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 @ 1:13 PM
Ignite Modification Date: 2025-12-25 @ 12:24 PM
NCT ID: NCT02559895
Description: 2 participants received duplicate randomization, participants are summarized within treatment group for which they actually received treatment.
Frequency Threshold: 5
Time Frame: Baseline to Week 56 (end of study)
Study: NCT02559895
Study Brief: A Multicenter Assessment of ALD403 in Frequent Episodic Migraine
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
300 mg ALD403 Participants received a single 300 mg IV infusion of ALD403 on Days 0, 84 (Week 12), 168 (Week 24) and 252 (Week 36). 0 None 3 224 44 224 View
100 mg ALD403 Participants received a single 100 mg IV infusion of ALD403 on Days 0, 84 (Week 12), 168 (Week 24) and 252 (Week 36). 0 None 4 223 44 223 View
30 mg ALD403 Participants received a single 30 mg IV infusion of ALD403 on Days 0, 84 (Week 12), 168 (Week 24) and 252 (Week 36). 0 None 4 219 44 219 View
Placebo Participants received a single placebo IV infusion on Days 0, 84 (Week 12), 168 (Week 24) and 252 (Week 36). 0 None 6 222 41 222 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Vertigo SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 20.1 View
Cholecystitis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 20.1 View
Hepatic Cholestatic SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 20.1 View
Cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20.1 View
Abdominal Wound Dehiscence SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 20.1 View
Postprocedural Complication SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 20.1 View
Procedural Pain SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 20.1 View
Stomal Hernia SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 20.1 View
Intervertebral Disc Protrusion SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 20.1 View
Rhabdomyolysis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 20.1 View
Benign Breast Neoplasm SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 20.1 View
Breast Cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 20.1 View
Breast Cancer Stage II SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 20.1 View
Migraine SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 20.1 View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 20.1 View
Panic Attack SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 20.1 View
Suicidal Ideation SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 20.1 View
Suicide Attempt SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 20.1 View
Acute Kidney Injury SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 20.1 View
Nephrolithiasis SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 20.1 View
Uterine Prolapse SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 20.1 View
Apnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 20.1 View
Chronic Obstructive Pulmonary Disease SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 20.1 View
Postprocedural Constipation SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 20.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20.1 View
Sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20.1 View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20.1 View