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 @ 7:55 PM
Ignite Modification Date:
2025-12-25 @ 5:30 PM
NCT ID:
NCT02087904
Description:
Safety population: all participants who took at least one dose of study drug.
Frequency Threshold:
5
Time Frame:
up to Week 52 (or last dose of study drug) plus 70 days
Study:
NCT02087904
Study Brief:
A Study Evaluating the Safety, Efficacy, and Pharmacodynamic Effects of ABT-981 in Patients With Knee Osteoarthritis
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| ABT-981 25 mg | 25 mg ABT-981 SC E2W | None | None | 11 | 89 | 63 | 89 | View |
| ABT-981 100 mg | 100 mg ABT-981 SC E2W | None | None | 8 | 85 | 65 | 85 | View |
| ABT-981 200 mg | 200 mg ABT-981 SC E2W | None | None | 4 | 88 | 75 | 88 | View |
| Placebo | Matching placebo SC E2W | None | None | 8 | 85 | 66 | 85 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| ADRENAL HAEMORRHAGE | SYSTEMATIC_ASSESSMENT | Endocrine disorders | 19.0 | View |
| COLITIS | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 19.0 | View |
| ENTERITIS | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 19.0 | View |
| ENTEROCOLITIS | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 19.0 | View |
| PANCREATITIS | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 19.0 | View |
| SMALL INTESTINAL OBSTRUCTION | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 19.0 | View |
| CHOLECYSTITIS | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | 19.0 | View |
| LIVER DISORDER | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | 19.0 | View |
| APPENDICITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | 19.0 | View |
| DIVERTICULITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | 19.0 | View |
| PERITONITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | 19.0 | View |
| PNEUMONIA | SYSTEMATIC_ASSESSMENT | Infections and infestations | 19.0 | View |
| URINARY TRACT INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | 19.0 | View |
| ANKLE FRACTURE | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | 19.0 | View |
| CERVICAL VERTEBRAL FRACTURE | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | 19.0 | View |
| CONCUSSION | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | 19.0 | View |
| FALL | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | 19.0 | View |
| HIP FRACTURE | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | 19.0 | View |
| HUMERUS FRACTURE | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | 19.0 | View |
| JOINT INJURY | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | 19.0 | View |
| LACERATION | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | 19.0 | View |
| PROCEDURAL INTESTINAL PERFORATION | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | 19.0 | View |
| RADIUS FRACTURE | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | 19.0 | View |
| ROAD TRAFFIC ACCIDENT | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | 19.0 | View |
| SKULL FRACTURE | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | 19.0 | View |
| TIBIA FRACTURE | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | 19.0 | View |
| UPPER LIMB FRACTURE | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | 19.0 | View |
| BACK PAIN | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | 19.0 | View |
| OSTEOARTHRITIS | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | 19.0 | View |
| BASAL CELL CARCINOMA | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 19.0 | View |
| COLON ADENOMA | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 19.0 | View |
| INVASIVE DUCTAL BREAST CARCINOMA | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 19.0 | View |
| LUNG CANCER METASTATIC | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 19.0 | View |
| AQUEDUCTAL STENOSIS | SYSTEMATIC_ASSESSMENT | Nervous system disorders | 19.0 | View |
| BRAIN OEDEMA | SYSTEMATIC_ASSESSMENT | Nervous system disorders | 19.0 | View |
| CEREBRAL HAEMORRHAGE | SYSTEMATIC_ASSESSMENT | Nervous system disorders | 19.0 | View |
| HYDROCEPHALUS | SYSTEMATIC_ASSESSMENT | Nervous system disorders | 19.0 | View |
| PARKINSON'S DISEASE | SYSTEMATIC_ASSESSMENT | Nervous system disorders | 19.0 | View |
| SEIZURE | SYSTEMATIC_ASSESSMENT | Nervous system disorders | 19.0 | View |
| SYNCOPE | SYSTEMATIC_ASSESSMENT | Nervous system disorders | 19.0 | View |
| NEPHROLITHIASIS | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | 19.0 | View |
| ALVEOLITIS ALLERGIC | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 19.0 | View |
| ASTHMA | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 19.0 | View |
| DYSPNOEA | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 19.0 | View |
| HYPERTENSION | SYSTEMATIC_ASSESSMENT | Vascular disorders | 19.0 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| NEUTROPENIA | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | 19.0 | View |
| DIARRHOEA | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 19.0 | View |
| NAUSEA | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 19.0 | View |
| FATIGUE | SYSTEMATIC_ASSESSMENT | General disorders | 19.0 | View |
| INJECTION SITE ERYTHEMA | SYSTEMATIC_ASSESSMENT | General disorders | 19.0 | View |
| INJECTION SITE PAIN | SYSTEMATIC_ASSESSMENT | General disorders | 19.0 | View |
| INJECTION SITE RASH | SYSTEMATIC_ASSESSMENT | General disorders | 19.0 | View |
| INJECTION SITE REACTION | SYSTEMATIC_ASSESSMENT | General disorders | 19.0 | View |
| PAIN | SYSTEMATIC_ASSESSMENT | General disorders | 19.0 | View |
| BRONCHITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | 19.0 | View |
| INFLUENZA | SYSTEMATIC_ASSESSMENT | Infections and infestations | 19.0 | View |
| NASOPHARYNGITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | 19.0 | View |
| SINUSITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | 19.0 | View |
| UPPER RESPIRATORY TRACT INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | 19.0 | View |
| URINARY TRACT INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | 19.0 | View |
| CONTUSION | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | 19.0 | View |
| FALL | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | 19.0 | View |
| LIGAMENT SPRAIN | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | 19.0 | View |
| NEUTROPHIL COUNT DECREASED | SYSTEMATIC_ASSESSMENT | Investigations | 19.0 | View |
| ARTHRALGIA | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | 19.0 | View |
| BACK PAIN | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | 19.0 | View |
| MUSCULOSKELETAL PAIN | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | 19.0 | View |
| MYALGIA | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | 19.0 | View |
| PAIN IN EXTREMITY | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | 19.0 | View |
| DIZZINESS | SYSTEMATIC_ASSESSMENT | Nervous system disorders | 19.0 | View |
| HEADACHE | SYSTEMATIC_ASSESSMENT | Nervous system disorders | 19.0 | View |
| COUGH | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 19.0 | View |
| OROPHARYNGEAL PAIN | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 19.0 | View |
| PRURITUS | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | 19.0 | View |
| RASH | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | 19.0 | View |
| HYPERTENSION | SYSTEMATIC_ASSESSMENT | Vascular disorders | 19.0 | View |