Adverse Events Module

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Adverse Events Module

For researchers submitting trial data to ClinicalTrials.gov, the Adverse Events module is one of four mandatory results sections. It requires reporting in three primary categories: All-Cause Mortality: A table tracking all deaths that occurred during the study, regardless of cause. Serious Adverse Events (SAEs): A tabular summary of events resulting in death, life-threatening conditions, hospitalization, or significant disability. Other Adverse Events: A table for non-serious events that exceed a specific frequency threshold, such as 5% within any study arm.

Adverse Events Module path is as follows:

Study -> Results Section -> Adverse Events Module -> Event Groups

Study -> Results Section -> Adverse Events Module -> Serious Events

Study -> Results Section -> Adverse Events Module -> Other Events

Adverse Events Module

Ignite Creation Date: 2025-12-26 @ 10:57 AM

Ignite Modification Date: 2025-12-26 @ 10:57 AM

NCT ID: NCT01972308

Description: None

Frequency Threshold: 1

Time Frame: one year

Study: NCT01972308

Study Brief: A Patient Advocate to Improve Real-world Asthma Management for Inner City Adults

Event Groups(If Any):

Event Groups

Title	Description	Deaths # Affected	Deaths # At Risk	Serious # Affected	Serious # At Risk	Other # Affected	Other # At Risk	View

Patient Advocate	Subject works with a Patient Advocate who coaches, models, and assists with preparations for a visit with the asthma doctor; attends the visit with permission of participant and provider; and confirms understanding. The PA facilitates scheduling, obtaining insurance coverage, overcoming patients' unique social and administrative barriers to carrying out medical advice, and transfer of information between providers and patients. Patient Advocate: Subject works with a Patient Advocate who coaches, models, and assists with preparations for a visit with the asthma doctor; attends the visit with permission of participant and provider; and confirms understanding. The PA facilitates scheduling, obtaining insurance coverage, overcoming patients' unique social and administrative barriers to carrying out medical advice, and transfer of information between providers and patients	4	None	89	156	71	156	View
Usual Care	Patient receives asthma care as usual from their asthma provider Patient Advocate: Subject works with a Patient Advocate who coaches, models, and assists with preparations for a visit with the asthma doctor; attends the visit with permission of participant and provider; and confirms understanding. The PA facilitates scheduling, obtaining insurance coverage, overcoming patients' unique social and administrative barriers to carrying out medical advice, and transfer of information between providers and patients	1	None	90	156	74	156	View

Serious Events(If Any):

