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 @ 3:22 AM
Ignite Modification Date:
2025-12-26 @ 2:00 AM
NCT ID:
NCT01698905
Description:
Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
Frequency Threshold:
5
Time Frame:
Adverse events were collected from first dose of study treatment until 30 days after the last dose of study treatment or the last day in the TFR/TFR-2 phase for approx. 35 months.
Study:
NCT01698905
Study Brief:
Treatment-free Remission After Achieving Sustained MR4.5 on Nilotinib (ENESTop)
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| All Patients | All patients enrolled in the study | 1 | None | 34 | 163 | 122 | 163 | View |
| TFR-2 Phase | treatment-free remission 2 | 0 | None | 0 | 2 | 0 | 2 | View |
| NTRI-2 Phase | nilotinib treatment re-initiation 2 | 0 | None | 0 | 1 | 0 | 1 | View |
| NTCT-P Phase | nilotinib treatment prolonged continuation | 0 | None | 0 | 6 | 2 | 6 | View |
| NTCS Phase | Patients with minimum 3 years of tyrosine kinase inhibitor treatment (first with imatinib and then switched to nilotinib) since initial diagnosis, at least 2 years of nilotinib treatment prior to study entry and who achieved MR4.5 (local laboratory assessment) during nilotinib treatment, and determined by a Novartis designated central PCR lab assessment at screening | 1 | None | 21 | 163 | 80 | 163 | View |
| TFR Phase | treatment-free remission | 0 | None | 8 | 126 | 70 | 126 | View |
| NTRI Phase | nilotinib treatment re-initiation | 0 | None | 4 | 51 | 29 | 51 | View |
| NTCT Phase | nilotinib treatment continuation | 0 | None | 3 | 26 | 11 | 26 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| ACUTE MYOCARDIAL INFARCTION | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (18.1) | View |
| ARRHYTHMIA | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (18.1) | View |
| ATRIAL FIBRILLATION | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (18.1) | View |
| ATRIOVENTRICULAR BLOCK | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (18.1) | View |
| CARDIAC FAILURE CONGESTIVE | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (18.1) | View |
| CORONARY ARTERY DISEASE | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (18.1) | View |
| SINUS TACHYCARDIA | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (18.1) | View |
| CONSTIPATION | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (18.1) | View |
| DIARRHOEA | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (18.1) | View |
| INTESTINAL OBSTRUCTION | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (18.1) | View |
| NECROSIS | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (18.1) | View |
| CELLULITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (18.1) | View |
| DIVERTICULITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (18.1) | View |
| GASTROENTERITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (18.1) | View |
| INFLUENZA | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (18.1) | View |
| PNEUMONIA | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (18.1) | View |
| POST PROCEDURAL INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (18.1) | View |
| LIGAMENT SPRAIN | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (18.1) | View |
| HAEMATOLOGY TEST ABNORMAL | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (18.1) | View |
| TRANSAMINASES INCREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (18.1) | View |
| TYPE 2 DIABETES MELLITUS | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (18.1) | View |
| BACK PAIN | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (18.1) | View |
| MUSCLE SPASMS | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (18.1) | View |
| PAIN IN EXTREMITY | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (18.1) | View |
| ADENOCARCINOMA | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.1) | View |
| LUNG ADENOCARCINOMA | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.1) | View |
| LYMPHOPROLIFERATIVE DISORDER | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.1) | View |
| PROSTATE CANCER | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.1) | View |
| URETERIC CANCER | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.1) | View |
| CARPAL TUNNEL SYNDROME | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (18.1) | View |
| CEREBRAL INFARCTION | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (18.1) | View |
| CEREBROVASCULAR ACCIDENT | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (18.1) | View |
| ISCHAEMIC STROKE | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (18.1) | View |
| RENAL FAILURE | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (18.1) | View |
| METRORRHAGIA | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA (18.1) | View |
| ASTHMA | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (18.1) | View |
| DYSPNOEA EXERTIONAL | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (18.1) | View |
| PLEURAL FIBROSIS | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (18.1) | View |
| ARTERIAL HAEMORRHAGE | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (18.1) | View |
| PERIPHERAL ARTERIAL OCCLUSIVE DISEASE | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (18.1) | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| ANAEMIA | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (18.1) | View |
| ABDOMINAL PAIN | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (18.1) | View |
| ABDOMINAL PAIN LOWER | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (18.1) | View |
| ABDOMINAL PAIN UPPER | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (18.1) | View |
| CONSTIPATION | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (18.1) | View |
| DIARRHOEA | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (18.1) | View |
| NAUSEA | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (18.1) | View |
| FATIGUE | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (18.1) | View |
| WEIGHT INCREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (18.1) | View |
| ARTHRALGIA | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (18.1) | View |
| MUSCLE SPASMS | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (18.1) | View |
| MUSCULOSKELETAL PAIN | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (18.1) | View |
| MYALGIA | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (18.1) | View |
| HEADACHE | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (18.1) | View |
| OROPHARYNGEAL PAIN | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (18.1) | View |
| RASH | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (18.1) | View |
| HYPERTENSION | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (18.1) | View |
| NASOPHARYNGITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (18.1) | View |
| UPPER RESPIRATORY TRACT INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (18.1) | View |
| DECREASED APPETITE | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (18.1) | View |
| HYPERTRIGLYCERIDAEMIA | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (18.1) | View |
| PAIN IN EXTREMITY | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (18.1) | View |