Trial · NCT03727139
Rasagiline Tablets Special Drug Use-Results Survey "Survey on Long-term Safety"
NCT03727139, Completed, Takeda; results first posted 2024-03-08
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Rasagiline Tablets Special Drug Use-Results Survey "Survey on Long-term Safety". Trials, record NCT03727139. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03727139
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Rasagiline Tablets Special Drug Use-Results Survey "Survey on Long-term Safety"
- NCT number
- NCT03727139
- Status
- Completed
- Enrollment
- 1,021 participants, actual
- Lead sponsor
- Takeda
- Conditions
- Parkinson's Disease
- Interventions
- Rasagiline
- First posted
- 2018-11-01
- Last updated
- 2024-03-08
- Results first posted
- 2024-03-08
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants Who Had One or More Adverse Events | 24 months | 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. |
| Primary | Number of Participants Who Had One or More Adverse Drug Reactions | 24 months | 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. Adverse drug reaction refers to AE related to administered drug. |
| Secondary | Change From Baseline in the Unified Parkinson's Disease Rating Scale (UPDRS) | Baseline, Up to Month 24 (Final Assessment Point) | 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). |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants Who Had One or More Adverse Events | 24 months | Safety Analysis Set, The safety analysis set was defined as all participants who completed the survey. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants Who Had One or More Adverse Drug Reactions | 24 months | Safety Analysis Set, The safety analysis set was defined as all participants who completed the survey. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change From Baseline in the Unified Parkinson's Disease Rating Scale (UPDRS) | Baseline, Up to Month 24 (Final Assessment Point) | 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. | Scores on a scale | MEAN |
Source ClinicalTrials.gov
Results by group3
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants Who Had One or More Adverse Events | Rasagiline 1 mg | 304 | Participants | ||
| Number of Participants Who Had One or More Adverse Drug Reactions | Rasagiline 1 mg | 189 | Participants | ||
| Change From Baseline in the Unified Parkinson's Disease Rating Scale (UPDRS) | Rasagiline 1 mg | -2.7 | Standard Deviation 9.46 | Scores on a scale |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Rasagiline 1 mg | 1,021 | |
| Overall Study | COMPLETED | Rasagiline 1 mg | 961 | |
| Overall Study | NOT COMPLETED | Rasagiline 1 mg | 60 |
Source ClinicalTrials.gov
Adverse events93
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Dizziness | Nervous system disorders | Rasagiline 1 mg | 14 | 961 | |
| other | Dyskinesia | Nervous system disorders | Rasagiline 1 mg | 40 | 961 | |
| other | Somnolence | Nervous system disorders | Rasagiline 1 mg | 15 | 961 | |
| other | Orthostatic hypotension | Vascular disorders | Rasagiline 1 mg | 24 | 961 | |
| other | Nausea | Gastrointestinal disorders | Rasagiline 1 mg | 15 | 961 | |
| other | Fall | Injury, poisoning and procedural complications | Rasagiline 1 mg | 28 | 961 | |
| serious | Bronchitis | Infections and infestations | Rasagiline 1 mg | 1 | 961 | |
| serious | Cellulitis | Infections and infestations | Rasagiline 1 mg | 1 | 961 | |
| serious | Pneumonia | Infections and infestations | Rasagiline 1 mg | 6 | 961 | |
| serious | Pneumonia aspiration | Infections and infestations | Rasagiline 1 mg | 4 | 961 |
1 to 10 of 93Source ClinicalTrials.gov
See all 93 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Rasagiline 1 mg | 11 | 961 |
| Total, other adverse events | Rasagiline 1 mg | 136 | 961 |
| Total, serious adverse events | Rasagiline 1 mg | 121 | 961 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 38124528 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03727139
GET https://conductscience.org/api/trials/v1/NCT03727139/events?page=2