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| ID | Type | Description | Link |
|---|---|---|---|
| U01NS074425 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Medical University of South Carolina | OTHER |
| National Institute of Neurological Disorders and Stroke (NINDS) | NIH |
| Massachusetts General Hospital | OTHER |
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The investigators hypothesize that treatment with the iron chelator, Deferoxamine Mesylate, improves the outcome of patients with brain hemorrhage.
The purpose of this study is to determine whether treatment with Deferoxamine Mesylate is of sufficient promise to improve outcome before pursuing a larger clinical trial to examine its effectiveness as a treatment for intracerebral hemorrhage.
This is a prospective, multi-center, double-blind, randomized, placebo-controlled, phase-II clinical trial.
Subjects will be randomized to either deferoxamine mesylate (DFO) at 32 mg/kg/day (up to a maximum daily dose of 6000 mg/day), or saline placebo, given by IV infusion for 3 consecutive days.
Treatment will be initiated within 24 hours after ICH symptom onset. Randomization will control baseline imbalances associated with baseline ICH score, ICH onset-to-treatment time (OTT), ICH volume, baseline NIHSS score, and warfarin use.
All subjects will be followed for 6 months and will receive standard of care therapy while participating in the study.
Throughout the study, we will continue to assess the safety of DFO. At the conclusion of the study, the proportion of DFO-treated subjects with a good clinical outcome at 3 months (defined as modified Rankin Scale (mRS) score of 0-2) will be compared to the placebo proportion in a futility analysis to determine if it is futile to move DFO forward to Phase III efficacy evaluation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Deferoxamine Mesylate | Experimental | Deferoxamine Mesylate (32 mg/kg/day) given by an intravenous infusion for 3 consecutive days |
|
| Normal Saline | Placebo Comparator | Normal saline (0.9% sodium chloride) given by intravenous infusion for 3 consecutive days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Deferoxamine Mesylate | Drug |
| ||
| Placebo (for Deferoxamine Mesylate) |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Patients With Modified Rankin Scale (mRS) Score 0-2 at 90 Days | The primary outcome measure of efficacy is the modified Rankin Scale (mRS) score, dichotomized to define good functional outcome as mRS 0-2 at 90 days. The mRS ranges from 0 to 6, with higher scores indicating worse outcome. | 90 days |
| Number of Subjects Experiencing Serious Adverse Events | Number of subjects experiencing Serious adverse events at any time from randomization through day 90 | 90 days |
| Number of Subjects With Serious Adverse Events Within 7 Days | Number of Subjects Experiencing Serious Adverse Events within 7 days of randomization | 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Patients With mRS Score 0-3 at 90 Days | Another measure of efficacy is the modified Rankin Scale (mRS) score, dichotomized to define good functional outcome as mRS 0-3 at 90 days. The mRS ranges from 0 to 6, with higher scores indicating worse outcome. Although mRS 0-3 is less favorable than the primary outcome of mRS 0-2, it would still be a desirable effect in patients with ICH given that no treatments exist to reduce disability. |
| Measure | Description | Time Frame |
|---|---|---|
| Ordinal Distribution of Scores on mRS at Day 90 | The overall ordinal distribution of scores on mRS at 90 days in DFO- and placebo-treated subjects will be determined. | 90 days |
| Ordinal Distribution of Scores on mRS at 180 Days |
Inclusion Criteria:
Exclusion Criteria:
Previous chelation therapy or known hypersensitivity to DFO products
Known severe iron deficiency anemia (defined as hemoglobin concentration < 7g/dL or requiring blood transfusions)
Abnormal renal function, defined as serum creatinine >2 mg/dL
Planned surgical evacuation of ICH prior to administration of study drug (placement of a catheter for ventricular drainage is not a contraindication to enrollment)
SUSPECTED secondary ICH related to tumour, ruptured aneurysm or arteriovenous malformation, hemorrhagic transformation of an ischemic infarct, or venous sinus thrombosis
Infratentorial hemorrhage
Irreversibly impaired brainstem function (bilateral fixed and dilated pupils and extensor motor posturing)
Complete unconsciousness, defined as a score of 3 on item 1a of the NIHSS (Responds only with reflex motor or autonomic effects or totally unresponsive, and flaccid)
Pre-existing disability, defined as pre-ICH mRS ≥2
Coagulopathy - defined as elevated aPTT or INR >1.3 upon presentation; concurrent use of direct thrombin inhibitors (such as dabigatran), direct factor Xa inhibitors (such as rivaroxaban or apixaban), or low-molecular-weight heparin
Patients with confirmed aspiration, pneumonia, or evident bilateral pulmonary infiltrates on chest x-ray or CT scan prior to enrollment
Patients with significant respiratory disease such as chronic obstructive pulmonary disease, pulmonary fibrosis, or any use (chronic or intermittent) of inhaled O2 at home
