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 @ 11:33 PM
Ignite Modification Date:
2025-12-25 @ 9:22 PM
NCT ID:
NCT00336856
Description:
None
Frequency Threshold:
0
Time Frame:
None
Study:
NCT00336856
Study Brief:
Irinotecan and Cetuximab for Colorectal Cancer as Second Line Therapy
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 AND CETUXIMAB | Cetuximab administered at an initial dose of 500 mg/m2 intravenously (IV) over 120 minutes, followed by 500 mg/m2 every 2 weeks IV over 60 minutes. Irinotecan administered at a dose of 150 or 180 mg/m2 IV over 60 minutes every two weeks. | None | None | 13 | 32 | 32 | 32 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Lymphopenia | None | Investigations | None | View |
| Fatigue (asthenia, lethargy, malaise) | None | General disorders | None | View |
| Fever (in the absence of neutropenia, where neutropenia is defined as AGC<1.0 x 10^9 cells/L) | None | General disorders | None | View |
| Rash: acne/acneiform | None | Skin and subcutaneous tissue disorders | None | View |
| Dehydration | None | Metabolism and nutrition disorders | None | View |
| Diarrhea | None | Gastrointestinal disorders | None | View |
| Fistula, GI, Abdomen NOS | None | Gastrointestinal disorders | None | View |
| Nausea | None | Gastrointestinal disorders | None | View |
| Obstruction, GI, Colon | None | Gastrointestinal disorders | None | View |
| Perforation, GI, Ileum | None | Gastrointestinal disorders | None | View |
| Vomiting | None | Gastrointestinal disorders | None | View |
| Infection with normal ANC or Grade 1 or 2 neutrophils, Abdomen NOS | None | Infections and infestations | None | View |
| Infection with normal ANC or Grade 1 or 2 neutrophils, Wound | None | Infections and infestations | None | View |
| Neutrophils/granulocytes (ANC/AGC) | None | Investigations | None | View |
| Supraventricular and nodal arrhythmia, Atrial fibrillation | None | Cardiac disorders | None | View |
| Cardiac General - Other | None | Cardiac disorders | None | View |
| Hypotension | None | Vascular disorders | None | View |
| INR (International Normalized Ratio of prothrombin time) | None | Blood and lymphatic system disorders | None | View |
| Constitutional Symptoms - Other | None | General disorders | None | View |
| Gastritis (including bile reflux gastritis) | None | Gastrointestinal disorders | None | View |
| Infection (documented clinically or microbiologically) with grade 3 or 4 neutropenia | None | Infections and infestations | None | View |
| Alkaline phosphatase | None | Metabolism and nutrition disorders | None | View |
| Bilirubin (hyperbilirubinemia) | None | Investigations | None | View |
| Glucose, serum-high (hyperglycemia) | None | Metabolism and nutrition disorders | None | View |
| Magnesium, serum-low (hypomagnesemia) | None | Metabolism and nutrition disorders | None | View |
| Uric acid, serum-high (hyperuricemia) | None | Metabolism and nutrition disorders | None | View |
| Neuropathy: motor | None | Nervous system disorders | None | View |
| Neuropathy: sensory | None | Nervous system disorders | None | View |
| Pain, Abdomen NOS | None | Gastrointestinal disorders | None | View |
| Adult Respiratory Distress Syndrome (ARDS) | None | Respiratory, thoracic and mediastinal disorders | None | View |
| Dyspnea (shortness of breath) | None | Respiratory, thoracic and mediastinal disorders | None | View |
| Pleural effusion (non-malignant) | None | Respiratory, thoracic and mediastinal disorders | None | View |
| Renal failure | None | Renal and urinary disorders | None | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Albumin, serum-low (hypoalbuminemia) | None | Metabolism and nutrition disorders | None | View |
| Alkaline phosphatase | None | Metabolism and nutrition disorders | None | View |
| Allergic reaction/hypersensitivity (including drug fever) | None | Immune system disorders | None | View |
| Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip) | None | Immune system disorders | None | View |
| ALT, SGPT (serum glutamic pyruvic transaminase) | None | Investigations | None | View |
| Anorexia | None | Metabolism and nutrition disorders | None | View |
| Ascites (non-malignant) | None | Gastrointestinal disorders | None | View |
| AST, SGOT(serum glutamic oxaloacetic transaminase) | None | Metabolism and nutrition disorders | None | View |
| Atelectasis | None | Respiratory, thoracic and mediastinal disorders | None | View |
| Bronchospasm, wheezing | None | Respiratory, thoracic and mediastinal disorders | None | View |
| Calcium, serum-low (hypocalcemia) | None | Metabolism and nutrition disorders | None | View |
| Cheilitis | None | Gastrointestinal disorders | None | View |
| Confusion | None | Psychiatric disorders | None | View |
| Constipation | None | Gastrointestinal disorders | None | View |
| Cough | None | Respiratory, thoracic and mediastinal disorders | None | View |
| Dehydration | None | Metabolism and nutrition disorders | None | View |
| Dermatology/Skin - Other | None | Skin and subcutaneous tissue disorders | None | View |
| Diarrhea | None | Gastrointestinal disorders | None | View |
| Distension/bloating, abdominal | None | Gastrointestinal disorders | None | View |
| Dizziness | None | Nervous system disorders | None | View |
| Dry eye syndrome | None | Eye disorders | None | View |
| Dry skin | None | Skin and subcutaneous tissue disorders | None | View |
| Dysphagia (difficulty swallowing) | None | Gastrointestinal disorders | None | View |
| Dyspnea (shortness of breath) | None | Respiratory, thoracic and mediastinal disorders | None | View |
