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 @ 12:59 AM
Ignite Modification Date:
2025-12-25 @ 11:13 PM
NCT ID:
NCT03569293
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:
NCT03569293
Study Brief:
Evaluation of Upadacitinib in Adolescent and Adult Patients With Moderate to Severe Atopic Dermatitis (Eczema)
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Adults: Placebo | Participants ≥ 18 years old received placebo orally once a day for 16 weeks. | 0 | None | 7 | 241 | 64 | 241 | View |
| Adults: Upadacitinib 15 mg QD | Participants ≥ 18 years old received upadacitinib 15 mg orally once daily for 16 weeks. | 0 | None | 5 | 239 | 67 | 239 | View |
| Adults: Upadacitinib 30 mg QD | Participants ≥ 18 years old received upadacitinib 30 mg orally once daily for 16 weeks. | 0 | None | 8 | 243 | 102 | 243 | View |
| Adolescents: Placebo | Adolescent participants (12 - 17 years old) received placebo orally once a day (QD) for 16 weeks. | 0 | None | 1 | 61 | 13 | 61 | View |
| Adolescents: Upadacitinib 15 mg QD | Adolescent participants (12 - 17 years old) received upadacitinib 15 mg orally once daily for 16 weeks. | 0 | None | 1 | 64 | 19 | 64 | View |
| Adolescents: Upadacitinib 30 mg QD | Adolescent participants (12 - 17 years old) received upadacitinib 30 mg orally once daily for 16 weeks. | 0 | None | 0 | 64 | 25 | 64 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| LYMPHADENOPATHY | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (22.1) | View |
| CHEST PAIN | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (22.1) | View |
| ANAPHYLACTIC REACTION | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA (22.1) | View |
| ANAPHYLACTIC SHOCK | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA (22.1) | View |
| FOOD ALLERGY | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA (22.1) | View |
| HYPERSENSITIVITY | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA (22.1) | View |
| APPENDICITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (22.1) | View |
| IMPETIGO | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (22.1) | View |
| PHARYNGEAL ABSCESS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (22.1) | View |
| PNEUMONIA STAPHYLOCOCCAL | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (22.1) | View |
| CARTILAGE INJURY | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (22.1) | View |
| FOOT FRACTURE | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (22.1) | View |
| TENDON RUPTURE | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (22.1) | View |
| GASTRIC CANCER | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (22.1) | View |
| INVASIVE DUCTAL BREAST CARCINOMA | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (22.1) | View |
| ASTHMA | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (22.1) | View |
| RHINITIS ALLERGIC | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (22.1) | View |
| DERMATITIS ATOPIC | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (22.1) | View |
| DERMATITIS CONTACT | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (22.1) | View |
| DERMATITIS EXFOLIATIVE GENERALISED | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (22.1) | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| NASOPHARYNGITIS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (22.1) | View |
| UPPER RESPIRATORY TRACT INFECTION | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (22.1) | View |
| BLOOD CREATINE PHOSPHOKINASE INCREASED | SYSTEMATIC_ASSESSMENT | Investigations | 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 |
| HEADACHE | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (22.1) | View |