FiO2 >0.35 (>4 L/min) prior to enrollment
Sepsis (present source of infection ± lactic acidosis); Systemic Inflammatory Response Syndrome (Temp >100.4F or <96.8F; Heart rate >90; Respiratory rate >20 or PaCo2 <32 mmHg; WBC >12, <4, or bands >10%); or shock (SBP <90 mmHg) at presentation
The presence of 4 or more of the following risk modifiers for ARDS prior to enrollment:
Taking iron supplements containing ≥ 325 mg of ferrous iron, or prochlorperazine
Patients with heart failure taking > 500 mg of vitamin C daily
Known severe hearing loss
Known pregnancy, or positive pregnancy test, or breastfeeding
Positive drug screen for cocaine upon presentation
Patients known or suspected of not being able to comply with the study protocol due to alcoholism, drug dependency, noncompliance, living in another state or any other cause
Any condition which, in the judgement of the investigator, might increase the risk to the patient
Life expectancy of less than 90 days due to co-morbid conditions
Concurrent participation in another research protocol for investigation of another experimental therapy
Indication that a new DNR or Comfort Measures Only (CMO) order will be implemented within the first 72 hours of hospitalization
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| Name | Affiliation | Role |
|---|---|---|
| Magdy Selim, MD, PhD | Beth Israel Deaconess Medical Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Joseph's Hospital / Barrow Neurological Institute | Phoenix | Arizona | United States | |||
| Stanford University Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23943316 | Background | Yeatts SD, Palesch YY, Moy CS, Selim M. High dose deferoxamine in intracerebral hemorrhage (HI-DEF) trial: rationale, design, and methods. Neurocrit Care. 2013 Oct;19(2):257-66. doi: 10.1007/s12028-013-9861-y. | |
| 21868742 | Background | Selim M, Yeatts S, Goldstein JN, Gomes J, Greenberg S, Morgenstern LB, Schlaug G, Torbey M, Waldman B, Xi G, Palesch Y; Deferoxamine Mesylate in Intracerebral Hemorrhage Investigators. Safety and tolerability of deferoxamine mesylate in patients with acute intracerebral hemorrhage. Stroke. 2011 Nov;42(11):3067-74. doi: 10.1161/STROKEAHA.111.617589. Epub 2011 Aug 25. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Deferoxamine Mesylate | Deferoxamine Mesylate (32 mg/kg/day) given by an intravenous infusion for 3 consecutive days Deferoxamine Mesylate |
| FG001 | Normal Saline | Normal saline (0.9% sodium chloride) given by intravenous infusion for 3 consecutive days Placebo (for Deferoxamine Mesylate) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
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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 | May 15, 2014 | May 8, 2019 |
Not provided
| University of Massachusetts, Worcester |
| OTHER |
| University of Pennsylvania | OTHER |
| Johns Hopkins University | OTHER |
| Duke University | OTHER |
| University of North Carolina | OTHER |
| University of Florida | OTHER |
| Henry Ford Hospital | OTHER |
| Ohio State University | OTHER |
| St. Joseph's Hospital and Medical Center, Phoenix | OTHER |
| University of California, San Francisco | OTHER |
| Oregon Health and Science University | OTHER |
| Yale New Haven Health System Center for Healthcare Solutions | OTHER |
| University of Iowa | OTHER |
| Hartford Hospital | OTHER |
| The University of Texas Health Science Center, Houston | OTHER |
| Rhode Island Hospital | OTHER |
| Stanford University | OTHER |
| University of Washington | OTHER |
| University of Calgary | OTHER |
| Hopital de l'Enfant-Jesus | OTHER |
| University of Alberta | OTHER |
| Rush University Medical Center | OTHER |
| University Hospitals Cleveland Medical Center | OTHER |
| Columbia University | OTHER |
| Weill Medical College of Cornell University | OTHER |
| NYU Langone Health | OTHER |
| Mount Sinai Hospital, New York | OTHER |
| Loyola University | OTHER |
Not provided
Not provided
Not provided
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| Drug |
|
| 90 days |
| Proportion of Patients With Modified Rankin Scale (mRS) Score 0-2 at 180 Days | Another measure of efficacy is the modified Rankin Scale (mRS) score, dichotomized to define good functional outcome as mRS 0-2 at 180 days. The mRS ranges from 0 to 6, with higher scores indicating worse outcome. | 180 days |
| Proportion of Patients With Modified Rankin Scale (mRS) Score 0-3 at 180 Days | Another measure of efficacy is the modified Rankin Scale (mRS) score, dichotomized to define good functional outcome as mRS 0-3 at 180 days. The mRS ranges from 0 to 6, with higher scores indicating worse outcome. | 180 days |
| Proportion of Subjects With Good Outcome (mRS 0-2) in the Early vs. Delayed Treatment Time Windows | Analyses will be expanded to include an interaction between treatment and OTT window and the magnitude of the treatment effect, and corresponding confidence interval, will be estimated for each time window (<12 hours vs. >/= 12 hours) in order to explore the presence of a differential treatment effect in the OTT windows. | 90 days |
The overall ordinal distribution of scores on mRS at 180 days in DFO- and placebo-treated subjects will be determined.
