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The goal of this study is to evaluate the effects of deferiprone, an iron-chelating drug, in patients with Parkinson's disease. Participants will be randomized to receive one of four different dosages of deferiprone or placebo, and will take the assigned study product twice a day for nine months.
This study will enroll 140 patients who have been diagnosed with Parkinson's disease within the last 3 years and are currently taking antiparkinsonian medication. There are four dosage cohorts, with patients in each cohort receiving either deferiprone tablets or placebo. At the baseline visit, participants will be randomized to a dosage cohort and to either active product or placebo within that cohort, and will take the assigned study product twice-daily for 9 months. They will come back to the study site for assessments at Months 1, 2, 3, 4, 5, 6, and 9, and will need to have their blood count checked weekly, at either the study site or a local laboratory.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Deferiprone 300 mg | Experimental | One-half of a 600 mg tablet of deferiprone twice a day, for a total daily dosage of 600 mg |
|
| Deferiprone 600 mg | Experimental | One 600 mg tablet of deferiprone twice a day, for a total daily dosage of 1200 mg |
|
| Deferiprone 900 mg | Experimental | One and a half 600 mg tablets of deferiprone twice a day, for a total daily dosage of 1800 mg |
|
| Deferiprone 1200 mg | Experimental | Two 600 mg tablets of deferiprone twice a day, for a total daily dosage of 2400 mg |
|
| Placebo | Placebo Comparator | Depending on dosage cohort, either one half-tablet, one tablet, one and a half tablets, or two tablets of placebo, twice a day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Deferiprone | Drug | 600 mg tablets |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Score on the Part III Subscale of the Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) | Change from baseline to Month 9 in the score for the Part III subscale (motor examination) of the MDS-UPDRS. Scores on this subscale can range from 0 (best) to 132 (worst); hence, an increase would indicate progression of the disease and a decrease would indicate improvement. The change in score was calculated as least square means. | Nine months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Total Score on the MDS-UPDRS | Change from baseline to Month 9 in total score on the MDS-UPDRS. The total score can range from 0 (best) to 260 (worst); hence, an increase would indicate progression of the disease and a decrease would indicate improvement. The change in score was calculated as least square means. | Nine months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Devos, MD | Hospitalier Régional Universitaire de Lille | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Toronto Western Hospital | Toronto | Ontario | Canada | |||
| CHU de Bordeaux, Centre Expert Parkinson |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39973479 | Derived | Devos D, Rascol O, Meissner WG, Foubert-Samier A, Lewis S, Tranchant C, Anheim M, Maltete D, Remy P, Eggert K, Pape H, Geny C, Couratier P, Carroll C, Sheridan R, Burn D, Pavese N, Raw J, Berg D, Suchowersky O, Kalia LV, Evans A, Drapier S, Danaila T, Schnitzler A, Corvol JC, Defer G, Temin NT, Fradette C, Tricta F, Moreau C; a Parkinson's disease study group. Therapeutic modalities of deferiprone in Parkinson's disease: SKY and EMBARK studies. J Parkinsons Dis. 2025 Feb;15(1):72-86. doi: 10.1177/1877718X241300295. Epub 2024 Dec 27. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Depending on dosage cohort, either one half-tablet, one tablet, one and a half tablets, or two tablets of placebo, twice a day Placebo: Tablets that match the deferiprone tablets in appearance |
| FG001 | Deferiprone 300 mg | One-half of a 600 mg tablet of deferiprone twice a day, for a total daily dosage of 600 mg Deferiprone: 600 mg tablets |
| FG002 | Deferiprone 600 mg | One 600 mg tablet of deferiprone twice a day, for a total daily dosage of 1200 mg Deferiprone: 600 mg tablets |
| FG003 | Deferiprone 900 mg | One and a half 600 mg tablets of deferiprone twice a day, for a total daily dosage of 1800 mg Deferiprone: 600 mg tablets |
| FG004 | Deferiprone 1200 mg | Two 600 mg tablets of deferiprone twice a day, for a total daily dosage of 2400 mg Deferiprone: 600 mg tablets |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Only patients in the Intent to Treat (ITT) population are presented. The ITT population was defined as all randomized patients who received at least one dose of study drug and had a baseline and at least one post-baseline efficacy assessment for the primary endpoint.
