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: 2025-12-25 @ 3:11 AM
Ignite Modification Date: 2025-12-26 @ 1:50 AM
NCT ID: NCT00844805
Description: The Safety Population consisted of all participants who received at least one dose of study medication.
Frequency Threshold: 5
Time Frame: Up to Week 52.
Study: NCT00844805
Study Brief: Infliximab for Treatment of Axial Spondyloarthritis (P05336 AM1)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Infliximab + Naproxen Infliximab administered at a dose of 5 mg/kg intravenously on Day 1 of Weeks 0, 2, 6, 12, 18, and 24, combined with naproxen administered at a daily dose of 1000 mg for 28 weeks during the 28-week treatment phase. None None 6 105 24 105 View
Placebo + Naproxen Placebo administered intravenously on Day 1 of Weeks 0, 2, 6, 12, 18, and 24, combined with naproxen administered at a daily dose of 1000 mg for 28 weeks, during the 28-week treatment phase. None None 3 52 8 52 View
Naproxen For participants who achieved remission during 28-week treatment phase, naproxen was continued at a daily dose of 1000 mg administered orally for an additional 24 weeks in the follow-up phase. None None 0 41 6 41 View
No Treatment For participants who achieved remission during Treatment phase, no treatment was administered for an additional 24 weeks in the follow-up phase. None None 3 41 11 41 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 14.1 View
Chest Discomfort SYSTEMATIC_ASSESSMENT General disorders MedDRA 14.1 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 14.1 View
Tuberculosis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 14.1 View
Ankylosing Spondylitis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 14.1 View
Breast Cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 14.1 View
Carcinoma In Situ SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 14.1 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 14.1 View
Foetal Distress Syndrome SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions MedDRA 14.1 View
Pregnancy SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions MedDRA 14.1 View
Uterine Hypotonus SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions MedDRA 14.1 View
Ovarian Cyst Ruptured SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 14.1 View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 14.1 View
Dermatitis Atopic SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 14.1 View
Hepatic Enzyme Increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 14.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Abdominal Pain Upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 14.1 View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 14.1 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 14.1 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 14.1 View
Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 14.1 View
Rhinitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 14.1 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 14.1 View