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 @ 12:55 AM
Ignite Modification Date: 2025-12-25 @ 11:09 PM
NCT ID: NCT00528567
Description: The analysis set was the safety population, defined as all randomized participants who received at least one dose of study drug. Participants who received at least one full or partial dose of bevacizumab were included in the bevacizumab and chemotherapy arm; all others, in the chemotherapy arm. MedDRA (15.0) and MedDRA (17.0) were used.
Frequency Threshold: 5
Time Frame: Through end of study, 30 June 2014
Study: NCT00528567
Study Brief: BEATRICE Study: A Study of Bevacizumab (Avastin) Adjuvant Therapy in Triple Negative Breast 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
Chemotherapy (0-18 Months) Occurring in participants who received chemotherapy alone, during treatment period (0-18 months) after first dose None None 250 1271 1233 1271 View
Chemotherapy (>18 Months) Occurring in participants who received chemotherapy alone, during follow-up period (\>18 months) after first dose None None 48 1271 0 1271 View
Bevacizumab and Chemotherapy (0-18 Months) Occurring in participants who received bevacizumab and chemotherapy, during treatment period (0-18 months) after first dose None None 379 1288 1268 1288 View
Bevacizumab and Chemotherapy (>18 Months) Occurring in participants who received bevacizumab and chemotherapy, during follow-up period (\>18 months) after first dose None None 45 1288 0 1288 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Febrile neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Leukopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Pancytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Febrile bone marrow aplasia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Neutropenic sepsis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Device related infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations None View
Neutropenic infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Diverticulitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Anal abscess SYSTEMATIC_ASSESSMENT Infections and infestations None View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations None View
H1N1 influenza SYSTEMATIC_ASSESSMENT Infections and infestations None View
Otitis externa SYSTEMATIC_ASSESSMENT Infections and infestations None View
Peritonsillitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Pilonidal cyst SYSTEMATIC_ASSESSMENT Infections and infestations None View
Pneumocystis jiroveci pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations None View
Pneumonia bacterial SYSTEMATIC_ASSESSMENT Infections and infestations None View
Post procedural infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Herpes zoster SYSTEMATIC_ASSESSMENT Infections and infestations None View
Mastitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Wound infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Gastroenteritis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Pharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Breast abscess SYSTEMATIC_ASSESSMENT Infections and infestations None View
Breast cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Febrile infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Gastrointestinal infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Lower respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Tooth infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Abscess limb SYSTEMATIC_ASSESSMENT Infections and infestations None View
Abscess oral SYSTEMATIC_ASSESSMENT Infections and infestations None View
Appendicitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Bartholin's abscess SYSTEMATIC_ASSESSMENT Infections and infestations None View
Breast infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Bronchopneumonia SYSTEMATIC_ASSESSMENT Infections and infestations None View
Catheter site cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Catheter site infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Chronic sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Clostridium difficile colitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Cystitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Enterocolitis infectious SYSTEMATIC_ASSESSMENT Infections and infestations None View
Erysipelas SYSTEMATIC_ASSESSMENT Infections and infestations None View
Escherichia sepsis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Gastroenteritis norovirus SYSTEMATIC_ASSESSMENT Infections and infestations None View
Groin abscess SYSTEMATIC_ASSESSMENT Infections and infestations None View
Herpes zoster disseminated SYSTEMATIC_ASSESSMENT Infections and infestations None View
Lymph node abscess SYSTEMATIC_ASSESSMENT Infections and infestations None View
Meningitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Oesophageal candidiasis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Osteomyelitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Postoperative wound infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Pseudomonal sepsis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Rectal abscess SYSTEMATIC_ASSESSMENT Infections and infestations None View
Skin infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Staphylococcal infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Tuberculosis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Stomatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Colitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Pancreatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Anal fistula SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Abdominal pain lower SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Abdominal pain upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Anal fissure SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Caecitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Diverticular perforation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Diverticulitis intestinal haemorrhagic SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Enterocolonic fistula SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Gastric ulcer haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Gastritis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Gastrointestinal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Gastrointestinal inflammation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Gingival ulceration SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Gingivitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Haematochezia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Haemorrhoids SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Inguinal hernia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Intestinal obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Neutropenic colitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Periodontitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Proctitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Rectal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Rectal polyp SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Subileus SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Toothache SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Umbilical hernia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders None View
General physical health deterioration SYSTEMATIC_ASSESSMENT General disorders None View
Chest pain SYSTEMATIC_ASSESSMENT General disorders None View
Non-cardiac chest pain SYSTEMATIC_ASSESSMENT General disorders None View
Chest discomfort SYSTEMATIC_ASSESSMENT General disorders None View
Thrombosis in device SYSTEMATIC_ASSESSMENT General disorders None View
Device damage SYSTEMATIC_ASSESSMENT General disorders None View
Malaise SYSTEMATIC_ASSESSMENT General disorders None View
Pain SYSTEMATIC_ASSESSMENT General disorders None View
Patient-device incompatibility SYSTEMATIC_ASSESSMENT General disorders None View
Adverse drug reaction SYSTEMATIC_ASSESSMENT General disorders None View
Asthenia SYSTEMATIC_ASSESSMENT General disorders None View
Catheter site haematoma SYSTEMATIC_ASSESSMENT General disorders None View
Catheter site inflammation SYSTEMATIC_ASSESSMENT General disorders None View
