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 @ 2:05 AM
Ignite Modification Date:
2025-12-26 @ 12:30 AM
NCT ID:
NCT00050960
Description:
Number of participants at risk reflects the number exposed to at least one dose of any study medication. Twenty-four subjects in Participant Flow did not receive any study medication.
Frequency Threshold:
5
Time Frame:
None
Study:
NCT00050960
Study Brief:
Evaluation of Efficacy, Safety and Tolerability of Targretin Capsules in Patients With Advanced or Metastatic 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 |
|---|---|---|---|---|---|---|---|---|
| Carboplatin and Paclitaxel | carboplatin IV (AUC 6) every 3 weeks and paclitaxel IV (200 mg/m\^2) every 3 weeks. | None | None | 242 | 295 | 295 | 295 | View |
| Bexarotene With Carboplatin and Paclitaxel | bexarotene capsules (400 mg/m\^2/day) in combination with carboplatin IV (AUC 6) every 3 weeks and paclitaxel IV (200 mg/m\^2) every 3 weeks. Subjects in this group also received an antilipid agent which was selected at the discretion of the investigator. | None | None | 256 | 293 | 293 | 293 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Non-small cell lung cancer | None | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | None | View |
| Non-small cell lung cancer Stage IV | None | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | None | View |
| Non-small cell lung cancer metastatic | None | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | None | View |
| Dehydration | None | Metabolism and nutrition disorders | None | View |
| Anorexia | None | Metabolism and nutrition disorders | None | View |
| Hyponatremia | None | Metabolism and nutrition disorders | None | View |
| Dyspnoea | None | Respiratory, thoracic and mediastinal disorders | None | View |
| Pulmonary embolism | None | Respiratory, thoracic and mediastinal disorders | None | View |
| Pleural effusion | None | Respiratory, thoracic and mediastinal disorders | None | View |
| Respiratory failure | None | Respiratory, thoracic and mediastinal disorders | None | View |
| Dyspnoea exacerbated | None | Respiratory, thoracic and mediastinal disorders | None | View |
| Haemoptysis | None | Respiratory, thoracic and mediastinal disorders | None | View |
| Hypoxia | None | Respiratory, thoracic and mediastinal disorders | None | View |
| Chronic obstructive airways disease exacerbated | None | Respiratory, thoracic and mediastinal disorders | None | View |
| Anaemia | None | Blood and lymphatic system disorders | None | View |
| Febrile neutropenia | None | Blood and lymphatic system disorders | None | View |
| Neutropenia | None | Blood and lymphatic system disorders | None | View |
| Thrombocytopenia | None | Blood and lymphatic system disorders | None | View |
| Pancytopenia | None | Blood and lymphatic system disorders | None | View |
| Vomiting | None | Gastrointestinal disorders | None | View |
| Nausea | None | Gastrointestinal disorders | None | View |
| Diarrhea | None | Gastrointestinal disorders | None | View |
| Abdominal pain | None | Gastrointestinal disorders | None | View |
| Constipation | None | Gastrointestinal disorders | None | View |
| Atrial fibrillation | None | Cardiac disorders | None | View |
| Cardiac failure congestive | None | Cardiac disorders | None | View |
| Pericardial effusion | None | Cardiac disorders | None | View |
| Pyrexia | None | General disorders | None | View |
| Asthenia | None | General disorders | None | View |
| Chest pain | None | General disorders | None | View |
| Fatigue | None | General disorders | None | View |
| Oedema peripheral | None | General disorders | None | View |
| Pain | None | General disorders | None | View |
| Hepatic failure | None | Hepatobiliary disorders | None | View |
| Arthralgia | None | Musculoskeletal and connective tissue disorders | None | View |
| Pain in extremity | None | Musculoskeletal and connective tissue disorders | None | View |
| Pneumonia | None | Infections and infestations | None | View |
| Sepsis | None | Infections and infestations | None | View |
| Convulsion | None | Nervous system disorders | None | View |
| Cerebrovascular accident | None | Nervous system disorders | None | View |
| Spinal cord compression | None | Nervous system disorders | None | View |
| Polyneuropathy | None | Nervous system disorders | None | View |
| Confusional state | None | Psychiatric disorders | None | View |
| Deep vein thrombosis | None | Vascular disorders | None | View |