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| ID | Title | Description |
|---|---|---|
| BG000 | 300 mg | Patients took 300 mg deferiprone twice daily, for a total daily dosage of 600 mg |
| BG001 | 600 mg | Patients took 600 mg deferiprone twice daily, for a total daily dosage of 1200 mg |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Score on the Part III Subscale of the Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) | Change from baseline to Month 9 in the score for the Part III subscale (motor examination) of the MDS-UPDRS. Scores on this subscale can range from 0 (best) to 132 (worst); hence, an increase would indicate progression of the disease and a decrease would indicate improvement. The change in score was calculated as least square means. | Intent-to-treat (ITT) population | Posted | Least Squares Mean | Standard Error | Score on a scale | Nine months |
|
10 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Depending on dosage cohort, either one half-tablet, one tablet, one and a half tablets, or two tablets of placebo, twice a day Placebo: Tablets that match the deferiprone tablets in appearance |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neutropenia | Blood and lymphatic system disorders | MedDRA (22.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lymphopenia | Blood and lymphatic system disorders | MedDRA (22.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Caroline Fradette, PhD | Chiesi Canada Corp. | 1-800-854-3534 | 7014 | c.fradette@chiesi.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 20, 2017 | Jun 14, 2022 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 18, 2019 | Jun 14, 2022 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Apr 7, 2017 | Jun 14, 2022 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D000077543 | Deferiprone |
| D007531 | Isoflurophate |
| ID | Term |
|---|---|
| D011728 | Pyridones |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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The placebo tablets had the same appearance as the deferiprone tablets, and within each dosing cohort, all participants took the same number of tablets at each dose.
| Placebo | Drug | Tablets that match the deferiprone tablets in appearance |
|
| Change in Score on the Part I Subscale of the MDS-UPDRS |
Change from baseline to Month 9 in the score for the Part I subscale (mentation, behavior, and mood) of the MDS-UPDRS. Scores on this subscale can range from 0 (best) to 52 (worst); hence, an increase would indicate progression of the disease and a decrease would indicate improvement. The change in score was calculated as least square means. |
| Nine months |
| Change in Score on the Part II Subscale of the MDS-UPDRS | Change from baseline to Month 9 in the score for the Part II subscale (activities of daily living) of the MDS-UPDRS. Scores on this subscale can range from 0 (best) to 52 (worst); hence, an increase would indicate progression of the disease and a decrease would indicate improvement. The change in score was calculated as least square means. | Nine months |
| Change in Score in the Part IV Subscale of the MDS-UPDRS | Change from baseline to Month 9 in the score for the Part IV subscale (motor complications) of the MDS-UPDRS. Scores on this subscale can range from 0 (best) to 24 (worst); hence, an increase would indicate progression of the disease and a decrease would indicate improvement. The change in score was calculated as least square means. | Nine months |
| Change in the Combined Scores From Parts II and III of the MDS-UPDRS | Change from baseline to Month 9 in the combined score for the Part II subscale (motor experiences of daily living) and the Part III subscale (motor examination) of the MDS-UPDRS. The scales for these two parts range from 0 (best) to 52 (worst) and from 0 (best) to 132 (worst), respectively. Hence, the combined score can range from 0 (best) to 184 (worst), and an increase would indicate progression of the disease and a decrease would indicate improvement. The change in score is presented as least square means. | Nine months |
