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 @ 9:25 PM
Ignite Modification Date:
2025-12-25 @ 7:10 PM
NCT ID:
NCT03822832
Description:
Double blind period: Safety Analysis Set (SAF): patients who were randomised, and received at least one dose during the trial.
Open label period: Open label period: Safety analysis set in the open-label treatment period (SAF-OL): This patient set includes all randomized patients who received at least one dose of study drug and received study medication after re-allocation visit (i.e., after Week 16 visit).
Frequency Threshold:
5
Time Frame:
Double blind period: Baseline to the last study drug administration date + REP (16 weeks). For patients who initiated the open label treatment the REP was shortened to the date of first open label treatment administration. Up to a total time frame of 28 weeks. Open label period: Week 16 to the last study drug administration date + REP (16 weeks), or end-of-study date, whichever occurred earlier. Up to a total time frame of 28 weeks (up to week 44).
Study:
NCT03822832
Study Brief:
A Study in Patients With Atopic Eczema to Test How Effective BI 655130 is and How Well it is Tolerated
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 (Week 1-16) and if no Treatment, Week 16-28 | Placebo intravenous (i.v.) infusion in the double blind period from baseline to Week 12 (inclusive) - the drug administered 4 times in total. At Week 16 patients were assessed based on their Eczema Area and Severity Index (EASI) score. Patients with EASI\>=75 were classified as responders and were followed-up from Week 16 to 28, although receiving no further treatment. Patients with EASI\<75 were classified as nonresponders and were offered 600mg Spesolimab treatment in the open label period from Week 16 to 28. | 0 | None | 1 | 18 | 10 | 18 | View |
| Spesolimab (Week 1-16) and no Treatment (Week 16-28) | 600mg Spesolimab (BI 655130) intravenous (i.v.) infusion in the double blind period from baseline to Week 12 (inclusive) - the drug administered 4 times in total. At Week 16 patients were assessed based on their Eczema Area and Severity Index (EASI) score. Patients with EASI\>=75 were classified as responders and were followed-up from Week 16 to 28, although receiving no further treatment. Patients with EASI\<75 were classified as non-responders and were offered 600mg Spesolimab treatment in the open label period from Week 16 to 28. | 0 | None | 3 | 33 | 16 | 33 | View |
| Spesolimab (Open Label Period, Week 16-44) | Following the double blind period (week 0 to 16) patients were assessed based on their Eczema Area and Severity Index (EASI) score, patients with EASI\<75 were classified as nonresponders and were offered an open label treatment with 600 mg Spesolimab (BI 655130) i.v. infusion once every 4 weeks from week 16 to 28 (4 treatments in total, last dose at week 28), end of study is at week 44. | 0 | None | 3 | 22 | 6 | 22 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Acute myocardial infarction | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 23.0 | View |
| Cardiac failure | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 23.0 | View |
| Hypersensitivity | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA 23.0 | View |
| Osteoarthritis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | View |
| Abortion spontaneous | SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA 23.0 | View |
| Depression | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 23.0 | View |
| Pulmonary hypertension | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | View |
| Dermatitis atopic | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 23.0 | View |
| Dermatitis exfoliative generalised | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 23.0 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Eye pruritus | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 23.0 | View |
| Abdominal distension | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 23.0 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 23.0 | View |
| Beta haemolytic streptococcal infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 23.0 | View |
| Conjunctivitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 23.0 | View |
| Folliculitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 23.0 | View |
| Nasopharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 23.0 | View |
| Staphylococcal skin infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 23.0 | View |
| Upper respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 23.0 | View |
| Road traffic accident | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 23.0 | View |
| Wound dehiscence | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 23.0 | View |
| Alanine aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 23.0 | View |
| Aspartate aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 23.0 | View |
| Blood urine present | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 23.0 | View |
| Transaminases increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 23.0 | View |
| Increased appetite | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 23.0 | View |
| Arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | View |
| Synovial cyst | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 23.0 | View |
| Migraine | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 23.0 | View |
| Anxiety | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 23.0 | View |
| Asthma | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | View |
| Cold urticaria | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 23.0 | View |
| Dermatitis atopic | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 23.0 | View |
| Dermatitis contact | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 23.0 | View |
| Rash | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 23.0 | View |
| Skin ulcer | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 23.0 | View |