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 @ 11:10 AM

Ignite Modification Date: 2025-12-26 @ 11:10 AM

NCT ID: NCT01336712

Description: None

Frequency Threshold: 5

Time Frame: None

Study: NCT01336712

Study Brief: Total Body Irradiation/Fludarabine Based Ablative Haploidentical Transplant for Hematologic Diseases

Event Groups(If Any):

Event Groups

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

Myeloablative Haploidentical Transplant	Haplo transplant Peripheral Blood Stem Cell Transplant: Total Body Irradiation 1200cGy (150cGy given in 8 fractions twice a day six hours apart on days -4, -3, -2 and -1. Fludarabine 30 mg/m2 given once a day for 3 days on days -7, -6 and -5 Cyclophosphamide 50mg/kg given one a day on days +3 and +4	None	None	13	30	30	30	View

Serious Events(If Any):

Serious Events

Term	Type	Organ System	Vocab	View

BK Virus	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
anorexia	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	None	View
Pneumonia	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	None	View
Hemolytic Uremic Syndrom	SYSTEMATIC_ASSESSMENT	Blood and lymphatic system disorders	None	View
Nausea & vomiting	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	None	View
Renal Insufficiency	SYSTEMATIC_ASSESSMENT	Renal and urinary disorders	None	View
Alveolar Hemorrhage	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	None	View
Syncope	SYSTEMATIC_ASSESSMENT	Cardiac disorders	None	View
Sepsis syndrome	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Veno-Occlusive Disease	SYSTEMATIC_ASSESSMENT	Hepatobiliary disorders	None	View

Other Events(If Any):