| Change in Score on the Montreal Cognitive Assessment (MoCA) Test | Change from baseline to Month 9 in the score for overall cognitive function as assessed by the MoCA. The total score on the MoCA can range from 0 (worst) to 30 (best). Hence, a decrease in score would indicate progression of the disease and an increase would indicate improvement. The change in score is presented as least square means. | Nine months |
| Safety of Deferiprone | Number of subjects with adverse events | Nine months |
| Cmax for Serum Deferiprone and Deferiprone 3-O-glucuronide | Blood samples for pharmacokinetics assessments were collected at baseline, and at pre-dose and specified time points up to 12 hours post-dose at the Month 3 visit. The maximum measured serum concentration (Cmax) at the Month 3 visit was determined for deferiprone and its main metabolite, deferiprone 3-O-glucuronide. | 4 hours |
| Tmax for Serum Deferiprone and Deferiprone 3-O-glucuronide | Blood samples for pharmacokinetics assessments were collected at baseline, and at pre-dose and specified time points up to 12 hours post-dose at the Month 3 visit. The time to maximum observed serum concentration (Tmax) at the Month 3 visit was determined for deferiprone and its main metabolite, deferiprone 3-O-glucuronide. | 4 hours |
| Area Under the Curve for Serum Deferiprone and Deferiprone 3-O-glucuronide | Blood samples for pharmacokinetics assessments were collected at baseline, and at pre-dose and specified time points up to 12 hours post-dose at the Month 3 visit. The total drug exposure, AUC0-∞ (area under the serum concentration time curve extrapolated to infinity) at the Month 3 visit was determined for deferiprone and its main metabolite, deferiprone 3-O-glucuronide. | 4 hours |
| Bordeaux |
| France |
| Hôpital Henri Mondor | Créteil | France |
| Centre Hospitalier Régional Universitaire de Lille, Hôpital Roger Salengro | Lille | France |
| CHU Dupuytren | Limoges | France |
| Hôpital Neurologique Pierre Wertheimer | Lyon | France |
| CHRU de Montpellier - Hôpital Gui de Chauliac | Montpellier | France |
| CHU Pontchaillou | Rennes | France |
| CHU Charles Nicoll - Rouen | Rouen | France |
| Hôpitaux Universitaires de Strasbourg, Hôpital de Hautepierre | Strasbourg | France |
| CHU Purpan, Hôpital Pierre Paul Riquet | Toulouse | France |
| Heinriche-Heine Universität Düsseldorf | Düsseldorf | Germany |
| UKSH Campus Kiel, Neurologie | Kiel | Germany |
| Universitätsklinikum Gießen und Marburg GmbH | Marburg | Germany |
| Klinikum rechts der Isar | Munich | Germany |
| Royal Devon & Exeter Hospital | Exeter | Devon | United Kingdom |
| Fairfield General Hospital | Bury | United Kingdom |
| Charing Cross Hospital | London | United Kingdom |
| Newcastle Clinical Ageing Research Unit | Newcastle upon Tyne | United Kingdom |
| Derriford Hospital | Plymouth | United Kingdom |
| Lack of Efficacy |
|
| Protocol Violation |
|
| Withdrawal by Subject |
|
| Use of rescue medication |
|
| BG002 | 900 mg | Patients took 900 mg deferiprone twice daily, for a total daily dosage of 1800 mg |
| BG003 | 1200 mg | Patients took 1200 mg deferiprone twice daily, for a total daily dosage of 2400 mg |
| BG004 | Placebo | Depending on which dosage cohort they were in, patients took a number of placebo tablets that matched the number of tablets taken by patients receiving active product |
| BG005 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| MDS-UPDRS Total Score | The Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) is used to follow the longitudinal course of Parkinson's disease. It contains 4 parts. Each item has a rating of 0-4: 0 (normal), 1 (slight), 2 (mild), 3 (moderate), and 4 (severe). The total score ranges from 0 to 260, with 0 indicating no disability and 260 indicating total disability. | Mean | Standard Deviation | units on a scale |
|
| MDS-UPDRS Part I | Part I of the MDS-UPDRS is the subscale that evaluates mentation, behavior, and mood. Scores range from 0 (best) to 52 (worst). | Mean | Standard Deviation | units on a scale |
