Adverse Events Module

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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 @ 3:02 AM

Ignite Modification Date: 2025-12-26 @ 1:42 AM

NCT ID: NCT01782833

Description: None

Frequency Threshold: 0

Time Frame: None

Study: NCT01782833

Study Brief: Pletaal SR Post Marketing Observational Study

Event Groups(If Any):

Event Groups

Title	Description	Deaths # Affected	Deaths # At Risk	Serious # Affected	Serious # At Risk	Other # Affected	Other # At Risk	View

Pletaal® SR Capsule	Subjects who received at least 1 dose of Pletaal® SR Capsule during the study period and had follow-up for safety assessment.	None	None	74	3365	372	3365	View

Serious Events(If Any):

Serious Events

Term	Type	Organ System	Vocab	View

Cerebral infarction	None	Nervous system disorders	None	View
Dizziness	None	Nervous system disorders	None	View
Cerebrovascular accident	None	Nervous system disorders	None	View
Headache	None	Nervous system disorders	None	View
Transient ischaemic attack	None	Nervous system disorders	None	View
Central pain syndrome	None	Nervous system disorders	None	View
Melaena	None	Gastrointestinal disorders	None	View
Nausea	None	Gastrointestinal disorders	None	View
Varices oesophageal	None	Gastrointestinal disorders	None	View
Chest pain	None	General disorders	None	View
Asthenia	None	General disorders	None	View
Chest discomfort	None	General disorders	None	View
Toxicity to various agents	None	Injury, poisoning and procedural complications	None	View
Peritoneal dialysis	None	Surgical and medical procedures	None	View
Musculoskeletal pain	None	Musculoskeletal and connective tissue disorders	None	View
Rhabdomyolysis	None	Musculoskeletal and connective tissue disorders	None	View
Diabetic foot	None	Skin and subcutaneous tissue disorders	None	View
Diabetic vascular disorder	None	Vascular disorders	None	View
Cerebral haemorrhage	None	Nervous system disorders	None	View
Dementia Alzheimer's type	None	Nervous system disorders	None	View
Dysarthria	None	Nervous system disorders	None	View
Hemiparesis	None	Nervous system disorders	None	View
Intracranial artery dissection	None	Nervous system disorders	None	View
Loss of consciousness	None	Nervous system disorders	None	View
Paraesthesia	None	Nervous system disorders	None	View
Status epilepticus	None	Nervous system disorders	None	View
Pneumonia	None	Infections and infestations	None	View
Cellulitis	None	Infections and infestations	None	View
Lung abscess	None	Infections and infestations	None	View
Pyelonephritis acute	None	Infections and infestations	None	View
Pyometra	None	Infections and infestations	None	View
Diarrhoea	None	Gastrointestinal disorders	None	View
Haematemesis	None	Gastrointestinal disorders	None	View
Inguinal hernia	None	Gastrointestinal disorders	None	View
Oedema	None	General disorders	None	View
Cholangitis	None	Hepatobiliary disorders	None	View
Cholecystitis	None	Hepatobiliary disorders	None	View
Cholelithiasis	None	General disorders	None	View
Cholelithiasis obstructive	None	General disorders	None	View
Humerus fracture	None	Injury, poisoning and procedural complications	None	View
Lumbar vertebral fracture	None	Injury, poisoning and procedural complications	None	View
Pneumoconiosis	None	Injury, poisoning and procedural complications	None	View
Rib fracture	None	Injury, poisoning and procedural complications	None	View
Asthma	None	Respiratory, thoracic and mediastinal disorders	None	View
Dyspnoea	None	Respiratory, thoracic and mediastinal disorders	None	View
Haemoptysis	None	Respiratory, thoracic and mediastinal disorders	None	View
Pleural effusion	None	Respiratory, thoracic and mediastinal disorders	None	View
Pulmonary embolism	None	Respiratory, thoracic and mediastinal disorders	None	View
Type 2 diabetes mellitus	None	Metabolism and nutrition disorders	None	View
Diabetic ketoacidosis	None	Metabolism and nutrition disorders	None	View
Hypoglycaemia	None	Metabolism and nutrition disorders	None	View
Lung neoplasm malignant	None	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	None	View
Prostate cancer	None	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	None	View
Renal cell carcinoma	None	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	None	View
Vulval cancer	None	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	None	View
Angina pectoris	None	Cardiac disorders	None	View
Coronary artery stenosis	None	Cardiac disorders	None	View
Intervertebral disc operation	None	Surgical and medical procedures	None	View
Intraocular lens implant	None	Surgical and medical procedures	None	View
Shock	None	Vascular disorders	None	View
Anaemia	None	Blood and lymphatic system disorders	None	View
Diabetic retinopathy	None	Eye disorders	None	View
Weight decreased	None	Investigations	None	View
Anxiety disorder	None	Psychiatric disorders	None	View
Nephrolithiasis	None	Renal and urinary disorders	None	View

