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 @ 10:36 PM
Ignite Modification Date:
2025-12-25 @ 8:07 PM
NCT ID:
NCT00319735
Description:
None
Frequency Threshold:
0
Time Frame:
None
Study:
NCT00319735
Study Brief:
Cetuximab and Radiation Therapy for Surgically Resectable Esophageal and Gastroesophageal (GE) Junction Carcinomas
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Single Arm Assignment | Cetuximab 400 mg/m2 IV over 120 minutes Day -14 (Loading Dose) Cetuximab 250 mg/m2 IV over 60 minutes Day -7 Cetuximab 250 mg/m2 IV over 60 minutes Days 1, 8, 15, 22, 29 and 36 Radiation Therapy: External beam radiation therapy, beginning on day 1, 4500 cGy to esophagus with boost of 540 cGy at 180 cGy per fraction for 6 weeks Surgery: Surgical resection of primary tumor and adjacent mediastinal and/or celiac lymph nodes by a transthoracic approach after satisfactory hematologic and functional recovery within 8 weeks of completion of radiation therapy Tissue Sample: For patients who give their consent, fresh frozen tissue will be obtained per EUS at baseline, per EUS 2 weeks after the initiation of chemotherapy, and at the time of surgery for pathology submission | None | None | 16 | 41 | 39 | 41 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| ASPIRATION | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAEv3 | View |
| BLOOD/BONE MARROW - OTHER (SPECIFY, __) | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAEv3 | View |
| CONSTITUTIONAL SYMPTOMS - OTHER (SPECIFY, __) | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAEv3 | View |
| DEHYDRATION | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAEv3 | View |
| DYSPHAGIA (DIFFICULTY SWALLOWING) | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAEv3 | View |
| DYSPNEA (SHORTNESS OF BREATH) | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAEv3 | View |
| FATIGUE (ASTHENIA, LETHARGY, MALAISE) | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAEv3 | View |
| FEVER (IN THE ABSENCE OF NEUTROPENIA, WHERE NEUTROPENIA IS DEFINED AS ANC <1.0 X 10E9/L) | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAEv3 | View |
| FISTULA, GI / ESOPHAGUS | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAEv3 | View |
| FRACTURE | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAEv3 | View |
| GLUCOSE, SERUM-HIGH (HYPERGLYCEMIA) | NON_SYSTEMATIC_ASSESSMENT | Investigations | CTCAEv3 | View |
| HEMORRHAGE, GI / ESOPHAGUS | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAEv3 | View |
| INFECTION WITH GRADE 3 OR 4 NEUTROPHILS (ANC <1.0 X 10E9/L) / ABDOMEN NOS | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAEv3 | View |
| INFECTION WITH GRADE 3 OR 4 NEUTROPHILS (ANC <1.0 X 10E9/L) / CATHETER-RELATED | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAEv3 | View |
| INFECTION - OTHER (SPECIFY, __) | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAEv3 | View |
| INFECTION WITH UNKNOWN ANC / LUNG (PNEUMONIA) | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAEv3 | View |
| PAIN / BACK | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAEv3 | View |
| PAIN / CHEST/THORAX NOS | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAEv3 | View |
| SODIUM, SERUM-HIGH (HYPERNATREMIA) | NON_SYSTEMATIC_ASSESSMENT | Investigations | CTCAEv3 | View |
| SODIUM, SERUM-LOW (HYPONATREMIA) | NON_SYSTEMATIC_ASSESSMENT | Investigations | CTCAEv3 | View |
| SUPRAVENTRICULAR AND NODAL ARRHYTHMIA / ATRIAL FIBRILLATION | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAEv3 | View |
| THROMBOSIS/THROMBUS/EMBOLISM | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAEv3 | View |
| URINARY RETENTION (INCLUDING NEUROGENIC BLADDER) | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAEv3 | View |
| VASCULAR - OTHER (SPECIFY, __) | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAEv3 | View |
| VOMITING | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAEv3 | View |
| WEIGHT LOSS | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAEv3 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| PLATELETS | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAEv3 | View |
| ALBUMIN, SERUM-LOW (HYPOALBUMINEMIA) | NON_SYSTEMATIC_ASSESSMENT | Investigations | CTCAEv3 | View |
| ALLERGIC REACTION/HYPERSENSITIVITY (INCLUDING DRUG FEVER) | NON_SYSTEMATIC_ASSESSMENT | Immune system disorders | CTCAEv3 | View |
| ALLERGIC RHINITIS (INCLUDING SNEEZING, NASAL STUFFINESS, POSTNASAL DRIP) | NON_SYSTEMATIC_ASSESSMENT | Immune system disorders | CTCAEv3 | View |
| ALT, SGPT (SERUM GLUTAMIC PYRUVIC TRANSAMINASE) | NON_SYSTEMATIC_ASSESSMENT | Investigations | CTCAEv3 | View |
| ANOREXIA | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAEv3 | View |
| ASPIRATION | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAEv3 | View |
| AST, SGOT(SERUM GLUTAMIC OXALOACETIC TRANSAMINASE) | NON_SYSTEMATIC_ASSESSMENT | Investigations | CTCAEv3 | View |
| CALCIUM, SERUM-LOW (HYPOCALCEMIA) | NON_SYSTEMATIC_ASSESSMENT | Investigations | CTCAEv3 | View |
| CHOLESTEROL, SERUM-HIGH (HYPERCHOLESTREMIA) | NON_SYSTEMATIC_ASSESSMENT | Investigations | CTCAEv3 | View |
| CONSTIPATION | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAEv3 | View |
| CONSTITUTIONAL SYMPTOMS - OTHER (SPECIFY, __) | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAEv3 | View |
| COUGH | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAEv3 | View |
| DEHYDRATION | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAEv3 | View |
| DERMATOLOGY/SKIN - OTHER (SPECIFY, __) | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAEv3 | View |
| DIARRHEA | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAEv3 | View |
| DRY MOUTH/SALIVARY GLAND (XEROSTOMIA) | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAEv3 | View |
