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: 2025-12-24 @ 10:48 PM
Ignite Modification Date: 2025-12-25 @ 8:18 PM
NCT ID: NCT02464969
Description: Serious and non-serious adverse events were collected for safety population that includes all randomized participants who received at least one dose of study drug. All cause mortality was collected for all the randomized participants.
Frequency Threshold: 5
Time Frame: Non-Serious adverse events were collected from first dose Day 1 up to end of treatment visit (Day 168) plus 35 days i.e., up to 203 days. Serious Adverse Events and all cause mortality was collected from Screening (Day -7) to end of treatment visit (Day 168) plus 35 days i.e., up to 210 days.
Study: NCT02464969
Study Brief: Apixaban for the Acute Treatment of Venous Thromboembolism in Children
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Participants Receiving Apixaban Participants between birth to \<18 years were dosed on a body weight tiered regimen. Subjects ≥35kg received 10mg twice daily(BID) for 7 days followed by 5mg BID thereafter;\<35kg to 25kg received 8mg BID for 7 days followed by 4mg BID thereafter;\<25 to 18kg received 6mg BID for 7 days and then 3mg BID thereafter;\<18 to 12kg received 4mg BID for 7 days and then 2mg BID thereafter;\<12 to 9kg received 3mg BID for 7 days and then 1.5mg BID thereafter;\< 9kg to 6kg received 2 mg BID for 7 days and 1mg BID thereafter;\<6kg to 5kg received 1mg BID for 7 days and 0.5mg BID thereafter;\<5kg to 4kg received 0.6mg twice daily for 7 days and 0.3mg BID thereafter; For sub group analysis, PK cohort neonates ≥ 2.6kg received 0.1mg BID. Dose was adjusted as determined by PK measurements (i.e., to 0.2mg BID, 0.1mg daily or dose stay the same).For the post PK cohort Neonates ˂4kg to 2.6kg, if confirmed by PK sub analysis ,participants received 0.2mg BID for 7 days and 0.1mg BID thereafter. 2 None 40 152 132 152 View
Participants Treated With Standard of Care Participants were treated with unfractionated heparin, low molecular weight heparin, and/or a vitamin K antagonist. For participants under 2 years of age, standard of care was limited to unfractionated heparin or low molecular weight heparin. 1 None 17 73 59 73 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Cold type haemolytic anaemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA v26.1 View
Febrile neutropenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA v26.1 View
Myelosuppression NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA v26.1 View
Neutropenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA v26.1 View
Pancytopenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA v26.1 View
Sickle cell anaemia with crisis NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA v26.1 View
Thrombocytopenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA v26.1 View
Cardiac arrest NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA v26.1 View
Cardio-respiratory arrest NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA v26.1 View
Cardiogenic shock NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA v26.1 View
Eye movement disorder NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA v26.1 View
Abdominal pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v26.1 View
Colitis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v26.1 View
Constipation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v26.1 View
Gastrointestinal pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v26.1 View
Gastrooesophageal reflux disease NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v26.1 View
Haematemesis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v26.1 View
Haematochezia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v26.1 View
Ileus paralytic NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v26.1 View
Oesophagitis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v26.1 View
Small intestinal obstruction NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v26.1 View
Stomatitis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v26.1 View
Chest pain NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA v26.1 View
Death NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA v26.1 View
Mucosal inflammation NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA v26.1 View
Multiple organ dysfunction syndrome NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA v26.1 View
Non-cardiac chest pain NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA v26.1 View
Peripheral swelling NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA v26.1 View
Pyrexia NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA v26.1 View
Drug-induced liver injury NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA v26.1 View
Atypical pneumonia NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v26.1 View
Cellulitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v26.1 View
Device related bacteraemia NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v26.1 View
Escherichia pyelonephritis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v26.1 View
Escherichia urinary tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v26.1 View
Gastroenteritis rotavirus NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v26.1 View
Infective pulmonary exacerbation of cystic fibrosis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v26.1 View
Meningitis bacterial NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v26.1 View
Osteomyelitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v26.1 View
Pneumonia viral NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v26.1 View
Pseudomonal bacteraemia NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v26.1 View
Pyomyositis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v26.1 View
Rhinovirus infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v26.1 View
Sepsis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v26.1 View
Toxic shock syndrome NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v26.1 View
Upper respiratory tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v26.1 View
Urinary tract infection bacterial NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v26.1 View
Varicella NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v26.1 View
Gun shot wound NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA v26.1 View
Incisional hernia NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA v26.1 View
Lower limb fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA v26.1 View
Shunt thrombosis NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA v26.1 View
Suture rupture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA v26.1 View
Alanine aminotransferase increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA v26.1 View
Blood urea increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA v26.1 View
Medical observation NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA v26.1 View
Weight increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA v26.1 View
Connective tissue disorder NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA v26.1 View
Cytarabine syndrome NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA v26.1 View
Embryonal rhabdomyosarcoma NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA v26.1 View
Cerebral venous sinus thrombosis NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA v26.1 View
Complex regional pain syndrome NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA v26.1 View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA v26.1 View
Hypoxic-ischaemic encephalopathy NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA v26.1 View
Seizure NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA v26.1 View
Thoracic outlet syndrome NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA v26.1 View
Transient ischaemic attack NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA v26.1 View
Device malfunction NON_SYSTEMATIC_ASSESSMENT Product Issues MedDRA v26.1 View
Depression NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA v26.1 View
Munchausen's syndrome NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA v26.1 View
Selective eating disorder NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA v26.1 View
Acute kidney injury NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA v26.1 View
Nephrotic syndrome NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA v26.1 View
Heavy menstrual bleeding NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA v26.1 View
Acute chest syndrome NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v26.1 View
Acute respiratory distress syndrome NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v26.1 View
Dyspnoea NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v26.1 View
Hyperventilation NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v26.1 View
Pleural effusion NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v26.1 View
Pneumomediastinum NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v26.1 View
Pulmonary embolism NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v26.1 View
Respiratory failure NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v26.1 View
Axillary vein thrombosis NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA v26.1 View
Post thrombotic syndrome NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA v26.1 View
Subclavian vein thrombosis NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA v26.1 View
Superficial vein thrombosis NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA v26.1 View
Transplant rejection NON_SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA v26.1 View
Mycoplasma infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v26.1 View
Intracranial pressure increased NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA v26.1 View
Polyuria NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA v26.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Anaemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA v26.1 View
Leukopenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA v26.1 View
Thrombocytopenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA v26.1 View
Abdominal discomfort NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v26.1 View
Abdominal pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v26.1 View
Abdominal pain upper NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v26.1 View
Constipation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v26.1 View
Diarrhoea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v26.1 View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v26.1 View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v26.1 View
Fatigue NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA v26.1 View
Injection site bruising NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA v26.1 View
Injection site haemorrhage NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA v26.1 View
Non-cardiac chest pain NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA v26.1 View
Pyrexia NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA v26.1 View
Upper respiratory tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v26.1 View
Contusion NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA v26.1 View
Hypokalaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA v26.1 View
Arthralgia NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA v26.1 View
Back pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA v26.1 View
Pain in extremity NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA v26.1 View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA v26.1 View
Heavy menstrual bleeding NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA v26.1 View
Cough NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v26.1 View
Dyspnoea NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v26.1 View
Epistaxis NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v26.1 View
Nasal congestion NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v26.1 View
Oropharyngeal pain NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v26.1 View