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 @ 10:59 PM
Ignite Modification Date: 2025-12-25 @ 8:28 PM
NCT ID: NCT00886769
Description: None
Frequency Threshold: 4
Time Frame: None
Study: NCT00886769
Study Brief: Single-dose Study to Assess Efficacy of Canakinumab (ACZ885) in Patients With Active Juvenile Idiopathic Arthritis (SJIA)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Canakinumab Patients received a single dose of subcutaneous(sc) injection of canakinumab (4 mg/kg) on Day 1. Maximal total single dose of canakinumab allowed was 300 mg. Any patient who required a dose greater than 150 mg (patients\>37.5 kg) received two sc injections. None None 2 43 17 43 View
Placebo Patients received a single dose matching placebo of canakinumab on day 1. None None 2 41 3 41 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Leukopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA (Unspecified) View
Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA (Unspecified) View
Hepatitis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA (Unspecified) View
Bronchopneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (Unspecified) View
Varicella SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (Unspecified) View
Gastroenteritis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (Unspecified) View
Histiocytosis haematophagic SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA (Unspecified) View
Rash maculo-papular SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA (Unspecified) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (Unspecified) View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (Unspecified) View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA (Unspecified) View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (Unspecified) View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (Unspecified) View
Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (Unspecified) View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (Unspecified) View