Other Events

Term	Type	Organ System	Vocab	View

abdominal cramping/discomfort	None	Gastrointestinal disorders	None	View
abdominal fullness	None	Gastrointestinal disorders	None	View
abdominal muscle soreness (secondary to cough)	None	Gastrointestinal disorders	None	View
abdominal tenderness	None	Gastrointestinal disorders	None	View
abnormal gait	None	Nervous system disorders	None	View
acidosis	None	Gastrointestinal disorders	None	View
acute GVHD - gut	None	Immune system disorders	None	View
acute GVHD - skin	None	Immune system disorders	None	View
agitation	None	Psychiatric disorders	None	View
increased alkaline phosphatase	None	Hepatobiliary disorders	None	View
increased ALT	None	Hepatobiliary disorders	None	View
neutropenia	None	Blood and lymphatic system disorders	None	View
anorexia	None	Gastrointestinal disorders	None	View
anxiety	None	Psychiatric disorders	None	View
increased AST	None	Hepatobiliary disorders	None	View
atelectasis	None	Respiratory, thoracic and mediastinal disorders	None	View
BK Virus	None	Renal and urinary disorders	None	View
bladder mass	None	Renal and urinary disorders	None	View
bladder pressure	None	Renal and urinary disorders	None	View
bladder spasms	None	Renal and urinary disorders	None	View
bleeding gums	None	Blood and lymphatic system disorders	None	View
blood clots in urine	None	Renal and urinary disorders	None	View
blood in sputum	None	Blood and lymphatic system disorders	None	View
blurred vision	None	Nervous system disorders	None	View
benign prostatic hyperplasia	None	Renal and urinary disorders	None	View
bradycardia	None	Cardiac disorders	None	View
bruising	None	Blood and lymphatic system disorders	None	View
bumps on skin	None	Skin and subcutaneous tissue disorders	None	View
c.difficile colitis	None	Infections and infestations	None	View
chest discomfort with inspiration	None	Respiratory, thoracic and mediastinal disorders	None	View
chest tightness	None	Cardiac disorders	None	View
chills	None	Investigations	None	View
CMV reactivation	None	Blood and lymphatic system disorders	None	View
coarse breath sounds	None	Respiratory, thoracic and mediastinal disorders	None	View
coated tongue	None	Gastrointestinal disorders	None	View
confusion	None	Nervous system disorders	None	View
constipation	None	Gastrointestinal disorders	None	View
dry cough	None	Respiratory, thoracic and mediastinal disorders	None	View
productive cough	None	Respiratory, thoracic and mediastinal disorders	None	View
cough NOS	None	Respiratory, thoracic and mediastinal disorders	None	View
increased creatinine	None	Renal and urinary disorders	None	View
CVC site bleeding	None	Investigations	None	View
CVC site edema	None	Investigations	None	View
CVC site soreness	None	Investigations	None	View
CVC site tenderness	None	Investigations	None	View
deconditioned	None	Investigations	None	View
decreased appetite	None	Gastrointestinal disorders	None	View
decreased breath sounds	None	Respiratory, thoracic and mediastinal disorders	None	View
decreased fluid intake	None	Gastrointestinal disorders	None	View
decreased oral intake	None	Gastrointestinal disorders	None	View
dehydration	None	Investigations	None	View
depression	None	Psychiatric disorders	None	View
diaphoresis	None	Skin and subcutaneous tissue disorders	None	View
diarrhea	None	Gastrointestinal disorders	None	View
difficulty swallowing	None	Gastrointestinal disorders	None	View
labored breathing	None	Respiratory, thoracic and mediastinal disorders	None	View
abdominal distention	None	Gastrointestinal disorders	None	View
dizziness	None	Nervous system disorders	None	View
drowsiness	None	Nervous system disorders	None	View
dry heaves	None	Gastrointestinal disorders	None	View
dry lips	None	Gastrointestinal disorders	None	View
dry mouth	None	Gastrointestinal disorders	None	View
dry skin	None	Skin and subcutaneous tissue disorders	None	View
dry throat	None	Gastrointestinal disorders	None	View
dysgeusia	None	Gastrointestinal disorders	None	View
dyspepsia	None	Gastrointestinal disorders	None	View
dysphagia	None	Gastrointestinal disorders	None	View
dysuria	None	Renal and urinary disorders	None	View
ear fullness	None	Ear and labyrinth disorders	None	View
edema of hands and feet	None	Cardiac disorders	None	View
lower extremity edema	None	Cardiac disorders	None	View
electrolyte wasting syndrome	None	Metabolism and nutrition disorders	None	View
epistaxis	None	Blood and lymphatic system disorders	None	View
generalized erythema	None	Skin and subcutaneous tissue disorders	None	View
throat erythema	None	Skin and subcutaneous tissue disorders	None	View
erythematous palms	None	Skin and subcutaneous tissue disorders	None	View
esophagitis	None	Gastrointestinal disorders	None	View
esophageal pain	None	Gastrointestinal disorders	None	View
exertional shortness of breath	None	Respiratory, thoracic and mediastinal disorders	None	View
facial flushing	None	Skin and subcutaneous tissue disorders	None	View
fatigue	None	Investigations	None	View
fever	None	Investigations	None	View
left lower flank pain	None	Musculoskeletal and connective tissue disorders	None	View
flat affect	None	Psychiatric disorders	None	View
flatulence	None	Gastrointestinal disorders	None	View
fluid overload	None	Cardiac disorders	None	View
folliculitis	None	Infections and infestations	None	View
