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 @ 5:03 PM
Ignite Modification Date:
2025-12-25 @ 2:43 PM
NCT ID:
NCT00308750
Description:
Study-specific clinical outcomes due to PD were not considered to be a SAE unless the investigator deemed it related to the use of the study drug.
Frequency Threshold:
5
Time Frame:
None
Study:
NCT00308750
Study Brief:
First Line Chemotherapy Treatment of Advanced Non-Small Cell Lung Cancer (NSCLC)
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Enzastaurin/Pemetrexed/Carboplatin | Enzastaurin loading dose of 1125 mg or 1200 mg on Day -7 (pre-chemotherapy) followed by 500 mg administered once daily starting from Day -6 until disease progression. Pemetrexed 500 mg/m\^2 and carboplatin AUC 6 mg\*min/mL as an intravenous infusion on Day 1 every 21 days for a maximum of 6 cycles (21-day cycle) or disease progression whichever came first. | None | None | 35 | 67 | 63 | 67 | View |
| Pemetrexed/Carboplatin | Pemetrexed 500 mg/m\^2 and carboplatin AUC 6 mg\*min/mL as an intravenous infusion on Day 1 every 21 days for a maximum of 6 cycles (21-day cycle) or disease progression whichever came first. | None | None | 20 | 72 | 70 | 72 | View |
| Docetaxel/Carboplatin | Docetaxel 75 mg/m\^2 and carboplatin AUC 6 mg\*min/mL as an intravenous infusion on Day 1 every 21 days for a maximum of 6 cycles (21-day cycle) or disease progression whichever came first. | None | None | 26 | 70 | 69 | 70 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Febrile neutropenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | 16.0 | View |
| Arrhythmia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | 16.0 | View |
| Cardio-respiratory arrest | SYSTEMATIC_ASSESSMENT | Cardiac disorders | 16.0 | View |
| Myocardial infarction | SYSTEMATIC_ASSESSMENT | Cardiac disorders | 16.0 | View |
| Caecitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 16.0 | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 16.0 | View |
| Duodenal ulcer | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 16.0 | View |
| Dysphagia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 16.0 | View |
| Enteritis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 16.0 | View |
| Impaired gastric emptying | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 16.0 | View |
| Lower gastrointestinal haemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 16.0 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 16.0 | View |
| Rectal haemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 16.0 | View |
| Stomatitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 16.0 | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 16.0 | View |
| Chest pain | SYSTEMATIC_ASSESSMENT | General disorders | 16.0 | View |
| Disease progression | SYSTEMATIC_ASSESSMENT | General disorders | 16.0 | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | 16.0 | View |
| Localised oedema | SYSTEMATIC_ASSESSMENT | General disorders | 16.0 | View |
| Oedema due to cardiac disease | SYSTEMATIC_ASSESSMENT | General disorders | 16.0 | View |
| Pain | SYSTEMATIC_ASSESSMENT | General disorders | 16.0 | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | 16.0 | View |
| Abdominal infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | 16.0 | View |
| Cellulitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | 16.0 | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | 16.0 | View |
| Sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | 16.0 | View |
| Fall | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | 16.0 | View |
| Fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | 16.0 | View |
| Aspartate aminotransferase | SYSTEMATIC_ASSESSMENT | Investigations | 16.0 | View |
| Blood creatinine | SYSTEMATIC_ASSESSMENT | Investigations | 16.0 | View |
| Blood potassium decreased | SYSTEMATIC_ASSESSMENT | Investigations | 16.0 | View |
| Blood sodium decreased | SYSTEMATIC_ASSESSMENT | Investigations | 16.0 | View |
| Haemoglobin | SYSTEMATIC_ASSESSMENT | Investigations | 16.0 | View |
| Neutrophil count | SYSTEMATIC_ASSESSMENT | Investigations | 16.0 | View |
| Platelet count | SYSTEMATIC_ASSESSMENT | Investigations | 16.0 | View |
| White blood cell count | SYSTEMATIC_ASSESSMENT | Investigations | 16.0 | View |
| Decreased appetite | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | 16.0 | View |
| Dehydration | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | 16.0 | View |
| Electrolyte imbalance | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | 16.0 | View |
| Hyperglycaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | 16.0 | View |
| Bone pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | 16.0 | View |
| Muscular weakness | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | 16.0 | View |
| Myalgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | 16.0 | View |
| Pain in extremity | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | 16.0 | View |
| Gastric cancer recurrent | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 16.0 | View |
| Cerebral ischaemia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | 16.0 | View |
| Convulsion | SYSTEMATIC_ASSESSMENT | Nervous system disorders | 16.0 | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | 16.0 | View |
| Syncope | SYSTEMATIC_ASSESSMENT | Nervous system disorders | 16.0 | View |
| Confusional state | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | 16.0 | View |
| Mental status changes | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | 16.0 | View |
| Renal failure | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | 16.0 | View |
| Dyspnoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 16.0 | View |
| Hypoxia | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 16.0 | View |
| Lung infiltration | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 16.0 | View |
| Orthopnoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 16.0 | View |
| Pleural effusion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 16.0 | View |