Catheter site pain SYSTEMATIC_ASSESSMENT General disorders None View
Chills SYSTEMATIC_ASSESSMENT General disorders None View
Device deployment issue SYSTEMATIC_ASSESSMENT General disorders None View
Device dislocation SYSTEMATIC_ASSESSMENT General disorders None View
Device extrusion SYSTEMATIC_ASSESSMENT General disorders None View
Device malfunction SYSTEMATIC_ASSESSMENT General disorders None View
Extravasation SYSTEMATIC_ASSESSMENT General disorders None View
Fatigue SYSTEMATIC_ASSESSMENT General disorders None View
Multi-organ failure SYSTEMATIC_ASSESSMENT General disorders None View
Pulmonary embolism SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pneumothorax SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Bronchospasm SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Nasal septum perforation SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Acute respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Asthma SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Atelectasis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Dyspnoea exertional SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Epistaxis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Haemoptysis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Hyperventilation SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Interstitial lung disease SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Lung disorder SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pharyngeal inflammation SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pleural effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pneumonitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pulmonary artery thrombosis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Vocal cord polyp SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Cardiac failure congestive SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Acute myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Left ventricular dysfunction SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Supraventricular tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Ventricular fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Angina pectoris SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Arrhythmia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Arteriosclerosis coronary artery SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Atrial thrombosis SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Cardiac failure SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Cardio-respiratory arrest SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Cardiogenic shock SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Congestive cardiomyopathy SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Coronary artery disease SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Coronary artery stenosis SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Left ventricular failure SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Mitral valve disease SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Deep vein thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders None View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders None View
Venous thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders None View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders None View
Thrombophlebitis superficial SYSTEMATIC_ASSESSMENT Vascular disorders None View
Arterial thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders None View
Hypertensive crisis SYSTEMATIC_ASSESSMENT Vascular disorders None View
Shock SYSTEMATIC_ASSESSMENT Vascular disorders None View
Venous thrombosis limb SYSTEMATIC_ASSESSMENT Vascular disorders None View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Transient ischaemic attack SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Convulsion SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Posterior reversible encephalopathy syndrome SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Cerebral ischaemia SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Cerebrovascular accident SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Neuropathy peripheral SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Sciatica SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Humerus fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Ligament rupture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Wound complication SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Wound dehiscence SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Ankle fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Cervical vertebral fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Coronary artery restenosis SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Femoral neck fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Forearm fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Head injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Hip fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
In-stent coronary artery restenosis SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Radiation skin injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Radius fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Rib fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Road traffic accident SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Intervertebral disc protrusion SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Arthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Musculoskeletal pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Bone pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Neck pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Osteonecrosis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypokalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Decreased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hyperglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hyponatraemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Menorrhagia SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Vaginal haemorrhage SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Ovarian cyst SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Bartholin's cyst SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Breast cyst SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Breast haematoma SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Endometrial hyperplasia SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Metrorrhagia SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Uterine prolapse SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Vaginal ulceration SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Haemoglobin decreased SYSTEMATIC_ASSESSMENT Investigations None View
Blood pressure decreased SYSTEMATIC_ASSESSMENT Investigations None View
Cytology abnormal SYSTEMATIC_ASSESSMENT Investigations None View
Ejection fraction decreased SYSTEMATIC_ASSESSMENT Investigations None View
Electrocardiogram QT prolonged SYSTEMATIC_ASSESSMENT Investigations None View
Gamma-glutamyltransferase increased SYSTEMATIC_ASSESSMENT Investigations None View
Influenza A virus test positive SYSTEMATIC_ASSESSMENT Investigations None View
Liver function test abnormal SYSTEMATIC_ASSESSMENT Investigations None View
Suicide attempt SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Agitation SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Disorientation SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Cholecystitis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Bile duct stone SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Cholecystitis acute SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Hepatic lesion SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Hepatitis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Hepatitis acute SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Dermatitis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Palmar-plantar erythrodysaesthesia syndrome SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Pruritus generalised SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Rash pruritic SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Skin lesion SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Skin necrosis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Meningioma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Benign breast neoplasm SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Squamous cell carcinoma of skin SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Renal failure acute SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
