Trial Outcomes & Findings for Rasagiline Tablets Special Drug Use-Results Survey "Survey on Long-term Safety" (NCT NCT03727139)

Last Updated: 2024-03-08

Results Overview

An adverse event (AE) is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.

Recruitment status

COMPLETED

Target enrollment

1021 participants

Primary outcome timeframe

24 months

Results posted on

2024-03-08

Participant Flow

Participants took part in the survey at 148 investigative sites in Japan, from 1 November 2018 to 31 October 2021.

Participants with a historical diagnosis of Parkinson's disease were enrolled. Participants received rasagiline as part of a routine medical care.

Participant milestones

Participant milestones
Measure	Rasagiline 1 mg Rasagiline 1 milligram (mg), orally, once daily for up to 24 months. Participants received interventions as part of routine medical care.
Overall Study STARTED	1021
Overall Study COMPLETED	961
Overall Study NOT COMPLETED	60

Reasons for withdrawal

Reasons for withdrawal
Measure	Rasagiline 1 mg Rasagiline 1 milligram (mg), orally, once daily for up to 24 months. Participants received interventions as part of routine medical care.
Overall Study Protocol Violation	60

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Rasagiline 1 mg n=961 Participants Rasagiline 1 milligram (mg), orally, once daily for up to 24 months. Participants received interventions as part of routine medical care.
Age, Continuous	72.5 Years STANDARD_DEVIATION 9.04 • n=961 Participants
Sex: Female, Male Female	517 Participants n=961 Participants
Sex: Female, Male Male	444 Participants n=961 Participants
Region of Enrollment Japan	961 Participants n=961 Participants
Duration of Diagnosis of Parkinson's Disease	6.82 Years STANDARD_DEVIATION 5.405 • n=911 Participants • The number analyzed is the number of participants with data available for analysis.
Healthcare Category Outpatient	896 Participants n=961 Participants
Healthcare Category Inpatient	65 Participants n=961 Participants
Medical Complications Had No Medical Complications	202 Participants n=961 Participants
Medical Complications Had Medical Complications	759 Participants n=961 Participants
Dementia Had No Dementia	891 Participants n=961 Participants
Dementia Had Dementia	70 Participants n=961 Participants
Height	157.9 Centimeters (cm) STANDARD_DEVIATION 9.86 • n=712 Participants • The number analyzed is the number of participants with data available for analysis.
Weight	54.84 Kilograms (kg) STANDARD_DEVIATION 11.463 • n=722 Participants • The number analyzed is the number of participants with data available for analysis.
Smoking Classification Never Smoked	567 Participants n=961 Participants
Smoking Classification Current Smoker	19 Participants n=961 Participants
Smoking Classification Ex-Smoker	122 Participants n=961 Participants
Smoking Classification Unknown	253 Participants n=961 Participants
Modified Hoehn & Yahr Stage Stage 0	1 Participants n=961 Participants
Modified Hoehn & Yahr Stage Stage 1	36 Participants n=961 Participants
Modified Hoehn & Yahr Stage Stage 1.5	21 Participants n=961 Participants
Modified Hoehn & Yahr Stage Stage 2	200 Participants n=961 Participants
Modified Hoehn & Yahr Stage Stage 2.5	78 Participants n=961 Participants
Modified Hoehn & Yahr Stage Stage 3	455 Participants n=961 Participants
Modified Hoehn & Yahr Stage Stage 4	150 Participants n=961 Participants
Modified Hoehn & Yahr Stage Stage 5	20 Participants n=961 Participants
Levodopa Use at Initiation of Treatment with the Study Drug Not Used	96 Participants n=961 Participants
Levodopa Use at Initiation of Treatment with the Study Drug Used	865 Participants n=961 Participants
Wearing-off Phenomenon Had No Wearing-off Phenomenon	394 Participants n=865 Participants • The number analyzed is the number of participants given levodopa at initiation of treatment with the study drug.
Wearing-off Phenomenon Had Wearing-off Phenomenon	471 Participants n=865 Participants • The number analyzed is the number of participants given levodopa at initiation of treatment with the study drug.
Dyskinesia Had No Dyskinesia	699 Participants n=865 Participants • The number analyzed is the number of participants given levodopa at initiation of treatment with the study drug.
Dyskinesia Had Dyskinesia	166 Participants n=865 Participants • The number analyzed is the number of participants given levodopa at initiation of treatment with the study drug.
Unified Parkinson's Disease Rating Scale (UPDRS) Part III Total Score	28.5 Scores on a Scale STANDARD_DEVIATION 14.36 • n=700 Participants • The number analyzed is the number of participants with data available for analysis.
Tremor Score	3.0 Scores on a Scale STANDARD_DEVIATION 3.56 • n=716 Participants • The number analyzed is the number of participants with data available for analysis.
Akinesia/Hypokinesia Score	11.6 Scores on a Scale STANDARD_DEVIATION 6.60 • n=702 Participants • The number analyzed is the number of participants with data available for analysis.
Rigidity Score	5.9 Scores on a Scale STANDARD_DEVIATION 3.47 • n=711 Participants • The number analyzed is the number of participants with data available for analysis.

