Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adver Events
Version 2.0
紫草茸
November 2014
Division of AIDS
National Institute of Allergy and Infectious Dias
National Institutes of Health
US Department of Health and Human Services
Table of Contents
Glossary and Acronyms (1)
Introduction (3)
Instructions for U (4)
Major Clinical Conditions (7)
Cardiovascular (7)
Dermatologic (9)
Endocrine and Metabolic (10)
Gastrointestinal (11)
Musculoskeletal (13)
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
AE Adver event; Any unfavorable and unintended sign (including an
abnormal laboratory finding), symptom, or dia temporally
associated with the u of a medical treatment or procedure regardless
上网认证of whether it is considered related to the medical treatment or
procedure.
ALT (SGPT) Alanine aminotransfera (rum glutamic pyruvic transamina) ANC Absolute neutrophil count
AST (SGOT) Aspartate aminotransfera (rum glutamic-oxaloacetic transamina) 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
lf with culturally appropriate eating implements.
BMI z-score Body mass index z- score; A body reference norm. Specifically, the
秋夜月number of standard deviations a participant's BMI differs from the
average BMI for their age, x, 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 x 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, x, and
ethnicity.
BPAP Bilevel positive airway pressure; A mode ud 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 Adver Experience Reporting System; An internet-bad
system developed for clinical rearch sites to report Expedited
Adver Events (EAEs) to DAIDS. It facilitates timely EAE report
submission and rves as a centralized location for accessing and
processing EAE information for reporting purpos.
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 adver event (e.g., for labor and delivery, cosmetic
一树寒梅白玉条surgery, social or administrative for temporary placement [for lack of a
好词佳句大全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 incread in verity 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 adver event.
IV Intravenous
IVIG Intravenous immune globulin时乐蒙
LDL Low density lipoprotein
LLN Lower limit of normal
Life-threatening AE Any adver 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 caud
death if it had occurred in a more vere form).
NA Not applicable
Participant ID The identification number assigned to a study participant which is ud
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 reprents the time
between the beginning of the contraction of the atria and the beginning闲气
of the contraction of the ventricles.
PT Prothrombin time展厅布置
PTT Partial thromboplastin time
QTc Interval The measure of time between the ont 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
tho which are part of regular activities of daily living, for example:
Adults
Adaptive tasks and desirable activities, such as going to work,
shopping, cooking, u 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
