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 @ 6:43 PM
Ignite Modification Date: 2025-12-25 @ 4:14 PM
NCT ID: NCT01312857
Description: None
Frequency Threshold: 0
Time Frame: 2 years
Study: NCT01312857
Study Brief: Study of Hepatic Arterial Infusion With Intravenous Irinotecan, 5FU and Leucovorin With or Without Panitumumab, in Patients With Wild Type RAS Who Have Resected Hepatic Metastases From 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
Randomization to Panitumumab Patients whose liver metastases have been completely resected will be randomized Arm A will receive Panitumumab in addition to HAI FUDR/Dexamethasone plus systemic CPT-11/5FU/LV panitumumab: All patients receive HAI FUDR (0.12 mg/kg/day X kg X pump volume) / pump flow rate and Dexamethasone flat dose of 25 mg on days 1. All patients receive CPT-11 (150 mg/m2 IV over 30 min to an hour), Leucovorin (400 mg/m2 IV, over 30 min to an hour) and 5FU (1000 mg/m2/day continuous infusion over two days) on days 15 and 29 Randomization to panitumumab 6 mg/kg day 15 and 29 Each cycle repeats every 36 days for a total of 6 cycles 15 None 14 37 27 37 View
Randomization to No Panitumumab Patients whose liver metastases have been completely resected will be randomized and patients randomized to Arm B will receive HAI FUDR/Dex plus systemic CPT-11/5FU/LV alone. Randomization to No Panitumumab: All patients receive HAI FUDR (0.12 mg/kg/day X kg X pump volume) / pump flow rate and Dexamethasone flat dose of 25 mg on days 1. All patients receive CPT-11 (150 mg/m2 IV over 30 min to an hour), Leucovorin (400 mg/m2 IV, over 30 min to an hour) and 5FU (1000 mg/m2/day continuous infusion over two days) on days 15 and 29 Randomization (to no panitumumab) Each cycle repeats every 36 days for a total of 6 cycles 27 None 6 38 26 38 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Anorexia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Hyperbilirubinemia SYSTEMATIC_ASSESSMENT Investigations None View
Chills SYSTEMATIC_ASSESSMENT General disorders None View
Colitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Colonic obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Enteritis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Fatigue SYSTEMATIC_ASSESSMENT General disorders None View
Fever SYSTEMATIC_ASSESSMENT General disorders None View
Fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Leukocytes SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Pain - Other SYSTEMATIC_ASSESSMENT General disorders None View
Presyncope SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Rash maculo-papular SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Rectal anastomotic leak SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Renal and urinary disorders - Other SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Surgical and medical procedures - Other SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Thromboembolic event SYSTEMATIC_ASSESSMENT Vascular disorders None View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Weight loss SYSTEMATIC_ASSESSMENT Investigations None View
Wound infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations None View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Hyperglycemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Lymphopenia SYSTEMATIC_ASSESSMENT Investigations None View
Hypophosphatemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Alkaline phosphatase increased SYSTEMATIC_ASSESSMENT Investigations None View
Blood bilirubin increased SYSTEMATIC_ASSESSMENT Investigations None View
Paronychia SYSTEMATIC_ASSESSMENT Infections and infestations None View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View