| 180 days |
| Adverse Event of Special Interest: Number of Patients With Allergic Reactions (During Infusion of Study Drug) | Adverse event of special interest: anaphylaxis at any time during the study infusion | during the study infusion |
| Adverse Event of Special Interest: Number of Patients With Hypotension | Hypotension requiring medical intervention at any time during the study infusion that could not be explained by other causes | during the study infusion |
| Adverse Event of Special Interest: Number of Patients With New Visual or Auditory Changes | Adverse event of special interest: development of new and unexplained visual or auditory changes after initiation of the study infusion | after initiation of study infusion |
| Adverse Event of Special Interest: Number of Patients With Respiratory Compromise | Adverse event of special interest: Respiratory compromise of any cause, including acute respiratory distress syndrome, in hospital until day 7 or discharge [whichever was earlier] | 7 days |
| Number of Patients With Symptomatic Cerebral Edema | Edema accompanied by an unexplained increase of more than four points on the US National Institutes of Health Stroke Scale or a decrease of more than two points in Glasgow Coma Scale score during the first week after the intracerebral haemorrhage. | 7 days |
| Palo Alto |
| California |
| United States |
| San Francisco General Hospital | San Francisco | California | United States |
| Yale New Haven Hospital | New Haven | Connecticut | United States |
| University of Florida | Jacksonville | Florida | United States |
| Loyola University Medical Center | Chicago | Illinois | United States |
| RUSH University Medical Center | Chicago | Illinois | United States |
| University of Iowa Medical Center | Iowa City | Iowa | United States |
| Johns Hopkins Hospital | Baltimore | Maryland | United States |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | United States |
| UMass Memorial Medical Center | Worcester | Massachusetts | United States |
| Henry Ford Hospital | Detroit | Michigan | United States |
| Columbia University | New York | New York | United States |
| Mount Sinai Hospital | New York | New York | United States |
| NYU Langone Medical Center | New York | New York | United States |
| Weill Medical College of Cornell University | New York | New York | United States |
| University of North Carolina Medical Center | Chapel Hill | North Carolina | United States |
| Duke University Medical Center | Durham | North Carolina | United States |
| University Hospital Case Medical Center | Cleveland | Ohio | United States |
| The Ohio State University Medical Center | Columbus | Ohio | United States |
| Oregon Health & Science University Medical Center | Portland | Oregon | United States |
| University of Pennsylvania Medical Center | Philadelphia | Pennsylvania | United States |
| Rhode Island Hospital | Providence | Rhode Island | United States |
| Medical University of South Carolina | Charleston | South Carolina | United States |
| University of Texas Health Sciences Center | Houston | Texas | United States |
| Foothills Hospital - University of Calgary | Calgary | Alberta | Canada |
| University of Alberta - Mackenzie Health Sciences Centre | Edmonton | Alberta | Canada |
| CHU de Québec - Hôpital de l'Enfant-Jésus | Québec | Canada |
| 19064798 | Background | Selim M. Deferoxamine mesylate: a new hope for intracerebral hemorrhage: from bench to clinical trials. Stroke. 2009 Mar;40(3 Suppl):S90-1. doi: 10.1161/STROKEAHA.108.533125. Epub 2008 Dec 8. |
| 24187595 | Background | Hatakeyama T, Okauchi M, Hua Y, Keep RF, Xi G. Deferoxamine reduces neuronal death and hematoma lysis after intracerebral hemorrhage in aged rats. Transl Stroke Res. 2013 Oct;4(5):546-53. doi: 10.1007/s12975-013-0270-5. |
| 24172580 | Background | Xie Q, Gu Y, Hua Y, Liu W, Keep RF, Xi G. Deferoxamine attenuates white matter injury in a piglet intracerebral hemorrhage model. Stroke. 2014 Jan;45(1):290-2. doi: 10.1161/STROKEAHA.113.003033. Epub 2013 Oct 30. |
| 20044521 | Background | Okauchi M, Hua Y, Keep RF, Morgenstern LB, Schallert T, Xi G. Deferoxamine treatment for intracerebral hemorrhage in aged rats: therapeutic time window and optimal duration. Stroke. 2010 Feb;41(2):375-82. doi: 10.1161/STROKEAHA.109.569830. Epub 2009 Dec 31. |
| 24366522 | Background | Sonni S, Lioutas VA, Selim MH. New avenues for treatment of intracranial hemorrhage. Curr Treat Options Cardiovasc Med. 2014 Jan;16(1):277. doi: 10.1007/s11936-013-0277-y. |
| 40789806 | Derived | Polymeris AA, Lioutas VA, Incontri D, Soman S, Selim MH; i-DEF Investigators. Evolution of Perihematomal Edema Mean Hounsfield Unit and Its Association with Clinical Outcome in Intracerebral Hemorrhage: A Post Hoc Analysis of the i-DEF Trial. Neurocrit Care. 2025 Dec;43(3):824-833. doi: 10.1007/s12028-025-02337-7. Epub 2025 Aug 11. |
| 40418029 | Derived | Polymeris AA, Lioutas VA, Foster LD, Incontri D, Heistand EC, Marchal J, Lazar A, Fischer U, Engelter ST, Seiffge DJ, Yeatts SD, Selim MH. Early neurological improvement with deferoxamine after intracerebral hemorrhage: A post hoc analysis of the i-DEF trial. Int J Stroke. 2025 Dec;20(10):1235-1245. doi: 10.1177/17474930251348088. Epub 2025 May 26. |
| 40399657 | Derived | Polymeris AA, Lioutas VA, Marchina S, Seiffge DJ, Roh DJ, Poyraz FC, Selim MH; i-DEF Investigators. Hemoglobin and Perihematomal Edema After Intracerebral Hemorrhage: A Post Hoc Analysis of the i-DEF Trial. Neurocrit Care. 2026 Feb;44(1):64-71. doi: 10.1007/s12028-025-02284-3. Epub 2025 May 21. |
