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 @ 11:29 PM
Ignite Modification Date:
2025-12-25 @ 9:16 PM
NCT ID:
NCT02119156
Description:
Treatment holiday group had two phases holiday phase was Day 0 visit to Week 24/Treatment Re-start phase and Re-start phase started one day after Week 24 up to Week 52. Non-serious adverse events and SAEs were collected for ITT Population.
Frequency Threshold:
5
Time Frame:
Non-serious adverse events and serious adverse events (SAE) were collected up to 52 weeks for all treatment groups. For Treatment Control and Treatment Holiday Re-start, it also included 16 weeks follow up after the last dose of belimumab for participants who did not continue in Maintenance phase. For Maintenance phase, non-SAE and SAE were collected until Week 48 of subsequent years (Maintenance is Year 2, 3, 4) and includes 16 weeks follow up after last dose of belimumab.
Study:
NCT02119156
Study Brief:
Belimumab Treatment Holiday and Treatment Re-start Study in Lupus Patients
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Treatment Phase: Long-term Discontinuation Group | Participants in this group discontinued belimumab 10 mg/kg therapy for 52 weeks but remained on standard of care therapy. Participants from BEL114333 (NCT01597622), BEL112233 (NCT00724867) and BEL112626 (NCT00583362) were part of this group. Participants had been treated with belimumab for at least 6 months in one of these continuation studies but had withdrawn from belimumab therapy for no longer than 8 weeks prior to entry into this study. | 0 | None | 6 | 39 | 30 | 39 | View |
| Treatment Phase: Treatment Control Group | Participants in this group continued to receive monthly belimumab 10 mg/kg therapy, in addition to standard of care SLE therapy for 52 weeks. Participants from BEL113750 (NCT01345253) and BEL114333 (NCT01597622) were part of this group. Participants had been treated with belimumab for at least 6 months in one of these continuation studies prior to entry into this study. Eligible participants on completion of 52-weeks entered Maintenance period and received belimumab 10 mg/kg every 4 weeks until Week 48 of subsequent years (Maintenance is Year 2, 3, 4). | 0 | None | 2 | 29 | 18 | 29 | View |
| Treatment Phase: Treatment Holiday Group - Holiday Phase | Participants in the Treatment Holiday Group underwent a 24-week belimumab treatment holiday while remaining on standard of care SLE therapy, Holiday Phase was Day 0 visit to Week 24/Treatment Re-start phase. Participants from BEL113750 (NCT01345253) and BEL114333 (NCT01597622) were part of this group. Participants had been treated with belimumab for at least 6 months in one of these continuation studies prior to entry into this study. In the event of a severe flare, participants were allowed to enter Maintenance Phase and receive belimumab 10 mg/Kg every 4 weeks until Week 48 of subsequent years (Maintenance is Year 2, 3, 4). | 0 | None | 0 | 12 | 7 | 12 | View |
| Treatment Phase: Treatment Holiday Group - Re-start Phase | Following Treatment holiday phase for 24 weeks, participants re-started belimumab therapy for 28 weeks while receiving standard of care SLE therapy for 52 weeks. Re-start Phase started one day after Week 24 up to Week 52. Participants from BEL113750 (NCT01345253) and BEL114333 (NCT01597622) were part of this group. Participants had been treated with belimumab for at least 6 months in one of these continuation studies prior to entry into this study. Eligible participants on completion of 52-weeks entered Maintenance period and received belimumab 10 mg/kg every 4 weeks until Week 48 of subsequent years (Maintenance is Year 2, 3, 4). | 0 | None | 1 | 11 | 9 | 11 | View |
| Maintenance Phase: Treatment Control | Participants from BEL113750 (NCT01345253) and BEL114333 (NCT01597622) were part of this group. Eligible participants on completion of 52-weeks entered Maintenance period and received belimumab 10 mg/kg every 4 weeks until Week 48 of subsequent years (Maintenance is Year 2, 3, 4). | 0 | None | 0 | 16 | 4 | 16 | View |
| Maintenance Phase: Treatment Holiday | Participants from BEL113750 (NCT01345253) and BEL114333 (NCT01597622) were part of this group. Eligible participants on completion of 52-weeks entered Maintenance period and received belimumab 10 mg/kg every 4 weeks until Week 48 of subsequent years (Maintenance is Year 2, 3, 4). | 0 | None | 0 | 10 | 8 | 10 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Diarrhoea infectious | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 21.1 | View |
| Pneumonia pseudomonal | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 21.1 | View |
| Sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 21.1 | View |
| Upper respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 21.1 | View |
| Lupus nephritis | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 21.1 | View |
| Pericarditis lupus | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 21.1 | View |
| Generalised oedema | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 21.1 | View |
| Lumbar vertebral fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 21.1 | View |
| Arthritis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 21.1 | View |
| Acute respiratory failure | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | View |
| Chronic obstructive pulmonary disease | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | View |
| Respiratory failure | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | View |
| Skin laceration | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 21.1 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Nasopharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 21.1 | View |
| Upper respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 21.1 | View |
| Sinusitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 21.1 | View |
| Upper respiratory tract infection bacterial | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 21.1 | View |
| Cystitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 21.1 | View |
| Gastroenteritis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 21.1 | View |
| Otitis externa bacterial | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 21.1 | View |
| Urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 21.1 | View |
| Viral upper respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 21.1 | View |
| Arthritis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 21.1 | View |
| Pain in extremity | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 21.1 | View |
| Bursitis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 21.1 | View |
| Musculoskeletal chest pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 21.1 | View |
| Systemic lupus erythematosus | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 21.1 | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 21.1 | View |
| Abdominal pain upper | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 21.1 | View |
| Dental caries | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 21.1 | View |
| Dyspepsia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 21.1 | View |
| Toothache | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 21.1 | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 21.1 | View |
| Periodontal disease | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 21.1 | View |
| Eczema | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 21.1 | View |
| Acne | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 21.1 | View |
| Rash pruritic | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 21.1 | View |
| Dermatitis allergic | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 21.1 | View |
| Dry skin | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 21.1 | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | View |
| Nasal congestion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | View |
| Hypokalaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 21.1 | View |
| Glucose tolerance impaired | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 21.1 | View |
| Hypercholesterolaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 21.1 | View |
| Hyperglycaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 21.1 | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 21.1 | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 21.1 | View |
| Increased tendency to bruise | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 21.1 | View |
| Lymphadenopathy | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 21.1 | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 21.1 | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 21.1 | View |
| Contusion | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 21.1 | View |
| Joint injury | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 21.1 | View |
| Insomnia | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 21.1 | View |
| Deafness | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA 21.1 | View |
| Vertigo | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA 21.1 | View |
| Seasonal allergy | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA 21.1 | View |
| Proteinuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 21.1 | View |
| Chalazion | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 21.1 | View |
| Ocular discomfort | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 21.1 | View |
| Gamma-glutamyltransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 21.1 | View |
| Conjunctivitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 21.1 | View |
| Gingivitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 21.1 | View |
| Herpes zoster | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 21.1 | View |
| Musculoskeletal stiffness | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 21.1 | View |
| Myopathy | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 21.1 | View |
| Intervertebral disc displacement | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 21.1 | View |
| Osteoporosis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 21.1 | View |
| Polymyositis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 21.1 | View |
| Stomatitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 21.1 | View |
| Abdominal discomfort | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 21.1 | View |
| Oropharyngeal pain | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | View |
| Iron deficiency anaemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 21.1 | View |
| Head injury | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 21.1 | View |
| Limb injury | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 21.1 | View |
| Chillblains | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 21.1 | View |
| Cataract | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 21.1 | View |
| Benign neoplasm of skin | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.1 | View |
| Adrenal insufficiency | SYSTEMATIC_ASSESSMENT | Endocrine disorders | MedDRA 21.1 | View |
| Drug eruption | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 21.1 | View |
| Angular cheilitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 21.1 | View |
| Viral myositis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 21.1 | View |
| Tinea versicolour | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 21.1 | View |
| Arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 21.1 | View |
| Back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 21.1 | View |