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 @ 2:18 AM
Ignite Modification Date:
2025-12-26 @ 12:49 AM
NCT ID:
NCT01379534
Description:
None
Frequency Threshold:
5
Time Frame:
None
Study:
NCT01379534
Study Brief:
A Phase II Study to Evaluate the Efficacy of TKI258 for the Treatment of Patients With FGFR2 Mutated or Wild-type Advanced and/or Metastatic Endometrial 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 |
|---|---|---|---|---|---|---|---|---|
| FGFR2 (MUT) | Participants were classified into two groups based on mutational status of FGFR2 and all participants were treated with 500 mg of TKI258on a 5 day on / 2 days off dosing regimen for 13 weeks. | None | None | 10 | 22 | 21 | 22 | View |
| FGFR2 (WT) | Participants were classified into two groups based on mutational status of FGFR2 and all participants were treated with 500 mg of TKI258on a 5 day on / 2 days off dosing regimen for 13 weeks. | None | None | 20 | 31 | 31 | 31 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| ANAEMIA | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | 17.0 | View |
| PANCYTOPENIA | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | 17.0 | View |
| CARDIAC ARREST | SYSTEMATIC_ASSESSMENT | Cardiac disorders | 17.0 | View |
| GASTROINTESTINAL ARTERIOVENOUS MALFORMATION | SYSTEMATIC_ASSESSMENT | Congenital, familial and genetic disorders | 17.0 | View |
| ABDOMINAL PAIN | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 17.0 | View |
| ABDOMINAL PAIN UPPER | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 17.0 | View |
| COLITIS ISCHAEMIC | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 17.0 | View |
| DIARRHOEA | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 17.0 | View |
| DYSPHAGIA | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 17.0 | View |
| LOWER GASTROINTESTINAL HAEMORRHAGE | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 17.0 | View |
| NAUSEA | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 17.0 | View |
| PANCREATIC DUCT DILATATION | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 17.0 | View |
| SMALL INTESTINAL OBSTRUCTION | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 17.0 | View |
| PERIPHERAL SENSORY NEUROPATHY | SYSTEMATIC_ASSESSMENT | Nervous system disorders | 17.0 | View |
| SPINAL CORD COMPRESSION | SYSTEMATIC_ASSESSMENT | Nervous system disorders | 17.0 | View |
| SYNCOPE | SYSTEMATIC_ASSESSMENT | Nervous system disorders | 17.0 | View |
| VOMITING | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 17.0 | View |
| FATIGUE | SYSTEMATIC_ASSESSMENT | General disorders | 17.0 | View |
| LOCALISED OEDEMA | SYSTEMATIC_ASSESSMENT | General disorders | 17.0 | View |
| MALAISE | SYSTEMATIC_ASSESSMENT | General disorders | 17.0 | View |
| OEDEMA PERIPHERAL | SYSTEMATIC_ASSESSMENT | General disorders | 17.0 | View |
| PYREXIA | SYSTEMATIC_ASSESSMENT | General disorders | 17.0 | View |
| HEPATITIS TOXIC | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | 17.0 | View |
| JAUNDICE | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | 17.0 | View |
| SEPSIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | 17.0 | View |
| URINARY TRACT INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | 17.0 | View |
| UROSEPSIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | 17.0 | View |
| GASTROENTERITIS RADIATION | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | 17.0 | View |
| ALANINE AMINOTRANSFERASE INCREASED | SYSTEMATIC_ASSESSMENT | Investigations | 17.0 | View |
| ASPARTATE AMINOTRANSFERASE INCREASED | SYSTEMATIC_ASSESSMENT | Investigations | 17.0 | View |
| BLOOD BILIRUBIN INCREASED | SYSTEMATIC_ASSESSMENT | Investigations | 17.0 | View |
| PLATELET COUNT DECREASED | SYSTEMATIC_ASSESSMENT | Investigations | 17.0 | View |
| TRANSAMINASES INCREASED | SYSTEMATIC_ASSESSMENT | Investigations | 17.0 | View |
| DECREASED APPETITE | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | 17.0 | View |
| DEHYDRATION | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | 17.0 | View |
| HYPOKALAEMIA | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | 17.0 | View |
| HYPONATRAEMIA | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | 17.0 | View |
| HYPOVOLAEMIA | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | 17.0 | View |
| GROIN PAIN | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | 17.0 | View |
| PAIN IN EXTREMITY | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | 17.0 | View |
| CEREBROVASCULAR ACCIDENT | SYSTEMATIC_ASSESSMENT | Nervous system disorders | 17.0 | View |