| 35676589 | Derived | Lee KH, Lioutas VA, Marchina S, Selim M; iDEF Investigators. The Prognostic Roles of Perihematomal Edema and Ventricular Size in Patients with Intracerebral Hemorrhage. Neurocrit Care. 2022 Oct;37(2):455-462. doi: 10.1007/s12028-022-01532-0. Epub 2022 Jun 8. |
| 35306827 | Derived | Foster L, Robinson L, Yeatts SD, Conwit RA, Shehadah A, Lioutas V, Selim M; i-DEF Investigators. Effect of Deferoxamine on Trajectory of Recovery After Intracerebral Hemorrhage: A Post Hoc Analysis of the i-DEF Trial. Stroke. 2022 Jul;53(7):2204-2210. doi: 10.1161/STROKEAHA.121.037298. Epub 2022 Mar 21. |
| 34789008 | Derived | Wei C, Wang J, Foster LD, Yeatts SD, Moy C, Mocco J, Selim M; i-DEF Investigators. Effect of Deferoxamine on Outcome According to Baseline Hematoma Volume: A Post Hoc Analysis of the i-DEF Trial. Stroke. 2022 Apr;53(4):1149-1156. doi: 10.1161/STROKEAHA.121.035421. Epub 2021 Nov 18. |
| 33758069 | Derived | Lun R, Yogendrakumar V, Ramsay T, Shamy M, Fahed R, Selim MH, Dowlatshahi D. Predicting long-term outcomes in acute intracerebral haemorrhage using delayed prognostication scores. Stroke Vasc Neurol. 2021 Dec;6(4):536-541. doi: 10.1136/svn-2020-000656. Epub 2021 Mar 23. |
| 30898550 | Derived | Selim M, Foster LD, Moy CS, Xi G, Hill MD, Morgenstern LB, Greenberg SM, James ML, Singh V, Clark WM, Norton C, Palesch YY, Yeatts SD; i-DEF Investigators. Deferoxamine mesylate in patients with intracerebral haemorrhage (i-DEF): a multicentre, randomised, placebo-controlled, double-blind phase 2 trial. Lancet Neurol. 2019 May;18(5):428-438. doi: 10.1016/S1474-4422(19)30069-9. Epub 2019 Mar 18. |
| Initiated Study Drug |
|
| 90 Day Outcome Obtained |
|
| 180 Day Outcome Obtained |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
As specified in the Statistical Analysis Plan, the target population is the modified ITT population, including only subjects in whom study drug was initiated.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Deferoxamine Mesylate | Deferoxamine Mesylate (32 mg/kg/day) given by an intravenous infusion for 3 consecutive days Deferoxamine Mesylate |
| BG001 | Normal Saline | Normal saline (0.9% sodium chloride) given by intravenous infusion for 3 consecutive days Placebo (for Deferoxamine Mesylate) |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Inter-Quartile Range | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Medical history: Hypertension | Count of Participants | Participants |
| ||||||||||||||||
| Medical history: Diabetes mellitus | Count of Participants | Participants |
| ||||||||||||||||
| Medical history: Cardiac disease | Count of Participants | Participants |
| ||||||||||||||||
| Medical history: Pulmonary disease | Count of Participants | Participants |
| ||||||||||||||||
| Medical history: Previous ischemic stroke or transient ischemic attack | Count of Participants | Participants |
| ||||||||||||||||
| Medical history: Previous intracerebral hemorrhage | Count of Participants | Participants |
| ||||||||||||||||
| Location of intracerebral hemorrhage | Count of Participants | Participants |
| ||||||||||||||||
| Intraventricular hemorrhage present | Count of Participants | Participants |
|
| 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 | Proportion of Patients With Modified Rankin Scale (mRS) Score 0-2 at 90 Days | The primary outcome measure of efficacy is the modified Rankin Scale (mRS) score, dichotomized to define good functional outcome as mRS 0-2 at 90 days. The mRS ranges from 0 to 6, with higher scores indicating worse outcome. | Per the SAP, the target population is the modified intention-to-treat population, including only subjects in whom study infusion is initiated. Complete case analysis was planned as the primary analytic approach. | Posted | Count of Participants | Participants | 90 days |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Number of Subjects Experiencing Serious Adverse Events | Number of subjects experiencing Serious adverse events at any time from randomization through day 90 | Per the SAP, the target population is the modified intention-to-treat population, including only subjects in whom study infusion is initiated. | Posted | Count of Participants | Participants | 90 days |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Number of Subjects With Serious Adverse Events Within 7 Days | Number of Subjects Experiencing Serious Adverse Events within 7 days of randomization | Per the SAP, the target population is the modified intention-to-treat population, including only subjects in whom study infusion is initiated. | Posted | Count of Participants | Participants | 7 days |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Proportion of Patients With mRS Score 0-3 at 90 Days | Another measure of efficacy is the modified Rankin Scale (mRS) score, dichotomized to define good functional outcome as mRS 0-3 at 90 days. The mRS ranges from 0 to 6, with higher scores indicating worse outcome. Although mRS 0-3 is less favorable than the primary outcome of mRS 0-2, it would still be a desirable effect in patients with ICH given that no treatments exist to reduce disability. | Per the SAP, the target population is the modified intention-to-treat population, including only subjects in whom study infusion is initiated. Complete case analysis was planned as the primary analytic approach. | Posted | Count of Participants | Participants | 90 days |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Proportion of Patients With Modified Rankin Scale (mRS) Score 0-2 at 180 Days | Another measure of efficacy is the modified Rankin Scale (mRS) score, dichotomized to define