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 @ 4:32 AM
Ignite Modification Date:
2025-12-26 @ 3:34 AM
NCT ID:
NCT01808118
Description:
TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
Frequency Threshold:
5
Time Frame:
Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration until 70 days after the last dose of study drug (up to 90 weeks).
Study:
NCT01808118
Study Brief:
Continuing Versus Withdrawing Adalimumab in Maintaining Remission in Non-Radiographic Axial Spondyloarthritis
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Double-blind Adalimumab (Period 2) | Adalimumab 40 mg every other week (eow), Weeks 28-68. Blinded adalimumab was discontinued in participants who met the criteria for flare. | 0 | None | 1 | 152 | 57 | 152 | View |
| Open-label (OL) Adalimumab (Period 1), Full Analysis Set | 40 mg every other week (eow), Weeks 0-28. The Full Analysis Set included all participants who enrolled in the open-label period (Period 1) and received at least 1 dose of adalimumab. | 0 | None | 19 | 673 | 221 | 673 | View |
| Placebo (Period 2) | Placebo every other week (eow), Weeks 28-68. Placebo was discontinued in participants who met the criteria for flare. | 0 | None | 10 | 153 | 51 | 153 | View |
| Any Adalimumab Population | The Any Adalimumab Population consisted of all participants who received at least 1 dose of adalimumab any time during the study (including the open-label period, double-blind period and rescue period). | 0 | None | 28 | 673 | 275 | 673 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| VENTRICULAR FIBRILLATION | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 19.1 | View |
| ILEUS | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 19.1 | View |
| APPENDICITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 19.1 | View |
| ATYPICAL PNEUMONIA | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 19.1 | View |
| SEPSIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 19.1 | View |
| CLAVICLE FRACTURE | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 19.1 | View |
| PROCEDURAL PAIN | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 19.1 | View |
| BURSITIS | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | View |
| UTERINE LEIOMYOMA | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.1 | View |
| MIGRAINE | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 19.1 | View |
| OPTIC NEURITIS | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 19.1 | View |
| VAGINAL PROLAPSE | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA 19.1 | View |
| CORONARY ARTERY STENOSIS | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 19.1 | View |
| MYOCARDIAL ISCHAEMIA | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 19.1 | View |
| SINUS TACHYCARDIA | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 19.1 | View |
| PAIN | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 19.1 | View |
| CHOLECYSTITIS ACUTE | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 19.1 | View |
| PNEUMONIA | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 19.1 | View |
| PNEUMONIA LEGIONELLA | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 19.1 | View |
| AXIAL SPONDYLOARTHRITIS | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | View |
| ADENOCARCINOMA GASTRIC | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.1 | View |
| PULMONARY EMBOLISM | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | View |
| ACUTE MYOCARDIAL INFARCTION | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 19.1 | View |
| VIRAL INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 19.1 | View |
| FOOT FRACTURE | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 19.1 | View |
| INTERVERTEBRAL DISC PROTRUSION | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | View |
| INTENTIONAL SELF-INJURY | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 19.1 | View |
| URETHRAL CYST | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 19.1 | View |
| CORONARY ARTERY DISEASE | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 19.1 | View |
| CELLULITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 19.1 | View |
| HEADACHE | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 19.1 | View |
| URETEROLITHIASIS | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 19.1 | View |
| SUBCUTANEOUS ABSCESS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 19.1 | View |
| THYROID ADENOMA | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.1 | View |
| PULMONARY MASS | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | View |
| PYREXIA | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 19.1 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| UPPER RESPIRATORY TRACT INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 19.1 | View |
| DIARRHOEA | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 19.1 | View |
| HEADACHE | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 19.1 | View |
| AXIAL SPONDYLOARTHRITIS | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | View |
| NASOPHARYNGITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 19.1 | View |