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:
2025-12-25 @ 1:28 AM
Ignite Modification Date:
2025-12-25 @ 11:40 PM
NCT ID:
NCT00454194
Description:
None
Frequency Threshold:
0
Time Frame:
Up to 2.6 years
Study:
NCT00454194
Study Brief:
Pemetrexed Disodium With or Without Sorafenib as Second-Line Therapy in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung 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 |
|---|---|---|---|---|---|---|---|---|
| Arm I (Pemetrexed + Sorafenib) | Patients receive oral sorafenib tosylate twice daily on days 1-21 and pemetrexed disodium IV over 10 minutes on day 1. | None | None | 13 | 47 | 47 | 47 | View |
| Arm II (Pemetrexed) | Patients receive pemetrexed disodium IV over 10 minutes on day 1. | None | None | 7 | 51 | 51 | 51 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Hemoglobin decreased | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAEV3.0 | View |
| Leukocyte count decreased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAEV3.0 | View |
| Bronchial hemorrhage | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAEV3.0 | View |
| Febrile neutropenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAEV3.0 | View |
| Abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAEV3.0 | View |
| Dry mouth | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAEV3.0 | View |
| Small intestinal perforation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAEV3.0 | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAEV3.0 | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | CTCAEV3.0 | View |
| Sudden death | SYSTEMATIC_ASSESSMENT | General disorders | CTCAEV3.0 | View |
| Aspartate aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAEV3.0 | View |
| Bilirubin increased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAEV3.0 | View |
| Lipase increased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAEV3.0 | View |
| Neutrophil count decreased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAEV3.0 | View |
| Platelet count decreased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAEV3.0 | View |
| Weight loss | SYSTEMATIC_ASSESSMENT | Investigations | CTCAEV3.0 | View |
| Anorexia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAEV3.0 | View |
| Chest wall pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAEV3.0 | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAEV3.0 | View |
| Ischemia cerebrovascular | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAEV3.0 | View |
| Dyspnea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAEV3.0 | View |
| Thrombosis | SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAEV3.0 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Febrile neutropenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAEV3.0 | View |
| Hemoglobin decreased | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAEV3.0 | View |
| Lymph node pain | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAEV3.0 | View |
| Lymphatic disorder | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAEV3.0 | View |
| Arrhythmia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAEV3.0 | View |
| Cardiac pain | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAEV3.0 | View |
| Myocardial ischemia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAEV3.0 | View |
| Hyperthyroidism | SYSTEMATIC_ASSESSMENT | Endocrine disorders | CTCAEV3.0 | View |
| Dry eye syndrome | SYSTEMATIC_ASSESSMENT | Eye disorders | CTCAEV3.0 | View |
| Vision blurred | SYSTEMATIC_ASSESSMENT | Eye disorders | CTCAEV3.0 | View |
| Watering eyes | SYSTEMATIC_ASSESSMENT | Eye disorders | CTCAEV3.0 | View |
| Abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAEV3.0 | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAEV3.0 | View |
| Diarrhea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAEV3.0 | View |
| Dry mouth | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAEV3.0 | View |
| Dyspepsia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAEV3.0 | View |
| Dysphagia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAEV3.0 | View |
| Ear, nose and throat examination abnormal | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAEV3.0 | View |
| Flatulence | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAEV3.0 | View |
| Mucositis oral | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAEV3.0 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAEV3.0 | View |
| Rectal hemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAEV3.0 | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAEV3.0 | View |
| Chest pain | SYSTEMATIC_ASSESSMENT | General disorders | CTCAEV3.0 | View |
| Chills | SYSTEMATIC_ASSESSMENT | General disorders | CTCAEV3.0 | View |
| Death | SYSTEMATIC_ASSESSMENT | General disorders | CTCAEV3.0 | View |
| Disease progression | SYSTEMATIC_ASSESSMENT | General disorders | CTCAEV3.0 | View |
| Edema limbs | SYSTEMATIC_ASSESSMENT | General disorders | CTCAEV3.0 | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | CTCAEV3.0 | View |
| Fever | SYSTEMATIC_ASSESSMENT | General disorders | CTCAEV3.0 | View |
| Flu-like symptoms | SYSTEMATIC_ASSESSMENT | General disorders | CTCAEV3.0 | View |
| Localized edema | SYSTEMATIC_ASSESSMENT | General disorders | CTCAEV3.0 | View |
| Pain | SYSTEMATIC_ASSESSMENT | General disorders | CTCAEV3.0 | View |
| Cholecystitis | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | CTCAEV3.0 | View |
| Hepatic failure | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | CTCAEV3.0 | View |
| Hypersensitivity | SYSTEMATIC_ASSESSMENT | Immune system disorders | CTCAEV3.0 | View |
| Abdominal infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAEV3.0 | View |
| Bladder infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAEV3.0 | View |
| Bronchitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAEV3.0 | View |
| Conjunctivitis infective | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAEV3.0 | View |
| Gingival infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAEV3.0 | View |
| Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAEV3.0 | View |
| Mucosal infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAEV3.0 | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAEV3.0 | View |
| Sinusitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAEV3.0 | View |
| Skin infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAEV3.0 | View |
| Upper respiratory infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAEV3.0 | View |
| Urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAEV3.0 | View |
| Activated partial thromboplastin time prolonged | SYSTEMATIC_ASSESSMENT | Investigations | CTCAEV3.0 | View |
| Alanine aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAEV3.0 | View |
| Alkaline phosphatase increased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAEV3.0 | View |
