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 @ 5:47 PM
Ignite Modification Date:
2025-12-25 @ 3:14 PM
NCT ID:
NCT00993668
Description:
None
Frequency Threshold:
5
Time Frame:
Adverse Event (AE) data summarized in the first two columns refer to the 6-week Single-Blind (SB) period of the study. The final column refers to AE data collected on subjects who received Cimzia at any time during the study (up to 42 weeks).
Study:
NCT00993668
Study Brief:
Assessing the Use of Certolizumab Pegol in Adult Subjects With Rheumatoid Arthritis on the Antibody Response When Receiving Influenza Virus and Pneumococcal Vaccines
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Placebo (Single Blind) | Placebo - Two 0.9% saline subcutaneous injections at Week 0, Week 2, and Week 4 | None | None | 1 | 114 | 29 | 114 | View |
| Cimzia (Single Blind) | Certolizumab pegol - Two 200 mg subcutaneous injections at Week 0, Week 2, and Week 4 | None | None | 2 | 110 | 22 | 110 | View |
| Cimzia at Any Time | Certolizumab pegol (at any time) - Subjects randomized to receive Certolizumab pegol (CZP) during the single blind (SB) period will receive two subcutaneous (sc) injections of SB CZP 200 mg at Weeks 0, 2, and 4 followed by one sc injection of Open-Label (OL) CZP 200 mg from Week 6 until last drug administration (up to Week 32). Subjects randomized to placebo during the SB period will receive two 0.9% saline sc injections at Week 0, Week 2, and Week 4, followed by two sc injections of OL CZP 200 mg at Weeks 6, 8 and 10, then one sc injection of CZP 200 mg every two weeks from Week 12 until last drug administration (up to Week 32). | None | None | 15 | 219 | 155 | 219 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Cardiac Failure Congestive | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (13.1) | View |
| Cardiogenic Shock | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (13.1) | View |
| Atrial Fibrillation | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (13.1) | View |
| Myocardial Infarction | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (13.1) | View |
| Diarrhoea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (13.1) | View |
| Small Intestinal Obstruction | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (13.1) | View |
| Abdominal Pain | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (13.1) | View |
| Vomiting | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (13.1) | View |
| Chest Pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (13.1) | View |
| Pneumonia | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (13.1) | View |
| Bronchitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (13.1) | View |
| Latent Tuberculosis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (13.1) | View |
| Pulmonary Tuberculosis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (13.1) | View |
| Gastroenteritis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (13.1) | View |
| Cellulitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (13.1) | View |
| Chest Wall Abscess | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (13.1) | View |
| Intervertebral Disc Protrusion | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (13.1) | View |
| Bladder Cancer | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (13.1) | View |
| Squamous Cell Carcinoma | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (13.1) | View |
| Chordoma | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (13.1) | View |
| Depressed Level Of Consciousness | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (13.1) | View |
| Syncope | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (13.1) | View |
| Carotid Artery Stenosis | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (13.1) | View |
| Transient Ischaemic Attack | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (13.1) | View |
| Endometriosis | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA (13.1) | View |
| Bronchial Hyperreactivity | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (13.1) | View |
| Chronic Obstructive Pulmonary Disease | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (13.1) | View |
| Pulmonary Granuloma | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (13.1) | View |
| Acute Respiratory Failure | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (13.1) | View |
| Acne | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (13.1) | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Nausea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (13.1) | View |
| Diarrhoea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (13.1) | View |
| Fatigue | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (13.1) | View |
| Pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (13.1) | View |
| Nasopharyngitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (13.1) | View |
| Upper Respiratory Tract Infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (13.1) | View |
| Oropharyngeal Pain | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (13.1) | View |
| Sinusitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (13.1) | View |
| Urinary Tract Infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (13.1) | View |
| Bronchitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (13.1) | View |
| Back Pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (13.1) | View |
| Pain In Extremity | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (13.1) | View |
| Rheumatoid Arthritis | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (13.1) | View |
| Arthralgia | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (13.1) | View |
| Headache | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (13.1) | View |
| Dizziness | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (13.1) | View |
| Cough | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (13.1) | View |
| Sinus Congestion | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (13.1) | View |
| Rash | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (13.1) | View |