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 @ 11:42 PM
Ignite Modification Date:
2025-12-25 @ 9:34 PM
NCT ID:
NCT02349451
Description:
A TEAE is defined as any AE with onset or worsening reported by a participant from the time that the first dose of adalimumab or ABT-122 is administered until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab or ABT-122 administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
Frequency Threshold:
0
Time Frame:
Treatment-emergent adverse events (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 21 weeks); Serious adverse events (AEs) were collected from the time informed consent was obtained (25.5 weeks).
Study:
NCT02349451
Study Brief:
A Phase 2 Study to Investigate the Safety, Tolerability and Efficacy of ABT-122 in Subjects With Active Psoriatic Arthritis (PsA) Who Have an Inadequate Response to Methotrexate (MTX)
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 EW | Double-blind placebo administered EW for 12 weeks | None | None | 1 | 24 | 10 | 24 | View |
| Adalimumab 40 mg EOW | Double-blind adalimumab 40 mg administered EOW for 12 weeks | None | None | 0 | 72 | 39 | 72 | View |
| ABT-122 120 mg EW | Double-blind ABT-122 120 mg administered EW for 12 weeks | None | None | 0 | 71 | 33 | 71 | View |
| ABT-122 240 mg EW | Double-blind ABT-122 240 mg administered EW for 12 weeks | None | None | 1 | 73 | 33 | 73 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| ROAD TRAFFIC ACCIDENT | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA version 19.1 | View |
| SKIN ABRASION | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA version 19.1 | View |
| UPPER LIMB FRACTURE | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA version 19.1 | View |
| HEART RATE DECREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA version 19.1 | View |
| SYNCOPE | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA version 19.1 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| GRANULOCYTOPENIA | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA version 19.1 | View |
| LEUKOPENIA | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA version 19.1 | View |
| LYMPHADENOPATHY | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA version 19.1 | View |
| LYMPHOCYTOSIS | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA version 19.1 | View |
| LYMPHOPENIA | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA version 19.1 | View |
| PALPITATIONS | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA version 19.1 | View |
| SINUS TACHYCARDIA | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA version 19.1 | View |
| HYDROCELE | SYSTEMATIC_ASSESSMENT | Congenital, familial and genetic disorders | MedDRA version 19.1 | View |
| VERTIGO | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA version 19.1 | View |
| BLEPHARITIS | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA version 19.1 | View |
| ERYTHEMA OF EYELID | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA version 19.1 | View |
| MYOPIA | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA version 19.1 | View |
| RETINAL VASCULAR DISORDER | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA version 19.1 | View |
| ABDOMINAL PAIN | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA version 19.1 | View |
| DIARRHOEA | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA version 19.1 | View |
| DYSPEPSIA | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA version 19.1 | View |
| FOOD POISONING | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA version 19.1 | View |
| GASTROOESOPHAGEAL REFLUX DISEASE | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA version 19.1 | View |
| HAEMATOCHEZIA | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA version 19.1 | View |
| INGUINAL HERNIA | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA version 19.1 | View |
| NAUSEA | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA version 19.1 | View |
| ORAL MUCOSA EROSION | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA version 19.1 | View |
| STOMATITIS | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA version 19.1 | View |
| TOOTHACHE | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA version 19.1 | View |
| VOMITING | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA version 19.1 | View |
| FATIGUE | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA version 19.1 | View |
| GAIT DISTURBANCE | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA version 19.1 | View |
| INFLUENZA LIKE ILLNESS | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA version 19.1 | View |
| INJECTION SITE BRUISING | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA version 19.1 | View |
| INJECTION SITE ERYTHEMA | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA version 19.1 | View |
| INJECTION SITE HAEMATOMA | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA version 19.1 | View |
| INJECTION SITE INDURATION | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA version 19.1 | View |
| INJECTION SITE PAPULE | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA version 19.1 | View |
| INJECTION SITE PRURITUS | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA version 19.1 | View |
| PERIPHERAL SWELLING | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA version 19.1 | View |
| VESSEL PUNCTURE SITE PHLEBITIS | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA version 19.1 | View |
| BILE DUCT OBSTRUCTION | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA version 19.1 | View |
| HYPERBILIRUBINAEMIA | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA version 19.1 | View |
| HYPERTRANSAMINASAEMIA | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA version 19.1 | View |
| ACUTE SINUSITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 19.1 | View |
| BRONCHITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 19.1 | View |
| CONJUNCTIVITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 19.1 | View |
| FOLLICULITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 19.1 | View |
| FURUNCLE | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 19.1 | View |
| GASTROENTERITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 19.1 | View |
| GASTROENTERITIS VIRAL | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 19.1 | View |
| HORDEOLUM | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 19.1 | View |
| INFLUENZA | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 19.1 | View |
| LARYNGITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 19.1 | View |
| NASOPHARYNGITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 19.1 | View |
| ORAL CANDIDIASIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 19.1 | View |
| ORAL HERPES | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 19.1 | View |
| PARONYCHIA | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 19.1 | View |
| PHARYNGITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 19.1 | View |
| PNEUMONIA | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 19.1 | View |
| RHINITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 19.1 | View |
| SINUSITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 19.1 | View |
| SUBCUTANEOUS ABSCESS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 19.1 | View |
| UPPER RESPIRATORY TRACT INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 19.1 | View |
