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 @ 5:41 PM
Ignite Modification Date:
2025-12-25 @ 3:10 PM
NCT ID:
NCT00942968
Description:
None
Frequency Threshold:
5
Time Frame:
None
Study:
NCT00942968
Study Brief:
Evaluation of Dalteparin for Long-term (One Year) Treatment of Blood Clots in Subjects With Cancer
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Dalteparin Sodium | Participants received subcutaneous (SC) injection of dalteparin sodium 200 international units per kilogram (IU/kg) once daily (QD) from Week 1-4 followed by SC injection of dalteparin sodium 150 IU/kg QD from Week 5-52. | None | None | 213 | 334 | 328 | 334 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Subdural haematoma | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 15.1 | View |
| Traumatic haematoma | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 15.1 | View |
| Haemoglobin decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 15.1 | View |
| Staphylococcus test positive | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 15.1 | View |
| Weight decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 15.1 | View |
| Dehydration | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 15.1 | View |
| Diabetic ketoacidosis | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 15.1 | View |
| Failure to thrive | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 15.1 | View |
| Hypercalcaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 15.1 | View |
| Hyperglycaemic hyperosmolar nonketotic syndrome | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 15.1 | View |
| Hyperkalaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 15.1 | View |
| Hyperphosphataemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 15.1 | View |
| Hypocalcaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 15.1 | View |
| Hypokalaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 15.1 | View |
| Hypomagnesaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 15.1 | View |
| Hyponatraemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 15.1 | View |
| Hypovolaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 15.1 | View |
| Malnutrition | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 15.1 | View |
| Tumour lysis syndrome | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 15.1 | View |
| Type 2 diabetes mellitus | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 15.1 | View |
| Back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | View |
| Lumbar spinal stenosis | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | View |
| Musculoskeletal chest pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | View |
| Osteolysis | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | View |
| Pain in extremity | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | View |
| Adenocarcinoma pancreas | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | View |
| Adrenocortical carcinoma | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | View |
| Bile duct cancer | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | View |
| Brain neoplasm | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | View |
| Brain neoplasm malignant | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | View |
| Bronchioloalveolar carcinoma | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | View |
| Cancer pain | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | View |
| Cervix cancer metastatic | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | View |
| Cervix carcinoma | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | View |
| Colon cancer metastatic | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | View |
| Endometrial cancer metastatic | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | View |
| Gastric cancer | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | View |
| Glioblastoma | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | View |
| Glioblastoma multiforme | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | View |
| Intracranial tumour haemorrhage | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | View |
| Liposarcoma | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | View |
| Lung cancer metastatic | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | View |
| Lung neoplasm malignant | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | View |
| Malignant neoplasm progression | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | View |
| Malignant ovarian cyst | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | View |
| Malignant pleural effusion | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | View |
| Mantle cell lymphoma | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | View |
| Metastases to central nervous system | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | View |
| Metastatic carcinoma of the bladder | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | View |
| Metastatic pain | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | View |
| Neoplasm | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | View |
| Non-Hodgkin's lymphoma recurrent | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | View |
| Non-small cell lung cancer | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | View |
| Non-small cell lung cancer metastatic | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | View |
| Non-small cell lung cancer stage IV | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | View |
| Oesophageal adenocarcinoma | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | View |
| Oesophageal carcinoma | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | View |
| Oncologic complication | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | View |
| Ovarian cancer | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | View |
| Pancreatic carcinoma | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | View |
| Pancreatic carcinoma metastatic | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | View |
| Prostate cancer metastatic | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | View |
| Rectal cancer | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | View |
| Rectal cancer metastatic | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | View |
| Renal cell carcinoma | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | View |
| Sarcoma | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | View |
| Small cell lung cancer stage unspecified | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | View |
| Small intestine carcinoma metastatic | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | View |
| Squamous cell carcinoma of the cervix | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | View |
| T-cell lymphoma recurrent | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | View |
| Tumour haemorrhage | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | View |
| Tumour invasion | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | View |
| Tumour necrosis | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | View |
| Uterine cancer | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | View |
| Uterine leiomyosarcoma | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | View |
| Vulval cancer | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | View |
| Brain oedema | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 15.1 | View |
| Cerebrovascular accident | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 15.1 | View |
| Embolic cerebral infarction | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 15.1 | View |
| Haemorrhage intracranial | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 15.1 | View |
| Haemorrhagic stroke | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 15.1 | View |
| Headache | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 15.1 | View |
| Hemiparesis | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 15.1 | View |
| Neuralgia | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 15.1 | View |
| Normal pressure hydrocephalus | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 15.1 | View |
| Paraplegia | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 15.1 | View |
| Stupor | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 15.1 | View |
| Syncope | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 15.1 | View |
