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 @ 7:15 PM
Ignite Modification Date: 2025-12-25 @ 4:52 PM
NCT ID: NCT00569803
Description: Study initiated: December 2007 Study completed: August 2008 Participants underwent regularly scheduled investigator assessments and clinical laboratory evaluations as described in the study protocol.
Frequency Threshold: 5
Time Frame: From Day 1 until 30 days post discontinuation of dosing, up to August 2008 (approximately 8 months)
Study: NCT00569803
Study Brief: Subcutaneous Pharmacokinetics of Belatacept
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Belatacept 50mg SC Belatacept 50 mg subcutaneous (SC) injection into anterior thigh, 0.4 mL injection volume None None 0 5 2 5 View
Belatacept 100mg SC Belatacept 100 mg SC injection into anterior thigh, 0.8 mL injection volume None None 0 5 3 5 View
Belatacept 125mg SC Belatacept 125 mg SC injection into anterior thigh, 1.0 mL injection volume None None 0 5 3 5 View
Belatacept 150mg SC Participants received 2 SC injections of 75 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection. None None 0 6 4 6 View
Belatacept 200mg SC Participants received 2 SC injections of 100 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection. None None 0 5 2 5 View
Belatacept 250mg SC Participants received 2 SC injections of 125 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection. None None 0 5 2 5 View
Belatacept 125mg IV 125 mg Belatacept intravenous (IV) injection None None 0 10 7 10 View
All Belatacept All participants treated with IV or SC Belatacept of any dose None None 0 41 23 41 View
PLACEBO Subcutaneous injection of placebo solution (product ID: 224818-N000- 029) None None 0 6 1 6 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11.0 View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 11.0 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.0 View
Arthropod sting SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 11.0 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.0 View
Injection site inflammation SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.0 View
Joint sprain SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 11.0 View
Oedema peripheral SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.0 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Mass SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.0 View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 11.0 View
Paraesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11.0 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.0 View
Gynaecomastia SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 11.0 View
Nasal congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11.0 View
Sinus headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11.0 View
Abdominal distension SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.0 View
Pharyngolaryngeal pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11.0 View
Rhinitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11.0 View
Muscle contractions involuntary SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.0 View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 11.0 View
Aphthous stomatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.0 View
Dermatitis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 11.0 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11.0 View
Eye irritation SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 11.0 View
Feeling hot SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.0 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Viral infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View