| URINARY TRACT INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 19.1 | View |
| URINARY TRACT INFECTION BACTERIAL | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 19.1 | View |
| VIRAL PHARYNGITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 19.1 | View |
| VIRAL UPPER RESPIRATORY TRACT INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 19.1 | View |
| ANIMAL SCRATCH | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA version 19.1 | View |
| CONTUSION | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA version 19.1 | View |
| FALL | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA version 19.1 | View |
| FOOT FRACTURE | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA version 19.1 | View |
| LIGAMENT RUPTURE | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA version 19.1 | View |
| ROAD TRAFFIC ACCIDENT | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA version 19.1 | View |
| SPINAL COMPRESSION FRACTURE | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA version 19.1 | View |
| SPLINTER | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA version 19.1 | View |
| ALANINE AMINOTRANSFERASE INCREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA version 19.1 | View |
| ASPARTATE AMINOTRANSFERASE INCREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA version 19.1 | View |
| BLOOD CALCIUM INCREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA version 19.1 | View |
| BLOOD CHOLESTEROL INCREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA version 19.1 | View |
| BLOOD PRESSURE INCREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA version 19.1 | View |
| BLOOD TRIGLYCERIDES INCREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA version 19.1 | View |
| BLOOD URIC ACID INCREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA version 19.1 | View |
| BODY TEMPERATURE INCREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA version 19.1 | View |
| CRYSTAL URINE PRESENT | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA version 19.1 | View |
| HAEMOGLOBIN INCREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA version 19.1 | View |
| LYMPHOCYTE COUNT DECREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA version 19.1 | View |
| MONOCYTE COUNT INCREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA version 19.1 | View |
| NEUTROPHIL COUNT DECREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA version 19.1 | View |
| TRANSAMINASES ABNORMAL | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA version 19.1 | View |
| TRANSAMINASES INCREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA version 19.1 | View |
| URINE OUTPUT DECREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA version 19.1 | View |
| WEIGHT INCREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA version 19.1 | View |
| WHITE BLOOD CELL COUNT DECREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA version 19.1 | View |
| DIABETES MELLITUS | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA version 19.1 | View |
| DYSLIPIDAEMIA | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA version 19.1 | View |
| HYPERCHOLESTEROLAEMIA | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA version 19.1 | View |
| HYPERLIPIDAEMIA | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA version 19.1 | View |
| HYPERTRIGLYCERIDAEMIA | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA version 19.1 | View |
| HYPERURICAEMIA | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA version 19.1 | View |
| HYPOGLYCAEMIA | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA version 19.1 | View |
| BACK PAIN | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA version 19.1 | View |
| INTERVERTEBRAL DISC PROTRUSION | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA version 19.1 | View |
| MYALGIA | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA version 19.1 | View |
| OSTEOARTHRITIS | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA version 19.1 | View |
| OSTEOPOROSIS | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA version 19.1 | View |
| ROTATOR CUFF SYNDROME | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA version 19.1 | View |
| SPINAL PAIN | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA version 19.1 | View |
| HEADACHE | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA version 19.1 | View |
| NEUROPATHY PERIPHERAL | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA version 19.1 | View |
| SOMNOLENCE | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA version 19.1 | View |
| ANXIETY | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA version 19.1 | View |
| DEPRESSION | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA version 19.1 | View |
| INSOMNIA | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA version 19.1 | View |
| STRESS | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA version 19.1 | View |
| CRYSTALLURIA | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA version 19.1 | View |
| MICTURITION URGENCY | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA version 19.1 | View |
| POLLAKIURIA | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA version 19.1 | View |
| PROTEINURIA | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA version 19.1 | View |
| CATARRH | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA version 19.1 | View |
| COUGH | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA version 19.1 | View |
| DYSPNOEA | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA version 19.1 | View |
| OROPHARYNGEAL PAIN | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA version 19.1 | View |
| RHINITIS ALLERGIC | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA version 19.1 | View |
| SINUS PAIN | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA version 19.1 | View |
| THROAT IRRITATION | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA version 19.1 | View |
| ACNE | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA version 19.1 | View |
| DERMATITIS ALLERGIC | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA version 19.1 | View |
| ERYTHEMA | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA version 19.1 | View |
| PRURITUS | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA version 19.1 | View |
| PSORIASIS | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA version 19.1 | View |
| RASH | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA version 19.1 | View |
| RASH ERYTHEMATOUS | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA version 19.1 | View |
| ECONOMIC PROBLEM | SYSTEMATIC_ASSESSMENT | Social circumstances | MedDRA version 19.1 | View |
| HYPERTENSION | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA version 19.1 | View |
| PHLEBITIS | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA version 19.1 | View |
| NEUTROPENIA | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA version 19.1 | View |
| INJECTION SITE OEDEMA | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA version 19.1 | View |
| INJURY | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA version 19.1 | View |
| BLOOD CREATININE INCREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA version 19.1 | View |
| PSORIATIC ARTHROPATHY | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA version 19.1 | View |