Serious Events

Term	Type	Organ System	Vocab	View

surgical and medical procedure	SYSTEMATIC_ASSESSMENT	Surgical and medical procedures	SAFETY PROFILER	View
abdominal pain	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	SAFETY PROFILER	View
back pain	SYSTEMATIC_ASSESSMENT	Musculoskeletal and connective tissue disorders	SAFETY PROFILER	View
chest pain	SYSTEMATIC_ASSESSMENT	Cardiac disorders	SAFETY PROFILER	View
allergic reaction	SYSTEMATIC_ASSESSMENT	Immune system disorders	SAFETY PROFILER	View
fall	SYSTEMATIC_ASSESSMENT	Injury, poisoning and procedural complications	SAFETY PROFILER	View
ankle sprain	SYSTEMATIC_ASSESSMENT	Injury, poisoning and procedural complications	SAFETY PROFILER	View
skin abscess	SYSTEMATIC_ASSESSMENT	Skin and subcutaneous tissue disorders	SAFETY PROFILER	View
skin infection	SYSTEMATIC_ASSESSMENT	Infections and infestations	SAFETY PROFILER	View
urinary tract infection	SYSTEMATIC_ASSESSMENT	Infections and infestations	SAFETY PROFILER	View
headache	SYSTEMATIC_ASSESSMENT	Nervous system disorders	SAFETY PROFILER	View
injury, poisoning and procedural complication	SYSTEMATIC_ASSESSMENT	Injury, poisoning and procedural complications	SAFETY PROFILER	View
hypertension	SYSTEMATIC_ASSESSMENT	Cardiac disorders	SAFETY PROFILER	View
pneumonia	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	SAFETY PROFILER	View
acute sinusitis	SYSTEMATIC_ASSESSMENT	Infections and infestations	SAFETY PROFILER	View
upper respiratory infection	SYSTEMATIC_ASSESSMENT	Infections and infestations	SAFETY PROFILER	View
vomiting	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	SAFETY PROFILER	View
sore throat	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	SAFETY PROFILER	View
stomach pain	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	SAFETY PROFILER	View
arthritis	SYSTEMATIC_ASSESSMENT	Musculoskeletal and connective tissue disorders	SAFETY PROFILER	View
constipation	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	SAFETY PROFILER	View
hyperglycemia	SYSTEMATIC_ASSESSMENT	Endocrine disorders	SAFETY PROFILER	View
psychiatric disorder	SYSTEMATIC_ASSESSMENT	Psychiatric disorders	SAFETY PROFILER	View
skin and subcutaneous tissue disorders	SYSTEMATIC_ASSESSMENT	Skin and subcutaneous tissue disorders	SAFETY PROFILER	View
diverticulitis	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	SAFETY PROFILER	View
hypoglycemia	SYSTEMATIC_ASSESSMENT	Endocrine disorders	SAFETY PROFILER	View
pregnancy	SYSTEMATIC_ASSESSMENT	Pregnancy, puerperium and perinatal conditions	SAFETY PROFILER	View
bronchial infection	SYSTEMATIC_ASSESSMENT	Infections and infestations	SAFETY PROFILER	View
anxiety	SYSTEMATIC_ASSESSMENT	Psychiatric disorders	SAFETY PROFILER	View
chest wall pain	SYSTEMATIC_ASSESSMENT	Cardiac disorders	SAFETY PROFILER	View
cough	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	SAFETY PROFILER	View
flu-like symptoms	SYSTEMATIC_ASSESSMENT	General disorders	SAFETY PROFILER	View
fracture	SYSTEMATIC_ASSESSMENT	Injury, poisoning and procedural complications	SAFETY PROFILER	View
gastrointestinal disorders	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	SAFETY PROFILER	View
acute and chronic respiratory failure with hypoxia	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	SAFETY PROFILER	View
respiratory, thoracic and medistinal disorders	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	SAFETY PROFILER	View
seizure	SYSTEMATIC_ASSESSMENT	Nervous system disorders	SAFETY PROFILER	View
skin ulcer	SYSTEMATIC_ASSESSMENT	Skin and subcutaneous tissue disorders	SAFETY PROFILER	View
urticaria	SYSTEMATIC_ASSESSMENT	Skin and subcutaneous tissue disorders	SAFETY PROFILER	View
vaginal bleeding	SYSTEMATIC_ASSESSMENT	Reproductive system and breast disorders	SAFETY PROFILER	View
wheeze	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	SAFETY PROFILER	View
lung infection	SYSTEMATIC_ASSESSMENT	Infections and infestations	SAFETY PROFILER	View
noncardiac chest pain	SYSTEMATIC_ASSESSMENT	General disorders	SAFETY PROFILER	View
GERD	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	SAFETY PROFILER	View
anaphylaxis	SYSTEMATIC_ASSESSMENT	Immune system disorders	SAFETY PROFILER	View
anemia	SYSTEMATIC_ASSESSMENT	Blood and lymphatic system disorders	SAFETY PROFILER	View
ankle fracture	SYSTEMATIC_ASSESSMENT	Injury, poisoning and procedural complications	SAFETY PROFILER	View
blood and lymphatic system disorders	SYSTEMATIC_ASSESSMENT	Blood and lymphatic system disorders	SAFETY PROFILER	View
blurred vision	SYSTEMATIC_ASSESSMENT	Eye disorders	SAFETY PROFILER	View
bruising	SYSTEMATIC_ASSESSMENT	Injury, poisoning and procedural complications	SAFETY PROFILER	View
colitis	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	SAFETY PROFILER	View
