CDE Detailed Report

NeuroRehab Supplemental - Highly Recommended for studies where adverse events are a potential concern. Any untoward medical occurrence in a study participant/subject that does not necessarily have a causal relationship with the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study intervention or study procedure, whether related or not related to the study intervention or procedure. Each AE should be listed on a separate row. Any worsening of a baseline condition or reoccurrence of a baseline condition that had previously ended for a time should be listed as an AE. Events, such as nausea and vomiting are considered two events, and therefore should be listed on separate lines. A participant/subject may experience an unexpected AE (UAE). An unexpected adverse reaction has a nature or severity of which is not consistent with the study intervention description (e.g., Investigator's Brochure for an unapproved investigational product or package insert/summary of product characteristics for an approved product). The unexpected AE must be reported, whether related to the study intervention or not, with as much detail as is available. See the Data Dictionary for additional information on coding the adverse events using either the Common Terminology Criteria for Adverse Events (CTCAE) or the Medical Dictionary for Regulatory Activities (MedDRA).

NeuroRehab Supplemental - Highly Recommended for studies where pain may be relevant to the outcome. On a scale from 0 to 10, with 0 being no pain and 10 being the worst pain imaginable, how bad is your pain right now? 0 = no pain; 10 = the most intense pain imaginable Please note that if there is more than one pain, this section should be consistent with the International Spinal Cord Injury Pain Basic Data Set and apply to Worst, 2nd Worst and 3rd Worst pains.

Enter the name of the study site.

NeuroRehab Supplemental - Highly Recommended for studies where adverse events are a potential concern. This question should only be answered YES if the outcome of the AE results in at least one of the following: death; a life-threatening adverse drug experience; results in inpatient hospitalization or prolongation of existing hospitalization; a persistent or significant disability/incapacity; or a congenital anomaly/birth defect. If an AE is serious, this provides a trigger that additional information must be provided by the site investigator. The site investigator then completes a SAE form. Additionally, the site institution and/or IRB may also have an SAE form and procedures for reporting SAEs. If an AE is serious, this provides a trigger that additional information must be provided by the site investigator. The site investigator then completes a SAE form. Additionally, the site institution and/or IRB may also have an SAE form and procedures for reporting SAEs. Serious Adverse Event: An adverse event is defined by the investigator or sponsor as "serious" when it is life-threatening, results in death, requires in-patient hospitalization, prolongs existing hospitalization, results in persistent or significant disability, or is a congenital anomaly/birth defect.

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Check box for Unknown

NeuroRehab Supplemental - Highly Recommended for studies where adverse events are a potential concern. Any untoward medical occurrence in a study participant/subject that does not necessarily have a causal relationship with the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study intervention or study procedure, whether related or not related to the study intervention or procedure. Each AE should be listed on a separate row. Any worsening of a baseline condition or reoccurrence of a baseline condition that had previously ended for a time should be listed as an AE. Events, such as nausea and vomiting are considered two events, and therefore should be listed on separate lines. A participant/subject may experience an unexpected AE (UAE). An unexpected adverse reaction has a nature or severity of which is not consistent with the study intervention description (e.g., Investigator's Brochure for an unapproved investigational product or package insert/summary of product characteristics for an approved product). The unexpected AE must be reported, whether related to the study intervention or not, with as much detail as is available. Code the adverse event verbatim text with the Medical Dictionary for Regulatory Activities (MedDRA) Lower Level Term (LLT) codes.

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In adults, hypertension is defined as a systolic pressure = 140 and a diastolic pressure = 90.

Choose one. Response is obtained by report of the participant/subject or caretaker. The assemblage of physical properties or qualities by which male is distinguished from female. Male is a person who belongs to the sex that normally produces sperm. The term is used to indicate biological sex distinctions, cultural gender role distinctions, or both. Female is a person who belongs to the sex that normally produces ova. The term is used to indicate biological sex distinctions, or cultural gender role distinctions, or both. Intersex is a person (one of unisexual specimens) who is born with genitalia and/or secondary sexual characteristics of indeterminate sex, or which combine features of both sexes. The NIH Guidelines on Inclusion of Women and Minorities as Subjects in Clinical Research: The Office of Management and Budget Directive No. 15.

The participant or subject identifiers or IDs should be assigned by the study.

Record the date/time according to the ISO 8601, the International Standard for the representation of dates and times (http://www.iso.org/iso/home.html). The date/time should be recorded to the level of granularity known (e.g., year, year and month, complete date plus hours and minutes, etc.) and in the format acceptable to the study database. Recording date of birth will give the most detailed information required for calculation of age and is recommended as first choice. However, in some studies recording date of birth may elicit discussions on a potential violation of privacy legislation and specifically HIPAA regulations. In these cases, the calculated age should be recorded.

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NeuroRehab Specific: Refers to the neurological disorder being studied. Record the date/time according to the ISO 8601, the International Standard for the representation of dates and times (http://www.iso.org/iso/home.html). The date/time should be recorded to the level of granularity known (e.g., year, year and month, complete date plus hours and minutes, etc.).

Record the date/time according to the ISO 8601, the International Standard for the representation of dates and times (http://www.iso.org/iso/home.html). The date/time should be recorded to the level of granularity known (e.g., year, year and month, complete date plus hours and minutes, etc.).

NeuroRehab Supplemental - Highly Recommended for studies where adverse events are a potential concern. Choose one. Record the investigator's assessment as to whether there is at least a reasonable possibility that the AE is related to (or caused by) use of the study intervention. Definitions for each of the relatedness response should be supplied in the protocol.