| Thrombotic stroke | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 15.1 | View |
| Transient ischaemic attack | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 15.1 | View |
| Delirium | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 15.1 | View |
| Depression | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 15.1 | View |
| Mental disorder | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 15.1 | View |
| Mental status changes | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 15.1 | View |
| Substance-induced psychotic disorder | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 15.1 | View |
| Calculus bladder | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 15.1 | View |
| Haematuria | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 15.1 | View |
| Postrenal failure | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 15.1 | View |
| Renal failure | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 15.1 | View |
| Renal failure acute | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 15.1 | View |
| Renal impairment | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 15.1 | View |
| Ovarian mass | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA 15.1 | View |
| Vaginal haemorrhage | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA 15.1 | View |
| Acute respiratory failure | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | View |
| Chronic obstructive pulmonary disease | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | View |
| Dyspnoea | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | View |
| Emphysema | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | View |
| Epistaxis | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | View |
| Hiccups | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | View |
| Hypoxia | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | View |
| Lung infiltration | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | View |
| Painful respiration | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | View |
| Pleural effusion | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | View |
| Pleuritic pain | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | View |
| Pneumonia aspiration | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | View |
| Pneumothorax | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | View |
| Pulmonary embolism | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | View |
| Respiratory failure | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | View |
| Stridor | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | View |
| Decubitus ulcer | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 15.1 | View |
| Urticaria | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 15.1 | View |
| Deep vein thrombosis | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 15.1 | View |
| Embolism venous | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 15.1 | View |
| Hypertension | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 15.1 | View |
| Hypotension | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 15.1 | View |
| Jugular vein thrombosis | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 15.1 | View |
| Subclavian artery stenosis | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 15.1 | View |
| Small intestinal perforation | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 15.1 | View |
| Pneumonia | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 15.1 | View |
| Anaemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 15.1 | View |
| Bone marrow failure | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 15.1 | View |
| Febrile neutropenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 15.1 | View |
| Heparin-induced thrombocytopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 15.1 | View |
| Leukocytosis | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 15.1 | View |
| Neutropenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 15.1 | View |
| Pancytopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 15.1 | View |
| Thrombocytopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 15.1 | View |
| Acute myocardial infarction | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 15.1 | View |
| Angina pectoris | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 15.1 | View |
| Atrial fibrillation | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 15.1 | View |
| Atrial flutter | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 15.1 | View |
| Cardiac failure congestive | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 15.1 | View |
| Cardio-respiratory arrest | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 15.1 | View |
| Coronary artery occlusion | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 15.1 | View |
| Endocarditis noninfective | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 15.1 | View |
| Myocardial infarction | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 15.1 | View |
| Vertigo | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA 15.1 | View |
| Adrenal haemorrhage | SYSTEMATIC_ASSESSMENT | Endocrine disorders | MedDRA 15.1 | View |
| Abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 15.1 | View |
| Ascites | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 15.1 | View |
| Colitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 15.1 | View |
| Colonic obstruction | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 15.1 | View |
| Diarrhoea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 15.1 | View |
| Diarrhoea haemorrhagic | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 15.1 | View |
| Duodenal obstruction | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 15.1 | View |
| Gastric ulcer haemorrhage | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 15.1 | View |
| Gastritis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 15.1 | View |
| Gastrointestinal haemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 15.1 | View |
| Gastrointestinal necrosis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 15.1 | View |
| Gastrooesophageal reflux disease | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 15.1 | View |
| Haematemesis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 15.1 | View |
| Intestinal obstruction | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 15.1 | View |
| Intestinal perforation | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 15.1 | View |
| Intra-abdominal haemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 15.1 | View |
| Lower gastrointestinal haemorrhage | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 15.1 | View |
| Narcotic bowel syndrome | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 15.1 | View |
| Nausea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 15.1 | View |
| Oesophageal obstruction | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 15.1 | View |
| Pancreatic mass | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 15.1 | View |
| Pancreatitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 15.1 | View |
| Peritoneal haemorrhage | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 15.1 | View |
| Rectal haemorrhage | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 15.1 | View |
| Rectal ulcer haemorrhage | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 15.1 | View |
| Small intestinal obstruction | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 15.1 | View |
| Subileus | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 15.1 | View |
| Upper gastrointestinal haemorrhage | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 15.1 | View |
| Varicose veins of abdominal wall | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 15.1 | View |
| Chills | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 15.1 | View |
| Device malfunction | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 15.1 | View |
| Device occlusion | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 15.1 | View |
| Disease progression | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 15.1 | View |
| Fatigue | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 15.1 | View |
| General physical health deterioration | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 15.1 | View |
