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 @ 3:03 AM
Ignite Modification Date:
2025-12-26 @ 1:42 AM
NCT ID:
NCT04784533
Description:
All-cause mortality: All randomized participants included all participants who were randomized in the study.
Adverse events: Safety population included all participants who received study drug during the treatment period.
Frequency Threshold:
5
Time Frame:
From first dose of study drug up to last follow up visit (Week 76)
Study:
NCT04784533
Study Brief:
A Study to Evaluate the Durability of Response of CTP-543 in Adult Patients With Moderate to Severe 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 |
|---|---|---|---|---|---|---|---|---|
| Part A: Period 2 - CTP-543 12 mg BID to Placebo | Participants who received CTP-543 12 mg during Period 1 of Part A and achieved an absolute SALT score of ≤20 at Week 24, received CTP-543 matched placebo tablets, orally, BID, for up to 24 weeks. | 0 | None | 0 | 25 | 9 | 25 | View |
| Part A: Period 2 - CTP-543 12 mg BID to 8 mg BID | Participants who received CTP-543 12 mg during Period 1 of Part A and achieved an absolute SALT score of ≤20 at Week 24, received CTP-543 8 mg tablets, orally, BID, for up to 24 weeks. | 0 | None | 0 | 25 | 10 | 25 | View |
| Part A: Period 1 - CTP-543 8 mg BID | Participants received CTP-543 8 mg tablets, orally, BID for up to 24 weeks. | 0 | None | 1 | 180 | 91 | 180 | View |
| Part A: Period 1 - CTP-543 12 mg BID | Participants received CTP-543 12 mg tablets, orally, BID for up to 24 weeks. | 0 | None | 5 | 137 | 82 | 137 | View |
| Part A: Period 2 - CTP-543 8 mg BID to 4 mg BID | Participants who received CTP-543 8 mg during Period 1 of Part A and achieved an absolute severity of alopecia tool (SALT) score of ≤20 at Week 24, received CTP-543 4 mg tablets, orally, BID, for up to 24 weeks. | 0 | None | 0 | 18 | 9 | 18 | View |
| Part A: Period 2 - CTP-543 8 mg BID to Placebo | Participants who received CTP-543 8 mg during Period 1 of Part A and achieved an absolute SALT score of ≤20 at Week 24, received CTP-543 matched placebo tablets, orally, BID, for up to 24 weeks. | 0 | None | 2 | 18 | 7 | 18 | View |
| Part B: CTP-543 8 mg BID to 4 mg BID to 8 mg BID | Participants who received CTP-543 8 mg during Period 1, followed by CTP-543 4 mg during Period 2 of Part A and met the criteria for loss of regrowth maintenance (LOM) (absolute SALT score of \> 20), received re-treatment with CTP-543 8 mg tablets, orally, BID, for up to 24 weeks. | 0 | None | 0 | 5 | 2 | 5 | View |
| Part B: CTP-543 12 mg BID to 8 mg BID to 12 mg BID | Participants who received CTP-543 8 mg during Period 1, followed by CTP-543 4 mg during Period 2 of Part A and met the criteria for loss of regrowth maintenance (LOM) (absolute SALT score of \> 20), received re-treatment with CTP-543 8 mg tablets, orally, BID, for up to 24 weeks. | 0 | None | 0 | 8 | 5 | 8 | View |
| Part B: CTP-543 8 mg BID to Placebo to 8 mg BID | Participants who received CTP-543 8 mg during Period 1, followed by CTP-543 matched placebo during Period 2 of Part A and met the criteria for LOM (absolute SALT score of \> 20), received re-treatment with CTP-543 8 mg tablets, orally, BID, for up to 24 weeks. | 0 | None | 0 | 15 | 12 | 15 | View |
| Part B: CTP-543 12 mg BID to Placebo to 12 mg BID | Participants who received CTP-543 12 mg during Period 1, followed by CTP-543 matched placebo during Period 2 of Part A and met the criteria for LOM (absolute SALT score of \> 20), received re-treatment with CTP-543 12 mg tablets, orally, BID, for up to 24 weeks. | 0 | None | 0 | 19 | 14 | 19 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Thrombocytopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | 23.1 | View |
| Thrombocytosis | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | 23.1 | View |
| Pancreatic Carcinoma Metastatic | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 23.1 | View |
| Ankle Fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | 23.1 | View |
| Crohn's Disease | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 23.1 | View |
| Suicidal Ideation | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | 23.1 | View |
| Malignant Melanoma in Situ | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 23.1 | View |
| Electrocardiogram T Wave Inversion | SYSTEMATIC_ASSESSMENT | Investigations | 23.1 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | 23.1 | View |
| Memory impairment | SYSTEMATIC_ASSESSMENT | Nervous system disorders | 23.1 | View |
| Migraine | SYSTEMATIC_ASSESSMENT | Nervous system disorders | 23.1 | View |
| Paraesthesia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | 23.1 | View |
| Contusion | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | 23.1 | View |
| Joint injury | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | 23.1 | View |