PRIMARY outcome

Timeframe: 24 months

Population: Safety Analysis Set, The safety analysis set was defined as all participants who completed the survey.

Outcome measures

Outcome measures
Measure	Rasagiline 1 mg n=961 Participants Rasagiline 1 milligram (mg), orally, once daily for up to 24 months. Participants received interventions as part of routine medical care.
Number of Participants Who Had One or More Adverse Events	304 Participants

PRIMARY outcome

Timeframe: 24 months

Population: Safety Analysis Set, The safety analysis set was defined as all participants who completed the survey.

Outcome measures

Outcome measures
Measure	Rasagiline 1 mg n=961 Participants Rasagiline 1 milligram (mg), orally, once daily for up to 24 months. Participants received interventions as part of routine medical care.
Number of Participants Who Had One or More Adverse Drug Reactions	189 Participants

SECONDARY outcome

Timeframe: Baseline, Up to Month 24 (Final Assessment Point)

Population: Efficacy assessment population, The efficacy assessment population was defined as participants who completed the survey and had efficacy data at baseline and post-baseline time points available.

UPDRS retains the four-scale structure with a reorganization of the various subscales; (Part I) Mentation, behavior and mood (4 items), (Part II) Activities of daily living (13 items), (Part III) Motor (14 items), and (Part IV) Complications (11 items). Each item on Part III has 0-4 ratings, where 0 = normal, 1 = slight, 2 = mild, 3 = moderate, and 4 = severe, some items will be scored for 2 or more body parts. Total score range on Part III is 0-108, higher scores represent more severe symptom of Parkinson's disease (worse outcome).

Outcome measures

Outcome measures
Measure	Rasagiline 1 mg n=527 Participants Rasagiline 1 milligram (mg), orally, once daily for up to 24 months. Participants received interventions as part of routine medical care.
Change From Baseline in the Unified Parkinson's Disease Rating Scale (UPDRS)	-2.7 Scores on a scale Standard Deviation 9.46

