulsion
|
0.65%
3/459 • Number of events 3 • From first to last study drug dose plus 30 days
|
|
Nervous system disorders
Metabolic encephalopathy
|
0.65%
3/459 • Number of events 3 • From first to last study drug dose plus 30 days
|
|
Nervous system disorders
Presyncope
|
0.65%
3/459 • Number of events 3 • From first to last study drug dose plus 30 days
|
|
Nervous system disorders
Encephalopathy
|
0.44%
2/459 • Number of events 2 • From first to last study drug dose plus 30 days
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.44%
2/459 • Number of events 2 • From first to last study drug dose plus 30 days
|
|
Nervous system disorders
Toxic encephalopathy
|
0.44%
2/459 • Number of events 2 • From first to last study drug dose plus 30 days
|
|
Nervous system disorders
Autonomic nervous system imbalance
|
0.22%
1/459 • Number of events 1 • From first to last study drug dose plus 30 days
|
|
Nervous system disorders
Burning sensation
|
0.22%
1/459 • Number of events 1 • From first to last study drug dose plus 30 days
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.22%
1/459 • Number of events 1 • From first to last study drug dose plus 30 days
|
|
Nervous system disorders
Haemorrhagic stroke
|
0.22%
1/459 • Number of events 1 • From first to last study drug dose plus 30 days
|
|
Nervous system disorders
Ischaemic stroke
|
0.22%
1/459 • Number of events 1 • From first to last study drug dose plus 30 days
|
|
Nervous system disorders
Lethargy
|
0.22%
1/459 • Number of events 1 • From first to last study drug dose plus 30 days
|
|
Nervous system disorders
Neuroleptic malignant syndrome
|
0.22%
1/459 • Number of events 1 • From first to last study drug dose plus 30 days
|
|
Nervous system disorders
On and off phenomenon
|
0.22%
1/459 • Number of events 1 • From first to last study drug dose plus 30 days
|
|
Nervous system disorders
Parkinsonism
|
0.22%
1/459 • Number of events 1 • From first to last study drug dose plus 30 days
|
|
Nervous system disorders
Sciatica
|
0.22%
1/459 • Number of events 1 • From first to last study drug dose plus 30 days
|
|
Psychiatric disorders
Mental status change
|
1.5%
7/459 • Number of events 7 • From first to last study drug dose plus 30 days
|
|
Psychiatric disorders
Psychotic disorder
|
1.5%
7/459 • Number of events 7 • From first to last study drug dose plus 30 days
|
|
Psychiatric disorders
Hallucination
|
1.3%
6/459 • Number of events 6 • From first to last study drug dose plus 30 days
|
|
Psychiatric disorders
Hallucination, visual
|
0.44%
2/459 • Number of events 2 • From first to last study drug dose plus 30 days
|
|
Psychiatric disorders
Abnormal behaviour
|
0.22%
1/459 • Number of events 1 • From first to last study drug dose plus 30 days
|
|
Psychiatric disorders
Aggression
|
0.22%
1/459 • Number of events 1 • From first to last study drug dose plus 30 days
|
|
Psychiatric disorders
Anxiety
|
0.22%
1/459 • Number of events 1 • From first to last study drug dose plus 30 days
|
|
Psychiatric disorders
Confusional state
|
0.22%
1/459 • Number of events 1 • From first to last study drug dose plus 30 days
|
|
Psychiatric disorders
Delirium
|
0.22%
1/459 • Number of events 1 • From first to last study drug dose plus 30 days
|
|
Psychiatric disorders
Delusion
|
0.22%
1/459 • Number of events 1 • From first to last study drug dose plus 30 days
|
|
Psychiatric disorders
Jealous delusion
|
0.22%
1/459 • Number of events 1 • From first to last study drug dose plus 30 days
|
|
Psychiatric disorders
Major depression
|
0.22%
1/459 • Number of events 1 • From first to last study drug dose plus 30 days
|
|
Psychiatric disorders
Panic attack
|
0.22%
1/459 • Number of events 1 • From first to last study drug dose plus 30 days
|
|
Psychiatric disorders
Suicide attempt
|
0.22%
1/459 • Number of events 1 • From first to last study drug dose plus 30 days
|
|
Renal and urinary disorders
Renal failure acute
|
0.44%
2/459 • Number of events 2 • From first to last study drug dose plus 30 days
|
|
Renal and urinary disorders
Urinary retention
|
0.44%
2/459 • Number of events 2 • From first to last study drug dose plus 30 days
|
|
Renal and urinary disorders
Bladder neck obstruction
|
0.22%
1/459 • Number of events 1 • From first to last study drug dose plus 30 days
|
|
Renal and urinary disorders
Calculus ureteric
|
0.22%
1/459 • Number of events 1 • From first to last study drug dose plus 30 days
|
|
Renal and urinary disorders
Haematuria
|
0.22%
1/459 • Number of events 1 • From first to last study drug dose plus 30 days
