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:
2025-12-24 @ 5:35 PM
Ignite Modification Date:
2025-12-25 @ 3:07 PM
NCT ID:
NCT01784068
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. 26 months.
Study:
NCT01784068
Study Brief:
Nilotinib Treatment-free Remission Study in CML (Chronic Myeloid Leukemia) Patients
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| NTCS Phase | Patients who received a minimum of two years of first line nilotinib treatment and with BCR-ABL1 transcript level of MR4.5 entered consolidation phase of the study (52 weeks of nilotinib 300 mg BID) | 2 | None | 20 | 215 | 136 | 215 | View |
| TFR Phase | Patients with Minimal Residual Disease (MRD) at the end of consolidation phase entered the Treatment-Free Remission (TFR) phase where no treatment was given | 1 | None | 15 | 190 | 91 | 190 | View |
| NTRI Phase | If at any time during TFR phase the patient lost MMR, nilotinib treatment was to be immediately re-initiated (nilotinib 300 mg BID) | 2 | None | 11 | 86 | 49 | 86 | View |
| NTCT Phase | Patients with no MRD at the end of consolidation phase entered the continuation phase of the study and continue with nilotinib 300 mg BID | 0 | None | 1 | 13 | 10 | 13 | View |
| TFR-2 Phase | Patients with MRD at the end of the continuation phase entered the TFR-2 phase of the study where no treatment was given | 0 | None | 0 | 8 | 1 | 8 | View |
| NTRI-2 Phase | If at any time during TFR phase or TFR-2 phase the patient lost MMR, nilotinib treatment was to be immediately re-initiated (nilotinib 300 mg BID) | 0 | None | 0 | 0 | 0 | 0 | View |
| NTCT-P Phase | Patients with no MRD at the end of continuation phase entered the prolonged continuation phase of the study | 0 | None | 0 | 2 | 0 | 2 | View |
| All Patients | All patients enrolled in the study | 5 | None | 40 | 215 | 171 | 215 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| ACUTE MYOCARDIAL INFARCTION | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (18.1) | View |
| ANGINA PECTORIS | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (18.1) | View |
| CARDIAC ARREST | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (18.1) | View |
| CARDIAC FAILURE CONGESTIVE | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (18.1) | View |
| ABDOMINAL PAIN | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (18.1) | View |
| ABDOMINAL PAIN UPPER | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (18.1) | View |
| ASCITES | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (18.1) | View |
| GASTRIC ULCER | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (18.1) | View |
| HAEMORRHOIDS | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (18.1) | View |
| INGUINAL HERNIA | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (18.1) | View |
| NAUSEA | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (18.1) | View |
| PANCREATITIS | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (18.1) | View |
| CHEST PAIN | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (18.1) | View |
| DEATH | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (18.1) | View |
| GENERALISED OEDEMA | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (18.1) | View |
| CHOLELITHIASIS | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (18.1) | View |
| HEPATOMEGALY | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (18.1) | View |
| CONTRAST MEDIA ALLERGY | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA (18.1) | View |
| DRUG HYPERSENSITIVITY | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA (18.1) | View |
| DACRYOCYSTITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (18.1) | View |
| ANKLE FRACTURE | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | 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 |
| CHONDROPATHY | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (18.1) | View |
| INTERVERTEBRAL DISC PROTRUSION | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (18.1) | View |
| ROTATOR CUFF SYNDROME | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (18.1) | View |
| BASAL CELL CARCINOMA | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.1) | View |
| BREAST CANCER | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.1) | View |
| BREAST CANCER IN SITU | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.1) | View |
| MALIGNANT MELANOMA | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.1) | View |
| MESOTHELIOMA | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.1) | View |
| RECTAL CANCER | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.1) | View |
| THYROID NEOPLASM | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.1) | View |
| MULTIPLE SCLEROSIS RELAPSE | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (18.1) | View |
| SCIATICA | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (18.1) | View |
| SYNCOPE | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (18.1) | View |
| TRANSIENT ISCHAEMIC ATTACK | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (18.1) | View |
| COMPLETED SUICIDE | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (18.1) | View |
| HAEMORRHAGE URINARY TRACT | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (18.1) | View |
| RENAL COLIC | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (18.1) | View |
| URINARY INCONTINENCE | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (18.1) | View |
| DYSPNOEA | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (18.1) | View |
| PLEURAL EFFUSION | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (18.1) | View |
| PNEUMONIA ASPIRATION | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (18.1) | View |
| PERIPHERAL ARTERIAL OCCLUSIVE DISEASE | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (18.1) | View |
| CORONARY ARTERY DISEASE | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (18.1) | View |
| MYOCARDIAL INFARCTION | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (18.1) | View |
| IRIS NEOVASCULARISATION | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (18.1) | View |
| HERPES ZOSTER | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (18.1) | View |
| PHARYNGEAL ABSCESS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (18.1) | View |
| RESPIRATORY TRACT INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (18.1) | View |
| TRANSITIONAL CELL CARCINOMA | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 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 |
| DIZZINESS | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (18.1) | View |
| HEADACHE | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (18.1) | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| GASTROENTERITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (18.1) | View |
| INFLUENZA | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (18.1) | View |
| LARYNGITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (18.1) | View |
| NASOPHARYNGITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (18.1) | View |
| PHARYNGITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (18.1) | View |
| UPPER RESPIRATORY TRACT INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (18.1) | View |
| FALL | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (18.1) | View |
| LIPASE INCREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (18.1) | View |
| DECREASED APPETITE | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (18.1) | View |
| HYPERCHOLESTEROLAEMIA | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (18.1) | View |
| HYPERTRIGLYCERIDAEMIA | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (18.1) | View |
| HYPOPHOSPHATAEMIA | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (18.1) | View |
| ARTHRALGIA | 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 |
| ROTATOR CUFF SYNDROME | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (18.1) | View |
| AMNESIA | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (18.1) | View |
| HEADACHE | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (18.1) | View |
| ANXIETY | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (18.1) | View |
| DEPRESSION | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (18.1) | View |
| MENSTRUATION IRREGULAR | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA (18.1) | View |
| COUGH | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (18.1) | View |
| DYSPHONIA | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (18.1) | View |
| DYSPNOEA | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (18.1) | View |
| OROPHARYNGEAL PAIN | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (18.1) | View |
| DRY SKIN | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (18.1) | View |
| PRURITUS | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue 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 |
| LIGAMENT SPRAIN | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (18.1) | View |
| LIP INJURY | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (18.1) | View |
| BLOOD CHOLESTEROL INCREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (18.1) | View |
| BLOOD CREATININE INCREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (18.1) | View |
| ARTHRITIS | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (18.1) | View |
| BACK PAIN | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (18.1) | View |
| BONE 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 |
| 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 |
| ABDOMINAL PAIN UPPER | 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 |
| VOMITING | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (18.1) | View |
| FATIGUE | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (18.1) | View |
| INFLUENZA LIKE ILLNESS | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (18.1) | View |
| LOCALISED OEDEMA | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (18.1) | View |