Other Events(If Any):

Other Events

Term	Type	Organ System	Vocab	View

Low density lipoprotein increased	None	Investigations	None	View
Urobilinogen urine increased	None	Investigations	None	View
Cough	None	Respiratory, thoracic and mediastinal disorders	None	View
Dyspnoea	None	Respiratory, thoracic and mediastinal disorders	None	View
Emphysema	None	Respiratory, thoracic and mediastinal disorders	None	View
Epistaxis	None	Respiratory, thoracic and mediastinal disorders	None	View
Rhinorrhoea	None	Respiratory, thoracic and mediastinal disorders	None	View
Fall	None	Injury, poisoning and procedural complications	None	View
Chronic kidney disease	None	Renal and urinary disorders	None	View
Azotaemia	None	Renal and urinary disorders	None	View
Bladder hypertrophy	None	Renal and urinary disorders	None	View
Calculus ureteric	None	Renal and urinary disorders	None	View
Calculus urinary	None	Renal and urinary disorders	None	View
Dysuria	None	Renal and urinary disorders	None	View
Urethral stenosis	None	Renal and urinary disorders	None	View
Peripheral coldness	None	Vascular disorders	None	View
Hypertension	None	Vascular disorders	None	View
Flushing	None	Vascular disorders	None	View
Hypotension	None	Vascular disorders	None	View
Orthostatic hypotension	None	Vascular disorders	None	View
Thrombophlebitis	None	Vascular disorders	None	View
Cataract	None	Eye disorders	None	View
Diabetic retinopathy	None	Eye disorders	None	View
Dacryostenosis acquired	None	Eye disorders	None	View
Diplopia	None	Eye disorders	None	View
Dry eye	None	Eye disorders	None	View
Keratitis	None	Eye disorders	None	View
Macular fibrosis	None	Eye disorders	None	View
Benign neoplasm of thyroid gland	None	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	None	View
Epigastric discomfort	None	Gastrointestinal disorders	None	View
Gastric ulcer	None	Gastrointestinal disorders	None	View
Large intestine polyp	None	Gastrointestinal disorders	None	View
Melaena	None	Gastrointestinal disorders	None	View
Abdominal discomfort	None	Gastrointestinal disorders	None	View
Anal pruritus	None	Gastrointestinal disorders	None	View
Chronic gastritis	None	Gastrointestinal disorders	None	View
Gastritis	None	Gastrointestinal disorders	None	View
Gastritis erosive	None	Gastrointestinal disorders	None	View
Gastrointestinal disorder	None	Gastrointestinal disorders	None	View
Gingival bleeding	None	Gastrointestinal disorders	None	View
Haemorrhoids	None	Gastrointestinal disorders	None	View
Hypoaesthesia oral	None	Gastrointestinal disorders	None	View
Toothache	None	Gastrointestinal disorders	None	View
Oedema	None	General disorders	None	View
Chest pain	None	General disorders	None	View
Oedema peripheral	None	General disorders	None	View
Chest discomfort	None	General disorders	None	View
Pain	None	General disorders	None	View
Asthenia	None	General disorders	None	View
Face oedema	None	General disorders	None	View
General symptom	None	General disorders	None	View
Generalised oedema	None	General disorders	None	View
Localised oedema	None	General disorders	None	View
Peripheral swelling	None	General disorders	None	View
Musculoskeletal pain	None	Musculoskeletal and connective tissue disorders	None	View
Arthralgia	None	Musculoskeletal and connective tissue disorders	None	View
Pain in extremity	None	Musculoskeletal and connective tissue disorders	None	View
Back pain	None	Musculoskeletal and connective tissue disorders	None	View
