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 @ 2:02 PM
Ignite Modification Date:
2025-12-25 @ 12:46 PM
NCT ID:
NCT01885195
Description:
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all the participants who received at least 1 dose of study treatment and had at least 1 post-baseline safety assessment.
Frequency Threshold:
5
Time Frame:
From Baseline up to 30 days following the last dose of study treatment (maximum up to 21 months)
Study:
NCT01885195
Study Brief:
MEK162 for Patients With RAS/RAF/MEK Activated Tumors
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Binimetinib (MEK162) | Participants received an oral dose of 45 mg of binimetinib tablets (3 tablets of 15 mg) twice daily in each cycle starting from Cycle 1 Day 1 (1 cycle =28 days) until disease progression, unacceptable toxicity, death, or discontinuation from the study treatment due to any other reason. Maximum treatment exposure was approximately of 19.4 months. | None | None | 50 | 110 | 110 | 110 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Ascites | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v18.1 | View |
| Diarrhoea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v18.1 | View |
| Gastric ulcer | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v18.1 | View |
| Haematemesis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v18.1 | View |
| Intestinal obstruction | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v18.1 | View |
| Mesenteric vein thrombosis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v18.1 | View |
| Nausea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v18.1 | View |
| Oesophageal haemorrhage | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v18.1 | View |
| Oesophageal obstruction | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v18.1 | View |
| Oesophageal perforation | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v18.1 | View |
| Pancreatitis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v18.1 | View |
| Upper gastrointestinal haemorrhage | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v18.1 | View |
| Oedema peripheral | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v18.1 | View |
| Asthenia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v18.1 | View |
| Chest pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v18.1 | View |
| Fatigue | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v18.1 | View |
| Oedema | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v18.1 | View |
| Pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v18.1 | View |
| Pyrexia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v18.1 | View |
| Bile duct obstruction | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA v18.1 | View |
| Pneumonia | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v18.1 | View |
| Urinary tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v18.1 | View |
| Cellulitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v18.1 | View |
| Sepsis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v18.1 | View |
| Cystitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v18.1 | View |
| Influenza | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v18.1 | View |
| Lung abscess | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v18.1 | View |
| Post procedural infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v18.1 | View |
| Streptococcal bacteraemia | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v18.1 | View |
| Upper respiratory tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v18.1 | View |
| Femur fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA v18.1 | View |
| Hip fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA v18.1 | View |
| Blood creatine phosphokinase increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v18.1 | View |
| Troponin I increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v18.1 | View |
| Troponin T increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v18.1 | View |
| Dehydration | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA v18.1 | View |
| Decreased appetite | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA v18.1 | View |
| Hypercalcaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA v18.1 | View |
| Back pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v18.1 | View |
| Musculoskeletal chest pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v18.1 | View |
| Myositis | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v18.1 | View |
| Pain in extremity | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v18.1 | View |
| Haemorrhage intracranial | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v18.1 | View |
| Peripheral motor neuropathy | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v18.1 | View |
| Peripheral sensory neuropathy | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v18.1 | View |
| Confusional state | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA v18.1 | View |
| Urinary retention | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA v18.1 | View |
| Dyspnoea | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v18.1 | View |
| Hypoxia | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v18.1 | View |
| Haemoptysis | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v18.1 | View |
| Pleural effusion | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v18.1 | View |
| Pulmonary embolism | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v18.1 | View |
| Chronic obstructive pulmonary disease | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v18.1 | View |
| Cough | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v18.1 | View |
| Pharyngeal oedema | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v18.1 | View |
| Pulmonary hypertension | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v18.1 | View |
| Respiratory distress | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v18.1 | View |
| Sleep apnoea syndrome | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v18.1 | View |
| Upper airway obstruction | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v18.1 | View |
| Embolism | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA v18.1 | View |
| Haemorrhage | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA v18.1 | View |
| Hypotension | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA v18.1 | View |
| Lymphoedema | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA v18.1 | View |
| Lymphorrhoea | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA v18.1 | View |
| Coagulopathy | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA v18.1 | View |
| Febrile neutropenia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA v18.1 | View |
| Dilatation ventricular | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA v18.1 | View |
| Cataract | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA v18.1 | View |
| Retinal artery occlusion | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA v18.1 | View |
| Retinal detachment | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA v18.1 | View |
| Retinal tear | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA v18.1 | View |
| Vitreous haemorrhage | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA v18.1 | View |
| Abdominal pain | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v18.1 | View |
| Small intestinal obstruction | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v18.1 | View |
| Vomiting | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v18.1 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Hypertension | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA v18.1 | View |
| Pleural effusion | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v18.1 | View |
| Anaemia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA v18.1 | View |
| Neutropenia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA v18.1 | View |
| Vision blurred | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA v18.1 | View |
| Chorioretinopathy | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA v18.1 | View |
| Periorbital oedema | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA v18.1 | View |
| Visual impairment | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA v18.1 | View |
| Diarrhoea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v18.1 | View |
| Nausea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v18.1 | View |
| Vomiting | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v18.1 | View |
| Constipation | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v18.1 | View |
| Dry mouth | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v18.1 | View |
| Dyspepsia | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v18.1 | View |
| Abdominal pain | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v18.1 | View |
| Stomatitis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v18.1 | View |
| Ascites | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v18.1 | View |
| Dysphagia | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v18.1 | View |
| Fatigue | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v18.1 | View |
| Oedema peripheral | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v18.1 | View |
| Mucosal inflammation | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v18.1 | View |
| Pyrexia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v18.1 | View |
| Asthenia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v18.1 | View |
| Face oedema | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v18.1 | View |
| Chills | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v18.1 | View |
| Oedema | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v18.1 | View |
| Urinary tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v18.1 | View |
| Blood creatine phosphokinase increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v18.1 | View |
| Aspartate aminotransferase increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v18.1 | View |
| Alanine aminotransferase increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v18.1 | View |
| Lipase increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v18.1 | View |
| Amylase increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v18.1 | View |
| Blood lactate dehydrogenase increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v18.1 | View |
| Ejection fraction decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v18.1 | View |
| Weight decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v18.1 | View |
| Blood alkaline phosphatase increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v18.1 | View |
| Blood phosphorus increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v18.1 | View |
| Blood creatinine increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v18.1 | View |
| Gamma-glutamyltransferase increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v18.1 | View |
| Intraocular pressure increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v18.1 | View |
| Troponin T increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v18.1 | View |
| White blood cell count decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v18.1 | View |
| Decreased appetite | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA v18.1 | View |
| Hypomagnesaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA v18.1 | View |
| Hyperglycaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA v18.1 | View |
| Dehydration | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA v18.1 | View |
| Hypokalaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA v18.1 | View |
| Hypoalbuminaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA v18.1 | View |
| Hyponatraemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA v18.1 | View |
| Hyperkalaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA v18.1 | View |
| Muscular weakness | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v18.1 | View |
| Back pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v18.1 | View |
| Pain in extremity | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v18.1 | View |
| Myalgia | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v18.1 | View |
| Arthralgia | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v18.1 | View |
| Dizziness | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v18.1 | View |
| Headache | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v18.1 | View |
| Neuropathy peripheral | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v18.1 | View |
| Insomnia | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA v18.1 | View |
| Anxiety | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA v18.1 | View |
| Dyspnoea | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v18.1 | View |
| Cough | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v18.1 | View |
| Epistaxis | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v18.1 | View |
| Rash | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA v18.1 | View |
| Dermatitis acneiform | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA v18.1 | View |
| Dry skin | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA v18.1 | View |
| Pruritus | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA v18.1 | View |
| Rash maculo-papular | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA v18.1 | View |