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.22%
1/459 • Number of events 1 • From first to last study drug dose plus 30 days
|
|
Renal and urinary disorders
Renail failure
|
0.22%
1/459 • Number of events 1 • From first to last study drug dose plus 30 days
|
|
Renal and urinary disorders
Renal failure chronic
|
0.22%
1/459 • Number of events 1 • From first to last study drug dose plus 30 days
|
|
Renal and urinary disorders
Urinary tract obstrcution
|
0.22%
1/459 • Number of events 1 • From first to last study drug dose plus 30 days
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.22%
1/459 • Number of events 1 • From first to last study drug dose plus 30 days
|
|
Reproductive system and breast disorders
Vaginal prolapse
|
0.22%
1/459 • Number of events 1 • From first to last study drug dose plus 30 days
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
2.4%
11/459 • Number of events 13 • From first to last study drug dose plus 30 days
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
1.7%
8/459 • Number of events 8 • From first to last study drug dose plus 30 days
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
1.1%
5/459 • Number of events 5 • From first to last study drug dose plus 30 days
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.65%
3/459 • Number of events 3 • From first to last study drug dose plus 30 days
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.44%
2/459 • Number of events 2 • From first to last study drug dose plus 30 days
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.44%
2/459 • Number of events 2 • From first to last study drug dose plus 30 days
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.22%
1/459 • Number of events 1 • From first to last study drug dose plus 30 days
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.22%
1/459 • Number of events 1 • From first to last study drug dose plus 30 days
|
|
Respiratory, thoracic and mediastinal disorders
Atypical pneumonia
|
0.22%
1/459 • Number of events 1 • From first to last study drug dose plus 30 days
|
|
Respiratory, thoracic and mediastinal disorders
Choking
|
0.22%
1/459 • Number of events 1 • From first to last study drug dose plus 30 days
|
|
Respiratory, thoracic and mediastinal disorders
Hydropneumothorax
|
0.22%
1/459 • Number of events 1 • From first to last study drug dose plus 30 days
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.22%
1/459 • Number of events 1 • From first to last study drug dose plus 30 days
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.22%
1/459 • Number of events 1 • From first to last study drug dose plus 30 days
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary haemorrhage
|
0.22%
1/459 • Number of events 1 • From first to last study drug dose plus 30 days
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.22%
1/459 • Number of events 1 • From first to last study drug dose plus 30 days
|
|
Surgical and medical procedures
Deep brain stimulation
|
0.22%
1/459 • Number of events 1 • From first to last study drug dose plus 30 days
|
|
Surgical and medical procedures
Skin neoplasm excision
|
0.22%
1/459 • Number of events 1 • From first to last study drug dose plus 30 days
|
|
Vascular disorders
Orthostatic hypotension
|
1.1%
5/459 • Number of events 6 • From first to last study drug dose plus 30 days
|
|
Vascular disorders
Hypertension
|
0.87%
4/459 • Number of events 4 • From first to last study drug dose plus 30 days
|
|
Vascular disorders
Deep vein thrombosis
|
0.44%
2/459 • Number of events 2 • From first to last study drug dose plus 30 days
|
|
Vascular disorders
Aortic aneurysm
|
0.22%
1/459 • Number of events 1 • From first to last study drug dose plus 30 days
|
|
Vascular disorders
Aortic dissection
|
0.22%
1/459 • Number of events 1 • From first to last study drug dose plus 30 days
|
|
Vascular disorders
Circulatory collapse
|
0.22%
1/459 • Number of events 1 • From first to last study drug dose plus 30 days
|
|
Vascular disorders
Hypertensive crisis
|
0.22%
1/459 • Number of events 2 • From first to last study drug dose plus 30 days
|
|
Vascular disorders
Hypotension
|
0.22%
1/459 • Number of events 1 • From first to last study drug dose plus 30 days
|
Other adverse events
| Measure |
Pimavanserin
n=459 participants at risk
Pimavanserin tartrate (ACP-103) tablets taken once daily by mouth for as long as the drug is considered to be tolerated and beneficial to patients
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
7.6%
35/459 • Number of events 37 • From first to last study drug dose plus 30 days
