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 @ 1:12 AM
Ignite Modification Date: 2025-12-25 @ 11:22 PM
NCT ID: NCT05061693
Description: Adverse events have been reported for members of the Safety Population, comprised of all participants who received at least 1 dose of study drug.
Frequency Threshold: 5
Time Frame: from the time of Informed Consent Form signing until at least 30 days after the last dose of study drug (up to approximately 44 weeks)
Study: NCT05061693
Study Brief: A Study to Evaluate the Efficacy and Safety of INCB054707 in Participants With Prurigo Nodularis
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Povorcitinib 45 mg On Day 1, participants were randomized to receive povorcitinib 45 mg QD and stratified by IGA score (3 versus 4). Participants received blinded study drug through Week 16. 0 None 4 35 19 35 View
Povorcitinib 75 mg On Day 1, participants were randomized to receive povorcitinib 75 mg QD and stratified by IGA score (3 versus 4). Participants received blinded study drug through Week 16. 0 None 3 37 22 37 View
Placebo to Povorcitinib 75 mg Participants who received placebo during the 16-week placebo-controlled period and were classified as non-responders at Week 16 received povorcitinib 75 mg QD for 24 weeks in the extension period. Non-responders were defined as participants not meeting the definition of a responder. 0 None 0 30 15 30 View
Povorcitinib 75 mg to 75 mg Participants who received povorcitinib 75 mg during the 16-week placebo-controlled period and were classified as non-responders at Week 16 received povorcitinib 75 mg QD for an additional 24 weeks in the extension period. Non-responders were defined as participants not meeting the definition of a responder. 0 None 3 18 13 18 View
Povorcitinib 15 mg On Day 1, participants were randomized to receive povorcitinib 15 milligrams (mg) QD and stratified by IGA score (3 versus 4). Participants received blinded study drug through Week 16. 1 None 2 36 17 36 View
Placebo On Day 1, participants were randomized to receive matching placebo once daily (QD) and stratified by Investigator's Global Assessment (IGA) score (3 versus 4). Participants received blinded study drug through Week 16. 0 None 1 37 14 37 View
Placebo to Povorcitinib 45 mg Participants who received placebo during the 16-week placebo-controlled period and were classified as responders at Week 16 received povorcitinib 45 mg QD for 24 weeks in the extension period. Responders were defined as participants who had a ≥4-point decrease in Itch Numerical Rating Scale (NRS) score and Investigator's Global Assessment-Treatment Success (IGA-TS) who did not receive rescue therapy during the placebo-controlled period. 0 None 0 1 0 1 View
Povorcitinib 15 mg to 45 mg Participants who received povorcitinib 15 mg during the 16-week placebo-controlled period and were classified as responders at Week 16 received povorcitinib 45 mg QD for 24 weeks in the extension period. Responders were defined as participants who had a ≥4-point decrease in Itch NRS score and IGA-TS who did not receive rescue therapy during the placebo-controlled period. 0 None 0 4 3 4 View
Povorcitinib 45 mg to 45 mg Participants who received povorcitinib 45 mg during the 16-week placebo-controlled period and were classified as responders at Week 16 received povorcitinib 45 mg QD for an additional 24 weeks in the extension period. Responders were defined as participants who had a ≥4-point decrease in Itch NRS score and IGA-TS who did not receive rescue therapy during the placebo-controlled period. 0 None 0 8 5 8 View
Povorcitinib 75 mg to 45 mg Participants who received povorcitinib 75 mg during the 16-week placebo-controlled period and were classified as responders at Week 16 received povorcitinib 45 mg QD for 24 weeks in the extension period. Responders were defined as participants who had a ≥4-point decrease in Itch NRS score and IGA-TS who did not receive rescue therapy during the placebo-controlled period. 0 None 1 15 6 15 View
Povorcitinib 15 mg to 75 mg Participants who received povorcitinib 15 mg during the 16-week placebo-controlled period and were classified as non-responders at Week 16 received povorcitinib 75 mg QD for 24 weeks in the extension period. Non-responders were defined as participants not meeting the definition of a responder. 0 None 1 25 15 25 View
Povorcitinib 45 mg to 75 mg Participants who received povorcitinib 45 mg during the 16-week placebo-controlled period and were classified as non-responders at Week 16 received povorcitinib 75 mg QD for 24 weeks in the extension period. Non-responders were defined as participants not meeting the definition of a responder. 0 None 2 23 13 23 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Abdominal pain upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27 View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 27 View
Appendicitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27 View
COVID-19 SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27 View
Colitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27 View
Death SYSTEMATIC_ASSESSMENT General disorders MedDRA 27 View
Erysipelas SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27 View
Hidradenitis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 27 View
Intervertebral disc protrusion SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 27 View
Mastitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27 View
Myopathy SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 27 View
Nasal septum deviation SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 27 View
Neurodermatitis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 27 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27 View
Tooth infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27 View
Transient ischaemic attack SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 27 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Asthma SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 27 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 27 View
Blepharitis SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 27 View
Blood creatine phosphokinase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 27 View
Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27 View
COVID-19 SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27 View
Cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27 View
Chest pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 27 View
Contusion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 27 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 27 View
Cystitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27 View
Dermatitis contact SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 27 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 27 View
Dry mouth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27 View
Dry skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 27 View
Ear discomfort SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 27 View
Epistaxis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 27 View
Eyelid folliculitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 27 View
Folliculitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27 View
Gastroenteritis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27 View
Gastrointestinal infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27 View
Haemoglobin decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 27 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 27 View
Herpes simplex SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27 View
Hypercholesterolaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 27 View
Hyperhidrosis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 27 View
Hyperkalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 27 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 27 View
Influenza SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27 View
Joint capsule rupture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 27 View
Lichen myxoedematosus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 27 View
Loose tooth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27 View
Migraine SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 27 View
Muscle strain SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 27 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27 View
Neurodermatitis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 27 View
Oral candidiasis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27 View
Oral herpes SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27 View
Perioral dermatitis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 27 View
Platelet count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 27 View
Pollakiuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 27 View
Polyneuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 27 View
Presyncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 27 View
Pulpitis dental SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27 View
Rosacea SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 27 View
Sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27 View
Skin candida SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27 View
Skin infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27 View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 27 View
Tonsillitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27 View
Tooth infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27 View
Trichoglossia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27 View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27 View
Urinary incontinence SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 27 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27 View
Vertigo SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 27 View
Weight increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 27 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27 View
Abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27 View
Animal scratch SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 27 View
Ankylosing spondylitis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 27 View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 27 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 27 View
Blood lactate dehydrogenase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 27 View
Conjunctivitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27 View
Erythema multiforme SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 27 View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 27 View
Heavy menstrual bleeding SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 27 View
Hypokalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 27 View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 27 View
Muscle spasms SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 27 View
Myelocyte count increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 27 View
Platelet count increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 27 View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 27 View
Seasonal allergy SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 27 View
Seizure SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 27 View
Staphylococcal infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27 View
Thermal burn SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 27 View
Transient ischaemic attack SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 27 View
Vitamin D deficiency SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 27 View
Oropharyngeal pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 27 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27 View
Sinus tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 27 View
Aspergillus test positive SYSTEMATIC_ASSESSMENT Investigations MedDRA 27 View