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 @ 4:29 AM
Ignite Modification Date:
2025-12-26 @ 3:32 AM
NCT ID:
NCT03568318
Description:
None
Frequency Threshold:
5
Time Frame:
From first dose of study drug up to Week 16, or 30 days after last dose for participants who did not enter the blinded extension period.
Study:
NCT03568318
Study Brief:
A Study to Evaluate Upadacitinib in Combination With Topical Corticosteroids in Adolescent and Adult Participants With Moderate to Severe Atopic Dermatitis
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Adolescents: Placebo + Topical Corticosteroids | Adolescent participants received placebo orally once a day and topical corticosteroids following a step-down regimen for 16 weeks in the double-blind treatment period. | 0 | None | 0 | 62 | 21 | 62 | View |
| Adolescents: Upadacitinib 15 mg + Topical Corticosteroids | Adolescent participants received upadacitinib 15 mg orally once a day and topical corticosteroids following a step-down regimen for 16 weeks in the double-blind treatment period. | 0 | None | 1 | 60 | 24 | 60 | View |
| Adolescents: Upadacitinib 30 mg + Topical Corticosteroids | Adolescent participants received upadacitinib 30 mg orally once a day and topical corticosteroids following a step-down regimen for 16 weeks in the double-blind treatment period. | 0 | None | 0 | 60 | 32 | 60 | View |
| Adults: Placebo + Topical Corticosteroids | Participants ≥ 18 years old received placebo orally once a day and topical corticosteroids following a step-down regimen for 16 weeks in the double-blind treatment period. | 0 | None | 9 | 264 | 99 | 264 | View |
| Adults: Upadacitinib 15 mg + Topical Corticosteroids | Participants ≥ 18 years old received upadacitinib 15 mg orally once a day and topical corticosteroids following a step-down regimen for 16 weeks in the double-blind treatment period. | 0 | None | 7 | 261 | 111 | 261 | View |
| Adults: Upadacitinib 30 mg + Topical Corticosteroids | Participants ≥ 18 years old received upadacitinib 30 mg orally once a day and topical corticosteroids following a step-down regimen for 16 weeks in the double-blind treatment period. | 0 | None | 4 | 260 | 123 | 260 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| STAPHYLOCOCCAL SEPSIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (22.1) | View |
| LIGAMENT RUPTURE | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (22.1) | View |
| ADENOCARCINOMA OF COLON | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (22.1) | View |
| ACUTE RESPIRATORY FAILURE | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (22.1) | View |
| OROPHARYNGEAL PAIN | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (22.1) | View |
| PLEURAL EFFUSION | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (22.1) | View |
| STATUS ASTHMATICUS | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (22.1) | View |
| DERMATITIS EXFOLIATIVE GENERALISED | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (22.1) | View |
| ERYTHRODERMIC ATOPIC DERMATITIS | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (22.1) | View |
| HAEMATOMA | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (22.1) | View |
| PANCYTOPENIA | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (22.1) | View |
| CARDIAC FAILURE CONGESTIVE | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (22.1) | View |
| RETINAL DETACHMENT | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (22.1) | View |
| RHEGMATOGENOUS RETINAL DETACHMENT | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (22.1) | View |
| VASCULAR STENT THROMBOSIS | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (22.1) | View |
| ANAPHYLACTIC REACTION | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA (22.1) | View |
| ANAL ABSCESS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (22.1) | View |
| APPENDICITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (22.1) | View |
| PERITONSILLAR ABSCESS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (22.1) | View |
| PHARYNGITIS STREPTOCOCCAL | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (22.1) | View |
| PNEUMONIA | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (22.1) | View |
| URINARY TRACT INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (22.1) | View |
| OVERDOSE | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (22.1) | View |
| HYDRONEPHROSIS | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (22.1) | View |
| NEPHROLITHIASIS | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (22.1) | View |
| ASTHMA | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (22.1) | View |
| ECZEMA | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (22.1) | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| ABDOMINAL PAIN | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (22.1) | View |
| DIARRHOEA | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (22.1) | View |
| VOMITING | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (22.1) | View |
| PYREXIA | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (22.1) | View |
| STAPHYLOCOCCAL SKIN INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (22.1) | View |
| UPPER RESPIRATORY TRACT INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (22.1) | View |
| VIRAL UPPER RESPIRATORY TRACT INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (22.1) | View |
| BLOOD CREATINE PHOSPHOKINASE INCREASED | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (22.1) | View |
| HEADACHE | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (22.1) | View |
| CATARRH | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (22.1) | View |
| COUGH | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (22.1) | View |
| ACNE | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (22.1) | View |
| DERMATITIS ATOPIC | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (22.1) | View |
| NASOPHARYNGITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (22.1) | View |
| ORAL HERPES | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (22.1) | View |