|
|
Gastrointestinal disorders
Constipation
|
10.0%
46/459 • Number of events 54 • From first to last study drug dose plus 30 days
|
|
Gastrointestinal disorders
Dysphagia
|
9.4%
43/459 • Number of events 46 • From first to last study drug dose plus 30 days
|
|
Gastrointestinal disorders
Nausea
|
8.5%
39/459 • Number of events 49 • From first to last study drug dose plus 30 days
|
|
General disorders
Oedema peripheral
|
9.4%
43/459 • Number of events 52 • From first to last study drug dose plus 30 days
|
|
Infections and infestations
Urinary tract infection
|
17.2%
79/459 • Number of events 160 • From first to last study drug dose plus 30 days
|
|
Injury, poisoning and procedural complications
Fall
|
31.6%
145/459 • Number of events 326 • From first to last study drug dose plus 30 days
|
|
Injury, poisoning and procedural complications
Contusion
|
8.1%
37/459 • Number of events 55 • From first to last study drug dose plus 30 days
|
|
Injury, poisoning and procedural complications
Laceration
|
7.8%
36/459 • Number of events 51 • From first to last study drug dose plus 30 days
|
|
Injury, poisoning and procedural complications
Excoriation
|
5.0%
23/459 • Number of events 41 • From first to last study drug dose plus 30 days
|
|
Investigations
Weight decreased
|
12.4%
57/459 • Number of events 65 • From first to last study drug dose plus 30 days
|
|
Metabolism and nutrition disorders
Dehydration
|
5.4%
25/459 • Number of events 34 • From first to last study drug dose plus 30 days
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.8%
31/459 • Number of events 42 • From first to last study drug dose plus 30 days
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
6.1%
28/459 • Number of events 38 • From first to last study drug dose plus 30 days
|
|
Nervous system disorders
Dizziness
|
9.4%
43/459 • Number of events 50 • From first to last study drug dose plus 30 days
|
|
Nervous system disorders
Dementia
|
6.5%
30/459 • Number of events 33 • From first to last study drug dose plus 30 days
|
|
Nervous system disorders
Somnolence
|
6.3%
29/459 • Number of events 33 • From first to last study drug dose plus 30 days
|
|
Nervous system disorders
Parkinson's disease
|
5.9%
27/459 • Number of events 30 • From first to last study drug dose plus 30 days
|
|
Nervous system disorders
Headache
|
5.0%
23/459 • Number of events 30 • From first to last study drug dose plus 30 days
|
|
Nervous system disorders
Tremor
|
5.0%
23/459 • Number of events 26 • From first to last study drug dose plus 30 days
|
|
Psychiatric disorders
Hallucination
|
13.5%
62/459 • Number of events 89 • From first to last study drug dose plus 30 days
|
|
Psychiatric disorders
Confusional state
|
10.9%
50/459 • Number of events 65 • From first to last study drug dose plus 30 days
|
|
Psychiatric disorders
Anxiety
|
8.9%
41/459 • Number of events 47 • From first to last study drug dose plus 30 days
|
|
Psychiatric disorders
Depression
|
8.5%
39/459 • Number of events 41 • From first to last study drug dose plus 30 days
|
|
Psychiatric disorders
Insomnia
|
7.4%
34/459 • Number of events 36 • From first to last study drug dose plus 30 days
|
|
Psychiatric disorders
Psychotic disorder
|
7.2%
33/459 • Number of events 39 • From first to last study drug dose plus 30 days
|
|
Psychiatric disorders
Agitation
|
7.0%
32/459 • Number of events 37 • From first to last study drug dose plus 30 days
|
|
Psychiatric disorders
Cognitive disorder
|
6.1%
28/459 • Number of events 33 • From first to last study drug dose plus 30 days
|
|
Vascular disorders
Orthostatic hypertension
|
8.7%
40/459 • Number of events 48 • From first to last study drug dose plus 30 days
|
|
Vascular disorders
Hypertension
|
7.4%
34/459 • Number of events 36 • From first to last study drug dose plus 30 days
|
Additional Information
Sr. Dir. Medical Information and Medical Communications
ACADIA Pharmaceuticals Inc.
Phone: 858-261-2897
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Investigator may publish the study results, relative to his/her own patients, only after review, comment and approval by the sponsor. No publication of confidential information shall be made without the sponsor's prior written consent. At least 60 days prior to submitting a manuscript or prior to any public presentation, a copy of the manuscript or presentation will be provided to the sponsor for review and comment. The sponsor has 60 days to review and comment.
- Publication restrictions are in place
Restriction type: OTHER