gastritis	None	Gastrointestinal disorders	None	View
generalized body aches	None	Musculoskeletal and connective tissue disorders	None	View
GERD	None	Gastrointestinal disorders	None	View
gastrointenstinal bleed	None	Gastrointestinal disorders	None	View
hallucinations	None	Psychiatric disorders	None	View
headache	None	Nervous system disorders	None	View
hematuria	None	Renal and urinary disorders	None	View
hemoptysis	None	Blood and lymphatic system disorders	None	View
hemorrhoids	None	Gastrointestinal disorders	None	View
anemia	None	Blood and lymphatic system disorders	None	View
hiccups	None	Gastrointestinal disorders	None	View
hyperactive bowel sounds	None	Gastrointestinal disorders	None	View
hyperbilirubinemia	None	Hepatobiliary disorders	None	View
hypercalcemia	None	Metabolism and nutrition disorders	None	View
hyperglycemia	None	Metabolism and nutrition disorders	None	View
hyperkalemia	None	Metabolism and nutrition disorders	None	View
hypermagnesemia	None	Metabolism and nutrition disorders	None	View
hypernatremia	None	Metabolism and nutrition disorders	None	View
hyperpigmented skin	None	Skin and subcutaneous tissue disorders	None	View
hypertension	None	Cardiac disorders	None	View
hypoactive bowel sounds	None	Gastrointestinal disorders	None	View
hypoalbuminemia	None	Metabolism and nutrition disorders	None	View
hypocalcemia	None	Metabolism and nutrition disorders	None	View
hypoglycemia	None	Metabolism and nutrition disorders	None	View
hypokalemia	None	Metabolism and nutrition disorders	None	View
hypomagnesemia	None	Metabolism and nutrition disorders	None	View
hyponatremia	None	Metabolism and nutrition disorders	None	View
hypotension	None	Cardiac disorders	None	View
hypoxia	None	Respiratory, thoracic and mediastinal disorders	None	View
stool incontinence	None	Gastrointestinal disorders	None	View
bacteremia infection (NOS)	None	Infections and infestations	None	View
influenza	None	Infections and infestations	None	View
insomnia	None	Psychiatric disorders	None	View
irregular heartbeat	None	Cardiac disorders	None	View
leg cramping	None	Musculoskeletal and connective tissue disorders	None	View
leg discomfort (2nd lower extremity edema)	None	Musculoskeletal and connective tissue disorders	None	View
lethargy	None	Investigations	None	View
lightheadedness	None	Nervous system disorders	None	View
limited mobility	None	Musculoskeletal and connective tissue disorders	None	View
limited sensory perception	None	Nervous system disorders	None	View
loss of balance	None	Nervous system disorders	None	View
lower extremity pain	None	Musculoskeletal and connective tissue disorders	None	View
lung crackles	None	Respiratory, thoracic and mediastinal disorders	None	View
lung infiltrates	None	Respiratory, thoracic and mediastinal disorders	None	View
lymphocytopenia	None	Blood and lymphatic system disorders	None	View
malaise	None	Investigations	None	View
malnutrition	None	Gastrointestinal disorders	None	View
melena	None	Gastrointestinal disorders	None	View
menstrual cramps	None	Reproductive system and breast disorders	None	View
metapneumovirus	None	Respiratory, thoracic and mediastinal disorders	None	View
migraine headaches	None	Nervous system disorders	None	View
mouth sores	None	Gastrointestinal disorders	None	View
mucositis	None	Gastrointestinal disorders	None	View
myalgias	None	Musculoskeletal and connective tissue disorders	None	View
nasal congestion	None	Respiratory, thoracic and mediastinal disorders	None	View
nausea	None	Gastrointestinal disorders	None	View
febrile neutropenia	None	Blood and lymphatic system disorders	None	View
night sweats	None	Investigations	None	View
nocturia	None	Renal and urinary disorders	None	View
oral candida	None	Infections and infestations	None	View
oral lesions	None	Gastrointestinal disorders	None	View
oral thrush	None	Investigations	None	View
orthostatic hypotension	None	Cardiac disorders	None	View
abdominal pain	None	Gastrointestinal disorders	None	View
ankle pain	None	Musculoskeletal and connective tissue disorders	None	View
arm pain	None	Musculoskeletal and connective tissue disorders	None	View
back pain	None	Musculoskeletal and connective tissue disorders	None	View
bladder pain	None	Renal and urinary disorders	None	View
bone pain	None	Musculoskeletal and connective tissue disorders	None	View
chest pain	None	Musculoskeletal and connective tissue disorders	None	View
chest pain (2nd cough)	None	Musculoskeletal and connective tissue disorders	None	View
CVC site pain	None	Investigations	None	View
fingertip pain	None	Musculoskeletal and connective tissue disorders	None	View
foot pain	None	Musculoskeletal and connective tissue disorders	None	View
hand pain	None	Musculoskeletal and connective tissue disorders	None	View
hemorrhoidal pain	None	Gastrointestinal disorders	None	View
jaw pain	None	Musculoskeletal and connective tissue disorders	None	View
joint pain	None	Musculoskeletal and connective tissue disorders	None	View
knee pain	None	Musculoskeletal and connective tissue disorders	None	View
leg pain	None	Musculoskeletal and connective tissue disorders	None	View
mouth pain	None	Gastrointestinal disorders	None	View
muscle pain	None	Musculoskeletal and connective tissue disorders	None	View
shoulder pain	None	Musculoskeletal and connective tissue disorders	None	View
