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: 2025-12-24 @ 11:03 PM
Ignite Modification Date: 2025-12-25 @ 8:34 PM
NCT ID: NCT01703169
Description: None
Frequency Threshold: 0
Time Frame: Approximately 3 years.
Study: NCT01703169
Study Brief: Efficacy and Safety of Eltrombopag In Patients With Severe and Very Severe Aplastic Anemia
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Eltrombopag Single arm study. Dose Escalation. Eltrombopag: Oral eltrombopag 150mg/day by mouth starting on Day 1 with dose modification over 12 weeks to a maximum of 300mg/day determined by platelet count 2 None 3 13 13 13 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
congestive heart failure SYSTEMATIC_ASSESSMENT Cardiac disorders None View
cholecystitis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
syncope SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
aches/pains SYSTEMATIC_ASSESSMENT General disorders None View
anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
arrhythmia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
purpura SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
bronzing of the skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
bruising SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
chest pain SYSTEMATIC_ASSESSMENT Cardiac disorders None View
chills SYSTEMATIC_ASSESSMENT General disorders None View
confusion SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
cramps SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
decreased lymphocyte count SYSTEMATIC_ASSESSMENT Investigations None View
decreased neutrophil count SYSTEMATIC_ASSESSMENT Investigations None View
thrombocytopenia SYSTEMATIC_ASSESSMENT Investigations None View
dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders None View
dry mouth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
dry skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
dysgeusia SYSTEMATIC_ASSESSMENT Nervous system disorders None View
dysuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
ecchymosis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
edema SYSTEMATIC_ASSESSMENT General disorders None View
Alkaline phosphatase increased SYSTEMATIC_ASSESSMENT Investigations None View
elevated ALT SYSTEMATIC_ASSESSMENT Investigations None View
elevated AST SYSTEMATIC_ASSESSMENT Investigations None View
elevated bilirubin SYSTEMATIC_ASSESSMENT Investigations None View
elevated creatinine SYSTEMATIC_ASSESSMENT Investigations None View
hyperglycemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
epistaxis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
erythema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
fatigue SYSTEMATIC_ASSESSMENT General disorders None View
gum hypertrophy SYSTEMATIC_ASSESSMENT Infections and infestations None View
gum lesions SYSTEMATIC_ASSESSMENT Infections and infestations None View
facial hair growth SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
hematoma SYSTEMATIC_ASSESSMENT Vascular disorders None View
hot flashes SYSTEMATIC_ASSESSMENT Vascular disorders None View
hypertension SYSTEMATIC_ASSESSMENT Vascular disorders None View
hypoalbunemia SYSTEMATIC_ASSESSMENT Investigations None View
hypocalcemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
hyponatremia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
hypoxia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
jaundice SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
menorrhagia SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
mouth sores SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
nasal congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
otitis externa SYSTEMATIC_ASSESSMENT Infections and infestations None View
nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
night sweats SYSTEMATIC_ASSESSMENT General disorders None View
opacity SYSTEMATIC_ASSESSMENT Eye disorders None View
pain SYSTEMATIC_ASSESSMENT General disorders None View
pallor SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
petechiae SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
port leak SYSTEMATIC_ASSESSMENT General disorders None View
pyelonephritis SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
rectal hemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
renal insufficiency SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
respiratory infection SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
sciatica SYSTEMATIC_ASSESSMENT Nervous system disorders None View
scleral icterus SYSTEMATIC_ASSESSMENT Eye disorders None View
shortness of breath SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
spelnomegaly SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
thrush SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
transfusion reaction SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
tremor SYSTEMATIC_ASSESSMENT Nervous system disorders None View
urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
weight gain SYSTEMATIC_ASSESSMENT Investigations None View