| Edema: limb | None | General disorders | None | View |
| Esophagitis | None | Gastrointestinal disorders | None | View |
| Fatigue (asthenia, lethargy, malaise) | None | General disorders | None | View |
| Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10^9 cells/L) | None | General disorders | None | View |
| Flatulence | None | Gastrointestinal disorders | None | View |
| Fracture | None | Injury, poisoning and procedural complications | None | View |
| Gastrointestinal - Other | None | Gastrointestinal disorders | None | View |
| Hair loss/alopecia (scalp or body) | None | Skin and subcutaneous tissue disorders | None | View |
| Heartburn/dyspepsia | None | Gastrointestinal disorders | None | View |
| Hemoglobin | None | Blood and lymphatic system disorders | None | View |
| Hemorrhage, GI, Lower GI NOS | None | Gastrointestinal disorders | None | View |
| Hemorrhage, GI, Rectum | None | Gastrointestinal disorders | None | View |
| Hemorrhoids | None | Gastrointestinal disorders | None | View |
| Hiccoughs (hiccups, singultus) | None | Respiratory, thoracic and mediastinal disorders | None | View |
| Hyperpigmentation | None | Skin and subcutaneous tissue disorders | None | View |
| Hypotension | None | Vascular disorders | None | View |
| Hypoxia | None | Respiratory, thoracic and mediastinal disorders | None | View |
| Infection - Other | None | Infections and infestations | None | View |
| Infection with normal ANC or Grade 1 or 2 neutrophils, Bladder (urinary) | None | Infections and infestations | None | View |
| Infection with normal ANC or Grade 1 or 2 neutrophils, Blood | None | Infections and infestations | None | View |
| Infection with normal ANC or Grade 1 or 2 neutrophils, Skin (cellulitis) | None | Infections and infestations | None | View |
| Infection with normal ANC or Grade 1 or 2 neutrophils, Upper airway NOS | None | Infections and infestations | None | View |
| Infection with normal ANC or Grade 1 or 2 neutrophils, Urinary tract NOS | None | Infections and infestations | None | View |
| Infection with normal ANC or Grade 1 or 2 neutrophils, Vulva | None | Infections and infestations | None | View |
| Injection site reaction/extravasation changes | None | General disorders | None | View |
| Insomnia | None | Psychiatric disorders | None | View |
| Leukocytes (total WBC) | None | Investigations | None | View |
| Magnesium, serum-low (hypomagnesemia) | None | Metabolism and nutrition disorders | None | View |
| Memory impairment | None | Nervous system disorders | None | View |
| Metabolic/Laboratory - Other | None | Metabolism and nutrition disorders | None | View |
| Mood alteration, Anxiety | None | Psychiatric disorders | None | View |
| Mood alteration, Depression | None | Psychiatric disorders | None | View |
| Mucositis/stomatitis (clinical exam), Oral cavity | None | Gastrointestinal disorders | None | View |
| Musculoskeletal/Soft Tissue - Other | None | Musculoskeletal and connective tissue disorders | None | View |
| Nail changes | None | Skin and subcutaneous tissue disorders | None | View |
| Nausea | None | Gastrointestinal disorders | None | View |
| Neurology - Other | None | Nervous system disorders | None | View |
| Neuropathy: motor | None | Nervous system disorders | None | View |
| Neuropathy: sensory | None | Nervous system disorders | None | View |
| Neutrophils/granulocytes (ANC/AGC) | None | Investigations | None | View |
| Obstruction, GI, Small bowel NOS | None | Gastrointestinal disorders | None | View |
| Ocular/Visual - Other | None | Eye disorders | None | View |
| Pain, Abdomen NOS | None | Gastrointestinal disorders | None | View |
| Pain, Back | None | Musculoskeletal and connective tissue disorders | None | View |
| Pain, Chest/thorax NOS | None | General disorders | None | View |
| Pain, Extremity-limb | None | Musculoskeletal and connective tissue disorders | None | View |
| Pain, Middle ear | None | Ear and labyrinth disorders | None | View |
| Pain, Rectum | None | Gastrointestinal disorders | None | View |
| Platelets | None | Investigations | None | View |
| Pleural effusion (non-malignant) | None | Respiratory, thoracic and mediastinal disorders | None | View |
| Pruritus/itching | None | Skin and subcutaneous tissue disorders | None | View |
| Rash/desquamation | None | Skin and subcutaneous tissue disorders | None | View |
| Rash: acne/acneiform | None | Skin and subcutaneous tissue disorders | None | View |
| Rash: hand-foot skin reaction | None | Skin and subcutaneous tissue disorders | None | View |
| Renal failure | None | Renal and urinary disorders | None | View |
| Renal/Genitourinary - Other | None | Renal and urinary disorders | None | View |
| Rigors/chills | None | General disorders | None | View |
| Speech impairment (e.g., dysphasia or aphasia) | None | Nervous system disorders | None | View |
| Supraventricular and nodal arrhythmia, Sinus bradycardia | None | Cardiac disorders | None | View |
| Sweating (diaphoresis) | None | Skin and subcutaneous tissue disorders | None | View |
| Taste alteration (dysgeusia) | None | Gastrointestinal disorders | None | View |
| Ulcer, GI, Stomach | None | Gastrointestinal disorders | None | View |
| Wound complication, non-infectious | None | Injury, poisoning and procedural complications | None | View |
| Pain - Other | None | General disorders | None | View |
| Ulceration | None | General disorders | None | View |
| Vitreous hemorrhage | None | Eye disorders | None | View |
| Vomiting | None | Gastrointestinal disorders | None | View |
| Weight gain | None | Investigations | None | View |
| Weight loss | None | Investigations | None | View |