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 @ 1:06 AM
Ignite Modification Date:
2025-12-25 @ 11:18 PM
NCT ID:
NCT01794793
Description:
Safety was monitored by collecting AEs/SAEs at every visit and throughout the study period (not limited to patient contact times) according to the sponsor's routine safety monitoring practices. Patients might have safety assessments performed by the clinic's local laboratory as per investigators judgement and standard of care at any time during the study period.
Frequency Threshold:
5
Time Frame:
Pasireotide s.c.: From start of study treatment up to 1 month after study treatment discontinuation (about 10 years) Pasireotide LAR: From start of study treatment up to 3 months after study treatment discontinuation (about 10 years)
Study:
NCT01794793
Study Brief:
Study to Allow Access to Pasireotide for Patients Benefiting From Pasireotide Treatment in Novartis-sponsored Studies
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 Subjects | Patients who were treated with and had benefitted from pasireotide in the parent studies remained enrolled in this study and were elegible for the analysis | 8 | None | 91 | 337 | 220 | 337 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Cholelithiasis | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MEdDRa (23.0) | View |
| Cholecystitis | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MEdDRa (23.0) | View |
| COVID-19 | SYSTEMATIC_ASSESSMENT | Infections and infestations | MEdDRa (23.0) | View |
| Cellulitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MEdDRa (23.0) | View |
| Febrile neutropenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MEdDRa (23.0) | View |
| Acute myocardial infarction | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MEdDRa (23.0) | View |
| Cardiac failure | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MEdDRa (23.0) | View |
| Coronary artery disease | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MEdDRa (23.0) | View |
| Myocardial infarction | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MEdDRa (23.0) | View |
| Angina pectoris | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MEdDRa (23.0) | View |
| Arrhythmia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MEdDRa (23.0) | View |
| Cardiorespiratory arrest | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MEdDRa (23.0) | View |
| Myocardial Ischaemia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MEdDRa (23.0) | View |
| Syringomyelia | SYSTEMATIC_ASSESSMENT | Congenital, familial and genetic disorders | MEdDRa (23.0) | View |
| Adrenal insufficiency | SYSTEMATIC_ASSESSMENT | Endocrine disorders | MEdDRa (23.0) | View |
| Hyperadrenocorticism | SYSTEMATIC_ASSESSMENT | Endocrine disorders | MEdDRa (23.0) | View |
| Cataract | SYSTEMATIC_ASSESSMENT | Eye disorders | MEdDRa (23.0) | View |
| Abdominal adhesion | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MEdDRa (23.0) | View |
| Abdominal fat apron | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MEdDRa (23.0) | View |
| Anal fistula | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MEdDRa (23.0) | View |
| Enteritis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MEdDRa (23.0) | View |
| Gastrointestinal haemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MEdDRa (23.0) | View |
| Large Intestin Polyp | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MEdDRa (23.0) | View |
| Pancreatitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MEdDRa (23.0) | View |
| Pancreatitis acute | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MEdDRa (23.0) | View |
| Small intestinal obstruction | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MEdDRa (23.0) | View |
| Stasis Syndrome | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MEdDRa (23.0) | View |
| Umbelical hernia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MEdDRa (23.0) | View |
| Asthenia | SYSTEMATIC_ASSESSMENT | General disorders | MEdDRa (23.0) | View |
| General physical health deterioration | SYSTEMATIC_ASSESSMENT | General disorders | MEdDRa (23.0) | View |
| Multiple organ dysfunction syndrome | SYSTEMATIC_ASSESSMENT | General disorders | MEdDRa (23.0) | View |
| Non-cardiac chest pain | SYSTEMATIC_ASSESSMENT | General disorders | MEdDRa (23.0) | View |
| Oedema peripheral | SYSTEMATIC_ASSESSMENT | General disorders | MEdDRa (23.0) | View |
| Cholangitis chronic | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MEdDRa (23.0) | View |
| Cholecystitis acute | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MEdDRa (23.0) | View |
| Cholecystitis chronic | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MEdDRa (23.0) | View |
| Hydrocholecystitis | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MEdDRa (23.0) | View |
| Hyperbilirubinaemia | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MEdDRa (23.0) | View |
| Appendicitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MEdDRa (23.0) | View |
| COVID-19 pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MEdDRa (23.0) | View |
| Septic shock | SYSTEMATIC_ASSESSMENT | Infections and infestations | MEdDRa (23.0) | View |
| Abscess jaw | SYSTEMATIC_ASSESSMENT | Infections and infestations | MEdDRa (23.0) | View |
| Acute sinusitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MEdDRa (23.0) | View |
| Coronavirus infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MEdDRa (23.0) | View |
| Diarrhoea infectious | SYSTEMATIC_ASSESSMENT | Infections and infestations | MEdDRa (23.0) | View |
| Endocarditis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MEdDRa (23.0) | View |
| Erysipelas | SYSTEMATIC_ASSESSMENT | Infections and infestations | MEdDRa (23.0) | View |
| Furuncle | SYSTEMATIC_ASSESSMENT | Infections and infestations | MEdDRa (23.0) | View |
| Gastroenteritis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MEdDRa (23.0) | View |
| Infected dermal cyst | SYSTEMATIC_ASSESSMENT | Infections and infestations | MEdDRa (23.0) | View |
| Influenza | SYSTEMATIC_ASSESSMENT | Infections and infestations | MEdDRa (23.0) | View |
| Meningitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MEdDRa (23.0) | View |
| Peritonitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MEdDRa (23.0) | View |
| Pneunomia pseudomonal | SYSTEMATIC_ASSESSMENT | Infections and infestations | MEdDRa (23.0) | View |
| Pneumonia viral | SYSTEMATIC_ASSESSMENT | Infections and infestations | MEdDRa (23.0) | View |
| Post procedural infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MEdDRa (23.0) | View |
| Pyelonephritis acute | SYSTEMATIC_ASSESSMENT | Infections and infestations | MEdDRa (23.0) | View |
| Sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MEdDRa (23.0) | View |
| Sinusitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MEdDRa (23.0) | View |
| Suspected COVID-19 | SYSTEMATIC_ASSESSMENT | Infections and infestations | MEdDRa (23.0) | View |
| Urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MEdDRa (23.0) | View |
| Viral upper respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MEdDRa (23.0) | View |
| Femur fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MEdDRa (23.0) | View |
| Joint injury | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MEdDRa (23.0) | View |
| Meniscus injury | SYSTEMATIC_ASSESSMENT | Infections and infestations | MEdDRa (23.0) | View |
| Poisoning | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MEdDRa (23.0) | View |
| Suture related complication | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MEdDRa (23.0) | View |
| Upper limb fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MEdDRa (23.0) | View |
| Hepatic enzyme increased | SYSTEMATIC_ASSESSMENT | Investigations | MEdDRa (23.0) | View |
| Weight decreased | SYSTEMATIC_ASSESSMENT | Infections and infestations | MEdDRa (23.0) | View |
| Diabetic ketoacidosis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MEdDRa (23.0) | View |
| Hypoglycaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MEdDRa (23.0) | View |
| Diabetes mellitus | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MEdDRa (23.0) | View |
| Diabetic ketosis | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MEdDRa (23.0) | View |
| Diabetic metabolic decompesation | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MEdDRa (23.0) | View |
| Hyperglycaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MEdDRa (23.0) | View |
| Hyponatraemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MEdDRa (23.0) | View |
| Back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MEdDRa (23.0) | View |
| Foot deformity | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MEdDRa (23.0) | View |
| Muscular weakness | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MEdDRa (23.0) | View |
| Neck mass | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MEdDRa (23.0) | View |
| Tendon disorder | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MEdDRa (23.0) | View |
| Adenocarcinoma of colon | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MEdDRa (23.0) | View |
| Colon cancer | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MEdDRa (23.0) | View |
| Leiomyoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MEdDRa (23.0) | View |
| Lung neoplasm | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MEdDRa (23.0) | View |
| Pituitary tumour recurrent | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MEdDRa (23.0) | View |
| Prostate cancer metastatic | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MEdDRa (23.0) | View |
| Thyroid cancer | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MEdDRa (23.0) | View |
| Epilepsy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MEdDRa (23.0) | View |
| Cerebrovascular accident | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MEdDRa (23.0) | View |
| Dementia | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MEdDRa (23.0) | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MEdDRa (23.0) | View |
| Hypoglycaemic coma | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MEdDRa (23.0) | View |
| Hypoglycaemic seizure | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MEdDRa (23.0) | View |
| Myasthenia gravis | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MEdDRa (23.0) | View |
| Transient Ischaemic attack | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MEdDRa (23.0) | View |
| Confusional state | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MEdDRa (23.0) | View |
| Depression | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MEdDRa (23.0) | View |
| Mental disorder | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MEdDRa (23.0) | View |
| Mental fatigue | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MEdDRa (23.0) | View |
| Psychiatric decompensation | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MEdDRa (23.0) | View |
| Nephrolithiasis | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MEdDRa (23.0) | View |
| Acute kidney injury | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MEdDRa (23.0) | View |
| Renal failure | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MEdDRa (23.0) | View |
| Breast pain | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MEdDRa (23.0) | View |
| Menorrhagia | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MEdDRa (23.0) | View |
| Metrorrhagia | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MEdDRa (23.0) | View |
| Pulmonary embolism | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MEdDRa (23.0) | View |
| Acute respiratory failure | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MEdDRa (23.0) | View |
| Chronic obstructive pulmonary disease | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MEdDRa (23.0) | View |
| Respiratory failure | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MEdDRa (23.0) | View |
| Aortic aneurysm | SYSTEMATIC_ASSESSMENT | Vascular disorders | MEdDRa (23.0) | View |
| Deep vein thrombosis | SYSTEMATIC_ASSESSMENT | Vascular disorders | MEdDRa (23.0) | View |
| Distributive shock | SYSTEMATIC_ASSESSMENT | Vascular disorders | MEdDRa (23.0) | View |
| Hypertensive emergency | SYSTEMATIC_ASSESSMENT | Vascular disorders | MEdDRa (23.0) | View |
| Peripheral arterial occlusive disease | SYSTEMATIC_ASSESSMENT | Vascular disorders | MEdDRa (23.0) | View |
| Peripheral embolism | SYSTEMATIC_ASSESSMENT | Vascular disorders | MEdDRa (23.0) | View |
| Thrombophlebitis | SYSTEMATIC_ASSESSMENT | Vascular disorders | MEdDRa (23.0) | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Nasopharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MEdDRa (23.0) | View |
| Back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MEdDRa (23.0) | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MEdDRa (23.0) | View |
| Hyperglycaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MEdDRa (23.0) | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MEdDRa (23.0) | View |
| Covid-19 | SYSTEMATIC_ASSESSMENT | Infections and infestations | MEdDRa (23.0) | View |
| Urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MEdDRa (23.0) | View |
| Influenza | SYSTEMATIC_ASSESSMENT | Infections and infestations | MEdDRa (23.0) | View |
| Diabetes mellitus | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MEdDRa (23.0) | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MEdDRa (23.0) | View |