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: 2025-12-25 @ 4:27 AM
Ignite Modification Date: 2025-12-26 @ 3:30 AM
NCT ID: NCT00382720
Description: 248 participants in the full analysis population (FAP) were analyzed for safety.
Frequency Threshold: 5
Time Frame: None
Study: NCT00382720
Study Brief: Docetaxel and Oxaliplatin in Gastric Cancer
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
(TE) Taxotere and Eloxatin Participants administered Docetaxel (Taxotere) 75 mg/m² as an 1-hour IV infusion on day 1 followed by Oxaliplatin (Eloxatin) 130 mg/m² as a two to six-hour IV infusion on day 1 per chemotherapy cycle. None None 35 78 75 78 View
(TEF) Taxotere, Eloxatin and 5-fluorouracil Participants administed with Docetaxel (Taxotere) 50 mg/m² as a 1-hour IV infusion day 1; Oxaliplatin (Eloxatin) 85 mg/m² simultaneously with folinic acid 400 mg/m² as a 2-hour IV infusion, followed by 5-FU 2400 mg/m² as a 46-hour continuous infusion day 1 per chemotherapy cycle. None None 24 88 87 88 View
(TEX) Taxotere, Eloxatin and Xeloda Participants administered Docetaxel (Taxotere) 50 mg/m² as a 1-hour intravenous (IV) infusion on day 1, Oxaliplatin (Eloxatin) 100 mg/m² as a two to six-hour IV infusion on day 1, Capecitabine (Xeloda) 625 mg/m2 two times a day continuously per chemotherapy cycle. None None 36 82 77 82 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
diarrhea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
abdominal pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
dysphagia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
gastric perforation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
intestinal obstruction NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
upper gastrointestinal hemorrhage NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
abdominal pain upper NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
colitis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
enterocolitis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
gastric hemorrhage NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
gastric ulcer perforation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
gastrointestinal hemorrhage NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
ileus NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
inguinal hernia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
intestinal perforation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
mechanical ileus NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
rectal obstruction NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
volvulus NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
febrile neutropenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
anemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
neutropenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
disseminated intravascular coagulation NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
leukopenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
general physical health deterioration NON_SYSTEMATIC_ASSESSMENT General disorders None View
pyrexia NON_SYSTEMATIC_ASSESSMENT General disorders None View
implant site reaction NON_SYSTEMATIC_ASSESSMENT General disorders None View
mucosal inflammation NON_SYSTEMATIC_ASSESSMENT General disorders None View
performance status decreased NON_SYSTEMATIC_ASSESSMENT General disorders None View
asthenia NON_SYSTEMATIC_ASSESSMENT General disorders None View
chest pain NON_SYSTEMATIC_ASSESSMENT General disorders None View
device occlusion NON_SYSTEMATIC_ASSESSMENT General disorders None View
fatigue NON_SYSTEMATIC_ASSESSMENT General disorders None View
device related infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
gastroenteritis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
pneumonia NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
abdominal wall abscess NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
bronchopneumonia NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
clostridium difficile colitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
device related sepsis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
neutropenic sepsis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
peritoneal abscess NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
sepsis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
septic arthritis staphylococcal NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
staphylococcal sepsis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
pulmonary embolism NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
pleural effusion NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
acute pulmonary edema NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
aspiration NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
dysesthesia pharynx NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
respiratory failure NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
decreased appetite NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
dehydration NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
cachexia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
hyperkalemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
hyponatremia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
hypovolemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
myocardial infarction NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
cardiac failure NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
cardiac failure congestive NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
cardiopulmonary failure NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
ataxia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
facial paresis NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
peripheral motor neuropathy NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
syncope NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
deep vein thromosis NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
cholecystitis NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
cholecystitis acute NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
hyperbilirubinemia NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
back pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
spondylolisthesis NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
malignant pleural effusion NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
metastases to ovary NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
renal failure acute NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
pyloric stenosis NON_SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders None View
investigations NON_SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders None View
hemoglobin decreased NON_SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders None View
nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
ascites NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
hematemesis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
generalised edema NON_SYSTEMATIC_ASSESSMENT General disorders None View
pelvic abscess NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
respiratory arrest NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
stomatitis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
abdominal pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
constipation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
abdominal pain upper NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
dyspepsia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
neutropenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
febrile neutropenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
diarrhoea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
dysphagia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
abdominal distension NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
oral pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
fatigue NON_SYSTEMATIC_ASSESSMENT General disorders None View
asthenia NON_SYSTEMATIC_ASSESSMENT General disorders None View
pyrexia NON_SYSTEMATIC_ASSESSMENT General disorders None View
oedema peripheral NON_SYSTEMATIC_ASSESSMENT General disorders None View
mucosal inflammation NON_SYSTEMATIC_ASSESSMENT General disorders None View
oedema NON_SYSTEMATIC_ASSESSMENT General disorders None View
peripheral sensory neuropathy NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
neuropathy peripheral NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
dysgeusia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
paraesthesia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
dizziness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
dysaesthesia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
neurotoxicity NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
alopecia NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
nail disorder NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
skin reaction NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
palmar-plantar erythrodysaesthesia syndrome NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
rash NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
dry skin NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
decreased appetite NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
dyspnoea NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
cough NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
epistaxis NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
oropharyngeal pain NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
hiccups NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
back pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
pain in extremity NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
hypotension NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
insomnia NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
anxiety NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
weight decreased NON_SYSTEMATIC_ASSESSMENT Investigations None View