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 @ 3:48 PM
Ignite Modification Date:
2025-12-25 @ 1:56 PM
NCT ID:
NCT03222492
Description:
None
Frequency Threshold:
5
Time Frame:
Adverse events were collected from the time a participant signed informed consent until study completion (week 48) or until 30 days after a participant withdrew early from the study.
Study:
NCT03222492
Study Brief:
Brentuximab Vedotin for Systemic Sclerosis
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| 0.6 mg/kg Brentuximab Vedotin | Participants receive intravenous administration of 0.6 mg/kg Brentuximab Vedotin every 3 weeks for 21 weeks, for a total of 8 doses. | 0 | None | 1 | 6 | 6 | 6 | View |
| 0.6 mg/kg Placebo | Participants receive intravenous administration of 0.6 mg/kg of a 0.9% Normal Saline solution every 3 weeks for 21 weeks, for a total of 8 doses. | 0 | None | 0 | 2 | 2 | 2 | View |
| 1.2 mg/kg Brentuximab Vedotin | Participants receive intravenous administration of 1.2 mg/kg Brentuximab Vedotin every 3 weeks for 21 weeks, for a total of 8 doses. | 0 | None | 2 | 7 | 6 | 7 | View |
| 1.2 mg/kg Placebo | Participants receive intravenous administration of 1.2 mg/kg of a 0.9% Normal Saline solution every 3 weeks for 21 weeks, for a total of 8 doses. | 0 | None | 0 | 2 | 0 | 2 | View |
| Brentuximab Vedotin in Pooled Participants | Participants receive intravenous administration of Brentuximab Vedotin every 3 weeks for 21 weeks, for a total of 8 doses. | 0 | None | 3 | 13 | 12 | 13 | View |
| Placebo in Pooled Participants | Participants receive intravenous administration of a 0.9% Normal Saline solution every 3 weeks for 21 weeks, for a total of 8 doses. | 0 | None | 0 | 4 | 2 | 4 | View |
Serious Events(If Any):
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Rash | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | 17.1 | View |
| Skin ulcer | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | 17.1 | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | 17.1 | View |
| Eosinophilia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | 17.1 | View |
| Lymphopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | 17.1 | View |
| Ventricular arrhythmia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | 17.1 | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 17.1 | View |
| Mouth ulceration | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 17.1 | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | 17.1 | View |
| Bronchitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | 17.1 | View |
| COVID-19 | SYSTEMATIC_ASSESSMENT | Infections and infestations | 17.1 | View |
| Helicobacter infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | 17.1 | View |
| Impetigo | SYSTEMATIC_ASSESSMENT | Infections and infestations | 17.1 | View |
| Oesophageal candidiasis | SYSTEMATIC_ASSESSMENT | Infections and infestations | 17.1 | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | 17.1 | View |
| Sinusitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | 17.1 | View |
| Tooth abscess | SYSTEMATIC_ASSESSMENT | Infections and infestations | 17.1 | View |
| Upper respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | 17.1 | View |
| Forced expiratory volume decreased | SYSTEMATIC_ASSESSMENT | Investigations | 17.1 | View |
| Forced vital capacity decreased | SYSTEMATIC_ASSESSMENT | Investigations | 17.1 | View |
| Lung diffusion test decreased | SYSTEMATIC_ASSESSMENT | Investigations | 17.1 | View |
| Lymphocyte count decreased | SYSTEMATIC_ASSESSMENT | Investigations | 17.1 | View |
| Weight increased | SYSTEMATIC_ASSESSMENT | Investigations | 17.1 | View |
| Abnormal loss of weight | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | 17.1 | View |
| Hypoalbuminaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | 17.1 | View |
| Hypokalaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | 17.1 | View |
| Arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | 17.1 | View |
| Arthritis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | 17.1 | View |
| Osteoporosis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | 17.1 | View |
| Synovitis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | 17.1 | View |
| Depression | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | 17.1 | View |
| Azotaemia | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | 17.1 | View |
| Chronic kidney disease | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | 17.1 | View |
| Gynaecomastia | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | 17.1 | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 17.1 | View |
| Productive cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 17.1 | View |
| Sleep apnoea syndrome | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 17.1 | View |
| Eczema | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | 17.1 | View |
| Psoriasis | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | 17.1 | View |
| Anaemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | 17.1 | View |