good functional outcome as mRS 0-2 at 180 days. The mRS ranges from 0 to 6, with higher scores indicating worse outcome. | Per the SAP, the target population is the modified intention-to-treat population, including only subjects in whom study infusion is initiated. Complete case analysis was planned as the primary analytic approach. | Posted | Count of Participants | Participants | 180 days |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Proportion of Patients With Modified Rankin Scale (mRS) Score 0-3 at 180 Days | Another measure of efficacy is the modified Rankin Scale (mRS) score, dichotomized to define good functional outcome as mRS 0-3 at 180 days. The mRS ranges from 0 to 6, with higher scores indicating worse outcome. | Per the SAP, the target population is the modified intention-to-treat population, including only subjects in whom study infusion is initiated. Complete case analysis was planned as the primary analytic approach. | Posted | Count of Participants | Participants | 180 days |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Proportion of Subjects With Good Outcome (mRS 0-2) in the Early vs. Delayed Treatment Time Windows | Analyses will be expanded to include an interaction between treatment and OTT window and the magnitude of the treatment effect, and corresponding confidence interval, will be estimated for each time window (<12 hours vs. >/= 12 hours) in order to explore the presence of a differential treatment effect in the OTT windows. | Per the SAP, the target population is the modified intention-to-treat population, including only subjects in whom study infusion is initiated. Complete case analysis was planned as the primary analytic approach. Subgroup analysis by Onset to treatment time window (<=12 hours vs >12 hours) | Posted | Count of Participants | Participants | 90 days |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Ordinal Distribution of Scores on mRS at Day 90 | The overall ordinal distribution of scores on mRS at 90 days in DFO- and placebo-treated subjects will be determined. | Per the SAP, the target population is the modified intention-to-treat population, including only subjects in whom study infusion is initiated. Complete case analysis was planned as the primary analytic approach. | Posted | Count of Participants | Participants | 90 days |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Ordinal Distribution of Scores on mRS at 180 Days | The overall ordinal distribution of scores on mRS at 180 days in DFO- and placebo-treated subjects will be determined. | Per the SAP, the target population is the modified intention-to-treat population, including only subjects in whom study infusion is initiated. Complete case analysis was planned as the primary analytic approach. | Posted | Count of Participants | Participants | 180 days |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Adverse Event of Special Interest: Number of Patients With Allergic Reactions (During Infusion of Study Drug) | Adverse event of special interest: anaphylaxis at any time during the study infusion | Per the SAP, the target population is the modified intention-to-treat population, including only subjects in whom study infusion is initiated. | Posted | Count of Participants | Participants | during the study infusion |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Adverse Event of Special Interest: Number of Patients With Hypotension | Hypotension requiring medical intervention at any time during the study infusion that could not be explained by other causes | Per the SAP, the target population is the modified intention-to-treat population, including only subjects in whom study infusion is initiated. | Posted | Count of Participants | Participants | during the study infusion |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Adverse Event of Special Interest: Number of Patients With New Visual or Auditory Changes | Adverse event of special interest: development of new and unexplained visual or auditory changes after initiation of the study infusion | Per the SAP, the target population is the modified intention-to-treat population, including only subjects in whom study infusion is initiated. | Posted | Count of Participants | Participants | after initiation of study infusion |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Adverse Event of Special Interest: Number of Patients With Respiratory Compromise | Adverse event of special interest: Respiratory compromise of any cause, including acute respiratory distress syndrome, in hospital until day 7 or discharge [whichever was earlier] | Per the SAP, the target population is the modified intention-to-treat population, including only subjects in whom study infusion is initiated. | Posted | Count of Participants | Participants | 7 days |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Number of Patients With Symptomatic Cerebral Edema | Edema accompanied by an unexplained increase of more than four points on the US National Institutes of Health Stroke Scale or a decrease of more than two points in Glasgow Coma Scale score during the first week after the intracerebral haemorrhage. | Per the SAP, the target population is the modified intention-to-treat population, including only subjects in whom study infusion is initiated. | Posted | Count of Participants | Participants | 7 days |
|
|
All-cause mortality was collected until 180 days post-randomization. Serious adverse events were collected until 90 days post-randomization. Non-serious adverse events were collected until day 7 post-randomization or hospital discharge, whichever is earlier.