Muscular weakness	None	Musculoskeletal and connective tissue disorders	None	View
Myalgia	None	Musculoskeletal and connective tissue disorders	None	View
Neck pain	None	Musculoskeletal and connective tissue disorders	None	View
Flank pain	None	Musculoskeletal and connective tissue disorders	None	View
Foot deformity	None	Musculoskeletal and connective tissue disorders	None	View
Muscle spasms	None	Musculoskeletal and connective tissue disorders	None	View
Musculoskeletal stiffness	None	Musculoskeletal and connective tissue disorders	None	View
Myofascial pain syndrome	None	Musculoskeletal and connective tissue disorders	None	View
Neck mass	None	Musculoskeletal and connective tissue disorders	None	View
Osteoarthritis	None	Musculoskeletal and connective tissue disorders	None	View
Periarthritis	None	Musculoskeletal and connective tissue disorders	None	View
Spinal column stenosis	None	Musculoskeletal and connective tissue disorders	None	View
Synovitis	None	Musculoskeletal and connective tissue disorders	None	View
Nasopharyngitis	None	Infections and infestations	None	View
Pneumonia	None	Infections and infestations	None	View
Pyelonephritis acute	None	Infections and infestations	None	View
Periodontitis	None	Infections and infestations	None	View
Sinusitis	None	Infections and infestations	None	View
Upper respiratory tract infection	None	Infections and infestations	None	View
Urinary tract infection	None	Infections and infestations	None	View
Chronic sinusitis	None	Infections and infestations	None	View
Periorbital cellulitis	None	Infections and infestations	None	View
Tinea pedis	None	Infections and infestations	None	View
Tooth abscess	None	Infections and infestations	None	View
Vestibular neuronitis	None	Infections and infestations	None	View
Palpitations	None	Cardiac disorders	None	View
Tachycardia	None	Cardiac disorders	None	View
Arrhythmia	None	Cardiac disorders	None	View
Atrial fibrillation	None	Cardiac disorders	None	View
Hypoglycaemia	None	Metabolism and nutrition disorders	None	View
Hyperglycaemia	None	Metabolism and nutrition disorders	None	View
Diabetes mellitus	None	Metabolism and nutrition disorders	None	View
Diabetes mellitus inadequate control	None	Metabolism and nutrition disorders	None	View
Hyperlipidaemia	None	Metabolism and nutrition disorders	None	View
Decreased appetite	None	Metabolism and nutrition disorders	None	View
Dyslipidaemia	None	Metabolism and nutrition disorders	None	View
Hyperuricaemia	None	Metabolism and nutrition disorders	None	View
Hypophagia	None	Metabolism and nutrition disorders	None	View
Pruritus	None	Skin and subcutaneous tissue disorders	None	View
Rash	None	Skin and subcutaneous tissue disorders	None	View
Chloasma	None	Skin and subcutaneous tissue disorders	None	View
Hyperhidrosis	None	Skin and subcutaneous tissue disorders	None	View
Ingrowing nail	None	Skin and subcutaneous tissue disorders	None	View
Macule	None	Skin and subcutaneous tissue disorders	None	View
Papule	None	Skin and subcutaneous tissue disorders	None	View
Pruritus generalised	None	Skin and subcutaneous tissue disorders	None	View
Skin lesion	None	Skin and subcutaneous tissue disorders	None	View
Blood glucose increased	None	Investigations	None	View
Liver function test abnormal	None	Investigations	None	View
Alanine aminotransferase increased	None	Investigations	None	View
Aspartate aminotransferase increased	None	Investigations	None	View
