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 @ 3:16 PM
Ignite Modification Date: 2025-12-25 @ 1:37 PM
NCT ID: NCT03524092
Description: All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.
Frequency Threshold: 5
Time Frame: Up To 40 Weeks
Study: NCT03524092
Study Brief: A Maintenance Study of Mirikizumab in Participants With Moderately to Severely Active Ulcerative Colitis
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Maintenance Period: Miri IR - 200 mg Miri SC Participants who were responders to blinded mirikizumab at Week 12 in induction study (LUCENT-1) randomized to continue to receive 200 mg mirikizumab SC Q4W from Week 0 of LUCENT-2 until Week 40 or until loss of response was confirmed. 0 None 13 389 90 389 View
Maintenance Period: PBO IR - PBO SC Participants who were responders to blinded placebo at Week 12 in induction study (LUCENT-1) continue to receive blinded placebo SC Q4W from Week 0 of LUCENT-2 until Week 40 or until loss of response was confirmed. 0 None 7 135 37 135 View
Loss of Response (LOR) Rescue Period:LOR Cohort-300 mg Miri IV Participants who received blinded PBO SC or blinded 200 mg mirikizumab SC Q4W during maintenance period and experienced a loss of response at or after Week 12, received rescue therapy with open label 300 mg mirikizumab intravenous (IV) Q4W for 3 doses. 0 None 3 90 13 90 View
Extended Induction: Induction Nonresponders - 300mg Miri IV Participants who were nonresponders to blinded mirikizumab or placebo in induction study (LUCENT-1), received additional 3 doses of open label 300 mg mirikizumab IV Q4W during extended induction period from Week 0 of LUCENT-2 until Week 12. 0 None 21 461 44 461 View
Maintenance Period: Miri IR - PBO SC Participants who were responders to blinded mirikizumab (miri) at Week 12 in induction study (LUCENT-1) randomized to withdraw from mirikizumab and start receiving PBO SC every 4 weeks (Q4W) from Week 0 of maintenance study (LUCENT-2) until Week 40 or until loss of response was confirmed. 1 None 15 192 57 192 View
Open Label Maintenance: Delayed Responders - 200 mg Miri SC Participants who initially did not respond to induction study (LUCENT-1), but responded to extended induction therapy at Week 12 of LUCENT-2 (delayed responders), received 200 mg mirikizumab SC Q4W during open label maintenance period from Week 12 until Week 40 or until early termination (rescue was not available for these participants). 0 None 8 271 54 271 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Immune thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 24.1 View
Acute coronary syndrome SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 24.1 View
Autoimmune thyroiditis SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 24.1 View
Maculopathy SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 24.1 View
Retinal detachment SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 24.1 View
Colitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.1 View
Colitis ulcerative SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.1 View
Ileus SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.1 View
Inguinal hernia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.1 View
Large intestine perforation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.1 View
Peptic ulcer SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.1 View
Pneumoperitoneum SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.1 View
Rectal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.1 View
Rectal polyp SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.1 View
Anaphylactic reaction SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 24.1 View
Appendicitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
Bacillus infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
Campylobacter gastroenteritis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
Cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
Covid-19 SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
Covid-19 pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
Cytomegalovirus colitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
Diverticulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
Escherichia infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
Gastroenteritis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
Influenza SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
Klebsiella infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
Large intestine infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
Subcutaneous abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
Tonsillitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
Brain contusion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24.1 View
Patella fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24.1 View
Road traffic accident SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24.1 View
Spinal compression fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24.1 View
Blood glucose increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.1 View
Hypoglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 24.1 View
Hypokalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 24.1 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24.1 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24.1 View
Intervertebral disc protrusion SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24.1 View
Sacral pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24.1 View
Adenocarcinoma of colon SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 24.1 View
Gastric cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 24.1 View
Kaposi's sarcoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 24.1 View
Lipoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 24.1 View
Rectal cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 24.1 View
Ischaemic stroke SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.1 View
Migraine SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.1 View
Presyncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.1 View
Depression suicidal SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 24.1 View
Neurologic somatic symptom disorder SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 24.1 View
Nephrolithiasis SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 24.1 View
Ureterolithiasis SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 24.1 View
Rectocele SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 24.1 View
Asthma SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.1 View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 24.1 View
Colectomy total SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 24.1 View
Retinopexy SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 24.1 View
Tooth extraction SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 24.1 View
Deep vein thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 24.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 24.1 View
Colitis ulcerative SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.1 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.1 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24.1 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.1 View