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 @ 10:58 PM
Ignite Modification Date:
2025-12-25 @ 8:26 PM
NCT ID:
NCT01833169
Description:
Consistent with EudraCT disclosure specifications, Novartis has reported under the Serious adverse events field "number of deaths resulting from adverse events" all those deaths resulting from serious adverse events that are deemed to be causally related to treatment by the investigator.
Frequency Threshold:
5
Time Frame:
Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Treatment Last Visit (LPLV). All AEs reported I this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 30 months.
Study:
NCT01833169
Study Brief:
BKM120 for Patients With PI3K-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 |
|---|---|---|---|---|---|---|---|---|
| BKM120 | BKM120 | None | None | 59 | 146 | 141 | 146 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Anaemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (19.0) | View |
| Anaemia of malignant disease | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (19.0) | View |
| Leukocytosis | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (19.0) | View |
| Thrombocytopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (19.0) | View |
| Acute myocardial infarction | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (19.0) | View |
| Cardio-respiratory arrest | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (19.0) | View |
| Sinus tachycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (19.0) | View |
| Tachycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (19.0) | View |
| Abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (19.0) | View |
| Abdominal pain lower | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (19.0) | View |
| Abdominal pain upper | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (19.0) | View |
| Ascites | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (19.0) | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (19.0) | View |
| Dysphagia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (19.0) | View |
| Intestinal obstruction | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (19.0) | View |
| Intestinal perforation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (19.0) | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (19.0) | View |
| Oesophageal perforation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (19.0) | View |
| Pancreatitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (19.0) | View |
| Small intestinal obstruction | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (19.0) | View |
| Upper gastrointestinal haemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (19.0) | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (19.0) | View |
| Chest pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (19.0) | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (19.0) | View |
| Oedema | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (19.0) | View |
| Oedema peripheral | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (19.0) | View |
| Pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (19.0) | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (19.0) | View |
| Bacteraemia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (19.0) | View |
| Catheter site infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (19.0) | View |
| Klebsiella infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (19.0) | View |
| Liver abscess | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (19.0) | View |
| Pelvic abscess | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (19.0) | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (19.0) | View |
| Sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (19.0) | View |
| Urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (19.0) | View |
| Urinary tract infection bacterial | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (19.0) | View |
| Alanine aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (19.0) | View |
| Ammonia increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (19.0) | View |
| Aspartate aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (19.0) | View |
| Blood alkaline phosphatase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (19.0) | View |
| Blood bilirubin increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (19.0) | View |
| Cachexia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (19.0) | View |
| Dehydration | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (19.0) | View |
| Failure to thrive | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (19.0) | View |
| Hypercalcaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (19.0) | View |
| Hyperglycaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (19.0) | View |
| Hyperkalaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (19.0) | View |
| Hypocalcaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (19.0) | View |
| Hypokalaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (19.0) | View |
| Hyponatraemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (19.0) | View |
| Hypophagia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (19.0) | View |
| Lactic acidosis | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (19.0) | View |
| Metabolic acidosis | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (19.0) | View |
| Flank pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | View |
| Soft tissue haemorrhage | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | View |
| Cancer pain | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.0) | View |
| Altered state of consciousness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (19.0) | View |
| Encephalopathy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (19.0) | View |
| Leukoencephalopathy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (19.0) | View |
| Peroneal nerve palsy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (19.0) | View |
| Seizure | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (19.0) | View |
| Spinal cord compression | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (19.0) | View |
| Subarachnoid haemorrhage | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (19.0) | View |
| Syncope | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (19.0) | View |
| Anxiety | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (19.0) | View |
| Confusional state | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (19.0) | View |
| Depression | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (19.0) | View |
| Mental status changes | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (19.0) | View |
| Psychotic disorder | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (19.0) | View |
| Acute kidney injury | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (19.0) | View |
| Haematuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (19.0) | View |
| Hydronephrosis | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (19.0) | View |
| Acute respiratory failure | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | View |
| Apnoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | View |
| Chronic obstructive pulmonary disease | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | View |
| Dyspnoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | View |
| Epistaxis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | View |
| Hypoxia | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | View |
| Pleural effusion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | View |
| Pneumonitis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | View |
| Pulmonary embolism | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | View |
| Respiratory distress | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | View |
| Respiratory failure | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | View |
| Erythema | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (19.0) | View |
| Palmar-plantar erythrodysaesthesia syndrome | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (19.0) | View |
| Psoriasis | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (19.0) | View |
| Rash | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (19.0) | View |
| Shock haemorrhagic | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (19.0) | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Anaemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (19.0) | View |
| Abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (19.0) | View |
| Abdominal pain upper | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (19.0) | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (19.0) | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (19.0) | View |
| Dry mouth | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (19.0) | View |
| Dyspepsia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (19.0) | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (19.0) | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (19.0) | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (19.0) | View |
| Mucosal inflammation | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (19.0) | View |
| Oedema peripheral | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (19.0) | View |
| Urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (19.0) | View |
| Alanine aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (19.0) | View |
| Aspartate aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (19.0) | View |
| Blood alkaline phosphatase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (19.0) | View |
| Blood bilirubin increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (19.0) | View |
| Gamma-glutamyltransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (19.0) | View |
| Lipase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (19.0) | View |
| Weight decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (19.0) | View |
| Decreased appetite | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (19.0) | View |
| Dehydration | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (19.0) | View |
| Hyperglycaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (19.0) | View |
| Hypokalaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (19.0) | View |
| Hypomagnesaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (19.0) | View |
| Hyponatraemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (19.0) | View |
| Hypophosphataemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (19.0) | View |
| Back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | View |
| Muscular weakness | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (19.0) | View |
| Dysgeusia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (19.0) | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (19.0) | View |
| Tremor | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (19.0) | View |
| Anxiety | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (19.0) | View |
| Confusional state | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (19.0) | View |
| Depression | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (19.0) | View |
| Insomnia | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (19.0) | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | View |
| Dyspnoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | View |
| Dry skin | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (19.0) | View |
| Pruritus | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (19.0) | View |
| Rash | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (19.0) | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (19.0) | View |