Adverse events were classified with MedDRA v15 combined with Principal Investigator preferred adjustments.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Deferoxamine Mesylate | Deferoxamine Mesylate (32 mg/kg/day) given by an intravenous infusion for 3 consecutive days Deferoxamine Mesylate | 12 | 144 | 39 | 144 | 107 | 144 |
| EG001 | Normal Saline | Normal saline (0.9% sodium chloride) given by intravenous infusion for 3 consecutive days Placebo (for Deferoxamine Mesylate) | 12 | 147 | 50 | 147 | 114 | 147 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Arrhythmia | Cardiac disorders | Systematic Assessment |
| ||
| Cardiac arrest | Cardiac disorders | Systematic Assessment |
| ||
| Myocardial infarction | Cardiac disorders | Systematic Assessment |
| ||
| Constipation | Gastrointestinal disorders | Systematic Assessment |
| ||
| Gastrointestinal haemorrhage | Gastrointestinal disorders | Systematic Assessment |
| ||
| Haematemesis | Gastrointestinal disorders | Systematic Assessment |
| ||
| Ileus | Gastrointestinal disorders | Systematic Assessment |
| ||
| Oedema mouth | Gastrointestinal disorders | Systematic Assessment |
| ||
| Retroperitoneal haemorrhage | Gastrointestinal disorders | Systematic Assessment |
| ||
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
| ||
| Chest pain | General disorders | Systematic Assessment |
| ||
| Systemic inflammatory response syndrome | General disorders | Systematic Assessment |
| ||
| Acute hepatic failure | Hepatobiliary disorders | Systematic Assessment |
| ||
| Hypersensitivity | Immune system disorders | Systematic Assessment |
| ||
| Bacteraemia | Infections and infestations | Systematic Assessment |
| ||
| Clostridium difficile colitis | Infections and infestations | Systematic Assessment |
| ||
| Pneumonia | Infections and infestations | Systematic Assessment |
| ||
| Sepsis | Infections and infestations | Systematic Assessment |
| ||
| Septic shock | Infections and infestations | Systematic Assessment |
| ||
| Tracheobronchitis | Infections and infestations | Systematic Assessment |
| ||
| Urinary tract infection | Infections and infestations | Systematic Assessment |
| ||
| Fall | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Rib fracture | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Wound decomposition | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Anaemia | Investigations | Systematic Assessment |
| ||
| Cardiac enzymes increased | Investigations | Systematic Assessment |
| ||
| Hyponatraemia | Investigations | Systematic Assessment |
| ||
| Dehydration | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Metastatic malignant melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| ||
| Autonomic nervous system imbalance | Nervous system disorders | Systematic Assessment |
| ||
| Brain herniation | Nervous system disorders | Systematic Assessment |
| ||
| Brain midline shift | Nervous system disorders | Systematic Assessment |
| ||
| Brain oedema | Nervous system disorders | Systematic Assessment |
| ||
| CNS ventriculitis | Nervous system disorders | Systematic Assessment |
| ||
| Cerebral haemorrhage | Nervous system disorders | Systematic Assessment |
| ||
| Cerebral hematoma expansion | Nervous system disorders | Systematic Assessment |
| ||
| Convulsion | Nervous system disorders | Systematic Assessment |
| ||
| Hydrocephalus | Nervous system disorders | Systematic Assessment |
| ||
| Hypoaesthesia | Nervous system disorders | Systematic Assessment |
| ||
| Intracranial pressure increased | Nervous system disorders | Systematic Assessment |
| ||
| Ischaemic stroke | Nervous system disorders | Systematic Assessment |
| ||
| Neurological decompensation | Nervous system disorders | Systematic Assessment |
| ||
| Syncope/Presyncope | Nervous system disorders | Systematic Assessment |
| ||
| Alcohol withdrawal syndrome | Psychiatric disorders | Systematic Assessment |
| ||
| Mental status changes | Psychiatric disorders | Systematic Assessment |
| ||
| Haematuria | Renal and urinary disorders | Systematic Assessment |
| ||
| Renal failure acute | Renal and urinary disorders | Systematic Assessment |
| ||
| Pelvic pain | Reproductive system and breast disorders | Systematic Assessment |
| ||
| Aspiration | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Asthma | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Bronchial obstruction | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Hypoxia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Lung consolidation | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Skin ulcer | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Withdrawal of life support | Surgical and medical procedures | Systematic Assessment |
| ||
| Deep vein thrombosis | Vascular disorders | Systematic Assessment |
| ||
| Hypertension | Vascular disorders | Systematic Assessment |
| ||
| Hypotension | Vascular disorders | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Arrhythmia | Cardiac disorders | Systematic Assessment |
| ||
| Myocardial infarction | Cardiac disorders | Systematic Assessment |
| ||
| Myocardial ischaemia | Cardiac disorders | Systematic Assessment |
| ||
| Ear pain | Ear and labyrinth disorders | Systematic Assessment |
| ||
| Hearing impaired | Ear and labyrinth disorders | Systematic Assessment |
| ||
| Tinnitus | Ear and labyrinth disorders | Systematic Assessment |
| ||
| Goitre | Endocrine disorders | Systematic Assessment |
| ||
