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 @ 12:57 AM
Ignite Modification Date:
2025-12-25 @ 11:12 PM
NCT ID:
NCT02033993
Description:
The CTC version 4.0
Frequency Threshold:
5
Time Frame:
42 months
Study:
NCT02033993
Study Brief:
Nab-Paclitaxel to Paclitaxel in Advanced Urothelial Cancer Progressing on or After Platinum Containing Regimen.
Event Groups(If Any):
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Febrile neutropenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | The CTC version 4.0 | View |
| Myocardial infarction | SYSTEMATIC_ASSESSMENT | Cardiac disorders | The CTC version 4.0 | View |
| Sinus tachycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | The CTC version 4.0 | View |
| Abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | The CTC version 4.0 | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | The CTC version 4.0 | View |
| Gastric perforation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | The CTC version 4.0 | View |
| Typhlitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | The CTC version 4.0 | View |
| Death NOS | SYSTEMATIC_ASSESSMENT | General disorders | The CTC version 4.0 | View |
| Edema limbs | SYSTEMATIC_ASSESSMENT | General disorders | The CTC version 4.0 | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | The CTC version 4.0 | View |
| Fever | SYSTEMATIC_ASSESSMENT | General disorders | The CTC version 4.0 | View |
| Pain | SYSTEMATIC_ASSESSMENT | General disorders | The CTC version 4.0 | View |
| Allergic reaction | SYSTEMATIC_ASSESSMENT | Immune system disorders | The CTC version 4.0 | View |
| Anaphylaxis | SYSTEMATIC_ASSESSMENT | Immune system disorders | The CTC version 4.0 | View |
| Device related infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | The CTC version 4.0 | View |
| Kidney infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | The CTC version 4.0 | View |
| Lung infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | The CTC version 4.0 | View |
| Sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | The CTC version 4.0 | View |
| Skin infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | The CTC version 4.0 | View |
| Urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | The CTC version 4.0 | View |
| Fall | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | The CTC version 4.0 | View |
| Blood bilirubin increased | SYSTEMATIC_ASSESSMENT | Investigations | The CTC version 4.0 | View |
| Dehydration | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | The CTC version 4.0 | View |
| Hypercalcemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | The CTC version 4.0 | View |
| Muscle weakness lower limb | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | The CTC version 4.0 | View |
| Muscle weakness right-sided | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | The CTC version 4.0 | View |
| Other nervous system disorders | SYSTEMATIC_ASSESSMENT | Nervous system disorders | The CTC version 4.0 | View |
| Peripheral motor neuropathy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | The CTC version 4.0 | View |
| Confusion | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | The CTC version 4.0 | View |
| Acute kidney injury | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | The CTC version 4.0 | View |
| Hematuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | The CTC version 4.0 | View |
| Other renal and urinary disorders | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | The CTC version 4.0 | View |
| Urinary tract obstruction | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | The CTC version 4.0 | View |
| Dyspnea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | The CTC version 4.0 | View |
| Hypoxia | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | The CTC version 4.0 | View |
| Pleural effusion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | The CTC version 4.0 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Febrile neutropenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | The CTC version 4.0 | View |
| Hearing impaired | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | The CTC version 4.0 | View |
| Tinnitus | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | The CTC version 4.0 | View |
| Blurred vision | SYSTEMATIC_ASSESSMENT | Eye disorders | The CTC version 4.0 | View |
| Abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | The CTC version 4.0 | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | The CTC version 4.0 | View |
| Diarrhea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | The CTC version 4.0 | View |
| Dyspepsia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | The CTC version 4.0 | View |
| Gastroesophageal reflux disease | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | The CTC version 4.0 | View |
| Mucositis oral | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | The CTC version 4.0 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | The CTC version 4.0 | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | The CTC version 4.0 | View |
| Chills | SYSTEMATIC_ASSESSMENT | General disorders | The CTC version 4.0 | View |
| Edema limbs | SYSTEMATIC_ASSESSMENT | General disorders | The CTC version 4.0 | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | The CTC version 4.0 | View |
| Fever | SYSTEMATIC_ASSESSMENT | General disorders | The CTC version 4.0 | View |
| Flu like symptoms | SYSTEMATIC_ASSESSMENT | General disorders | The CTC version 4.0 | View |
| Non-cardiac chest pain | SYSTEMATIC_ASSESSMENT | General disorders | The CTC version 4.0 | View |
| Pain | SYSTEMATIC_ASSESSMENT | General disorders | The CTC version 4.0 | View |
| Upper respiratory infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | The CTC version 4.0 | View |
| Urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | The CTC version 4.0 | View |
| Weight loss | SYSTEMATIC_ASSESSMENT | Investigations | The CTC version 4.0 | View |
| Anorexia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | The CTC version 4.0 | View |
| Dehydration | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | The CTC version 4.0 | View |
| Hypomagnesemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | The CTC version 4.0 | View |
| Arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | The CTC version 4.0 | View |
| Back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | The CTC version 4.0 | View |
| Bone pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | The CTC version 4.0 | View |
| Flank pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | The CTC version 4.0 | View |
| Generalized muscle weakness | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | The CTC version 4.0 | View |
| Muscle weakness lower limb | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | The CTC version 4.0 | View |
| Myalgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | The CTC version 4.0 | View |
| Neck pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | The CTC version 4.0 | View |
| Other musculoskeletal and connective tissue disorder | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | The CTC version 4.0 | View |
| Pain in extremity | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | The CTC version 4.0 | View |
| Tumor pain | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | The CTC version 4.0 | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | The CTC version 4.0 | View |
| Dysgeusia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | The CTC version 4.0 | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | The CTC version 4.0 | View |
| Paresthesia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | The CTC version 4.0 | View |
| Peripheral motor neuropathy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | The CTC version 4.0 | View |
| Peripheral sensory neuropathy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | The CTC version 4.0 | View |
| Anxiety | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | The CTC version 4.0 | View |
| Depression | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | The CTC version 4.0 | View |
| Insomnia | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | The CTC version 4.0 | View |
| Hematuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | The CTC version 4.0 | View |
| Other renal and urinary disorders | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | The CTC version 4.0 | View |
| Urinary frequency | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | The CTC version 4.0 | View |
| Urinary incontinence | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | The CTC version 4.0 | View |
| Urinary tract obstruction | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | The CTC version 4.0 | View |
| Urinary tract pain | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | The CTC version 4.0 | View |
| Pelvic pain | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | The CTC version 4.0 | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | The CTC version 4.0 | View |
| Dyspnea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | The CTC version 4.0 | View |
| Pleural effusion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | The CTC version 4.0 | View |
| Alopecia | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | The CTC version 4.0 | View |
| Dry skin | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | The CTC version 4.0 | View |
| Other skin and subcutaneous tissue disorders | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | The CTC version 4.0 | View |
| Pruritus | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | The CTC version 4.0 | View |
| Rash acneiform | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | The CTC version 4.0 | View |
| Rash maculo-papular | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | The CTC version 4.0 | View |
| Hot flashes | SYSTEMATIC_ASSESSMENT | Vascular disorders | The CTC version 4.0 | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | The CTC version 4.0 | View |
| Hypotension | SYSTEMATIC_ASSESSMENT | Vascular disorders | The CTC version 4.0 | View |
| Thromboembolic event | SYSTEMATIC_ASSESSMENT | Vascular disorders | The CTC version 4.0 | View |