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 @ 7:46 PM
Ignite Modification Date: 2025-12-25 @ 5:23 PM
NCT ID: NCT00515203
Description: The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Frequency Threshold: 5
Time Frame: 12 week treatment period
Study: NCT00515203
Study Brief: Safety and Efficacy Study of Romiplostim (AMG 531) to Treat ITP in Pediatric Subjects
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Placebo None None None 0 5 5 5 View
Romiplostim None None None 1 17 16 17 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Influenza SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 11.0 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.0 View
Abdominal pain upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.0 View
Chapped lips SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.0 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.0 View
Mouth haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.0 View
Toothache SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.0 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.0 View
Chest discomfort SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.0 View
Injection site haematoma SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.0 View
Malaise SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.0 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.0 View
Hypersensitivity SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 11.0 View
Ear infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Herpes simplex SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Skin laceration SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 11.0 View
Spleen palpable SYSTEMATIC_ASSESSMENT Investigations MedDRA 11.0 View
Genital haemorrhage SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 11.0 View
Respiratory tract congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11.0 View
Haemorrhage SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 11.0 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Otitis media SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Contusion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 11.0 View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 11.0 View
Scratch SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 11.0 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 11.0 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 11.0 View
Inguinal mass SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 11.0 View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 11.0 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11.0 View
Emotional disorder SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 11.0 View
Dysuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 11.0 View
Urethral disorder SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 11.0 View
Vaginal discharge SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 11.0 View
Asthma SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11.0 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11.0 View
Dyspnoea exertional SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11.0 View
Epistaxis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11.0 View
Nasal congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11.0 View
Oropharyngeal pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11.0 View
Pharyngeal erythema SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11.0 View
Rhinorrhoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11.0 View
Wheezing SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11.0 View
Erythema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 11.0 View
Hyperhidrosis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 11.0 View
Petechiae SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 11.0 View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 11.0 View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 11.0 View
Rash macular SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 11.0 View
Haematoma SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 11.0 View