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 @ 2:30 PM
Ignite Modification Date:
2025-12-25 @ 1:04 PM
NCT ID:
NCT00551759
Description:
None
Frequency Threshold:
5
Time Frame:
Assessed every 6 weeks while on treatment and for 30 days after the end of treatment
Study:
NCT00551759
Study Brief:
Chemotherapy, Radiation Therapy, and Cetuximab Followed by Surgery, Docetaxel, and Cetuximab in Treating Patients With Esophageal Cancer or Gastroesophageal Junction 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 |
|---|---|---|---|---|---|---|---|---|
| Neoadjuvant Therapy, Surgery, Adjuvant Therapy | 35 days of neoadjuvant chemoradiotherapy with oxaliplatin and infusional 5-fluorouracil plus cetuximab followed by post-operative docetaxel and cetuximab. | None | None | 19 | 22 | 22 | 22 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Allergic reaction | SYSTEMATIC_ASSESSMENT | Immune system disorders | CTCAE 3.0 | View |
| Anemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE 3.0 | View |
| Leukocytes decreased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE 3.0 | View |
| Lymphopenia | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE 3.0 | View |
| Neutrophils decreased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE 3.0 | View |
| Platelets decreased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE 3.0 | View |
| Heart block asystole | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE 3.0 | View |
| Atrial fibrillation | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE 3.0 | View |
| Cardiac troponin I (cTnI) increased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE 3.0 | View |
| Hypotension | SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE 3.0 | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE 3.0 | View |
| Weight loss | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE 3.0 | View |
| Activated partial thromboplastin time pr | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE 3.0 | View |
| Thrombotic microangiopathy | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE 3.0 | View |
| Coagulation-other | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE 3.0 | View |
| Rash/desquamation | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE 3.0 | View |
| Rash: acne/acneiform | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE 3.0 | View |
| Radiation dermatitis | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | CTCAE 3.0 | View |
| Death - multiorgan failure | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE 3.0 | View |
| Anorexia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE 3.0 | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE 3.0 | View |
| Dehydration | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE 3.0 | View |
| Diarrhea w/o prior colostomy | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE 3.0 | View |
| Distention/bloating, abdominal | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE 3.0 | View |
| Dysphagia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE 3.0 | View |
| Esophagitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE 3.0 | View |
| Malabsorption | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE 3.0 | View |
| Muco/stomatitis (symptom) esophagus | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE 3.0 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE 3.0 | View |
| Necrosis, small bowel NOS | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE 3.0 | View |
| Perforation, colon | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE 3.0 | View |
| Stenosis (incl anastomotic) esophagus | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE 3.0 | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE 3.0 | View |
| Surgical hemorrhage | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | CTCAE 3.0 | View |
| Infection Gr0-2 neut, brain | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE 3.0 | View |
| Infection Gr0-2 neut, colon | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE 3.0 | View |
| Infection Gr0-2 neut, lung | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE 3.0 | View |
| Infection Gr0-2 neut, sm bowel | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE 3.0 | View |
| Infection w/ unk ANC wound | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE 3.0 | View |
| Infection Gr0-2 neut, blood | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE 3.0 | View |
| Hypoalbuminemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE 3.0 | View |
| Alkaline phosphatase increased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE 3.0 | View |
| Hypocalcemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE 3.0 | View |
| Hyperglycemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE 3.0 | View |
| Hypomagnesemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE 3.0 | View |
| Hypophosphatemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE 3.0 | View |
| Hypokalemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE 3.0 | View |
| Hyponatremia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE 3.0 | View |
| Nonneuropathic generalized weakness | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE 3.0 | View |
| Laryngeal nerve dysfunction | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE 3.0 | View |
| Neuropathy-motor | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE 3.0 | View |
| Depressed level of consciousness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE 3.0 | View |
| Syncope | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE 3.0 | View |
| Abdomen, pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE 3.0 | View |
| Esophagus, pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE 3.0 | View |
| (ARDS) | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE 3.0 | View |
| Dyspnea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE 3.0 | View |
| Hiccoughs | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE 3.0 | View |
| Hypoxia | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE 3.0 | View |
| Pleural effusion (non-malignant) | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE 3.0 | View |
| Pneumonitis/pulmonary infiltrates | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE 3.0 | View |
| Pulmonary/Upper Respiratory-other | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE 3.0 | View |
| Vascular access,Thrombosis/embolism | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | CTCAE 3.0 | View |
| Thrombosis/thrombus/embolism | SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE 3.0 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Anemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE 3.0 | View |
| Leukocytes decreased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE 3.0 | View |
| Lymphopenia | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE 3.0 | View |
| Neutrophils decreased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE 3.0 | View |
| Platelets decreased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE 3.0 | View |
| Palpitations | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE 3.0 | View |
| Hypotension | SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE 3.0 | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE 3.0 | View |
| Fever w/o neutropenia | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE 3.0 | View |
| Insomnia | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | CTCAE 3.0 | View |
| Weight loss | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE 3.0 | View |
| Dry skin | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE 3.0 | View |
| Alopecia | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE 3.0 | View |
| Nail changes | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE 3.0 | View |
| Rash/desquamation | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE 3.0 | View |
| Rash: acne/acneiform | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE 3.0 | View |
| Radiation dermatitis | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | CTCAE 3.0 | View |
| Hand-foot reaction | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE 3.0 | View |
| Anorexia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE 3.0 | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE 3.0 | View |
| Dehydration | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE 3.0 | View |
| Diarrhea w/o prior colostomy | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE 3.0 | View |
| Dysphagia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE 3.0 | View |
| Esophagitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE 3.0 | View |
| Dyspepsia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE 3.0 | View |
| Muco/stomatitis (symptom) esophagus | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE 3.0 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE 3.0 | View |
| Salivary | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE 3.0 | View |
| Taste disturbance | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE 3.0 | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE 3.0 | View |
| Nose, hemorrhage | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE 3.0 | View |
| Edema limb | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE 3.0 | View |
| Hypoalbuminemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE 3.0 | View |
| Alkaline phosphatase increased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE 3.0 | View |
| Alanine aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE 3.0 | View |
| Aspartate aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE 3.0 | View |
| Acidosis | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE 3.0 | View |
| Hypocalcemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE 3.0 | View |
| Hyperglycemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE 3.0 | View |
| Hypomagnesemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE 3.0 | View |
| Hypokalemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE 3.0 | View |
| Hyponatremia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE 3.0 | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE 3.0 | View |
| Depression | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | CTCAE 3.0 | View |
| Neuropathy-motor | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE 3.0 | View |
| Neuropathy-sensory | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE 3.0 | View |
| Abdomen, pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE 3.0 | View |
| Chest/thoracic pain NOS | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE 3.0 | View |
| Esophagus, pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE 3.0 | View |
| Head/headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE 3.0 | View |
| Atelectasis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE 3.0 | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE 3.0 | View |
| Dyspnea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE 3.0 | View |
| Pleural effusion (non-malignant) | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE 3.0 | View |
| Voice changes/dysarthria | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE 3.0 | View |