| Depression | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | 23.1 | View |
| Suicidal ideation | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | 23.1 | View |
| Eye disorder | SYSTEMATIC_ASSESSMENT | Eye disorders | 23.1 | View |
| Visual impairment | SYSTEMATIC_ASSESSMENT | Eye disorders | 23.1 | View |
| Tendonitis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | 23.1 | View |
| Eczema | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | 23.1 | View |
| Fungal skin infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | 23.1 | View |
| Influenza | SYSTEMATIC_ASSESSMENT | Infections and infestations | 23.1 | View |
| Nasopharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | 23.1 | View |
| Arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | 23.1 | View |
| Limb traumatic amputation | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | 23.1 | View |
| Asymptomatic COVID-19 | SYSTEMATIC_ASSESSMENT | Infections and infestations | 23.1 | View |
| Candida infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | 23.1 | View |
| Conjunctivitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | 23.1 | View |
| COVID-19 | SYSTEMATIC_ASSESSMENT | Infections and infestations | 23.1 | View |
| Folliculitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | 23.1 | View |
| Upper respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | 23.1 | View |
| Urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | 23.1 | View |
| Viral upper respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | 23.1 | View |
| Costochondritis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | 23.1 | View |
| Intervertebral disc protrusion | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | 23.1 | View |
| Joint stiffness | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | 23.1 | View |
| Myalgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | 23.1 | View |
| Acne | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | 23.1 | View |
| Pruritus | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | 23.1 | View |
| Dysaesthesia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | 23.1 | View |
| Sunburn | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | 23.1 | View |
| Alanine aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | 23.1 | View |
| Amylase increased | SYSTEMATIC_ASSESSMENT | Investigations | 23.1 | View |
| Aspartate aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | 23.1 | View |
| C-reactive protein increased | SYSTEMATIC_ASSESSMENT | Investigations | 23.1 | View |
| Haemoglobin decreased | SYSTEMATIC_ASSESSMENT | Investigations | 23.1 | View |
| Lipase increased | SYSTEMATIC_ASSESSMENT | Investigations | 23.1 | View |
| Neutrophil count decreased | SYSTEMATIC_ASSESSMENT | Investigations | 23.1 | View |
| Neutrophil percentage decreased | SYSTEMATIC_ASSESSMENT | Investigations | 23.1 | View |
| Platelet count increased | SYSTEMATIC_ASSESSMENT | Investigations | 23.1 | View |
| Red blood cell count decreased | SYSTEMATIC_ASSESSMENT | Investigations | 23.1 | View |
| Weight increased | SYSTEMATIC_ASSESSMENT | Investigations | 23.1 | View |
| White blood cell count decreased | SYSTEMATIC_ASSESSMENT | Investigations | 23.1 | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | 23.1 | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 23.1 | View |
| Nasal congestion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 23.1 | View |
| Oropharyngeal pain | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 23.1 | View |
| Tonsillolith | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 23.1 | View |
| Abdominal discomfort | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 23.1 | View |
| Abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 23.1 | View |
| Crohn's disease | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 23.1 | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 23.1 | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 23.1 | View |
| Anaemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | 23.1 | View |
| Thrombocytosis | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | 23.1 | View |
| Bundle branch block left | SYSTEMATIC_ASSESSMENT | Cardiac disorders | 23.1 | View |
| Hyperlipidaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | 23.1 | View |
| Endometrial hyperplasia | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | 23.1 | View |
| Uterine polyp | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | 23.1 | View |
| Blood creatine phosphokinase increased | SYSTEMATIC_ASSESSMENT | Investigations | 23.1 | View |
| Gastroenteritis | SYSTEMATIC_ASSESSMENT | Infections and infestations | 23.1 | View |
| Seborrhoeic dermatitis | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | 23.1 | View |