Adverse Events

Rasagiline 1 mg

Serious events: 121 serious events

Other events: 136 other events

Deaths: 11 deaths

Serious adverse events

Serious adverse events
Measure	Rasagiline 1 mg n=961 participants at risk Rasagiline 1 milligram (mg), orally, once daily for up to 24 months. Participants received interventions as part of routine medical care.
Nervous system disorders Parkinson's disease	0.73% 7/961 • 24 months At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
Nervous system disorders Aqueductal stenosis	0.10% 1/961 • 24 months At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
Ear and labyrinth disorders Vertigo	0.10% 1/961 • 24 months At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
Cardiac disorders Bradycardia	0.10% 1/961 • 24 months At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
Cardiac disorders Cardiac failure	0.10% 1/961 • 24 months At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
Cardiac disorders Cardiac failure chronic	0.10% 1/961 • 24 months At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
Cardiac disorders Cardiac failure congestive	0.10% 1/961 • 24 months At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
Cardiac disorders Cardiomyopathy	0.10% 1/961 • 24 months At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
Cardiac disorders Tachycardia	0.10% 1/961 • 24 months At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
Vascular disorders Aortic dissection	0.10% 1/961 • 24 months At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
Infections and infestations Bronchitis	0.10% 1/961 • 24 months At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
Infections and infestations Cellulitis	0.10% 1/961 • 24 months At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
Infections and infestations Pneumonia	0.62% 6/961 • 24 months At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
Infections and infestations Pneumonia aspiration	0.42% 4/961 • 24 months At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
Infections and infestations Psoas abscess	0.10% 1/961 • 24 months At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
Infections and infestations Enteritis infectious	0.10% 1/961 • 24 months At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	0.10% 1/961 • 24 months At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lymphoma	0.10% 1/961 • 24 months At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant neoplasm of renal pelvis	0.10% 1/961 • 24 months At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic carcinoma	0.10% 1/961 • 24 months At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Uterine cancer	0.10% 1/961 • 24 months At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm malignant	0.10% 1/961 • 24 months At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
Blood and lymphatic system disorders Disseminated intravascular coagulation	0.10% 1/961 • 24 months At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
Endocrine disorders Thyroid cyst	0.10% 1/961 • 24 months At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
Metabolism and nutrition disorders Dehydration	0.10% 1/961 • 24 months At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
Metabolism and nutrition disorders Hypoalbuminaemia	0.10% 1/961 • 24 months At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
Metabolism and nutrition disorders Decreased appetite	0.52% 5/961 • 24 months At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
Psychiatric disorders Delirium	0.21% 2/961 • 24 months At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
Psychiatric disorders Delusion	0.31% 3/961 • 24 months At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
Psychiatric disorders Hallucination	2.3% 22/961 • 24 months At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
Psychiatric disorders Hallucination, visual	2.0% 19/961 • 24 months At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
Psychiatric disorders Insomnia	0.10% 1/961 • 24 months At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
Nervous system disorders Altered state of consciousness	0.10% 1/961 • 24 months At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
Nervous system disorders Cerebral infarction	0.42% 4/961 • 24 months At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
Nervous system disorders Dementia Alzheimer's type	0.10% 1/961 • 24 months At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
Nervous system disorders Dizziness postural	0.10% 1/961 • 24 months At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
Nervous system disorders Dyskinesia	0.10% 1/961 • 24 months At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
Nervous system disorders Loss of consciousness	0.42% 4/961 • 24 months At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
Nervous system disorders Neuroleptic malignant syndrome	0.10% 1/961 • 24 months At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
Nervous system disorders Subarachnoid haemorrhage	0.10% 1/961 • 24 months At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
Nervous system disorders Syncope	0.21% 2/961 • 24 months At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
Nervous system disorders Sudden onset of sleep	0.10% 1/961 • 24 months At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
Vascular disorders Blood pressure fluctuation	0.21% 2/961 • 24 months At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
Vascular disorders Hypertension	0.10% 1/961 • 24 months At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
Vascular disorders Orthostatic hypotension	0.62% 6/961 • 24 months At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
Respiratory, thoracic and mediastinal disorders Asphyxia	0.10% 1/961 • 24 months At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
Respiratory, thoracic and mediastinal disorders Asthma	0.10% 1/961 • 24 months At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
Respiratory, thoracic and mediastinal disorders Emphysema	0.10% 1/961 • 24 months At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
Respiratory, thoracic and mediastinal disorders Laryngeal stenosis	0.10% 1/961 • 24 months At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