| Aspartate aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAEV3.0 | View |
| Cardiac troponin I increased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAEV3.0 | View |
| Creatinine increased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAEV3.0 | View |
| Laboratory test abnormal | SYSTEMATIC_ASSESSMENT | Investigations | CTCAEV3.0 | View |
| Leukocyte count decreased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAEV3.0 | View |
| Lipase increased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAEV3.0 | View |
| Lymphocyte count decreased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAEV3.0 | View |
| Neutrophil count decreased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAEV3.0 | View |
| Platelet count decreased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAEV3.0 | View |
| Weight gain | SYSTEMATIC_ASSESSMENT | Investigations | CTCAEV3.0 | View |
| Weight loss | SYSTEMATIC_ASSESSMENT | Investigations | CTCAEV3.0 | View |
| Anorexia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAEV3.0 | View |
| Blood glucose increased | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAEV3.0 | View |
| Dehydration | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAEV3.0 | View |
| Serum albumin decreased | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAEV3.0 | View |
| Serum calcium decreased | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAEV3.0 | View |
| Serum magnesium decreased | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAEV3.0 | View |
| Serum magnesium increased | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAEV3.0 | View |
| Serum phosphate decreased | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAEV3.0 | View |
| Serum potassium decreased | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAEV3.0 | View |
| Serum potassium increased | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAEV3.0 | View |
| Serum sodium decreased | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAEV3.0 | View |
| Serum sodium increased | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAEV3.0 | View |
| Back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAEV3.0 | View |
| Bone pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAEV3.0 | View |
| Chest wall pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAEV3.0 | View |
| Joint disorder | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAEV3.0 | View |
| Joint pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAEV3.0 | View |
| Muscle weakness | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAEV3.0 | View |
| Muscle weakness lower limb | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAEV3.0 | View |
| Muscle weakness upper limb | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAEV3.0 | View |
| Myalgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAEV3.0 | View |
| Neck pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAEV3.0 | View |
| Osteonecrosis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAEV3.0 | View |
| Pain in extremity | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAEV3.0 | View |
| Depressed level of consciousness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAEV3.0 | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAEV3.0 | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAEV3.0 | View |
| Peripheral motor neuropathy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAEV3.0 | View |
| Peripheral sensory neuropathy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAEV3.0 | View |
| Seizure | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAEV3.0 | View |
| Speech disorder | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAEV3.0 | View |
| Taste alteration | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAEV3.0 | View |
| Anxiety | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | CTCAEV3.0 | View |
| Confusion | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | CTCAEV3.0 | View |
| Depression | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | CTCAEV3.0 | View |
| Insomnia | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | CTCAEV3.0 | View |
| Protein urine positive | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAEV3.0 | View |
| Urinary frequency | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAEV3.0 | View |
| Allergic rhinitis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAEV3.0 | View |
| Bronchial hemorrhage | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAEV3.0 | View |
| Bronchospasm | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAEV3.0 | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAEV3.0 | View |
| Dyspnea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAEV3.0 | View |
| Hemorrhage nasal | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAEV3.0 | View |
| Hiccough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAEV3.0 | View |
| Hypoxia | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAEV3.0 | View |
| Pharyngeal examination abnormal | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAEV3.0 | View |
| Pharyngeal mucositis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAEV3.0 | View |
| Pleural effusion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAEV3.0 | View |
| Pleuritic pain | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAEV3.0 | View |
| Pneumonitis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAEV3.0 | View |
| Pneumothorax | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAEV3.0 | View |
| Pulmonary hemorrhage | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAEV3.0 | View |
| Pulmonary hypertension | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAEV3.0 | View |
| Voice alteration | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAEV3.0 | View |
| Alopecia | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAEV3.0 | View |
| Dry skin | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAEV3.0 | View |
| Hand-and-foot syndrome | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAEV3.0 | View |
| Nail disorder | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAEV3.0 | View |
| Photosensitivity | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAEV3.0 | View |
| Pruritus | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAEV3.0 | View |
| Rash acneiform | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAEV3.0 | View |
| Rash desquamating | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAEV3.0 | View |
| Sweating | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAEV3.0 | View |
| Hot flashes | SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAEV3.0 | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAEV3.0 | View |
| Hypotension | SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAEV3.0 | View |
| Thrombosis | SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAEV3.0 | View |