throat pain (2nd mucositis)	None	Gastrointestinal disorders	None	View
tooth pain	None	Gastrointestinal disorders	None	View
pain with swallowing	None	Gastrointestinal disorders	None	View
pale skin	None	Skin and subcutaneous tissue disorders	None	View
palpitations	None	Cardiac disorders	None	View
panic attack	None	Nervous system disorders	None	View
parainfluenza	None	Infections and infestations	None	View
parotid gland edema	None	Investigations	None	View
parotid gland tenderness	None	Investigations	None	View
parotitis	None	Infections and infestations	None	View
pericardial effusion	None	Cardiac disorders	None	View
peripheral neuropathy	None	Nervous system disorders	None	View
perirectal irritation	None	Gastrointestinal disorders	None	View
perirectal pain	None	Gastrointestinal disorders	None	View
petechiae	None	Blood and lymphatic system disorders	None	View
photosensitivity	None	Nervous system disorders	None	View
platelet infusion reaction	None	Investigations	None	View
thrombocytopenia	None	Blood and lymphatic system disorders	None	View
pneumonia	None	Infections and infestations	None	View
postnasal drainage	None	Respiratory, thoracic and mediastinal disorders	None	View
prolonged urine stream	None	Renal and urinary disorders	None	View
pruritus	None	Skin and subcutaneous tissue disorders	None	View
rales	None	Respiratory, thoracic and mediastinal disorders	None	View
rash	None	Skin and subcutaneous tissue disorders	None	View
rash (arms, thighs)	None	Skin and subcutaneous tissue disorders	None	View
renal failure	None	Renal and urinary disorders	None	View
acute renal insufficiency	None	Renal and urinary disorders	None	View
respiratory insufficiency	None	Respiratory, thoracic and mediastinal disorders	None	View
restless legs	None	Nervous system disorders	None	View
rhinitis	None	Respiratory, thoracic and mediastinal disorders	None	View
rhinorrhea	None	Respiratory, thoracic and mediastinal disorders	None	View
rhinovirus	None	Infections and infestations	None	View
rhonchi	None	Respiratory, thoracic and mediastinal disorders	None	View
rigors	None	General disorders	None	View
saliva thickening	None	Gastrointestinal disorders	None	View
scalloped tongue border	None	Gastrointestinal disorders	None	View
scrotal edema	None	Reproductive system and breast disorders	None	View
seasonal allergies	None	General disorders	None	View
sedation	None	Nervous system disorders	None	View
serous otitis	None	Ear and labyrinth disorders	None	View
sinus congestion	None	Respiratory, thoracic and mediastinal disorders	None	View
sinus drainage	None	Respiratory, thoracic and mediastinal disorders	None	View
sinus headache	None	Nervous system disorders	None	View
sinus pressure	None	General disorders	None	View
sinus tenderness	None	General disorders	None	View
sinusitis	None	General disorders	None	View
skin dyspigmentation	None	Skin and subcutaneous tissue disorders	None	View
skin irriation	None	Skin and subcutaneous tissue disorders	None	View
skin lesions	None	Skin and subcutaneous tissue disorders	None	View
skin tenderness	None	Skin and subcutaneous tissue disorders	None	View
small bowel obstruction	None	Gastrointestinal disorders	None	View
sneezing	None	General disorders	None	View
shortness of breath	None	Respiratory, thoracic and mediastinal disorders	None	View
somnolence	None	Nervous system disorders	None	View
sore throat	None	Gastrointestinal disorders	None	View
splenomegaly	None	Endocrine disorders	None	View
staphylococcus hemolyticus bacteremia	None	Infections and infestations	None	View
steroid-induced diabetes	None	Metabolism and nutrition disorders	None	View
stomatitis	None	Gastrointestinal disorders	None	View
suprapubic tenderness	None	Musculoskeletal and connective tissue disorders	None	View
facial swelling	None	General disorders	None	View
tachycardia	None	Cardiac disorders	None	View
tachypnea	None	Cardiac disorders	None	View
taste alteration	None	Nervous system disorders	None	View
thick oral secretions	None	Gastrointestinal disorders	None	View
throat swelling	None	General disorders	None	View
tongue ridging	None	Gastrointestinal disorders	None	View
tongue swelling	None	General disorders	None	View
tremors	None	Nervous system disorders	None	View
tremors (hands)	None	Nervous system disorders	None	View
unsteady gait	None	Nervous system disorders	None	View
urinary frequency	None	Renal and urinary disorders	None	View
urinary hesitancy	None	Renal and urinary disorders	None	View
urinary incontinence	None	Renal and urinary disorders	None	View
urinary retention	None	Renal and urinary disorders	None	View
urinary urgency	None	Renal and urinary disorders	None	View
vaginal bleeding/spotting	None	Reproductive system and breast disorders	None	View
volume depletion	None	General disorders	None	View
volume overload	None	General disorders	None	View
vomiting	None	Gastrointestinal disorders	None	View
vancomycin-resistant enterococci	None	Infections and infestations	None	View
leukopenia	None	Blood and lymphatic system disorders	None	View
weakness	None	General disorders	None	View
weight gain	None	Gastrointestinal disorders	None	View
weight loss	None	Gastrointestinal disorders	None	View
wheezing	None	Respiratory, thoracic and mediastinal disorders	None	View
abcessed tooth	None	Gastrointestinal disorders	None	View
abdominal bloating	None	Gastrointestinal disorders	None	View