Adverse Events Module

Home Icon Home Search Icon Search Certify Doc Icon Certify Doc Certify Doc Icon Genes Certify Doc Icon Clinical Trials Certify Doc Icon CompTox Processes Icon DrugMatrix Open Targets Icon Open Targets Processes Icon Products Support Icon Support Bugs Icon Bugs
Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug
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 @ 1:56 PM
Ignite Modification Date: 2025-12-25 @ 12:44 PM
NCT ID: NCT04596995
Description: Treatment-emergent AEs are defined as AEs starting after the time of first investigational medicinal product (IMP) administration up to and including 8 weeks (56 days) after the final dose. TEAEs were analyzed for Safety Set.
Frequency Threshold: 5
Time Frame: From Baseline to end of Safety Follow-Up Period (up to Week 60)
Study: NCT04596995
Study Brief: A Study to Investigate the Long-term Safety, Tolerability, and Efficacy of Rozanolixizumab in Study Participants With Persistent or Chronic Primary Immune Thrombocytopenia (ITP)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Rozanolixizumab In TP0004, participants received a fixed unit dose of rozanolixizumab sc infusion at the assigned dose level in the parent studies (TP0003 and TP0006), for one year, starting from Day 1 (which corresponds to Week 25 of the parent studies). The dose of rozanolixizumab could be increased or decreased based upon the platelet count and across body weight tiers. 0 None 9 43 31 43 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Pyrexia NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA v24.0 View
Immune thrombocytopenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA v24.0 View
COVID-19 NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v24.0 View
Joint dislocation NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA v24.0 View
Radius fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA v24.0 View
Platelet count decreased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA v24.0 View
Leiomyoma NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA v24.0 View
Uterine haemorrhage NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA v24.0 View
Purpura NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA v24.0 View
Skin haemorrhage NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA v24.0 View
Haemorrhage NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA v24.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Anaemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA v24.0 View
Diarrhoea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v24.0 View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v24.0 View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v24.0 View
Fatigue NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA v24.0 View
Pyrexia NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA v24.0 View
COVID-19 NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v24.0 View
Pharyngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v24.0 View
Upper respiratory tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v24.0 View
Contusion NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA v24.0 View
Body temperature increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA v24.0 View
Pain in extremity NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA v24.0 View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA v24.0 View
Petechiae NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA v24.0 View
Rash NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA v24.0 View