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 @ 12:16 AM
Ignite Modification Date: 2025-12-25 @ 10:19 PM
NCT ID: NCT05073458
Description: For safety analysis, participants who transitioned from treatment with placebo to treatment with parsaclisib 2.5 milligrams (mg) once daily (QD) in the the open-label treatment period and the long-term extension period have been counted both in the placebo arm and the parsaclisib arm.
Frequency Threshold: 5
Time Frame: up to 446 days
Study: NCT05073458
Study Brief: Study of the Efficacy and Safety of Parsaclisib in Participants With Primary Warm Autoimmune Hemolytic Anemia
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 Participants received matching placebo QD for 24 weeks during the double-blind treatment period. Participants who completed the double-blind treatment period, tolerated study treatment, and, in the investigator's opinion, benefited from treatment had the option of continuing into an open-label treatment period for 24 weeks of parsaclisib 2.5 mg QD, and then the long-term extension period to receive parsaclisib 2.5 mg QD for up to 2 years. Participants may have received parsaclisib before reaching Week 24. 0 None 0 6 4 6 View
Parsaclisib Participants received parsaclisib 2.5 milligrams (mg) once daily (QD) for 24 weeks during the double-blind treatment period. Participants who completed the double-blind treatment period, tolerated study treatment, and, in the investigator's opinion, benefited from treatment had the option of continuing into an open-label treatment period for an additional 24 weeks of parsaclisib 2.5 mg QD, and then the long-term extension period to receive parsaclisib 2.5 mg QD for up to 2 years. 0 None 6 11 10 11 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Immune-mediated enterocolitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 27 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27 View
Haemoglobin decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 27 View
Cholecystitis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 27 View
Colitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27 View
Abdominal pain lower SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27 View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 27 View
Alopecia SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 27 View
Amnesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 27 View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 27 View
Dysuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 27 View
Embolism SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 27 View
Erythema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 27 View
Faeces soft SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27 View
Flatulence SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27 View
Gastritis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27 View
Haemorrhoidal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 27 View
Hot flush SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 27 View
Hyperglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 27 View
Influenza like illness SYSTEMATIC_ASSESSMENT General disorders MedDRA 27 View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 27 View
Iron overload SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 27 View
Lymphopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 27 View
Micturition disorder SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 27 View
Mood altered SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 27 View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 27 View
Neutrophil count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 27 View
Oedema SYSTEMATIC_ASSESSMENT General disorders MedDRA 27 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27 View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 27 View
Rash erythematous SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 27 View
Respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27 View
Skin abrasion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 27 View
Asthenia SYSTEMATIC_ASSESSMENT General disorders MedDRA 27 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 27 View
Blood alkaline phosphatase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 27 View
Blood potassium decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 27 View
C-reactive protein increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 27 View
COVID-19 SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27 View
Catarrh SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 27 View
Choluria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 27 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 27 View
Cytomegalovirus infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27 View
Decreased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 27 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27 View
Gamma-glutamyltransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 27 View
Oedema peripheral SYSTEMATIC_ASSESSMENT General disorders MedDRA 27 View