|
| MDS-UPDRS Part II | Part II of the MDS-UPDRS is the subscale for motor experiences of daily living. Scores range from 0 (best) to 52 (worst). | Mean | Standard Deviation | units on a scale |
|
| MDS-UPDRS Part III | Part III of the MDS-UPDRS is the subscale for motor examination. Scores range from 0 (best) to 132 (worst). | Mean | Standard Deviation | units on a scale |
|
| MDS-UPDRS Part II/Part III | The combined score from the Part II subscale (motor experiences of daily living) and the Part III subscale (motor examination) of the MDS-UPDRS. For Part II, scores can range from 0 (best) to 52 (worst), and for Part III, they can range from 0 (best) to 132 (worst). Hence, the combined score can range from 0 (best) to 184 (worst). | Mean | Standard Deviation | units on a scale |
|
| MDS-UPDRS Part IV | Part IV of the MDS-UPDRS is the subscale for motor complications. Scores range from 0 (best) to 24 (worst). | Mean | Standard Deviation | units on a scale |
|
| Montreal Cognitive Assessment | The Montreal Cognitive Assessment (MoCA) test is a rapid screening instrument for the detection of mild cognitive dysfunction. It is used to assess the following cognitive domains: short-term memory recall, visuospatial abilities, executive functions, attention, concentration, working memory, language, and orientation to time and place. The total score on the MoCA can range from 0 (worst) to 30 (best). | Mean | Standard Deviation | units on a scale |
|
| OG001 |
| Deferiprone 300 mg |
One-half of a 600 mg tablet of deferiprone twice a day, for a total daily dosage of 600 mg Deferiprone: 600 mg tablets |
| OG002 | Deferiprone 600 mg | One 600 mg tablet of deferiprone twice a day, for a total daily dosage of 1200 mg Deferiprone: 600 mg tablets |
| OG003 | Deferiprone 900 mg | One and a half 600 mg tablets of deferiprone twice a day, for a total daily dosage of 1800 mg Deferiprone: 600 mg tablets |
| OG004 | Deferiprone 1200 mg | Two 600 mg tablets of deferiprone twice a day, for a total daily dosage of 2400 mg Deferiprone: 600 mg tablets |
|
|
|
| Secondary | Change in Total Score on the MDS-UPDRS | Change from baseline to Month 9 in total score on the MDS-UPDRS. The total score can range from 0 (best) to 260 (worst); hence, an increase would indicate progression of the disease and a decrease would indicate improvement. The change in score was calculated as least square means. | ITT population | Posted | Least Squares Mean | Standard Error | Score on a scale | Nine months |
|
|
|
|
| Secondary | Change in Score on the Part I Subscale of the MDS-UPDRS | Change from baseline to Month 9 in the score for the Part I subscale (mentation, behavior, and mood) of the MDS-UPDRS. Scores on this subscale can range from 0 (best) to 52 (worst); hence, an increase would indicate progression of the disease and a decrease would indicate improvement. The change in score was calculated as least square means. | ITT population | Posted | Least Squares Mean | Standard Error | Score on a scale | Nine months |
|
|
|
|
| Secondary | Change in Score on the Part II Subscale of the MDS-UPDRS | Change from baseline to Month 9 in the score for the Part II subscale (activities of daily living) of the MDS-UPDRS. Scores on this subscale can range from 0 (best) to 52 (worst); hence, an increase would indicate progression of the disease and a decrease would indicate improvement. The change in score was calculated as least square means. | ITT population | Posted | Least Squares Mean | Standard Error | Score on a scale | Nine months |
|
|
|
|
| Secondary | Change in Score in the Part IV Subscale of the MDS-UPDRS | Change from baseline to Month 9 in the score for the Part IV subscale (motor complications) of the MDS-UPDRS. Scores on this subscale can range from 0 (best) to 24 (worst); hence, an increase would indicate progression of the disease and a decrease would indicate improvement. The change in score was calculated as least square means. | ITT population | Posted | Least Squares Mean | Standard Error | Score on a scale | Nine months |
