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 @ 7:30 PM
Ignite Modification Date:
2025-12-25 @ 5:11 PM
NCT ID:
NCT05041803
Description:
Subjects could be counted in both CTP-543 dose groups due to dose changes.
Frequency Threshold:
5
Time Frame:
108 Weeks
Study:
NCT05041803
Study Brief:
European Extension Study to Evaluate Safety and Efficacy of CTP-543 in Adults With Alopecia Areata
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| CTP-543 8 mg BID | Participants received CTP-543 8 mg tablets, orally, twice a day | 0 | None | 16 | 367 | 176 | 367 | View |
| CTP-543 12 mg BID | Participants received CTP-543 12 mg tablets, orally, twice a day | 0 | None | 5 | 273 | 127 | 273 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Bartholin's abscess | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Type 1 diabetes mellitus | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | None | View |
| Hepatitis E | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Infectious mononucleosis | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Tonsillitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Wound infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Humerus fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Spinal fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Tibia fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Osteoarthritis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Synovial cyst | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Anaphylactic reaction | SYSTEMATIC_ASSESSMENT | Immune system disorders | None | View |
| Gastric cancer stage IV | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | None | View |
| Tongue neoplasm malignant stage unspecified | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | None | View |
| Bartholin's cyst | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | None | View |
| Menorrhagia | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | None | View |
| Asthma | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Pulmonary embolism | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Anaemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
| Tricuspid valve incompetence | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Intracranial hypotension | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Abortion spontaneous | SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | None | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Hypercholesterolaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | None | View |
| Anaemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
| Thrombocytosis | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
| Weight increased | SYSTEMATIC_ASSESSMENT | Investigations | None | View |
| Nasopharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Asymptomatic COVID-19 | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| COVID-19 | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Upper respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Folliculitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Blood creatine phosphokinase increased | SYSTEMATIC_ASSESSMENT | Investigations | None | View |