| Pneumothorax | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 16.0 | View |
| Pulmonary embolism | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 16.0 | View |
| Pulmonary fibrosis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 16.0 | View |
| Respiratory failure | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 16.0 | View |
| Respiratory tract haemorrhage | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 16.0 | View |
| Hyperhidrosis | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | 16.0 | View |
| Aortic thrombosis | SYSTEMATIC_ASSESSMENT | Vascular disorders | 16.0 | View |
| Deep vein thrombosis | SYSTEMATIC_ASSESSMENT | Vascular disorders | 16.0 | View |
| Embolism | SYSTEMATIC_ASSESSMENT | Vascular disorders | 16.0 | View |
| Haematoma | SYSTEMATIC_ASSESSMENT | Vascular disorders | 16.0 | View |
| Haemorrhage | SYSTEMATIC_ASSESSMENT | Vascular disorders | 16.0 | View |
| Hypotension | SYSTEMATIC_ASSESSMENT | Vascular disorders | 16.0 | View |
| Thrombosis | SYSTEMATIC_ASSESSMENT | Vascular disorders | 16.0 | View |
| Pericardial effusion | SYSTEMATIC_ASSESSMENT | Cardiac disorders | 16.0 | View |
| Abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 16.0 | View |
| Blood bilirubin | SYSTEMATIC_ASSESSMENT | Investigations | 16.0 | View |
| Blood calcium decreased | SYSTEMATIC_ASSESSMENT | Investigations | 16.0 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| White blood cell count | SYSTEMATIC_ASSESSMENT | Investigations | 16.0 | View |
| Hypersensitivity | SYSTEMATIC_ASSESSMENT | Immune system disorders | 16.0 | View |
| Rhinitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | 16.0 | View |
| Vaginal infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | 16.0 | View |
| Alanine aminotransferase | SYSTEMATIC_ASSESSMENT | Investigations | 16.0 | View |
| Aspartate aminotransferase | SYSTEMATIC_ASSESSMENT | Investigations | 16.0 | View |
| Blood albumin decreased | SYSTEMATIC_ASSESSMENT | Investigations | 16.0 | View |
| Lacrimation increased | SYSTEMATIC_ASSESSMENT | Eye disorders | 16.0 | View |
| Abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 16.0 | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 16.0 | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 16.0 | View |
| Dyspepsia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 16.0 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 16.0 | View |
| Stomatitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 16.0 | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 16.0 | View |
| Chest pain | SYSTEMATIC_ASSESSMENT | General disorders | 16.0 | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | 16.0 | View |
| Localised oedema | SYSTEMATIC_ASSESSMENT | General disorders | 16.0 | View |
| Oedema peripheral | SYSTEMATIC_ASSESSMENT | General disorders | 16.0 | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | 16.0 | View |
| Blood alkaline phosphatase | SYSTEMATIC_ASSESSMENT | Investigations | 16.0 | View |
| Blood creatinine | SYSTEMATIC_ASSESSMENT | Investigations | 16.0 | View |
| Blood magnesium decreased | SYSTEMATIC_ASSESSMENT | Investigations | 16.0 | View |
| Blood potassium decreased | SYSTEMATIC_ASSESSMENT | Investigations | 16.0 | View |
| Blood potassium increased | SYSTEMATIC_ASSESSMENT | Investigations | 16.0 | View |
| Blood sodium decreased | SYSTEMATIC_ASSESSMENT | Investigations | 16.0 | View |
| Haemoglobin | SYSTEMATIC_ASSESSMENT | Investigations | 16.0 | View |
| Neutrophil count | SYSTEMATIC_ASSESSMENT | Investigations | 16.0 | View |
| Platelet count | SYSTEMATIC_ASSESSMENT | Investigations | 16.0 | View |
| Weight decreased | SYSTEMATIC_ASSESSMENT | Investigations | 16.0 | View |
| Decreased appetite | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | 16.0 | View |
| Dehydration | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | 16.0 | View |
| Hyperglycaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | 16.0 | View |
| Arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | 16.0 | View |
| Back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | 16.0 | View |
| Muscular weakness | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | 16.0 | View |
| Myalgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | 16.0 | View |
| Pain in extremity | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | 16.0 | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | 16.0 | View |
| Dysgeusia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | 16.0 | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | 16.0 | View |
| Peripheral sensory neuropathy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | 16.0 | View |
| Syncope | SYSTEMATIC_ASSESSMENT | Nervous system disorders | 16.0 | View |
| Anxiety | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | 16.0 | View |
| Depressed mood | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | 16.0 | View |
| Insomnia | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | 16.0 | View |
| Pollakiuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | 16.0 | View |
| Erectile dysfunction | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | 16.0 | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 16.0 | View |
| Dyspnoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 16.0 | View |
| Oropharyngeal pain | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 16.0 | View |
| Respiratory tract haemorrhage | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 16.0 | View |
| Alopecia | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | 16.0 | View |
| Dry skin | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | 16.0 | View |
| Exfoliative rash | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | 16.0 | View |
| Pruritus | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | 16.0 | View |
| Hypotension | SYSTEMATIC_ASSESSMENT | Vascular disorders | 16.0 | View |
| Lymphopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | 16.0 | View |
| Arrhythmia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | 16.0 | View |
| Dry eye | SYSTEMATIC_ASSESSMENT | Eye disorders | 16.0 | View |