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 @ 10:58 PM
Ignite Modification Date:
2025-12-25 @ 8:27 PM
NCT ID:
NCT00871169
Description:
Study participants were assessed for toxicity at every scheduled study visit through a full clinical exam. Patient-reported toxicities were also collected.
Frequency Threshold:
5
Time Frame:
None
Study:
NCT00871169
Study Brief:
Combination of Irinotecan, Oxaliplatin and Cetuximab for Locally Advanced or Metastatic Pancreatic 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 |
|---|---|---|---|---|---|---|---|---|
| Irinotecan, Oxaliplatin, and Cetuximab | The goal is to administer at least 4 cycles to each patient, but treatment may stop earlier if the treating physician deems stopping to be in the best interest of the patient. Repeated treatment may be given to patients who benefit (either complete or partial response or stabilization of disease) Irinotecan, oxaliplatin, and cetuximab: Irinotecan at 90 mg/m2 intravenously every two weeks (administered over 60 minutes) + Oxaliplatin at 60 mg/m2 intravenously every two weeks(administered over 60 minutes) + Cetuximab at 250 mg/m2 intravenously every two weeks (administered over 90 minutes). The treatment interval (one cycle) is every 14 days. | None | None | 24 | 58 | 56 | 58 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Acidosis | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (3.0) | View |
| Anorexia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| Ascites | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| Bacteremia | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (3.0) | View |
| Cholangitis (Biliary tract infection) | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (3.0) | View |
| Dehydration | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| Diarrhea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| Hemorrhage - Gastrointestinal | SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE (3.0) | View |
| Hyperbilirubinemia (Elevated bilirubin) | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (3.0) | View |
| Hyperglycemia (High blood glucose) | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (3.0) | View |
| Hypotension | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE (3.0) | View |
| Ileus (bowel obstruction) | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| Infection - biliary tract (cholangitis) | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (3.0) | View |
| Infection - Urinary tract | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (3.0) | View |
| Infection of unknown origin | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (3.0) | View |
| Intracranial hemorrhage | SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE (3.0) | View |
| Mental status changes | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | CTCAE (3.0) | View |
| Muscle weakness upper limb | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| Pain - Abdomen | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
| Pulmonary Emboli | SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE (3.0) | View |
| Renal failure | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE (3.0) | View |
| Seizure | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | CTCAE (3.0) | View |
| Sinus tachycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE (3.0) | View |
| Thrombosis/embolism (vascular access) | SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE (3.0) | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (3.0) | View |
| Weight loss | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (3.0) | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Abdominal distention | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE version 3.0 | View |
| Acneiform rash | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE version 3.0 | View |
| Alanine aminotransferase increased | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE version 3.0 | View |
| Alkaline phosphatase increased | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE version 3.0 | View |
| Alopecia | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE version 3.0 | View |
| Anemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE version 3.0 | View |
| Anorexia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE version 3.0 | View |
| Anxiety | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE version 3.0 | View |
| Ascites | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE version 3.0 | View |
| Aspartate aminotransferase increased | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE version 3.0 | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE version 3.0 | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE version 3.0 | View |
| Decreased hemoglobin | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE version 3.0 | View |
| Dehydration | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE version 3.0 | View |
| Depression | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE version 3.0 | View |
| Diarrhea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE version 3.0 | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE version 3.0 | View |
| Dry skin | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE version 3.0 | View |
| Dyspepsia (Heartburn) | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE version 3.0 | View |
| Dyspnea (Shortness of breath) | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE version 3.0 | View |
| Edema - limbs | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE version 3.0 | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE version 3.0 | View |
| Fever | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE version 3.0 | View |
| Gamma-glutamyltransferase increased | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE version 3.0 | View |
| Hemorrhage - Nasal | SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE version 3.0 | View |
| Hypoalbuminemia (Low blood albumin) | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE version 3.0 | View |
| Hypocalcemia (Low calcium levels) | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE version 3.0 | View |
| Hypokalemia (Low potassium levels) | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE version 3.0 | View |
| Hypomagnesemia (Low magnesium levels) | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE version 3.0 | View |
| Hyponatremia (Low sodium levels) | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE version 3.0 | View |
| Hypophosphatemia (Low phosphate levels) | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE version 3.0 | View |
| Infection - Urinary tract | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE version 3.0 | View |
| Insomnia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE version 3.0 | View |
| Leukopenia (Decreased leukocytes) | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE version 3.0 | View |
| Mucositis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE version 3.0 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE version 3.0 | View |
| Neutropenia (Decreased neutrophils) | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE version 3.0 | View |
| Pain - Abdomen | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE version 3.0 | View |
| Pain - Back | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE version 3.0 | View |
| Peripheral sensory neuropathy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE version 3.0 | View |
| Pruritis (Itching) | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE version 3.0 | View |
| Rash | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE version 3.0 | View |
| Rigors/chills | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE version 3.0 | View |
| Taste alteration | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE version 3.0 | View |
| Thrombocytopenia (decreased platelets) | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE version 3.0 | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE version 3.0 | View |
| Weight loss | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE version 3.0 | View |
| Hyperbilirubinemia (High bilirubin levels) | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE version 3.0 | View |
| Hyperglycemia (High glucose levels) | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE version 3.0 | View |