Gastrointestinal disorders Dysphagia	0.10% 1/961 • 24 months At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
Gastrointestinal disorders Gastric ulcer haemorrhage	0.10% 1/961 • 24 months At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.10% 1/961 • 24 months At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
Gastrointestinal disorders Ileus	0.10% 1/961 • 24 months At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
Gastrointestinal disorders Intestinal obstruction	0.10% 1/961 • 24 months At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
Gastrointestinal disorders Rectal stenosis	0.10% 1/961 • 24 months At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
Hepatobiliary disorders Hepatic function abnormal	0.10% 1/961 • 24 months At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
Hepatobiliary disorders Congestive hepatopathy	0.10% 1/961 • 24 months At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
Musculoskeletal and connective tissue disorders Back pain	0.21% 2/961 • 24 months At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
Musculoskeletal and connective tissue disorders Lumbar spinal stenosis	0.21% 2/961 • 24 months At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
Musculoskeletal and connective tissue disorders Muscle spasms	0.10% 1/961 • 24 months At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
Musculoskeletal and connective tissue disorders Muscular weakness	0.10% 1/961 • 24 months At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
Musculoskeletal and connective tissue disorders Myalgia	0.10% 1/961 • 24 months At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
Musculoskeletal and connective tissue disorders Rhabdomyolysis	0.10% 1/961 • 24 months At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
Musculoskeletal and connective tissue disorders Mobility decreased	0.10% 1/961 • 24 months At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
Renal and urinary disorders Azotaemia	0.10% 1/961 • 24 months At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
Renal and urinary disorders Neurogenic bladder	0.10% 1/961 • 24 months At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
Renal and urinary disorders Urinary retention	0.10% 1/961 • 24 months At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
Renal and urinary disorders Renal impairment	0.10% 1/961 • 24 months At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
Renal and urinary disorders Acute kidney injury	0.10% 1/961 • 24 months At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
General disorders Death	0.10% 1/961 • 24 months At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
General disorders Drowning	0.10% 1/961 • 24 months At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
General disorders Sudden death	0.21% 2/961 • 24 months At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
General disorders Multiple organ dysfunction syndrome	0.10% 1/961 • 24 months At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
Investigations Blood creatine phosphokinase increased	0.10% 1/961 • 24 months At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
Investigations Fibrin D dimer increased	0.10% 1/961 • 24 months At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
Investigations C-reactive protein increased	0.10% 1/961 • 24 months At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
Injury, poisoning and procedural complications Fall	0.52% 5/961 • 24 months At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
Injury, poisoning and procedural complications Femoral neck fracture	0.52% 5/961 • 24 months At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
Injury, poisoning and procedural complications Femur fracture	0.10% 1/961 • 24 months At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
Injury, poisoning and procedural complications Injury	0.10% 1/961 • 24 months At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
Injury, poisoning and procedural complications Patella fracture	0.10% 1/961 • 24 months At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
Injury, poisoning and procedural complications Rib fracture	0.10% 1/961 • 24 months At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
Injury, poisoning and procedural complications Spinal compression fracture	0.62% 6/961 • 24 months At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
Injury, poisoning and procedural complications Subdural haematoma	0.31% 3/961 • 24 months At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
Injury, poisoning and procedural complications Pelvic fracture	0.21% 2/961 • 24 months At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
Injury, poisoning and procedural complications Heat illness	0.10% 1/961 • 24 months At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
Surgical and medical procedures Hospitalisation	0.10% 1/961 • 24 months At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.

Other adverse events

Other adverse events
Measure	Rasagiline 1 mg n=961 participants at risk Rasagiline 1 milligram (mg), orally, once daily for up to 24 months. Participants received interventions as part of routine medical care.
Nervous system disorders Dizziness	1.5% 14/961 • 24 months At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
Nervous system disorders Dyskinesia	4.2% 40/961 • 24 months At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
Nervous system disorders Somnolence	1.6% 15/961 • 24 months At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
Vascular disorders Orthostatic hypotension	2.5% 24/961 • 24 months At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
Gastrointestinal disorders Nausea	1.6% 15/961 • 24 months At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
Injury, poisoning and procedural complications Fall	2.9% 28/961 • 24 months At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.

Additional Information

Study Director

Takeda

Phone: +1-877-825-3327

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.
Publication restrictions are in place

Restriction type: OTHER