| DYSPHAGIA (DIFFICULTY SWALLOWING) | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAEv3 | View |
| DYSPNEA (SHORTNESS OF BREATH) | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAEv3 | View |
| ESOPHAGITIS | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAEv3 | View |
| FATIGUE (ASTHENIA, LETHARGY, MALAISE) | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAEv3 | View |
| FEVER (IN THE ABSENCE OF NEUTROPENIA, WHERE NEUTROPENIA IS DEFINED AS ANC <1.0 X 10E9/L) | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAEv3 | View |
| FLU-LIKE SYNDROME | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAEv3 | View |
| GASTROINTESTINAL - OTHER (SPECIFY, __) | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAEv3 | View |
| GLUCOSE, SERUM-HIGH (HYPERGLYCEMIA) | NON_SYSTEMATIC_ASSESSMENT | Investigations | CTCAEv3 | View |
| HEARTBURN/DYSPEPSIA | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAEv3 | View |
| HEMOGLOBIN | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAEv3 | View |
| HEMORRHAGE, PULMONARY/UPPER RESPIRATORY / NOSE | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAEv3 | View |
| HOT FLASHES/FLUSHES | NON_SYSTEMATIC_ASSESSMENT | Endocrine disorders | CTCAEv3 | View |
| HYPERTENSION | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAEv3 | View |
| HYPOTENSION | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAEv3 | View |
| INFECTION - OTHER (SPECIFY, __) | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAEv3 | View |
| INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS / SKIN (CELLULITIS) | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAEv3 | View |
| INFECTION WITH UNKNOWN ANC / CONJUNCTIVA | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAEv3 | View |
| INFECTION WITH UNKNOWN ANC / UPPER AIRWAY NOS | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAEv3 | View |
| INSOMNIA | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAEv3 | View |
| LEFT VENTRICULAR SYSTOLIC DYSFUNCTION | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAEv3 | View |
| LEUKOCYTES (TOTAL WBC) | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAEv3 | View |
| MAGNESIUM, SERUM-LOW (HYPOMAGNESEMIA) | NON_SYSTEMATIC_ASSESSMENT | Investigations | CTCAEv3 | View |
| MOOD ALTERATION / DEPRESSION | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | CTCAEv3 | View |
| MUCOSITIS/STOMATITIS (CLINICAL EXAM) / ORAL CAVITY | NON_SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | CTCAEv3 | View |
| MUCOSITIS/STOMATITIS (FUNCTIONAL/SYMPTOMATIC) / ORAL CAVITY | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAEv3 | View |
| NAIL CHANGES | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAEv3 | View |
| NAUSEA | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAEv3 | View |
| NEUROPATHY: SENSORY | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAEv3 | View |
| PAIN / ABDOMEN NOS | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAEv3 | View |
| PAIN / BACK | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAEv3 | View |
| PAIN / CHEST/THORAX NOS | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAEv3 | View |
| PAIN / ESOPHAGUS | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAEv3 | View |
| PAIN / EXTREMITY-LIMB | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAEv3 | View |
| PAIN / FACE | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAEv3 | View |
| PAIN / HEAD/HEADACHE | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAEv3 | View |
| PAIN / JOINT | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAEv3 | View |
| PAIN / MUSCLE | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAEv3 | View |
| PAIN / PAIN NOS | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAEv3 | View |
| PAIN / THROAT/PHARYNX/LARYNX | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAEv3 | View |
| PAIN - OTHER (SPECIFY, __) | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAEv3 | View |
| PALPITATIONS | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAEv3 | View |
| PLEURAL EFFUSION (NON-MALIGNANT) | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAEv3 | View |
| POTASSIUM, SERUM-LOW (HYPOKALEMIA) | NON_SYSTEMATIC_ASSESSMENT | Investigations | CTCAEv3 | View |
| PRURITUS/ITCHING | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAEv3 | View |
| PULMONARY/UPPER RESPIRATORY - OTHER (SPECIFY, __) | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAEv3 | View |
| RASH/DESQUAMATION | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAEv3 | View |
| RASH: ACNE/ACNEIFORM | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAEv3 | View |
| RASH: DERMATITIS ASSOCIATED WITH RADIATION / CHEMORADIATION | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAEv3 | View |
| RASH: ERYTHEMA MULTIFORME (E.G., STEVENS-JOHNSON SYNDROME, TOXIC EPIDERMAL NECROLYSIS) | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAEv3 | View |
| RIGORS/CHILLS | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAEv3 | View |
| SEIZURE | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAEv3 | View |
| SODIUM, SERUM-LOW (HYPONATREMIA) | NON_SYSTEMATIC_ASSESSMENT | Investigations | CTCAEv3 | View |
| STRICTURE/STENOSIS (INCLUDING ANASTOMOTIC), GI / ESOPHAGUS | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAEv3 | View |
| SUPRAVENTRICULAR AND NODAL ARRHYTHMIA / ATRIAL FIBRILLATION | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAEv3 | View |
| TASTE ALTERATION (DYSGEUSIA) | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAEv3 | View |
| VOICE CHANGES/DYSARTHRIA (E.G., HOARSENESS, LOSS OR ALTERATION IN VOICE, LARYNGITIS) | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAEv3 | View |
| VOMITING | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAEv3 | View |
| WEIGHT LOSS | NON_SYSTEMATIC_ASSESSMENT | General disorders | CTCAEv3 | View |