| HEADACHE | SYSTEMATIC_ASSESSMENT | Nervous system disorders | 17.0 | View |
| TRANSIENT ISCHAEMIC ATTACK | SYSTEMATIC_ASSESSMENT | Nervous system disorders | 17.0 | View |
| HYDRONEPHROSIS | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | 17.0 | View |
| RENAL FAILURE | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | 17.0 | View |
| RENAL FAILURE ACUTE | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | 17.0 | View |
| URINARY TRACT OBSTRUCTION | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | 17.0 | View |
| UROGENITAL FISTULA | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | 17.0 | View |
| FEMALE GENITAL TRACT FISTULA | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | 17.0 | View |
| VAGINAL HAEMORRHAGE | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | 17.0 | View |
| LUNG INFILTRATION | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 17.0 | View |
| PLEURAL EFFUSION | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 17.0 | View |
| PNEUMONIA ASPIRATION | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 17.0 | View |
| PULMONARY EMBOLISM | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 17.0 | View |
| RESPIRATORY FAILURE | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 17.0 | View |
| ERYTHEMA MULTIFORME | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | 17.0 | View |
| DEEP VEIN THROMBOSIS | SYSTEMATIC_ASSESSMENT | Vascular disorders | 17.0 | View |
| EMBOLISM | SYSTEMATIC_ASSESSMENT | Vascular disorders | 17.0 | View |
| HYPERTENSION | SYSTEMATIC_ASSESSMENT | Vascular disorders | 17.0 | View |
| HYPOTENSION | SYSTEMATIC_ASSESSMENT | Vascular disorders | 17.0 | View |
| ORTHOSTATIC HYPOTENSION | SYSTEMATIC_ASSESSMENT | Vascular disorders | 17.0 | View |
| PELVIC VENOUS THROMBOSIS | SYSTEMATIC_ASSESSMENT | Vascular disorders | 17.0 | View |
| PERIPHERAL ISCHAEMIA | SYSTEMATIC_ASSESSMENT | Vascular disorders | 17.0 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| ANAEMIA | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | 17.0 | View |
| LEUKOPENIA | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | 17.0 | View |
| LYMPHOPENIA | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | 17.0 | View |
| NEUTROPENIA | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | 17.0 | View |
| THROMBOCYTOPENIA | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | 17.0 | View |
| TINNITUS | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | 17.0 | View |
| DRY EYE | SYSTEMATIC_ASSESSMENT | Eye disorders | 17.0 | View |
| EYE DISCHARGE | SYSTEMATIC_ASSESSMENT | Eye disorders | 17.0 | View |
| OCULAR HYPERAEMIA | SYSTEMATIC_ASSESSMENT | Eye disorders | 17.0 | View |
| VISION BLURRED | SYSTEMATIC_ASSESSMENT | Eye disorders | 17.0 | View |
| ABDOMINAL PAIN | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 17.0 | View |
| ABDOMINAL PAIN LOWER | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 17.0 | View |
| ABDOMINAL PAIN UPPER | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 17.0 | View |
| CONSTIPATION | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 17.0 | View |
| DIARRHOEA | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 17.0 | View |
| DRY MOUTH | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 17.0 | View |
| DYSPEPSIA | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 17.0 | View |
| FLATULENCE | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 17.0 | View |
| GASTROOESOPHAGEAL REFLUX DISEASE | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 17.0 | View |
| NAUSEA | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 17.0 | View |
| STOMATITIS | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 17.0 | View |
| VOMITING | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 17.0 | View |
| ASTHENIA | SYSTEMATIC_ASSESSMENT | General disorders | 17.0 | View |
| FATIGUE | SYSTEMATIC_ASSESSMENT | General disorders | 17.0 | View |
| LOCAL SWELLING | SYSTEMATIC_ASSESSMENT | General disorders | 17.0 | View |
| OEDEMA PERIPHERAL | SYSTEMATIC_ASSESSMENT | General disorders | 17.0 | View |
| PAIN | SYSTEMATIC_ASSESSMENT | General disorders | 17.0 | View |
| UPPER RESPIRATORY TRACT INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | 17.0 | View |
| URINARY TRACT INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | 17.0 | View |
| CONTUSION | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | 17.0 | View |
| FALL | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | 17.0 | View |
| ALANINE AMINOTRANSFERASE INCREASED | SYSTEMATIC_ASSESSMENT | Investigations | 17.0 | View |