| Mucosal inflammation | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 15.1 | View |
| Multi-organ failure | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 15.1 | View |
| Oedema peripheral | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 15.1 | View |
| Pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 15.1 | View |
| Pyrexia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 15.1 | View |
| Bile duct obstruction | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 15.1 | View |
| Cholecystitis | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 15.1 | View |
| Cholelithiasis | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 15.1 | View |
| Cholestasis | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 15.1 | View |
| Gallbladder disorder | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 15.1 | View |
| Hepatic failure | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 15.1 | View |
| Jaundice | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 15.1 | View |
| Appendicitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 15.1 | View |
| Bacteraemia | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 15.1 | View |
| Bacterial infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 15.1 | View |
| Bacterial sepsis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 15.1 | View |
| Bronchitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 15.1 | View |
| Candiduria | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 15.1 | View |
| Cellulitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 15.1 | View |
| Clostridial infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 15.1 | View |
| Clostridium difficile colitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 15.1 | View |
| Device related infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 15.1 | View |
| Diverticulitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 15.1 | View |
| Escherichia sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 15.1 | View |
| Gastroenteritis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 15.1 | View |
| Gastroenteritis viral | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 15.1 | View |
| Haematoma infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 15.1 | View |
| Infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 15.1 | View |
| Lobar pneumonia | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 15.1 | View |
| Lung abscess | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 15.1 | View |
| Peritonitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 15.1 | View |
| Postoperative wound infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 15.1 | View |
| Pyelonephritis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 15.1 | View |
| Respiratory tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 15.1 | View |
| Sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 15.1 | View |
| Septic shock | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 15.1 | View |
| Streptococcal sepsis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 15.1 | View |
| Urinary tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 15.1 | View |
| Urosepsis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 15.1 | View |
| Wound infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 15.1 | View |
| Abdominal wound dehiscence | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 15.1 | View |
| Fractured sacrum | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 15.1 | View |
| Humerus fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 15.1 | View |
| Inadequate analgesia | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 15.1 | View |
| Incisional hernia, obstructive | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 15.1 | View |
| Lumbar vertebral fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 15.1 | View |
| Meniscus lesion | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 15.1 | View |
| Pneumothorax traumatic | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 15.1 | View |
| Post procedural haemorrhage | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 15.1 | View |
| Procedural complication | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 15.1 | View |
| Vomiting | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 15.1 | View |
| Asthenia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 15.1 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Injection site hematoma | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 15.1 | View |
| Fatigue | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 15.1 | View |
| Nausea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 15.1 | View |
| Odema peripheral | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 15.1 | View |
| Constipation | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 15.1 | View |
| Diarrhea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 15.1 | View |
| Anemia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 15.1 | View |
| Contusion | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 15.1 | View |
| Dyspnoea | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | View |
| Decreased appetite | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 15.1 | View |
| Back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | View |
| Thrombocytopenia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 15.1 | View |
| Disease progression | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 15.1 | View |
| Cough | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | View |
| Hypokalemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 15.1 | View |
| Weight decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 15.1 | View |
| Epistaxis | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | View |
| Pneumonia | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 15.1 | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 15.1 | View |
| Pain in extremity | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | View |
| Urinary tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 15.1 | View |
| Pleural effusion | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | View |
| Anxiety | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 15.1 | View |
| Dizziness | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 15.1 | View |
| Insomnia | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 15.1 | View |
| Neutropenia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 15.1 | View |
| Arthralgia | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | View |
| Dehydration | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 15.1 | View |
| Pulmonary embolism | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | View |
| Pyrexia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 15.1 | View |
| Hypotension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 15.1 | View |
| Alopecia | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 15.1 | View |
| Ascites | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 15.1 | View |
| Hematuria | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 15.1 | View |
| Neuropathy peripheral | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 15.1 | View |
| Rash | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 15.1 | View |
| Upper respiratory tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 15.1 | View |
| Hyponatremia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 15.1 | View |
| Asthenia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 15.1 | View |
| Dry skin | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 15.1 | View |
| Ecchymosis | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 15.1 | View |
| Tachycardia | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 15.1 | View |
| Hemoglobin decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 15.1 | View |
| Injection site hemorrhage | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 15.1 | View |
| Muscle spasms | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | View |
| Abdominal pain | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 15.1 | View |
| Cellulitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 15.1 | View |
| Vomiting | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 15.1 | View |