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 @ 2:14 PM
Ignite Modification Date: 2025-12-25 @ 12:52 PM
NCT ID: NCT01696695
Description: Safety Population included all enrolled participants.
Frequency Threshold: 5
Time Frame: Baseline up to Day 1254
Study: NCT01696695
Study Brief: An Observational Study of First-Line Capecitabine Based Chemotherapy in Participants With Metastatic Colorectal 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
mCRC Participants Newly diagnosed mCRC participants, who received first line capecitabine based chemotherapy according to effective official Summary of Product Characteristics, were observed. The choice of therapy was based on exclusively the medical decision of the treating physician before study enrollment. The study protocol did not enforce treatment initiation and also did not specify any treatment regimen. None None 55 882 140 882 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Anemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Febrile neutropenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Neutropenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Atrial fibrillation NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Heart failure NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Cardiopulmonary failure NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Myocardial ischaemia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Melaena NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Abdominal pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Bowel movement irregularity NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Diarrhoea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Gastrointestinal haemorrhage NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Ileus NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Subileus NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Thrombosis mesenteric vessel NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Pyrexia NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
thrombosis NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
Large intestine perforatio NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Death NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
General physical health deterioration NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Mucosal inflammation NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Jaundice NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA View
Anaphylactic reaction NON_SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA View
White blood cell count decreased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Cachexia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Dehydration NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Aphasia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Cerebral ischaemia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Cerebrovascular accident NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Peripheral neuropathy NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Paraparesis NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Acute kidney injury NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
Renal failure NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
Pneumothorax NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Pulmonary embolism NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Cutaneous symptom NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Palmar-plantar erythrodysaesthesia syndroma NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Nephrostomy NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA View
Deep vein thrombosis NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
Embolism NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Diarrhea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Palmar-plantar erythrodysesthesia syndrome NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View