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 @ 3:31 PM
Ignite Modification Date: 2025-12-25 @ 1:45 PM
NCT ID: NCT04067492
Description: The safety population included all subjects who received at least one dose of the investigational product. This population was used for all treatment safety assessments. The safety analysis of data was performed based on the actual treatment received by the patients.
Frequency Threshold: 0
Time Frame: The safety of the investigational product was assessed over a 60-day period of therapy and follow-up. The tables show AEs that developed from the start of therapy.
Study: NCT04067492
Study Brief: Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Evaluation of RPH-104 Administered at Different Doses to Patients With Acute Gout Attack
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
RPH - 20 mg RPH-104, 20 mg, subcutaneous single-dose injection. 0.5 mL of 40 mg/mL RPH-104 solution is injected. 0 None 0 6 1 6 View
RPH - 40 mg RPH-104, 40 mg, subcutaneous single-dose injection. 1 mL of 40 mg/mL RPH-104 solution is injected. 0 None 0 6 3 6 View
RPH - 80 mg RPH-104, 80 mg, subcutaneous single-dose injection. 2 mL (whole vial) of 40 mg/mL RPH-104 solution is injected. 0 None 2 6 3 6 View
RPH - 160 mg RPH-104, 160 mg, two subcutaneous injections of 80 mg administered at different injection sites. 1 vial of 2mL 40 mg/mL solution per each site 0 None 0 5 4 5 View
RPH - 4 mg RPH-104, 4 mg, subcutaneous single-dose injection. 0.1 mL of 40 mg/mL RPH-104 solution is injected. 0 None 0 15 11 15 View
Voltaren® (Diclofenac) Voltaren® (diclofenac) orally with water at the dose 50 mg thrice daily for 3 days (150 mg total daily dose), then 25 mg thrice daily for 9 days (75 mg total daily dose) (Voltaren®: Enteric-coated tablets, 25 mg and 50 mg) 0 None 1 9 2 9 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Mycobacterium tuberculosis complex test positive SYSTEMATIC_ASSESSMENT Investigations MedDRA 22.1 View
pulmonary fibrosis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 22.1 View
drug-induced liver injury SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 22.1 View
Cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Leukocytosis SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 22.1 View
Sinus bradycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 22.1 View
Sinus tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 22.1 View
Diverticulum intestinal SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 22.1 View
Gastric disorder SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 22.1 View
Gastrointestinal scarring SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 22.1 View
Gastrooesophageal reflux disease SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 22.1 View
Pancreatitis chronic SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 22.1 View
Administration site haemorrhage SYSTEMATIC_ASSESSMENT General disorders MedDRA 22.1 View
Asthenia SYSTEMATIC_ASSESSMENT General disorders MedDRA 22.1 View
Injection site erythema SYSTEMATIC_ASSESSMENT General disorders MedDRA 22.1 View
Injection site pruritus SYSTEMATIC_ASSESSMENT General disorders MedDRA 22.1 View
Pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 22.1 View
Cholecystitis chronic SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 22.1 View
Genitourinary chlamydia infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22.1 View
Mycoplasma infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22.1 View
Ureaplasma infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22.1 View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 22.1 View
Bilirubin conjugated increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 22.1 View
Blood bilirubin increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 22.1 View
Blood cholesterol increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 22.1 View
Blood creatinine increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 22.1 View
Blood triglycerides increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 22.1 View
Blood urea increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 22.1 View
Blood uric acid increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 22.1 View
C-reactive protein increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 22.1 View
Creatinine renal clearance decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 22.1 View
Gamma-glutamyltransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 22.1 View
Hepatic enzyme increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 22.1 View
Lymphocyte count increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 22.1 View
Mycobacterium tuberculosis complex test positive SYSTEMATIC_ASSESSMENT Investigations MedDRA 22.1 View
Neutrophil count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 22.1 View
Neutrophil percentage decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 22.1 View
Hyperglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 22.1 View
Type 2 diabetes mellitus SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 22.1 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 22.1 View
Arthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 22.1 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 22.1 View
Gouty arthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 22.1 View
Joint swelling SYSTEMATIC_ASSESSMENT Investigations MedDRA 22.1 View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 22.1 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 22.1 View
Daydreaming SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 22.1 View
Haematuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 22.1 View
Micturition disorder SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 22.1 View
Nephrolithiasis SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 22.1 View
Proteinuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 22.1 View
Balanoposthitis SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 22.1 View
Dermatitis allergic SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 22.1 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 22.1 View