| AMYLASE INCREASED | SYSTEMATIC_ASSESSMENT | Investigations | 17.0 | View |
| ASPARTATE AMINOTRANSFERASE INCREASED | SYSTEMATIC_ASSESSMENT | Investigations | 17.0 | View |
| BLOOD ALKALINE PHOSPHATASE INCREASED | SYSTEMATIC_ASSESSMENT | Investigations | 17.0 | View |
| BLOOD BILIRUBIN INCREASED | SYSTEMATIC_ASSESSMENT | Investigations | 17.0 | View |
| BLOOD CHOLESTEROL INCREASED | SYSTEMATIC_ASSESSMENT | Investigations | 17.0 | View |
| BLOOD CREATININE INCREASED | SYSTEMATIC_ASSESSMENT | Investigations | 17.0 | View |
| GAMMA-GLUTAMYLTRANSFERASE INCREASED | SYSTEMATIC_ASSESSMENT | Investigations | 17.0 | View |
| LIPASE INCREASED | SYSTEMATIC_ASSESSMENT | Investigations | 17.0 | View |
| LYMPHOCYTE COUNT DECREASED | SYSTEMATIC_ASSESSMENT | Investigations | 17.0 | View |
| PLATELET COUNT DECREASED | SYSTEMATIC_ASSESSMENT | Investigations | 17.0 | View |
| WEIGHT DECREASED | SYSTEMATIC_ASSESSMENT | Investigations | 17.0 | View |
| DECREASED APPETITE | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | 17.0 | View |
| DEHYDRATION | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | 17.0 | View |
| HYPERCHOLESTEROLAEMIA | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | 17.0 | View |
| HYPERGLYCAEMIA | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | 17.0 | View |
| HYPERTRIGLYCERIDAEMIA | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | 17.0 | View |
| HYPOALBUMINAEMIA | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | 17.0 | View |
| HYPOCALCAEMIA | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | 17.0 | View |
| HYPOMAGNESAEMIA | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | 17.0 | View |
| HYPONATRAEMIA | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | 17.0 | View |
| ARTHRALGIA | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | 17.0 | View |
| BACK PAIN | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | 17.0 | View |
| BONE PAIN | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | 17.0 | View |
| MUSCLE SPASMS | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | 17.0 | View |
| MUSCULAR WEAKNESS | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | 17.0 | View |
| MUSCULOSKELETAL PAIN | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | 17.0 | View |
| MYALGIA | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | 17.0 | View |
| PAIN IN EXTREMITY | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | 17.0 | View |
| DIZZINESS | SYSTEMATIC_ASSESSMENT | Nervous system disorders | 17.0 | View |
| DYSGEUSIA | SYSTEMATIC_ASSESSMENT | Nervous system disorders | 17.0 | View |
| HEADACHE | SYSTEMATIC_ASSESSMENT | Nervous system disorders | 17.0 | View |
| PARAESTHESIA | SYSTEMATIC_ASSESSMENT | Nervous system disorders | 17.0 | View |
| SOMNOLENCE | SYSTEMATIC_ASSESSMENT | Nervous system disorders | 17.0 | View |
| ANXIETY | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | 17.0 | View |
| INSOMNIA | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | 17.0 | View |
| DYSURIA | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | 17.0 | View |
| PROTEINURIA | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | 17.0 | View |
| VAGINAL DISCHARGE | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | 17.0 | View |
| VAGINAL HAEMORRHAGE | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | 17.0 | View |
| COUGH | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 17.0 | View |
| DYSPNOEA | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 17.0 | View |
| EPISTAXIS | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 17.0 | View |
| OROPHARYNGEAL PAIN | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 17.0 | View |
| PLEURITIC PAIN | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 17.0 | View |
| DERMATITIS ACNEIFORM | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | 17.0 | View |
| PALMAR-PLANTAR ERYTHRODYSAESTHESIA SYNDROME | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | 17.0 | View |
| PRURITUS | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | 17.0 | View |
| RASH | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | 17.0 | View |
| RASH MACULO-PAPULAR | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | 17.0 | View |
| DEEP VEIN THROMBOSIS | SYSTEMATIC_ASSESSMENT | Vascular disorders | 17.0 | View |
| EMBOLISM | SYSTEMATIC_ASSESSMENT | Vascular disorders | 17.0 | View |
| HYPERTENSION | SYSTEMATIC_ASSESSMENT | Vascular disorders | 17.0 | View |
| HYPOTENSION | SYSTEMATIC_ASSESSMENT | Vascular disorders | 17.0 | View |