|
|
|
|
| Secondary | Change in the Combined Scores From Parts II and III of the MDS-UPDRS | Change from baseline to Month 9 in the combined score for the Part II subscale (motor experiences of daily living) and the Part III subscale (motor examination) of the MDS-UPDRS. The scales for these two parts range from 0 (best) to 52 (worst) and from 0 (best) to 132 (worst), respectively. Hence, the combined score can range from 0 (best) to 184 (worst), and an increase would indicate progression of the disease and a decrease would indicate improvement. The change in score is presented as least square means. | ITT population | Posted | Least Squares Mean | Standard Error | Score on a scale | Nine months |
|
|
|
|
| Secondary | Change in Score on the Montreal Cognitive Assessment (MoCA) Test | Change from baseline to Month 9 in the score for overall cognitive function as assessed by the MoCA. The total score on the MoCA can range from 0 (worst) to 30 (best). Hence, a decrease in score would indicate progression of the disease and an increase would indicate improvement. The change in score is presented as least square means. | ITT population | Posted | Least Squares Mean | Standard Error | Score on a scale | Nine months |
|
|
|
|
| Secondary | Safety of Deferiprone | Number of subjects with adverse events | Safety population | Posted | Count of Participants | Participants | Nine months |
|
|
|
| Secondary | Cmax for Serum Deferiprone and Deferiprone 3-O-glucuronide | Blood samples for pharmacokinetics assessments were collected at baseline, and at pre-dose and specified time points up to 12 hours post-dose at the Month 3 visit. The maximum measured serum concentration (Cmax) at the Month 3 visit was determined for deferiprone and its main metabolite, deferiprone 3-O-glucuronide. | Pharmacokinetics (PK) population: Included all patients who had sufficient PK data to derive at least one PK parameter. | Posted | Mean | Standard Deviation | μg/mL | 4 hours |
|
|
|
| Secondary | Tmax for Serum Deferiprone and Deferiprone 3-O-glucuronide | Blood samples for pharmacokinetics assessments were collected at baseline, and at pre-dose and specified time points up to 12 hours post-dose at the Month 3 visit. The time to maximum observed serum concentration (Tmax) at the Month 3 visit was determined for deferiprone and its main metabolite, deferiprone 3-O-glucuronide. | Pharmacokinetics population: Included all patients who had sufficient PK data to derive at least one PK parameter. | Posted | Median | Full Range | Hours | 4 hours |
|
|
|
| Secondary | Area Under the Curve for Serum Deferiprone and Deferiprone 3-O-glucuronide | Blood samples for pharmacokinetics assessments were collected at baseline, and at pre-dose and specified time points up to 12 hours post-dose at the Month 3 visit. The total drug exposure, AUC0-∞ (area under the serum concentration time curve extrapolated to infinity) at the Month 3 visit was determined for deferiprone and its main metabolite, deferiprone 3-O-glucuronide. | Pharmacokinetics population: Included all patients who had sufficient PK data to derive at least one PK parameter. | Posted | Mean | Standard Deviation | μg*h/mL | 4 hours |
|
|
|
| 0 |
| 28 |
| 2 |
| 28 |
| 26 |
| 28 |
| EG001 | Deferiprone 300 mg | One-half of a 600 mg tablet of deferiprone twice a day, for a total daily dosage of 600 mg Deferiprone: 600 mg tablets | 0 | 28 | 1 | 28 | 25 | 28 |
| EG002 | Deferiprone 600 mg | One 600 mg tablet of deferiprone twice a day, for a total daily dosage of 1200 mg Deferiprone: 600 mg tablets | 0 | 28 | 3 | 28 | 23 | 28 |
| EG003 | Deferiprone 900 mg | One and a half 600 mg tablets of deferiprone twice a day, for a total daily dosage of 1800 mg Deferiprone: 600 mg tablets | 0 | 28 | 4 | 28 | 25 | 28 |
| EG004 | Deferiprone 1200 mg | Two 600 mg tablets of deferiprone twice a day, for a total daily dosage of 2400 mg Deferiprone: 600 mg tablets | 0 | 28 | 1 | 28 | 25 | 28 |
| Atrial fibrillation | Cardiac disorders | MedDRA (22.0) | Systematic Assessment |
|