| Inappropriate antidiuretic hormone secretion | Endocrine disorders | Systematic Assessment |
| ||
| Blindness | Eye disorders | Systematic Assessment |
| ||
| Colour blindness | Eye disorders | Systematic Assessment |
| ||
| Conjunctivitis | Eye disorders | Systematic Assessment |
| ||
| Diplopia | Eye disorders | Systematic Assessment |
| ||
| Eye pain | Eye disorders | Systematic Assessment |
| ||
| Gaze palsy | Eye disorders | Systematic Assessment |
| ||
| Pupils unequal | Eye disorders | Systematic Assessment |
| ||
| Scleral oedema | Eye disorders | Systematic Assessment |
| ||
| Abdominal distension | Gastrointestinal disorders | Systematic Assessment |
| ||
| Abdominal pain | Gastrointestinal disorders | Systematic Assessment |
| ||
| Anorectal disorder | Gastrointestinal disorders | Systematic Assessment |
| ||
| Constipation | Gastrointestinal disorders | Systematic Assessment |
| ||
| Diarrhoea | Gastrointestinal disorders | Systematic Assessment |
| ||
| Dry mouth | Gastrointestinal disorders | Systematic Assessment |
| ||
| Dysphagia | Gastrointestinal disorders | Systematic Assessment |
| ||
| Ileus | Gastrointestinal disorders | Systematic Assessment |
| ||
| Lip swelling | Gastrointestinal disorders | Systematic Assessment |
| ||
| Nausea | Gastrointestinal disorders | Systematic Assessment |
| ||
| Reflux gastritis | Gastrointestinal disorders | Systematic Assessment |
| ||
| Swollen tongue | Gastrointestinal disorders | Systematic Assessment |
| ||
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
| ||
| Chest pain | General disorders | Systematic Assessment |
| ||
| Discomfort | General disorders | Systematic Assessment |
| ||
| Fatigue | General disorders | Systematic Assessment |
| ||
| Inflammation | General disorders | Systematic Assessment |
| ||
| Infusion site extravasation | General disorders | Systematic Assessment |
| ||
| Infusion site pain | General disorders | Systematic Assessment |
| ||
| Injection site irritation | General disorders | Systematic Assessment |
| ||
| Injection site reaction | General disorders | Systematic Assessment |
| ||
| Nodule | General disorders | Systematic Assessment |
| ||
| Oedema | General disorders | Systematic Assessment |
| ||
| Oedema peripheral | General disorders | Systematic Assessment |
| ||
| Pain | General disorders | Systematic Assessment |
| ||
| Pyrexia | General disorders | Systematic Assessment |
| ||
| Systemic inflammatory response syndrome | General disorders | Systematic Assessment |
| ||
| Bacteraemia | Infections and infestations | Systematic Assessment |
| ||
| Cellulitis | Infections and infestations | Systematic Assessment |
| ||
| Otitis media | Infections and infestations | Systematic Assessment |
| ||
| Pneumonia | Infections and infestations | Systematic Assessment |
| ||
| Sinusitis | Infections and infestations | Systematic Assessment |
| ||
| Skin candida | Infections and infestations | Systematic Assessment |
| ||
| Tinea pedis | Infections and infestations | Systematic Assessment |
| ||
| Tracheobronchitis | Infections and infestations | Systematic Assessment |
| ||
| Urinary tract infection | Infections and infestations | Systematic Assessment |
| ||
| Anaphylactic transfusion reaction | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Fall | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Activated partial thromboplastin time prolonged | Investigations | Systematic Assessment |
| ||
| Anaemia | Investigations | Systematic Assessment |
| ||
| Blood creatinine increased | Investigations | Systematic Assessment |
| ||
| Blood glucose increased | Investigations | Systematic Assessment |
| ||
| Blood potassium decreased | Investigations | Systematic Assessment |
| ||
| Blood urea increased | Investigations | Systematic Assessment |
| ||
| Cardiac enzymes increased | Investigations | Systematic Assessment |
| ||
| Coagulopathy | Investigations | Systematic Assessment |
| ||
| Hepatic enzyme increased | Investigations | Systematic Assessment |
| ||
| Hyperglycaemia | Investigations | Systematic Assessment |
| ||
| Hypernatraemia | Investigations | Systematic Assessment |
| ||
| Hyperphosphataemia | Investigations | Systematic Assessment |
| ||
| Hypoalbuminaemia | Investigations | Systematic Assessment |
| ||
| Hypocalcaemia | Investigations | Systematic Assessment |
| ||
| Hypokalaemia | Investigations | Systematic Assessment |
| ||
| Hypomagnesaemia | Investigations | Systematic Assessment |
| ||
| Hyponatraemia | Investigations | Systematic Assessment |
| ||
| Hypophosphataemia | Investigations | Systematic Assessment |
| ||
| International normalised ratio increased | Investigations | Systematic Assessment |
| ||
| Laboratory test abnormal | Investigations | Systematic Assessment |
| ||
| Leukocytosis | Investigations | Systematic Assessment |
| ||
| Monocyte count | Investigations | Systematic Assessment |
| ||
| Prothrombin time prolonged | Investigations | Systematic Assessment |
| ||
| Pyuria | Investigations | Systematic Assessment |
| ||
| Rubulavirus test positive | Investigations | Systematic Assessment |
| ||
| Thrombocytopenia | Investigations | Systematic Assessment |
| ||
| Urine output decreased | Investigations | Systematic Assessment |
| ||