conjunctivitis	SYSTEMATIC_ASSESSMENT	Eye disorders	SAFETY PROFILER	View
dehydration	SYSTEMATIC_ASSESSMENT	Metabolism and nutrition disorders	SAFETY PROFILER	View
dental caries	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	SAFETY PROFILER	View
depression	SYSTEMATIC_ASSESSMENT	Psychiatric disorders	SAFETY PROFILER	View
diarrhea	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	SAFETY PROFILER	View
dry mouth	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	SAFETY PROFILER	View
ear pain	SYSTEMATIC_ASSESSMENT	Ear and labyrinth disorders	SAFETY PROFILER	View
corneal abrasion	SYSTEMATIC_ASSESSMENT	Eye disorders	SAFETY PROFILER	View
eye irritation	SYSTEMATIC_ASSESSMENT	Eye disorders	SAFETY PROFILER	View
facial pain	SYSTEMATIC_ASSESSMENT	Injury, poisoning and procedural complications	SAFETY PROFILER	View
fatigue	SYSTEMATIC_ASSESSMENT	General disorders	SAFETY PROFILER	View
fever	SYSTEMATIC_ASSESSMENT	General disorders	SAFETY PROFILER	View
gait disturbance	SYSTEMATIC_ASSESSMENT	General disorders	SAFETY PROFILER	View
gall bladder pain	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	SAFETY PROFILER	View
general disorders	SYSTEMATIC_ASSESSMENT	General disorders	SAFETY PROFILER	View
hematuria	SYSTEMATIC_ASSESSMENT	Renal and urinary disorders	SAFETY PROFILER	View
immune system disorders	SYSTEMATIC_ASSESSMENT	Immune system disorders	SAFETY PROFILER	View
knee swelling	SYSTEMATIC_ASSESSMENT	Musculoskeletal and connective tissue disorders	SAFETY PROFILER	View
metabolism and nutrition disorders	SYSTEMATIC_ASSESSMENT	Metabolism and nutrition disorders	SAFETY PROFILER	View
musculoskeletal and connective tissue disorders	SYSTEMATIC_ASSESSMENT	Musculoskeletal and connective tissue disorders	SAFETY PROFILER	View
trigeminal neurlagia	SYSTEMATIC_ASSESSMENT	Nervous system disorders	SAFETY PROFILER	View
ear infection	SYSTEMATIC_ASSESSMENT	Infections and infestations	SAFETY PROFILER	View
shoulder pain	SYSTEMATIC_ASSESSMENT	Musculoskeletal and connective tissue disorders	SAFETY PROFILER	View
palpitations	SYSTEMATIC_ASSESSMENT	Cardiac disorders	SAFETY PROFILER	View
paresthesia	SYSTEMATIC_ASSESSMENT	Nervous system disorders	SAFETY PROFILER	View
pleurisy	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	SAFETY PROFILER	View
pruritis	SYSTEMATIC_ASSESSMENT	Skin and subcutaneous tissue disorders	SAFETY PROFILER	View
kidney stone	SYSTEMATIC_ASSESSMENT	Renal and urinary disorders	SAFETY PROFILER	View
reproductive system and breast disorders	SYSTEMATIC_ASSESSMENT	Reproductive system and breast disorders	SAFETY PROFILER	View
sepsis	SYSTEMATIC_ASSESSMENT	Infections and infestations	SAFETY PROFILER	View
seroma	SYSTEMATIC_ASSESSMENT	Injury, poisoning and procedural complications	SAFETY PROFILER	View
sleep apnea	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	SAFETY PROFILER	View
small intestine obstruction	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	SAFETY PROFILER	View
stroke symptoms	SYSTEMATIC_ASSESSMENT	Nervous system disorders	SAFETY PROFILER	View
suicidal ideation	SYSTEMATIC_ASSESSMENT	Psychiatric disorders	SAFETY PROFILER	View
transient ischemic attack	SYSTEMATIC_ASSESSMENT	Nervous system disorders	SAFETY PROFILER	View
urinary retention	SYSTEMATIC_ASSESSMENT	Renal and urinary disorders	SAFETY PROFILER	View
uterine pain	SYSTEMATIC_ASSESSMENT	Reproductive system and breast disorders	SAFETY PROFILER	View
vaginal infection	SYSTEMATIC_ASSESSMENT	Infections and infestations	SAFETY PROFILER	View
deep venous thrombosis	SYSTEMATIC_ASSESSMENT	Vascular disorders	SAFETY PROFILER	View
ventricular arrhrythmia	SYSTEMATIC_ASSESSMENT	Cardiac disorders	SAFETY PROFILER	View
ear and labyrinth disorders	SYSTEMATIC_ASSESSMENT	Ear and labyrinth disorders	SAFETY PROFILER	View
corneal ulcer	SYSTEMATIC_ASSESSMENT	Eye disorders	SAFETY PROFILER	View
infection and infestations	SYSTEMATIC_ASSESSMENT	Infections and infestations	SAFETY PROFILER	View
edema	SYSTEMATIC_ASSESSMENT	General disorders	SAFETY PROFILER	View
angina	SYSTEMATIC_ASSESSMENT	Cardiac disorders	SAFETY PROFILER	View
peritoneal infection	SYSTEMATIC_ASSESSMENT	Infections and infestations	SAFETY PROFILER	View
sinus disorder	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	SAFETY PROFILER	View
soft tissue infection	SYSTEMATIC_ASSESSMENT	Infections and infestations	SAFETY PROFILER	View
vulvovaginal candidiasis	SYSTEMATIC_ASSESSMENT	Infections and infestations	SAFETY PROFILER	View
foot weakness	SYSTEMATIC_ASSESSMENT	Musculoskeletal and connective tissue disorders	SAFETY PROFILER	View
Bronchospasm	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	SAFETY PROFILER	View
foot pain	SYSTEMATIC_ASSESSMENT	Musculoskeletal and connective tissue disorders	SAFETY PROFILER	View
short of breath	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	SAFETY PROFILER	View