IGA nephropathy SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Stress urinary incontinence SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Basedow's disease SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Goitre SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Sudden hearing loss SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Hypersensitivity SYSTEMATIC_ASSESSMENT Immune system disorders None View
Cardiac arrest SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA (16.0) View
Acute coronary syndrome SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Angina unstable SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA (16.0) View
Cataract SYSTEMATIC_ASSESSMENT Eye disorders MedDRA (16.0) View
Diplopia SYSTEMATIC_ASSESSMENT Eye disorders None View
Gaze palsy SYSTEMATIC_ASSESSMENT Eye disorders None View
Hyperparathyroidism primary SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA (16.0) View
Crohn's Disease SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Gastrooesophageal reflux disease SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Ileus SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Oesophagitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Lipogranuloma SYSTEMATIC_ASSESSMENT General disorders MedDRA (16.0) View
Oedema peripheral SYSTEMATIC_ASSESSMENT General disorders MedDRA (16.0) View
Salpingo-oophoritis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (16.0) View
Wound abscess SYSTEMATIC_ASSESSMENT Infections and infestations None View
Tonsillitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (16.0) View
Atypical pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (16.0) View
Procedural complication SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (16.0) View
Contusion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (16.0) View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (16.0) View
Fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (16.0) View
Injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (16.0) View
Multiple injuries SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (16.0) View
Periprosthetic fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Pubis fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Radiation pneumonitis SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Tibia fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Wound SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Abortion spontaneous SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions MedDRA (16.0) View
Hyperemesis gravidarum SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions None View
Premature delivery SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions None View
Breast prosthesis implantation SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Hysterectomy SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Rehabilitation therapy SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Intervertebral disc disorder SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (16.0) View
Antiomyolipoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Basal cell carcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Bowen's disease SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Haemangioma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Leiomyoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Oesophageal neoplasm SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Ovarian fibroma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Uterine Leiomyoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Presyncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (16.0) View
Loss of consciousness SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Carpal tunnel syndrome SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Hypoaesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (16.0) View
Hypoxic-ischaemic encephalopathy SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Conversion disorder SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA (16.0) View
Panic attack SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Psychotic disorder SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Calculus ureteric SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Endometriosis SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Adenomyosis SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Breast calcifications SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Breast mass SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Dysfunctional uterine bleeding SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Vaginal prolapse SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Hypertrophic scar SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA (16.0) View
Haematoma SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA (16.0) View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Stomatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Abdominal pain upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Gingival bleeding SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dry mouth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Haemorrhoids SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Alopecia SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Nail disorder SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Erythema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Palmar-Plantar erythrodysaesthesia syndrome SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Dry skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Skin hyperpigmentation SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Fatigue SYSTEMATIC_ASSESSMENT General disorders None View
Asthenia SYSTEMATIC_ASSESSMENT General disorders None View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders None View
Oedema peripheral SYSTEMATIC_ASSESSMENT General disorders None View
Pain SYSTEMATIC_ASSESSMENT General disorders None View
Influenza like illness SYSTEMATIC_ASSESSMENT General disorders None View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Bone pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Dysgeusia SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Neuropathy peripheral SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Peripheral sensory neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Paraesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Leukopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Epistaxis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Oropharyngeal pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Rhinorrhoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Dysphonia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders None View
Hot flush SYSTEMATIC_ASSESSMENT Vascular disorders None View
Lymphoedema SYSTEMATIC_ASSESSMENT Vascular disorders None View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Decreased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Ejection fraction decreased SYSTEMATIC_ASSESSMENT Investigations None View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations None View
Gamma-glutamyltransferase increased SYSTEMATIC_ASSESSMENT Investigations None View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations None View
Weight decreased SYSTEMATIC_ASSESSMENT Investigations None View
Left ventricular dysfunction SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Radiation skin injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Lacrimation increased SYSTEMATIC_ASSESSMENT Eye disorders None View
Proteinuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Breast pain SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Musculoskeletal pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View