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 @ 1:25 AM
Ignite Modification Date: 2025-12-25 @ 11:36 PM
NCT ID: NCT03636893
Description: All 74 randomized participants were assessed for all-cause mortality per intention-to-treat analysis. According to the study protocol, serious adverse events and other adverse events were systematically collected for all 74 participants during the study period, including events leading to treatment discontinuation. Adverse events leading to dropout were captured as protocol violations or serious adverse events as appropriate.
Frequency Threshold: 0
Time Frame: From randomization through 5 years follow-up (median follow-up 65.7 months)
Study: NCT03636893
Study Brief: Dragon III: Neoadjuvant Chemotherapy (FLOT Versus SOX) for 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
FLOT Chemotherpy Regimen A total of four preoperative and four postoperative cycles of FLOT chemotherapy administered A cycle consist of Day 1 5-FU 2600mg/M2 administered via intravenous PICC for 24 hour Leucovorin 200mg/M2 intravenous Oxaliplatin 85mg/ M2 intravenous Docetaxel 50mg/M2 intravenous Repeated every 15th day Three drug Chemotherapy: 5-FU+CF+Docetaxel+Oxaliplatin 21 None 9 40 9 40 View
SOX Chemotherapy Regimen Three preoperative cycles and three postoperative cycles of SOX chemotherapy administered A cycle consist of Day 1: Oxaliplatin 130mg/M2 intravenous Day 1-14Tegafur gimeracil oteracil potassium capsule 80mg/M2 oral (twice daily) Repeated every 21st day Two drug Chemotherapy: Oxaliplatin+TGO 20 None 8 34 5 34 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Overall postoperative complication SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Postoperative complications: Death SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Grade IV hematological toxicity with multiple organ failure NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Acute cerebral infarction NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Deep venous thrombosis NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Grade 3+Grade 4 Decrease in white blood cells NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Grade 3+Grade 4 Neutrophil count decreased SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Grade 3+Grade 4 Platelet count decreased SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Febrile neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
ALT SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Acute bleeding requiring emergency surgery NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
AST SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View