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 @ 4:25 AM
Ignite Modification Date:
2025-12-26 @ 3:28 AM
NCT ID:
NCT03978520
Description:
TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on treatment was 286.1 days, 289.8 days, 297.7 days, 226.4 days, and 228.6 days, for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
Frequency Threshold:
5
Time Frame:
All-cause mortality is reported from enrollment to end of study; median time on follow-up was 337.0 days, 337.0 days, 338.5 days, 281.0 days, and 295.0 days for the placebo, ABBV-599 High Dose, upadacitinib, ABBV-599 Low Dose, and elsubrutinib groups, respectively.
Study:
NCT03978520
Study Brief:
A Study to Investigate the Safety and Efficacy of Elsubrutinib and Upadacitinib Given Alone or in Combination in Participants With Moderately to Severely Active Systemic Lupus Erythematosus (SLE)
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Elsubrutinib Placebo/Upadacitinib Placebo | Placebo capsule for elsubrutinib once a day by mouth for up to 48 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for up to 48 weeks | 0 | None | 13 | 75 | 39 | 75 | View |
| ABBV-599 High Dose (Elsubrutinib 60 mg/Upadacitinib 30 mg) | 60 mg elsubrutinib capsule once a day by mouth for up to 48 weeks; 30 mg upadacitinib film-coated tablet once a day by mouth for up to 48 weeks | 2 | None | 7 | 68 | 38 | 68 | View |
| Elsubrutinib Placebo/Upadacitinib 30 mg | Placebo capsule for elsubrutinib once a day by mouth for up to 48 weeks; 30 mg upadacitinib film-coated tablet once a day by mouth for up to 48 weeks | 0 | None | 13 | 62 | 35 | 62 | View |
| ABBV-599 Low Dose (Elsubrutinib 60 mg/Upadacitinib 15 mg) | 60 mg elsubrutinib capsule once a day by mouth for up to 24 weeks; 15 mg upadacitinib film-coated tablet once a day by mouth for up to 24 weeks | 0 | None | 9 | 69 | 28 | 69 | View |
| Elsubrutinib 60 mg/Upadacitinib Placebo | 60 mg elsubrutinib capsule once a day by mouth for up to 24 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for up to 24 weeks | 2 | None | 7 | 67 | 36 | 67 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| ACUTE MYOCARDIAL INFARCTION | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 25.0 | View |
| PERICARDIAL EFFUSION | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 25.0 | View |
| STRESS CARDIOMYOPATHY | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 25.0 | View |
| DYSPHAGIA | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 25.0 | View |
| GASTRITIS | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 25.0 | View |
| OESOPHAGITIS | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 25.0 | View |
| ACCIDENTAL DEATH | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 25.0 | View |
| ABSCESS LIMB | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.0 | View |
| COVID-19 | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.0 | View |
| COVID-19 PNEUMONIA | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.0 | View |
| DISSEMINATED VARICELLA ZOSTER VIRUS INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.0 | View |
| DIVERTICULITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.0 | View |
| ENDOCARDITIS BACTERIAL | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.0 | View |
| ESCHERICHIA SEPSIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.0 | View |
| GASTROENTERITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.0 | View |
| GASTROENTERITIS VIRAL | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.0 | View |
| HERPES ZOSTER | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.0 | View |
| MENINGITIS TUBERCULOUS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.0 | View |
| MYCOPLASMA INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.0 | View |
| OESOPHAGEAL CANDIDIASIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.0 | View |
| PELVIC ABSCESS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.0 | View |
| PNEUMOCYSTIS JIROVECII PNEUMONIA | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.0 | View |
| PNEUMONIA | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.0 | View |
| PNEUMONIA FUNGAL | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.0 | View |
| PNEUMONIA PNEUMOCOCCAL | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.0 | View |
| PNEUMONIA RESPIRATORY SYNCYTIAL VIRAL | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.0 | View |
| SEPSIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.0 | View |
| FALL | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 25.0 | View |
| JOINT INJURY | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 25.0 | View |
| TIBIA FRACTURE | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 25.0 | View |
| SYSTEMIC LUPUS ERYTHEMATOSUS DISEASE ACTIVITY INDEX INCREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 25.0 | View |
| DIABETES MELLITUS | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 25.0 | View |
| OSTEONECROSIS | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | View |
| SYSTEMIC LUPUS ERYTHEMATOSUS | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | View |
| CENTRAL NERVOUS SYSTEM LUPUS | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 25.0 | View |
| CEREBROVASCULAR ACCIDENT | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 25.0 | View |
| MIGRAINE | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 25.0 | View |
| RUPTURED CEREBRAL ANEURYSM | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 25.0 | View |
| SPINAL CORD COMPRESSION | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 25.0 | View |
| SUBARACHNOID HAEMORRHAGE | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 25.0 | View |
| BIPOLAR DISORDER | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 25.0 | View |
| ACUTE KIDNEY INJURY | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 25.0 | View |
| LUPUS NEPHRITIS | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 25.0 | View |
| NEPHROLITHIASIS | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 25.0 | View |
| URETEROLITHIASIS | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 25.0 | View |
| BREAST MASS | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA 25.0 | View |
| ACUTE RESPIRATORY FAILURE | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | View |
| EPISTAXIS | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | View |
| PNEUMONITIS | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | View |
| ABORTION INDUCED | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA 25.0 | View |
| HYPERTENSIVE URGENCY | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 25.0 | View |
| VENOUS THROMBOSIS LIMB | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 25.0 | View |
| NEUTROPENIA | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 25.0 | View |
| THROMBOCYTOPENIA | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 25.0 | View |
| URINARY TRACT INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.0 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| DIARRHOEA | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 25.0 | View |
| GASTRITIS | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 25.0 | View |
| VOMITING | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 25.0 | View |
| FATIGUE | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 25.0 | View |
| BRONCHITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.0 | View |
| COVID-19 | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.0 | View |
| NASOPHARYNGITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.0 | View |
| ORAL HERPES | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.0 | View |
| UPPER RESPIRATORY TRACT INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.0 | View |
| WEIGHT INCREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 25.0 | View |
| ARTHRALGIA | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | View |
| BACK PAIN | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | View |
| HEADACHE | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 25.0 | View |
| INSOMNIA | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 25.0 | View |
| ACNE | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 25.0 | View |
| CONSTIPATION | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 25.0 | View |
| NAUSEA | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 25.0 | View |
| PYREXIA | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 25.0 | View |
| HERPES ZOSTER | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.0 | View |
| URINARY TRACT INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 25.0 | View |