Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events
Version 2.0
November 2014
Division of AIDS
National Institute of Allergy and Infectious Diseases
National Institutes of Health
US Department of Health and Human Services
Table of Contents
Glossary and Acronyms (1)
Introduction (3)
Instructions for Use (4)
Major Clinical Conditions (7)
Cardiovascular (7)
Dermatologic (9)
Endocrine and Metabolic (10)
Gastrointestinal (11)
Musculoskeletal (13)
董洁拍的电视剧Neurologic (14)
Pregnancy, Puerperium, and Perinatal (16)
Psychiatric (17)
Respiratory (18)
Sensory (19)
Systemic (20)
Urinary (22)
Site Reactions to Injections and Infusions (23)
Laboratory Values (24)
Chemistries (24)
Hematology (27)
Urinalysis (29)
Appendix A. Total Bilirubin Table for Term and Preterm Neonates (30)
Glossary and Acronyms
好笑的电视剧AE Adverse event; Any unfavorable and unintended sign (including an
abnormal laboratory finding), symptom, or disease temporally
associated with the use of a medical treatment or procedure regardless
of whether it is considered related to the medical treatment or
procedure.
ALT (SGPT) Alanine aminotransferase (serum glutamic pyruvic transaminase) ANC Absolute neutrophil count
AST (SGOT) Aspartate aminotransferase (serum glutamic-oxaloacetic transaminase) AV Atrioventricular
Basic Self-care Functions Adult
Activities such as bathing, dressing, toileting, transfer or movement,
continence, and feeding.
Young Children
Activities that are age and culturally appropriate, such as feeding one’s
self with culturally appropriate eating implements.
BMI z-score Body mass index z- score; A body reference norm. Specifically, the
number of standard deviations a participant's BMI differs from the
average BMI for their age, sex, and ethnicity.
BMD t-score Bone mineral density t-score; The number of standard deviations above
or below the mean bone mineral density of a healthy 30 year old adult
of the same sex and ethnicity as the participant.
BMD z-score Bone mineral density z-score; The number of standard deviations a
participant's BMD differs from the average BMD for their age, sex, and
ethnicity.
BPAP Bilevel positive airway pressure; A mode used during noninvasive
positive pressure ventilation.
Chemical Pregnancy A pregnancy in which a positive pregnancy test is followed by a
negative pregnancy test without evidence of a clinical pregnancy loss. CNS Central nervous system
CPAP Continuous positive airway pressure
DAERS DAIDS Adverse Experience Reporting System; An internet-based常情如此不可推卸
system developed for clinical research sites to report Expedited
如何美发Adverse Events (EAEs) to DAIDS. It facilitates timely EAE report
submission and serves as a centralized location for accessing and
processing EAE information for reporting purposes.
Disability A substantial disruption of a person’s ability to conduct normal life
functions.
ECG Electrocardiogram
eGFR Estimated glomerular filtration rate
Hospitalization Does not include the following hospital admissions: under 24 hours,
unrelated to an adverse event (e.g., for labor and delivery, cosmetic
surgery, social or administrative for temporary placement [for lack of a
宋林静和杨童舒是一个人吗place to sleep]), protocol-specified, and for diagnosis or therapy of a
condition that existed before the receipt of a study agent and which has
not increased in severity or frequency.
INR International normalized ratio
Glossary and Acronyms
Intervention Medical, surgical, or other procedures recommended or provided by a
healthcare professional for the treatment of an adverse event.
IV Intravenous
IVIG Intravenous immune globulin
LDL Low density lipoprotein
LLN Lower limit of normal
Life-threatening AE Any adverse event that places the participant, in the view of the
investigator, at immediate risk of death from the reaction when it
occurred (i.e., it does not include a reaction that would have caused
death if it had occurred in a more severe form).
NA Not applicable
Participant ID The identification number assigned to a study participant which is used
to track study-related documentation, including any reported AEs.
PR Interval The interval between the beginning of the P wave and the beginning of
the QRS complex of an electrocardiogram that represents the time
between the beginning of the contraction of the atria and the beginning
of the contraction of the ventricles.
PT Prothrombin time
PTT Partial thromboplastin time
QTc Interval The measure of time between the onset of ventricular depolarization
and completion of ventricular repolarization corrected for ventricular
rate.
RBC Red blood cell
SI Standard international unit
ULN Upper limit of normal
Usual Social & Functional Activities Activities which adults and children perform on a routine basis and
those which are part of regular activities of daily living, for example:
三年级放风筝满分作文Adults
Adaptive tasks and desirable activities, such as going to work,
shopping, cooking, use of transportation, or pursuing a hobby.
Young Children
Activities that are age and culturally appropriate, such as social
interactions, play activities, or learning tasks.
WBC White blood cell
WHO World Health Organization
WNL Within normal limits
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