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 @ 7:19 PM
Ignite Modification Date: 2025-12-25 @ 4:58 PM
NCT ID: NCT01824303
Description: None
Frequency Threshold: 5
Time Frame: None
Study: NCT01824303
Study Brief: Safety, Tolerability and Efficacy Study of LiRIS® 400 mg in Women With Interstitial Cystitis
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
LiRIS 400 mg_Randomized Study LiRIS 400 mg: investigational drug-delivery system which contains Lidocaine; the system remains in the bladder for 14 days in the randomized study. None None 0 16 11 16 View
LiRIS Placebo_Randomized Study LiRIS Placebo: investigational drug-delivery system which contains Lactose and no Lidocaine; the system remains in the bladder for 14 days in the randomized study. None None 0 14 12 14 View
LiRIS 400 mg_Open Label Extension LiRIS 400 mg: investigational drug-delivery system which contains Lidocaine; the system remains in the bladder for 14 days in the randomized study then LiRIS 400 mg in the Open Label Extension. None None 0 12 6 12 View
LiRIS Placebo/LiRIS 400 mg _Open Label Extension LiRIS Placebo: investigational drug-delivery system which contains Lactose and no Lidocaine; the system remains in the bladder for 14 days in the randomized study then LiRIS 400 mg in the Open Label Extension. None None 0 11 6 11 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Dysuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 15.1 View
Bladder pain SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 15.1 View
Bladder discomfort SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 15.1 View
Pollakiuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 15.1 View
Haematuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 15.1 View
Urethral pain SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 15.1 View
Bladder spasm SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 15.1 View
Cystitis interstitial SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 15.1 View
Micturition urgency SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 15.1 View
Nocturia SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 15.1 View
Urinary incontinence SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 15.1 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.1 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.1 View
Cystitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.1 View
Genital herpes SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.1 View
Sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.1 View
Tooth abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.1 View
Allergy to arthropod bite SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 15.1 View
Allergy to arthropod sting SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 15.1 View
Blood creatine phosphokinase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 15.1 View
Residual urine volume increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 15.1 View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 15.1 View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 15.1 View
Dysfunctional uterine bleeding SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 15.1 View
Pelvic discomfort SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 15.1 View
Vaginal haemorrhage SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 15.1 View
Dermatitis contact SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 15.1 View
Dry skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 15.1 View
Conjunctivitis SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 15.1 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.1 View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 15.1 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 15.1 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 15.1 View
Fungal infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.1 View
Lower respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.1 View
Tonsillitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.1 View
Vulvovaginal mycotic infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.1 View
Urethritis noninfective SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 15.1 View
Abdominal pain lower SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.1 View
Vitamin D decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 15.1 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.1 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.1 View
Migraine SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.1 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 15.1 View
Pallor SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 15.1 View
Burning sensation SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.1 View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 15.1 View