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 @ 4:08 AM
Ignite Modification Date:
2025-12-26 @ 3:04 AM
NCT ID:
NCT00329420
Description:
For the fifth column, 'Total 2', this presents the data summarized in 'Total 1' PLUS adverse event data from the double-blind main study for subjects who received certolizumab pegol (CZP) in the main study and then entered this extension study (i.e., up to 44 weeks).
Frequency Threshold:
5
Time Frame:
Adverse event data summarized in the first four columns were collected from the day after the end of the double-blind main study up to and including 12 weeks following the last dose received in this extension study for each subject (i.e., up to 36 weeks).
Study:
NCT00329420
Study Brief:
Maintenance Study Including Re-induction Therapy for Patients Who Did Not Show a Clinical Effect in Study C87037 (NCT00291668)
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| CZP 400 mg / Placebo | Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668) | None | None | 1 | 18 | 15 | 18 | View |
| CZP 400 mg / CZP 200 mg | Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668) | None | None | 3 | 13 | 10 | 13 | View |
| CZP 400 mg / CZP 400 mg | Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668) | None | None | 4 | 15 | 13 | 15 | View |
| Total 1 (This Extension Study Only) | This includes all adverse event data collected in this extension study for all 46 subjects who entered this extension study. | None | None | 8 | 46 | 38 | 46 | View |
| Total 2 (Treatment With CZP in Main Study and Extension Study) | This includes all adverse event data from the 6-week double-blind main study (N00291668) and this extension study for all 46 subjects who entered this extension study C87048, whilst they were receiving treatment with certolizumab pegol (CZP) in either study. Adverse events recorded in the double-blind main study (NCT00291668) for subjects who received Placebo treatment during that study are not included here. | None | None | 8 | 46 | 40 | 46 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Osteomalacia | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 9.0 | View |
| Perianal abscess | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 9.0 | View |
| Psychotic disorder | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 9.0 | View |
| Pulmonary tuberculosis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 9.0 | View |
| Suicide attempt | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 9.0 | View |
| Tetany | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 9.0 | View |
| Crohn's disease | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 9.0 | View |
| Electrolyte imbalance | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 9.0 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Abdominal pain lower | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 9.0 | View |
| Abdominal pain upper | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 9.0 | View |
| Alopecia | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 9.0 | View |
| Anaemia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 9.0 | View |
| Anaphylactic reaction | NON_SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA 9.0 | View |
| Anorexia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 9.0 | View |
| Blood calcium decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 9.0 | View |
| Blood potassium decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 9.0 | View |
| Chest pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 9.0 | View |
| Contusion | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 9.0 | View |
| Cough | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 | View |
| Crohn's disease | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 9.0 | View |
| Cystitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 9.0 | View |
| DNA antibody positive | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 9.0 | View |
| Dental caries | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 9.0 | View |
| Depressive symptom | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 9.0 | View |
| Dermatitis atopic | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 9.0 | View |
| Dizziness postural | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 9.0 | View |
| Dry skin | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 9.0 | View |
| Duodenal ulcer | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 9.0 | View |
| Dyspnoea | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 | View |
| Ear discomfort | NON_SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA 9.0 | View |
| Eczema | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 9.0 | View |
| Eczema asteatotic | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 9.0 | View |
| Electrolyte imbalance | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 9.0 | View |
| Emotional distress | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 9.0 | View |
| Excoriation | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 9.0 | View |
| Fall | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 9.0 | View |
| Foot fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 9.0 | View |
| Gastroduodenitis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 9.0 | View |
| Haemoglobin decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 9.0 | View |
| Headache | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 9.0 | View |
| Hepatic function abnormal | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 9.0 | View |
| Herpes zoster | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 9.0 | View |
| Hypoaesthesia | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 9.0 | View |
| Hypoalbuminaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 9.0 | View |
| Influenza | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 9.0 | View |
| Initial insomnia | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 9.0 | View |
| Injection site eyrthema | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 9.0 | View |
| Insomnia | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 9.0 | View |
| Loss of consciousness | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 9.0 | View |
| Malaise | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 9.0 | View |
| Muscle tightness | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 9.0 | View |
| Nasopharyngitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 9.0 | View |
| Nausea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA | View |
| Ocular hyperaemia | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 9.0 | View |
| Palpitations | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 9.0 | View |
| Paronychia | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 9.0 | View |
| Perianal abscess | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 9.0 | View |
| Periodontitis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 9.0 | View |
| Pharyngitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 9.0 | View |
| Pharyngolaryngeal pain | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 | View |
| Pneumothorax | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 | View |
| Pruritus | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 9.0 | View |
| Pulpitis dental | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 9.0 | View |
| Pyrexia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 9.0 | View |
| Rhinitis allergic | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 | View |
| Rib fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 9.0 | View |
| Salivary gland disorder | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 9.0 | View |
| Stomatitis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 9.0 | View |
| Swelling | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 9.0 | View |
| Tachycardia | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 9.0 | View |
| Toothache | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 9.0 | View |
| Upper respiratory tract inflammation | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 | View |
| Urinary tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 9.0 | View |
| Vitamin D deficiency | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 9.0 | View |
| Vomiting | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 9.0 | View |
| White blood cell count decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 9.0 | View |