| Hypotension | None | Vascular disorders | None | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Anorexia | None | Metabolism and nutrition disorders | None | View |
| Dehydration | None | Metabolism and nutrition disorders | None | View |
| Hypercholesterolemia | None | Metabolism and nutrition disorders | None | View |
| Hypomagnesemia | None | Metabolism and nutrition disorders | None | View |
| Skin desquamation | None | Skin and subcutaneous tissue disorders | None | View |
| Arthralgia | None | Musculoskeletal and connective tissue disorders | None | View |
| Myalgia | None | Musculoskeletal and connective tissue disorders | None | View |
| Weight decreased | None | Investigations | None | View |
| Blood triglycerides increased | None | Investigations | None | View |
| Hypothyroidism | None | Endocrine disorders | None | View |
| Anemia | None | Blood and lymphatic system disorders | None | View |
| Neutropenia | None | Blood and lymphatic system disorders | None | View |
| Thrombocytopenia | None | Blood and lymphatic system disorders | None | View |
| Leukopenia | None | Blood and lymphatic system disorders | None | View |
| Febrile neutropenia | None | Blood and lymphatic system disorders | None | View |
| Hypotriglyceridemia | None | Metabolism and nutrition disorders | None | View |
| Hypokalaemia | None | Metabolism and nutrition disorders | None | View |
| Hyperglycaemia | None | Metabolism and nutrition disorders | None | View |
| Hyponatremia | None | Metabolism and nutrition disorders | None | View |
| Hyperlipidemia | None | Metabolism and nutrition disorders | None | View |
| Insomnia | None | Psychiatric disorders | None | View |
| Depression | None | Psychiatric disorders | None | View |
| Anxiety | None | Psychiatric disorders | None | View |
| Confusional state | None | Psychiatric disorders | None | View |
| Neuropathy peripheral | None | Nervous system disorders | None | View |
| Dizziness | None | Nervous system disorders | None | View |
| Headache | None | Nervous system disorders | None | View |
| Paraesthesia | None | Nervous system disorders | None | View |
| Polyneuropathy | None | Nervous system disorders | None | View |
| Neuropathy | None | Nervous system disorders | None | View |
| Dysgeusia | None | Nervous system disorders | None | View |
| Dyspnoea | None | Respiratory, thoracic and mediastinal disorders | None | View |
| Cough | None | Respiratory, thoracic and mediastinal disorders | None | View |
| Dyspnoea exacerbated | None | Respiratory, thoracic and mediastinal disorders | None | View |
| Haemoptysis | None | Respiratory, thoracic and mediastinal disorders | None | View |
| Epistaxis | None | Respiratory, thoracic and mediastinal disorders | None | View |
| Pharyngolaryngeal pain | None | Respiratory, thoracic and mediastinal disorders | None | View |
| Hoarseness | None | Respiratory, thoracic and mediastinal disorders | None | View |
| Hypotension | None | Vascular disorders | None | View |
| Flushing | None | Vascular disorders | None | View |
| Nausea | None | Gastrointestinal disorders | None | View |
| Diarrhoea | None | Gastrointestinal disorders | None | View |
| Vomiting | None | Gastrointestinal disorders | None | View |
| Constipation | None | Gastrointestinal disorders | None | View |
| Abdominal pain | None | Gastrointestinal disorders | None | View |
| Dyspepsia | None | Gastrointestinal disorders | None | View |
| Stomatitis | None | Gastrointestinal disorders | None | View |
| Abdominal pain upper | None | Gastrointestinal disorders | None | View |
| Dysphagia | None | Gastrointestinal disorders | None | View |
| Alopecia | None | Skin and subcutaneous tissue disorders | None | View |
| Rash | None | Skin and subcutaneous tissue disorders | None | View |
| Pruritis | None | Skin and subcutaneous tissue disorders | None | View |
| Dermatitis exfoliative | None | Skin and subcutaneous tissue disorders | None | View |
| Dry skin | None | Skin and subcutaneous tissue disorders | None | View |
| Pain in extremity | None | Musculoskeletal and connective tissue disorders | None | View |
| Back pain | None | Musculoskeletal and connective tissue disorders | None | View |
| Bone pain | None | Musculoskeletal and connective tissue disorders | None | View |
| Fatigue | None | General disorders | None | View |
| Asthenia | None | General disorders | None | View |
| Chest pain | None | General disorders | None | View |
| Oedema peripheral | None | General disorders | None | View |
| Pain | None | General disorders | None | View |
| Pyrexia | None | General disorders | None | View |