| Head injury | Injury, poisoning and procedural complications | MedDRA (22.0) | Systematic Assessment |
|
| Renal cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (22.0) | Systematic Assessment |
|
| Squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (22.0) | Systematic Assessment |
|
| Jealous delusion | Psychiatric disorders | MedDRA (22.0) | Systematic Assessment |
|
| Renal colic | Renal and urinary disorders | MedDRA (22.0) | Systematic Assessment |
|
| Renal impairment | Renal and urinary disorders | MedDRA (22.0) | Systematic Assessment |
|
| Intermittent claudication | Vascular disorders | MedDRA (22.0) | Systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | MedDRA (22.0) | Systematic Assessment |
|
| Cataract | Eye disorders | MedDRA (22.0) | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (22.0) | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA (22.0) | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA (22.0) | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA (22.0) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (22.0) | Systematic Assessment |
|
| Toothache | Gastrointestinal disorders | MedDRA (22.0) | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA (22.0) | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA (22.0) | Systematic Assessment |
|
| Chest discomfort | General disorders | MedDRA (22.0) | Systematic Assessment |
|
| Chest pain | General disorders | MedDRA (22.0) | Systematic Assessment |
|
| Condition aggravated | General disorders | MedDRA (22.0) | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA (22.0) | Systematic Assessment |
|
| Gait disturbance | General disorders | MedDRA (22.0) | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA (22.0) | Systematic Assessment |
|
| Arthropod bite | Injury, poisoning and procedural complications | MedDRA (22.0) | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA (22.0) | Systematic Assessment |
|
| Limb injury | Injury, poisoning and procedural complications | MedDRA (22.0) | Systematic Assessment |
|
| Amylase increased | Investigations | MedDRA (22.0) | Systematic Assessment |
|
| Blood urine present | Investigations | MedDRA (22.0) | Systematic Assessment |
|
| Neutrophil count decreased | Investigations | MedDRA (22.0) | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (22.0) | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (22.0) | Systematic Assessment |
|
| Joint swelling | Musculoskeletal and connective tissue disorders | MedDRA (22.0) | Systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA (22.0) | Systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA (22.0) | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (22.0) | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (22.0) | Systematic Assessment |
|
| Akinesia | Nervous system disorders | MedDRA (22.0) | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA (22.0) | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (22.0) | Systematic Assessment |
|
| Parkinson's disease | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (22.0) | Systematic Assessment |
|
| Sciatica | Nervous system disorders | MedDRA (22.0) | Systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA (22.0) | Systematic Assessment |
|
| Tremor | Nervous system disorders | MedDRA (22.0) | Systematic Assessment |
|
| Hallucination | Psychiatric disorders | MedDRA (22.0) | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA (22.0) | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (22.0) | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (22.0) | Systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA (22.0) | Systematic Assessment |
|
| Cataract operation | Surgical and medical procedures | MedDRA (22.0) | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA (22.0) | Systematic Assessment |
|
Not provided
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| D063066 |
| Organofluorophosphonates |
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
| Serum deferiprone 3-O-glucuronide |
|
| Serum deferiprone 3-O-glucuronide |
|
| Serum deferiprone 3-O-glucuronide |
|