Bacterial test	None	Investigations	None	View
Blood glucose abnormal	None	Investigations	None	View
Blood pressure decreased	None	Investigations	None	View
Gamma-glutamyltransferase increased	None	Investigations	None	View
Hepatic enzyme abnormal	None	Investigations	None	View
International normalised ratio increased	None	Investigations	None	View
Lipids increased	None	Investigations	None	View
Complex regional pain syndrome	None	Nervous system disorders	None	View
VIIth nerve paralysis	None	Nervous system disorders	None	View
Diarrhoea	None	Gastrointestinal disorders	None	View
Dyspepsia	None	Gastrointestinal disorders	None	View
Abdominal pain	None	Gastrointestinal disorders	None	View
Headache	None	Nervous system disorders	None	View
Dizziness	None	Nervous system disorders	None	View
Paraesthesia	None	Nervous system disorders	None	View
Hypoaesthesia	None	Nervous system disorders	None	View
Cerebral infarction	None	Nervous system disorders	None	View
Migraine	None	Nervous system disorders	None	View
Amnesia	None	Nervous system disorders	None	View
Dizziness postural	None	Nervous system disorders	None	View
Hemiparesis	None	Nervous system disorders	None	View
Syncope	None	Nervous system disorders	None	View
Cerebellar ataxia	None	Nervous system disorders	None	View
Cervicogenic headache	None	Nervous system disorders	None	View
Peripheral sensory neuropathy	None	Nervous system disorders	None	View
Resting tremor	None	Nervous system disorders	None	View
Nausea	None	Gastrointestinal disorders	None	View
Vomiting	None	Gastrointestinal disorders	None	View
Abdominal pain upper	None	Gastrointestinal disorders	None	View
Constipation	None	Gastrointestinal disorders	None	View
Lumbar vertebral fracture	None	Injury, poisoning and procedural complications	None	View
Rib fracture	None	Injury, poisoning and procedural complications	None	View
Accident	None	Injury, poisoning and procedural complications	None	View
Arthropod bite	None	Injury, poisoning and procedural complications	None	View
Contusion	None	Injury, poisoning and procedural complications	None	View
Femoral neck fracture	None	Injury, poisoning and procedural complications	None	View
Femur fracture	None	Injury, poisoning and procedural complications	None	View
Lip injury	None	Injury, poisoning and procedural complications	None	View
Insomnia	None	Psychiatric disorders	None	View
Anxiety	None	Psychiatric disorders	None	View
Delirium	None	Psychiatric disorders	None	View
Dysthymic disorder	None	Psychiatric disorders	None	View
Hallucination, auditory	None	Psychiatric disorders	None	View
Mood altered	None	Psychiatric disorders	None	View
Sleep disorder	None	Psychiatric disorders	None	View
Vertigo	None	Ear and labyrinth disorders	None	View
Tinnitus	None	Ear and labyrinth disorders	None	View
Vertigo positional	None	Ear and labyrinth disorders	None	View
Otorrhoea	None	Ear and labyrinth disorders	None	View
Haematuria	None	Renal and urinary disorders	None	View
Lymphoma	None	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	None	View
Tooth extraction	None	Surgical and medical procedures	None	View
Polypectomy	None	Surgical and medical procedures	None	View
Benign prostatic hyperplasia	None	Reproductive system and breast disorders	None	View
Erectile dysfunction	None	Reproductive system and breast disorders	None	View
Breast pain	None	Reproductive system and breast disorders	None	View
Anaemia	None	Blood and lymphatic system disorders	None	View