Other Events(If Any):

Other Events

Term	Type	Organ System	Vocab	View

stomach pain	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	SAFETY PROFILER	View
GERD	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	SAFETY PROFILER	View
allergic rhinitis	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	SAFETY PROFILER	View
blood and lymphatic system disorders	SYSTEMATIC_ASSESSMENT	Blood and lymphatic system disorders	SAFETY PROFILER	View
bruising	SYSTEMATIC_ASSESSMENT	Injury, poisoning and procedural complications	SAFETY PROFILER	View
cardiac disorders	SYSTEMATIC_ASSESSMENT	Cardiac disorders	SAFETY PROFILER	View
chest wall pain	SYSTEMATIC_ASSESSMENT	Musculoskeletal and connective tissue disorders	SAFETY PROFILER	View
dehydration	SYSTEMATIC_ASSESSMENT	Metabolism and nutrition disorders	SAFETY PROFILER	View
dysphagia	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	SAFETY PROFILER	View
ear pain	SYSTEMATIC_ASSESSMENT	Ear and labyrinth disorders	SAFETY PROFILER	View
diverticulitis	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	SAFETY PROFILER	View
hemorroids	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	SAFETY PROFILER	View
hyperglycemia	SYSTEMATIC_ASSESSMENT	Metabolism and nutrition disorders	SAFETY PROFILER	View
injury, poisoning and procedural complications	SYSTEMATIC_ASSESSMENT	Injury, poisoning and procedural complications	SAFETY PROFILER	View
menorrhagia	SYSTEMATIC_ASSESSMENT	Reproductive system and breast disorders	SAFETY PROFILER	View
pharyngitis	SYSTEMATIC_ASSESSMENT	Infections and infestations	SAFETY PROFILER	View
pregnancy, puerperium and perinatal conditions	SYSTEMATIC_ASSESSMENT	Pregnancy, puerperium and perinatal conditions	SAFETY PROFILER	View
presyncope	SYSTEMATIC_ASSESSMENT	Nervous system disorders	SAFETY PROFILER	View
rash	SYSTEMATIC_ASSESSMENT	Skin and subcutaneous tissue disorders	SAFETY PROFILER	View
renal and urinary disorders	SYSTEMATIC_ASSESSMENT	Renal and urinary disorders	SAFETY PROFILER	View
reproductive system and breast disorders	SYSTEMATIC_ASSESSMENT	Reproductive system and breast disorders	SAFETY PROFILER	View
sinus pain	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	SAFETY PROFILER	View
sore throat	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	SAFETY PROFILER	View
toothache	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	SAFETY PROFILER	View
transient ischemic attack	SYSTEMATIC_ASSESSMENT	Nervous system disorders	SAFETY PROFILER	View
bladder tumor	SYSTEMATIC_ASSESSMENT	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	SAFETY PROFILER	View
ear and labyrinth disorders	SYSTEMATIC_ASSESSMENT	Ear and labyrinth disorders	SAFETY PROFILER	View
corneal ulcer	SYSTEMATIC_ASSESSMENT	Eye disorders	SAFETY PROFILER	View
infections and infestations	SYSTEMATIC_ASSESSMENT	Infections and infestations	SAFETY PROFILER	View
wound complication	SYSTEMATIC_ASSESSMENT	Injury, poisoning and procedural complications	SAFETY PROFILER	View
esophageal infection	SYSTEMATIC_ASSESSMENT	Infections and infestations	SAFETY PROFILER	View
lung infection	SYSTEMATIC_ASSESSMENT	Infections and infestations	SAFETY PROFILER	View
autoimmune disorder	SYSTEMATIC_ASSESSMENT	Immune system disorders	SAFETY PROFILER	View
dysuria	SYSTEMATIC_ASSESSMENT	Renal and urinary disorders	SAFETY PROFILER	View
