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 @ 3:28 AM
Ignite Modification Date:
2025-12-26 @ 2:09 AM
NCT ID:
NCT01650805
Description:
None
Frequency Threshold:
5
Time Frame:
Patients were followed-up for AEs from the time of informed consent until 30 days after the close of the trial. The median follow-up was 4.97 months (range: 0.03, 17.57) for ponatinib patients, and 5.32 months (range: 0.49, 14.05) for imatinib patients.
Study:
NCT01650805
Study Brief:
Ponatinib in Newly Diagnosed Chronic Myeloid Leukemia (CML) (EPIC)
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Ponatinib 45 mg | ponatinib: 45 mg tablet, taken orally once daily | None | None | 49 | 154 | 145 | 154 | View |
| Imatinib 400 mg | imatinib (Gleevec/ Glivec): 400 mg tablet, taken orally once daily | None | None | 13 | 152 | 144 | 152 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| ACUTE MYOCARDIAL INFARCTION | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 16.0 | View |
| ANGINA PECTORIS | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 16.0 | View |
| ATRIAL FIBRILLATION | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 16.0 | View |
| CARDIAC ARREST | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 16.0 | View |
| CARDIAC FAILURE | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 16.0 | View |
| CORONARY ARTERY DISEASE | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 16.0 | View |
| MYOPERICARDITIS | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 16.0 | View |
| PERICARDIAL EFFUSION | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 16.0 | View |
| VERTIGO POSITIONAL | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA 16.0 | View |
| EYE PAIN | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 16.0 | View |
| PHOTOPHOBIA | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 16.0 | View |
| ABDOMINAL PAIN | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 16.0 | View |
| NAUSEA | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 16.0 | View |
| PANCREATITIS | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 16.0 | View |
| SMALL INTESTINAL OBSTRUCTION | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 16.0 | View |
| VOMITING | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 16.0 | View |
| NON-CARDIAC CHEST PAIN | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 16.0 | View |
| OEDEMA PERIPHERAL | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 16.0 | View |
| PYREXIA | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 16.0 | View |
| SYSTEMIC INFLAMMATORY RESPONSE SYNDROME | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 16.0 | View |
| CHOLECYSTITIS | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 16.0 | View |
| HEPATITIS | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 16.0 | View |
| BACTERIAL PYELONEPHRITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 16.0 | View |
| CERVICITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 16.0 | View |
| DISSEMINATED TUBERCULOSIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 16.0 | View |
| DIVERTICULITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 16.0 | View |
| HEPATITIS B | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 16.0 | View |
| HERPES ZOSTER | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 16.0 | View |
| LUNG INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 16.0 | View |
| PARAINFLUENZAE VIRUS INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 16.0 | View |
| PARASPINAL ABSCESS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 16.0 | View |
| PERICOLIC ABSCESS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 16.0 | View |
| PNEUMONIA | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 16.0 | View |
| PYELONEPHRITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 16.0 | View |
| RESPIRATORY TRACT INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 16.0 | View |
| SEPSIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 16.0 | View |
| VESTIBULAR NEURONITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 16.0 | View |
| VIRAL UPPER RESPIRATORY TRACT INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 16.0 | View |
| COMPRESSION FRACTURE | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 16.0 | View |
| SPLENIC RUPTURE | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 16.0 | View |
| ALANINE AMINOTRANSFERASE INCREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 16.0 | View |
| AMYLASE INCREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 16.0 | View |
| C-REACTIVE PROTEIN INCREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 16.0 | View |
| PLATELET COUNT DECREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 16.0 | View |
| DECREASED APPETITE | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 16.0 | View |
| FAILURE TO THRIVE | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 16.0 | View |
| HYPONATRAEMIA | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 16.0 | View |
| BACK PAIN | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | View |
| BONE PAIN | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | View |
| MUSCULOSKELETAL CHEST PAIN | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | View |
| NECK PAIN | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | View |
| POLYARTHRITIS | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | View |
| SACROILIITIS | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | View |
| ANGIOMYOLIPOMA | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | View |
| BLAST CRISIS IN MYELOGENOUS LEUKAEMIA | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | View |
| CHLOROMA | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | View |
| CEREBROVASCULAR ACCIDENT | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 16.0 | View |
| DYSARTHRIA | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 16.0 | View |
| HEADACHE | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 16.0 | View |
