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 @ 3:19 AM
Ignite Modification Date: 2025-12-26 @ 1:57 AM
NCT ID: NCT00601705
Description: Adverse events were reported separately for pre-operative therapy (60 participants) and post-operative therapy (48 participants).
Frequency Threshold: 5
Time Frame: Participants were followed for adverse events while on study, treatment and the 30 days following treatment discontinuation over a period of up to 1 year.
Study: NCT00601705
Study Brief: Epirubicin, Oxaliplatin and Fluorouracil (EOF) in Cancer of the Esophagus, Gastroesophageal Junction, or Stomach
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Epirubicin, Oxaliplatin and Fluorouracil cisplatin: 20 mg/m2/day IV continuous infusion over 24 hours for 96 hours. epirubicin hydrochloride: 50 mg/m2 IV bolus fluorouracil: 200 mg/m2/day continuous infusion for all 9 weeks, beginning on day 1. oxaliplatin: 130 mg/m2 IV infusion over 2 hours adjuvant therapy: At 6-10 weeks after surgery patients will begin postoperative chemoradiotherapy. Daily radiation therapy fractions of 180-200 cGy will be given. Concurrent with this radiation, two cycles of chemotherapy will be given, during the first and fourth weeks of the radiation neoadjuvant therapy: Three weeks after discontinuing the fluorouracil patients will be fully restaged to assess for a clinical response, and to ensure that there is no contraindication to surgical resection, which will be scheduled for app 41 None 24 60 60 60 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Diarrhea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Dysphagia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Enteritis - inflammation of the small bowel NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Fistula, GI - Stomach NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Mucositis/stomatitis - oral cavity NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Colitis, infectious NON_SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (3.0) View
Neuropathy NON_SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (3.0) View
Syncope NON_SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (3.0) View
Dehydration NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (3.0) View
Cholecystitis NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders CTCAE (3.0) View
Thrombosis NON_SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE (3.0) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Chylothorax NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (3.0) View
pneumonia NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (3.0) View
wound infections NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications CTCAE (3.0) View
Hand-foot syndrome NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (3.0) View
Hand-foot syndrome NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (3.0) View
Neutropenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (3.0) View
Neutropenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (3.0) View
Febrile neutropenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (3.0) View
Platelets <50,000/μl NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders CTCAE (3.0) View