noncardiac chest pain	SYSTEMATIC_ASSESSMENT	Musculoskeletal and connective tissue disorders	SAFETY PROFILER	View
cystitis noninfective	SYSTEMATIC_ASSESSMENT	Renal and urinary disorders	SAFETY PROFILER	View
papularpustulo rash	SYSTEMATIC_ASSESSMENT	Skin and subcutaneous tissue disorders	SAFETY PROFILER	View
muscle weakness upper limb	SYSTEMATIC_ASSESSMENT	Musculoskeletal and connective tissue disorders	SAFETY PROFILER	View
Bronchospasm	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	SAFETY PROFILER	View
short of breath	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	SAFETY PROFILER	View
foot pain	SYSTEMATIC_ASSESSMENT	General disorders	SAFETY PROFILER	View
depression	SYSTEMATIC_ASSESSMENT	Psychiatric disorders	SAFETY PROFILER	View
upper respiratory infection	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	SAFETY PROFILER	View
headache	SYSTEMATIC_ASSESSMENT	Nervous system disorders	SAFETY PROFILER	View
sinusitis	SYSTEMATIC_ASSESSMENT	Infections and infestations	SAFETY PROFILER	View
skin disorders	SYSTEMATIC_ASSESSMENT	Skin and subcutaneous tissue disorders	SAFETY PROFILER	View
surgical and medical procedures	SYSTEMATIC_ASSESSMENT	Surgical and medical procedures	SAFETY PROFILER	View
abdominal pain	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	SAFETY PROFILER	View
back pain	SYSTEMATIC_ASSESSMENT	Musculoskeletal and connective tissue disorders	SAFETY PROFILER	View
chest pain	SYSTEMATIC_ASSESSMENT	Cardiac disorders	SAFETY PROFILER	View
cough	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	SAFETY PROFILER	View
flu-like symptoms	SYSTEMATIC_ASSESSMENT	General disorders	SAFETY PROFILER	View
allergic reaction	SYSTEMATIC_ASSESSMENT	Immune system disorders	SAFETY PROFILER	View
fall	SYSTEMATIC_ASSESSMENT	Injury, poisoning and procedural complications	SAFETY PROFILER	View
abscess	SYSTEMATIC_ASSESSMENT	Skin and subcutaneous tissue disorders	SAFETY PROFILER	View
pneumonia	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	SAFETY PROFILER	View
bronchial infection	SYSTEMATIC_ASSESSMENT	Infections and infestations	SAFETY PROFILER	View
arthritis	SYSTEMATIC_ASSESSMENT	Musculoskeletal and connective tissue disorders	SAFETY PROFILER	View
hypertension	SYSTEMATIC_ASSESSMENT	Cardiac disorders	SAFETY PROFILER	View
neck pain	SYSTEMATIC_ASSESSMENT	Musculoskeletal and connective tissue disorders	SAFETY PROFILER	View
arthralgia shoulder	SYSTEMATIC_ASSESSMENT	Musculoskeletal and connective tissue disorders	SAFETY PROFILER	View
gastrointestinal disorder	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	SAFETY PROFILER	View
musculoskeletal and connective tissue disorders	SYSTEMATIC_ASSESSMENT	Musculoskeletal and connective tissue disorders	SAFETY PROFILER	View
neoplasm benign	SYSTEMATIC_ASSESSMENT	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	SAFETY PROFILER	View
ear infection	SYSTEMATIC_ASSESSMENT	Infections and infestations	SAFETY PROFILER	View
pain	SYSTEMATIC_ASSESSMENT	General disorders	SAFETY PROFILER	View
cellulitis	SYSTEMATIC_ASSESSMENT	Skin and subcutaneous tissue disorders	SAFETY PROFILER	View
palpitations	SYSTEMATIC_ASSESSMENT	Cardiac disorders	SAFETY PROFILER	View
respiratory, thoracic, and mediastinal disorders	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	SAFETY PROFILER	View
skin infection	SYSTEMATIC_ASSESSMENT	Infections and infestations	SAFETY PROFILER	View