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 @ 2:22 AM
Ignite Modification Date:
2025-12-26 @ 12:54 AM
NCT ID:
NCT02181634
Description:
None
Frequency Threshold:
5
Time Frame:
Assessed every week for the first 2 cycles, then every two cycles (every 8 weeks) and 30 days after the last dose of therapy
Study:
NCT02181634
Study Brief:
Phase II Trial of Nab-Paclitaxel and Gemcitabine for First-Line Treatment of Patients With Cholangiocarcinoma
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Nab-Paclitaxel and Gemcitabine | Nab-Paclitaxel 125 mg/m² IV and Gemcitabine 1000 mg/m² on days 1, 8 and 15 every 28 days until progression or unacceptable toxicity. Nab-Paclitaxel and Gemcitabine: Nab-Paclitaxel will be administered first, at a dose of 125 mg/m² IV over a period of 30 minutes; gemcitabine will be administered second, at a dose of 1000 mg/m² over a period of 30 minutes. | None | None | 42 | 74 | 72 | 74 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Anemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE (4.0) | View |
| Febrile neutropenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE (4.0) | View |
| Haemolytic uraemic syndrome | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE (4.0) | View |
| Neutropenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE (4.0) | View |
| Atrial fibrillation | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE (4.0) | View |
| Cardiac failure | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE (4.0) | View |
| Cardiac failure congestive | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE (4.0) | View |
| Pericardial effusion | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE (4.0) | View |
| Tachycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE (4.0) | View |
| Abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (4.0) | View |
| Ascites | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (4.0) | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (4.0) | View |
| Diarrhea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (4.0) | View |
| Gastrointestinal haemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (4.0) | View |
| Hypovolaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (4.0) | View |
| Facial nerve disorder | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (4.0) | View |
| Haemorrhage intracranial | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (4.0) | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (4.0) | View |
| Disease progression | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (4.0) | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (4.0) | View |
| Generalised oedema | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (4.0) | View |
| Multi-organ failure | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (4.0) | View |
| Oedema peripheral | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (4.0) | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (4.0) | View |
| Bile duct obstruction | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | CTCAE (4.0) | View |
| Bile duct stenosis | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | CTCAE (4.0) | View |
| Biliary fistula | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | CTCAE (4.0) | View |
| Hepatic encephalopathy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (4.0) | View |
| Syncope | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (4.0) | View |
| Acute kidney injury | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE (4.0) | View |
| Renal failure | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE (4.0) | View |
| Acute respiratory distress syndrome | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | View |
| Dyspnoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | View |
| Pneumonitis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | View |
| Pulmonary embolism | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | View |
| Respiratory failure | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | View |
| Rash macular | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (4.0) | View |
| Rash maculo-papular | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (4.0) | View |
| Deep vein thrombosis | SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE (4.0) | View |
| Embolism | SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE (4.0) | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE (4.0) | View |
| Hypotension | SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE (4.0) | View |
| Thrombosis | SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE (4.0) | View |
| Cholangitis | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | CTCAE (4.0) | View |
| Cholecystitis | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | CTCAE (4.0) | View |
| Cholestasis | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | CTCAE (4.0) | View |
| Hyperbilirubinaemia | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | CTCAE (4.0) | View |
| Abscess | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (4.0) | View |
| Biliary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (4.0) | View |
| Clostridium difficile infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (4.0) | View |
| Device related infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (4.0) | View |
| Diverticulitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (4.0) | View |
| Emphysematous cholecystitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (4.0) | View |
| Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (4.0) | View |
| Lung infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (4.0) | View |
| Neutropenic sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (4.0) | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (4.0) | View |
| Sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (4.0) | View |
| Humerus fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | CTCAE (4.0) | View |
| Post procedural haemorrhage | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | CTCAE (4.0) | View |
| Neutrophil count decreased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (4.0) | View |
| Hyponatraemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (4.0) | View |
| Encephalopathy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (4.0) | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (4.0) | View |
| Acute kidney injury | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE (4.0) | View |
| Alanine aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (4.0) | View |
| Alopecia | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (4.0) | View |
| Anemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE (4.0) | View |
| Arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | View |
| Ascites | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (4.0) | View |
| Aspartate aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (4.0) | View |
| Asthenia | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (4.0) | View |
| Back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | View |
| Blood alkaline phosphatase increased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (4.0) | View |
| Blood bilirubin increased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (4.0) | View |
| Bone pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (4.0) | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | View |
| Deep vein thrombosis | SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE (4.0) | View |
| Dehydration | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (4.0) | View |
| Diarrhea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (4.0) | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (4.0) | View |
| Dyspnea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | View |
| Hot flashes | SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE (4.0) | View |
| Hyperbilirubinemia | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (4.0) | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE (4.0) | View |
| Hypoalbuminemia | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (4.0) | View |
| Hypokalaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (4.0) | View |
| Hyponatremia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (4.0) | View |
| Influenza like illness | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (4.0) | View |
| Insomnia | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | CTCAE (4.0) | View |
| Leukopenia | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (4.0) | View |
| Mucosal inflammation | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (4.0) | View |
| Muscular weakness | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | View |
| Musculoskeletal pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | View |
| Myalgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | View |
| Nail discolouration | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (4.0) | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (4.0) | View |
| Neuropathy peripheral | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (4.0) | View |
| Pain | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (4.0) | View |
| Pain in extremity | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | View |
| Peripheral sensory neuropathy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (4.0) | View |
| Pruritus | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (4.0) | View |
| Rash | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (4.0) | View |
| Rash maculo-papular | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (4.0) | View |
| Tremor | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (4.0) | View |
| Vision blurred | SYSTEMATIC_ASSESSMENT | Eye disorders | CTCAE (4.0) | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (4.0) | View |
| Weight increased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (4.0) | View |
| White blood cell count decreased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (4.0) | View |
| Chills | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (4.0) | View |
| Decreased appetite | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (4.0) | View |
| Dry mouth | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (4.0) | View |
| Dysgeusia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (4.0) | View |
| Embolism | SYSTEMATIC_ASSESSMENT | Vascular disorders | CTCAE (4.0) | View |
| Epistaxis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (4.0) | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (4.0) | View |
| Hypocalcemia | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (4.0) | View |
| Neutropenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE (4.0) | View |
| Neutrophil count decreased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (4.0) | View |
| Oedema peripheral | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (4.0) | View |
| Platelet count decreased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (4.0) | View |
| Pleural effusion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (4.0) | View |
| Sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | CTCAE (4.0) | View |
| Stomatitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (4.0) | View |
| Thrombocytopenia | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (4.0) | View |
| Weight decreased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (4.0) | View |
| Abdominal distension | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (4.0) | View |