| HYPOXIC-ISCHAEMIC ENCEPHALOPATHY | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 16.0 | View |
| LOSS OF CONSCIOUSNESS | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 16.0 | View |
| POLYNEUROPATHY | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 16.0 | View |
| PRESYNCOPE | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 16.0 | View |
| RADICULITIS CERVICAL | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 16.0 | View |
| TRANSIENT ISCHAEMIC ATTACK | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 16.0 | View |
| DYSPNOEA | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | View |
| PLEURAL EFFUSION | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | View |
| PULMONARY OEDEMA | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | View |
| RESPIRATORY FAILURE | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | View |
| HYPERTENSION | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 16.0 | View |
| PERIPHERAL ARTERIAL OCCLUSIVE DISEASE | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 16.0 | View |
| PERIPHERAL ARTERY THROMBOSIS | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 16.0 | View |
| RETINAL VEIN THROMBOSIS | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 16.0 | View |
| PERIORBITAL CONTUSION | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 16.0 | View |
| CLEAR CELL RENAL CELL CARCINOMA | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | View |
| BENIGN PROSTATIC HYPERPLASIA | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA 16.0 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| ANAEMIA | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 16.0 | View |
| DRY EYE | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 16.0 | View |
| EYELID OEDEMA | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 16.0 | View |
| PERIORBITAL OEDEMA | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 16.0 | View |
| ABDOMINAL DISCOMFORT | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 16.0 | View |
| ABDOMINAL PAIN | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 16.0 | View |
| CONSTIPATION | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 16.0 | View |
| DIARRHOEA | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 16.0 | View |
| DRY MOUTH | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 16.0 | View |
| DYSPEPSIA | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 16.0 | View |
| NAUSEA | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 16.0 | View |
| VOMITING | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 16.0 | View |
| ASTHENIA | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 16.0 | View |
| CHILLS | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 16.0 | View |
| FATIGUE | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 16.0 | View |
| OEDEMA PERIPHERAL | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 16.0 | View |
| PAIN | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 16.0 | View |
| PYREXIA | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 16.0 | View |
| UPPER RESPIRATORY TRACT INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 16.0 | View |
| ALANINE AMINOTRANSFERASE INCREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 16.0 | View |
| AMYLASE INCREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 16.0 | View |
| ASPARTATE AMINOTRANSFERASE INCREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 16.0 | View |
| BLOOD ALKALINE PHOSPHATASE INCREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 16.0 | View |
| LIPASE INCREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 16.0 | View |
| NEUTROPHIL COUNT DECREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 16.0 | View |
| PLATELET COUNT DECREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 16.0 | View |
| WEIGHT DECREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 16.0 | View |
| WHITE BLOOD CELL COUNT DECREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 16.0 | View |
| DECREASED APPETITE | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 16.0 | View |
| HYPERTRIGLYCERIDAEMIA | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 16.0 | View |
| ARTHRALGIA | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | View |
| BACK PAIN | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | View |
| BONE PAIN | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | View |
| MUSCLE SPASMS | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | View |
| MUSCULOSKELETAL PAIN | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | View |
| MYALGIA | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | View |
| PAIN IN EXTREMITY | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | View |
| DIZZINESS | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 16.0 | View |
| HEADACHE | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 16.0 | View |
| LETHARGY | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 16.0 | View |
| ANXIETY | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 16.0 | View |
| DEPRESSION | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 16.0 | View |
| INSOMNIA | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 16.0 | View |
| COUGH | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | View |
| DYSPNOEA | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | View |
| OROPHARYNGEAL PAIN | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | View |
| ALOPECIA | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 16.0 | View |
| DRY SKIN | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 16.0 | View |
| ERYTHEMA | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 16.0 | View |
| PRURITUS | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 16.0 | View |
| RASH | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 16.0 | View |
| RASH PRURITIC | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 16.0 | View |
| HYPERTENSION | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 16.0 | View |
| NIGHT SWEATS | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 16.0 | View |