| Dehydration | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Diabetes mellitus | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Fluid retention | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Gout | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hypovolaemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Arthralgia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Back pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Chondrocalcinosis pyrophosphate | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Joint effusion | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Joint swelling | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Limb discomfort | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Muscle spasms | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Neck pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Pain in extremity | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Pain in jaw | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Brain midline shift | Nervous system disorders | Systematic Assessment |
| ||
| Brain oedema | Nervous system disorders | Systematic Assessment |
| ||
| Cerebral haemorrhage | Nervous system disorders | Systematic Assessment |
| ||
| Cerebral hematoma expansion | Nervous system disorders | Systematic Assessment |
| ||
| Convulsion | Nervous system disorders | Systematic Assessment |
| ||
| Encephalopathy | Nervous system disorders | Systematic Assessment |
| ||
| Headache | Nervous system disorders | Systematic Assessment |
| ||
| Hemiparesis | Nervous system disorders | Systematic Assessment |
| ||
| Hemiplegia | Nervous system disorders | Systematic Assessment |
| ||
| Hydrocephalus | Nervous system disorders | Systematic Assessment |
| ||
| Intracranial aneurysm | Nervous system disorders | Systematic Assessment |
| ||
| Intracranial pressure increased | Nervous system disorders | Systematic Assessment |
| ||
| Ischaemic stroke | Nervous system disorders | Systematic Assessment |
| ||
| Lethargy | Nervous system disorders | Systematic Assessment |
| ||
| Neurological decompensation | Nervous system disorders | Systematic Assessment |
| ||
| Paraesthesia | Nervous system disorders | Systematic Assessment |
| ||
| Sensory loss | Nervous system disorders | Systematic Assessment |
| ||
| Somnolence | Nervous system disorders | Systematic Assessment |
| ||
| Subarachnoid haemorrhage | Nervous system disorders | Systematic Assessment |
| ||
| Syncope/Presyncope | Nervous system disorders | Systematic Assessment |
| ||
| Tremor | Nervous system disorders | Systematic Assessment |
| ||
| Visual field defect | Nervous system disorders | Systematic Assessment |
| ||
| Agitation | Psychiatric disorders | Systematic Assessment |
| ||
| Alcohol withdrawal syndrome | Psychiatric disorders | Systematic Assessment |
| ||
| Anxiety | Psychiatric disorders | Systematic Assessment |
| ||
| Confusional state | Psychiatric disorders | Systematic Assessment |
| ||
| Delirium | Psychiatric disorders | Systematic Assessment |
| ||
| Depression | Psychiatric disorders | Systematic Assessment |
| ||
| Insomnia | Psychiatric disorders | Systematic Assessment |
| ||
| Dysuria | Renal and urinary disorders | Systematic Assessment |
| ||
| Haematuria | Renal and urinary disorders | Systematic Assessment |
| ||
| Incontinence | Renal and urinary disorders | Systematic Assessment |
| ||
| Nephropathy | Renal and urinary disorders | Systematic Assessment |
| ||
| Renal failure acute | Renal and urinary disorders | Systematic Assessment |
| ||
| Renal failure chronic | Renal and urinary disorders | Systematic Assessment |
| ||
| Renal tubular necrosis | Renal and urinary disorders | Systematic Assessment |
| ||
| Urinary incontinence | Renal and urinary disorders | Systematic Assessment |
| ||
| Urinary retention | Renal and urinary disorders | Systematic Assessment |
| ||
| Breast mass | Reproductive system and breast disorders | Systematic Assessment |
| ||
| Aspiration | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Atelectasis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Hypoxia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Pulmonary hypertension | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Tachypnoea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Wheezing | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Hyperhidrosis | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Pruritus | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Skin ulcer | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Deep vein thrombosis | Vascular disorders | Systematic Assessment |
| ||
| Haematoma | Vascular disorders | Systematic Assessment |
| ||
| Hypertension | Vascular disorders | Systematic Assessment |
| ||
| Hypotension | Vascular disorders | Systematic Assessment |
| ||
| Neurogenic shock | Vascular disorders | Systematic Assessment |
| ||
| Thrombophlebitis superficial | Vascular disorders | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Magdy Selim, MD, PhD | Beth Israel Deaconess Medical Center | 617-632-8913 | mselim@bidmc.harvard.edu |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 11, 2018 | May 8, 2019 | SAP_001.pdf |
| ID | Term |
|---|---|
| D002543 | Cerebral Hemorrhage |
| D020300 | Intracranial Hemorrhages |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D003676 | Deferoxamine |
| ID | Term |
|---|---|
| D006877 | Hydroxamic Acids |
| D006898 | Hydroxylamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D006880 | Hydroxy Acids |
| D002264 | Carboxylic Acids |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Deep (thalamic) |
|
| Deep (non-thalamic) |
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