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 @ 5:38 PM
Ignite Modification Date:
2025-12-25 @ 3:08 PM
NCT ID:
NCT04972968
Description:
None
Frequency Threshold:
5
Time Frame:
All-cause mortality were reported from enrollment to the end of study, median time on follow up was 288.5, 292.0, 300.0, and 299.0 Days for Placebo and ABBV-154 (40mg/150mg/340mg), respectively. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug within 70 days after the last dose of study drug; mean duration on study drug was 235.2, 239.9, 234.6 and 230.3 days for Placebo and ABBV-154 (40mg/150mg/340mg), respectively.
Study:
NCT04972968
Study Brief:
A Study to Evaluate the Change in Disease State and Adverse Events in Adult Participants With Polymyalgia Rheumatica (PMR) Dependent on Glucocorticoid Treatment, Receiving Subcutaneous Injections of ABBV-154
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 | Participants received placebo subcutaneously (SC) every other week (eow) for 52 weeks. In addition, participants received a glucocorticoid oral tablet taper. Placebo: Subcutaneous Injection Glucocorticoid: Oral Tablet | 0 | None | 8 | 50 | 27 | 50 | View |
| ABBV-154 40mg SC | Participants in this group received 40mg dose of ABBV-154 SC eow for 52 weeks. In addition, participants received a glucocorticoid oral tablet taper. ABBV-154: Subcutaneous Injection Glucocorticoid: Oral Tablet | 0 | None | 5 | 42 | 25 | 42 | View |
| ABBV-154 150mg SC | Participants in this group received 150mg dose of ABBV-154 SC eow for 52 weeks. In addition, participants received a glucocorticoid oral tablet taper. ABBV-154: Subcutaneous Injection Glucocorticoid: Oral Tablet | 0 | None | 8 | 45 | 30 | 45 | View |
| ABBV-154 340mg SC | Participants in this group received 340mg dose of ABBV-154 SC eow for 52 weeks. In addition, participants received a glucocorticoid oral tablet taper. ABBV-154: Subcutaneous Injection Glucocorticoid: Oral Tablet | 0 | None | 9 | 44 | 37 | 44 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| PNEUMONIA PNEUMOCOCCAL | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.0 | View |
| APPENDICITIS PERFORATED | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.0 | View |
| CELLULITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.0 | View |
| LOWER RESPIRATORY TRACT INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.0 | View |
| RESPIRATORY TRACT INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.0 | View |
| ATRIAL FIBRILLATION | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 26.0 | View |
| CORONARY ARTERY DISEASE | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 26.0 | View |
| LEFT VENTRICULAR FAILURE | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 26.0 | View |
| SUPRAVENTRICULAR TACHYCARDIA | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 26.0 | View |
| VENTRICULAR EXTRASYSTOLES | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 26.0 | View |
| ATRIAL SEPTAL DEFECT | SYSTEMATIC_ASSESSMENT | Congenital, familial and genetic disorders | MedDRA 26.0 | View |
| ABDOMINAL PAIN UPPER | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 26.0 | View |
| INGUINAL HERNIA | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 26.0 | View |
| PANCREATIC PSEUDOCYST | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 26.0 | View |
| PANCREATITIS | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 26.0 | View |
| CHOLANGITIS ACUTE | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 26.0 | View |
| PERITONITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.0 | View |
| PNEUMONIA | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.0 | View |
| SEPSIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.0 | View |
| URINARY TRACT INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.0 | View |
| UROSEPSIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.0 | View |
| DEHYDRATION | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 26.0 | View |
| DIABETES MELLITUS | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 26.0 | View |
| OSTEOARTHRITIS | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | View |
| ACUTE MYELOID LEUKAEMIA | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.0 | View |
| PROSTATE CANCER | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.0 | View |
| DIZZINESS | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 26.0 | View |
| SCIATICA | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 26.0 | View |
| THALAMIC INFARCTION | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 26.0 | View |
| FEMALE GENITAL TRACT FISTULA | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA 26.0 | View |
| DYSPNOEA AT REST | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| NEUTROPENIA | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 26.0 | View |
| DIARRHOEA | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 26.0 | View |
| NAUSEA | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 26.0 | View |
| FATIGUE | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 26.0 | View |
| INJECTION SITE ERYTHEMA | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 26.0 | View |
| INJECTION SITE PAIN | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 26.0 | View |
| INJECTION SITE RASH | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 26.0 | View |
| OEDEMA PERIPHERAL | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 26.0 | View |
| PYREXIA | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 26.0 | View |
| COVID-19 | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.0 | View |
| NASOPHARYNGITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.0 | View |
| UPPER RESPIRATORY TRACT INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.0 | View |
| URINARY TRACT INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 26.0 | View |
| CONTUSION | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 26.0 | View |
| SKIN LACERATION | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 26.0 | View |
| ARTHRALGIA | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | View |
| OSTEOARTHRITIS | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | View |
| ROTATOR CUFF SYNDROME | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 26.0 | View |
| DIZZINESS | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 26.0 | View |
| HEADACHE | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 26.0 | View |
| COUGH | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | View |
| HYPERHIDROSIS | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 26.0 | View |
| RASH | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 26.0 | View |
| HYPERTENSION | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 26.0 | View |