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 @ 3:55 AM
Ignite Modification Date:
2025-12-26 @ 2:45 AM
NCT ID:
NCT00936702
Description:
None
Frequency Threshold:
0
Time Frame:
Up to 3 years
Study:
NCT00936702
Study Brief:
Carboplatin, Paclitaxel, and Everolimus in Treating Patients With Previously Untreated Cancer of Unknown Primary
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Treatment (Carboplatin, Paclitaxel, and Everolimus) | Patients receive carboplatin IV over 30 minutes and paclitaxel IV over 3 hours on day 1. Patients also receive everolimus PO QD on days 1, 8, and 15. | None | None | 21 | 46 | 45 | 46 | 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 |
| Cardiac disorder | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAEV3.0 | View |
| Sinus tachycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAEV3.0 | View |
| Abdominal distension | SYSTEMATIC_ASSESSMENT | Gastrointestinal 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 |
| Dysphagia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAEV3.0 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAEV3.0 | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAEV3.0 | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | CTCAEV3.0 | View |
| Abdominal infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAEV3.0 | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAEV3.0 | View |
| Sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAEV3.0 | View |
| Upper respiratory infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAEV3.0 | View |
| Alkaline phosphatase increased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAEV3.0 | View |
| Leukocyte 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 |
| Anorexia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAEV3.0 | View |
| Dehydration | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAEV3.0 | View |
| Serum magnesium decreased | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAEV3.0 | View |
| Serum potassium decreased | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAEV3.0 | View |
| Serum sodium decreased | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAEV3.0 | View |
| Muscle weakness lower limb | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAEV3.0 | View |
| Dyspnea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAEV3.0 | View |
| Hypoxia | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAEV3.0 | View |
| Respiratory disorder | 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 |
| Extraocular muscle paresis | SYSTEMATIC_ASSESSMENT | Eye disorders | CTCAEV3.0 | View |
| Eye disorder | SYSTEMATIC_ASSESSMENT | Eye disorders | CTCAEV3.0 | View |
| Abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAEV3.0 | View |
| Ascites | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAEV3.0 | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAEV3.0 | View |
| Diarrhea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAEV3.0 | View |
| Dyspepsia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAEV3.0 | View |
| Ear, nose and throat examination abnormal | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAEV3.0 | View |
| Mucositis oral | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAEV3.0 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAEV3.0 | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal 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 |
| Pain | SYSTEMATIC_ASSESSMENT | General disorders | CTCAEV3.0 | View |
| Cytokine release syndrome | SYSTEMATIC_ASSESSMENT | Immune system disorders | CTCAEV3.0 | View |
| Hypersensitivity | SYSTEMATIC_ASSESSMENT | Immune system disorders | CTCAEV3.0 | View |
| Bladder infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAEV3.0 | View |
| Pharyngitis | 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 |
| Tooth 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 |
| Forced expiratory volume decreased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAEV3.0 | View |
| Leukocyte count decreased | 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 |
| Serum cholesterol increased | 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 calcium increased | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAEV3.0 | View |
| Serum magnesium decreased | 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 triglycerides increased | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAEV3.0 | View |
| Arthritis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue 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 |
| 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 |
| Pain in extremity | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAEV3.0 | View |
| Tumor pain | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAEV3.0 | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAEV3.0 | View |
| Neuralgia | 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 |
| Anxiety | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | CTCAEV3.0 | View |
| Confusion | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | CTCAEV3.0 | View |
| Insomnia | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | CTCAEV3.0 | View |
| Glomerular filtration rate decreased | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAEV3.0 | View |
| Erectile dysfunction | SYSTEMATIC_ASSESSMENT | Reproductive system and breast 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 |
| Pneumonitis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAEV3.0 | View |
| Alopecia | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAEV3.0 | View |
| Decubitus ulcer | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAEV3.0 | View |
| Dry skin | 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 |
| Hypotension | SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAEV3.0 | View |
| Thrombosis | SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAEV3.0 | View |