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 @ 2:20 PM
Ignite Modification Date: 2025-12-25 @ 12:56 PM
NCT ID: NCT00522795
Description: None
Frequency Threshold: 0
Time Frame: None
Study: NCT00522795
Study Brief: Neoadjuvant Paclitaxel Poliglumex, Cisplatin and Radiation for Esophageal Cancer: A Phase II Trial (CTI#X64001)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
PPX, Cisplatin, Radiation * PPX: 50 mg/m2/week days 1, 8, 15, 22, 29, 36. * Cisplatin: 25 mg/m2/week days 1, 8, 15, 22, 29, 36. Cisplatin, will be administered over ½ hour in 250 cc ns weekly for 6 weeks. Cisplatin will be administered after PPX None None 14 40 2 40 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
esophagitis, nauseam dehydration, electrolyte imbalance, potassium and mood alteration SYSTEMATIC_ASSESSMENT Investigations None View
allergic reaction/hypersensitivity SYSTEMATIC_ASSESSMENT Investigations None View
nausea, dehydration, esophagitis, death SYSTEMATIC_ASSESSMENT Investigations None View
multiorgan failure SYSTEMATIC_ASSESSMENT Investigations None View
leukopenia, esophagitis, dehydration, nausea, vomiting, neutropenia, hypotension SYSTEMATIC_ASSESSMENT Investigations None View
hyperglycemia, dehydration SYSTEMATIC_ASSESSMENT Investigations None View
infection of gallbladder with normal ANC SYSTEMATIC_ASSESSMENT Investigations None View
dysphagia, dizziness, dehydration SYSTEMATIC_ASSESSMENT Investigations None View
hypokalemia, hypomagnesemia, weakness, anorexia, opportunistic infection SYSTEMATIC_ASSESSMENT Investigations None View
thrombosis, hematoma, hypomagnesemia, extrapyramidal/restless SYSTEMATIC_ASSESSMENT Investigations None View
nausea, vomiting, weakness, ischemic colitis SYSTEMATIC_ASSESSMENT Investigations None View
thrombosis/embolism SYSTEMATIC_ASSESSMENT Investigations None View
infection with normal ANC (cellulitis) and albumin SYSTEMATIC_ASSESSMENT Investigations None View
pneumothorax SYSTEMATIC_ASSESSMENT Investigations None View
DVT SYSTEMATIC_ASSESSMENT Investigations None View
acute vascular leak, GI other, hypotension, anorexia, hypothermia,INR SYSTEMATIC_ASSESSMENT Investigations None View
abdominal pain and dehydration SYSTEMATIC_ASSESSMENT Investigations None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
esophagitis SYSTEMATIC_ASSESSMENT Investigations None View