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 @ 2:22 PM
Ignite Modification Date: 2025-12-25 @ 12:59 PM
NCT ID: NCT01183559
Description: Adverse events evaluated for severity and relationship to therapy using a grading system in which Grade 3 = severe, Grade 4 = life-threatening or disabling and Grade 5 = death
Frequency Threshold: 5
Time Frame: From initiation of Vandetanib therapy through 6 months
Study: NCT01183559
Study Brief: A Trial of ZD6474, Paclitaxel, Carboplatin, 5-Fluorouracil, and Radiation Therapy Followed by Surgery
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Vandetanib All patients were treated with vandetanib with dose escalation from 100 mg (dose level 1) to 200 mg (dose level 2) orally daily for the duration of radiation therapy None None 1 9 9 9 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Aortic-enteric fistula SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Anorexia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
ALT-SGPT SYSTEMATIC_ASSESSMENT Investigations CTCAE (4.0) View
AST-SGPT SYSTEMATIC_ASSESSMENT Investigations CTCAE (4.0) View
Leukocyte, total WBC SYSTEMATIC_ASSESSMENT Investigations CTCAE (4.0) View
Mood alteration, Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCAE (4.0) View
Neutrophills, ANC/AGC SYSTEMATIC_ASSESSMENT Investigations CTCAE (4.0) View
Pain, upper abdomen SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Sodium, serum low (hyponatremia) SYSTEMATIC_ASSESSMENT Investigations CTCAE (4.0) View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (4.0) View
Mucositis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Stomach-Bronchial fistula SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View