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 @ 11:37 PM
Ignite Modification Date:
2025-12-25 @ 9:27 PM
NCT ID:
NCT03763656
Description:
Protocol definition of SAE for SCA associated complications, AEs only became reportable SAEs if the hospital admission was prolonged \>7days. SCA related hospitalisations \<7days recorded as AEs due to the frequency of admissions within population and chronic nature of the condition. Attendance of emergency room without admission or for elective procedures were not considered SAEs unless prolonged. All SAEs unrelated to SCA condition were reportable in line with standard definitions.
Frequency Threshold:
0
Time Frame:
Screening to safety follow up call at 64 weeks (maximum 15 months on treatment).
Study:
NCT03763656
Study Brief:
Pharmacokinetics of Oral Hydroxyurea Solution
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Oral Hydroxyurea | Participants received Oral Hydroxyurea 15 mg/kg once daily. Escalated by 5 mg/kg/day every 8-12 weeks until maximum tolerated dose achieved, up to a maximum 35 mg/kg/day. Hydroxyurea: Oral Hydroxyurea 100 mg/ml solution | 0 | None | 6 | 32 | 31 | 32 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Acute Chest Syndrome (ACS) Grade 3 | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (23.1) | View |
| Acute Chest Syndrome (ACS) Grade 2 | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (23.1) | View |
| Vaso-occlusive Crisis (VOC) | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (23.1) | View |
| Anemia secondary to SCD | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (23.1) | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Anemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (23.1) | View |
| Neutropenia/Low ANC Count | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (23.1) | View |
| Thrombocytopenia/Low Platelet Count | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (23.1) | View |
| Haemoglobin (Hb) Decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (23.1) | View |
| Absolute Reticulocyte Count (ARC) Decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (23.1) | View |
| Red Blood Cell (RBC) Count Decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (23.1) | View |
| Gamma-Glutamyltransferase (GGT) Increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (23.1) | View |
| Hematocrit (HCT) Decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (23.1) | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (23.1) | View |
| Alopecia | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (23.1) | View |
| Nail Discolouration | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (23.1) | View |
| Rash | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (23.1) | View |
| Rash Papular | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (23.1) | View |
| Sickle Cell Anemia with Crisis/Vaso-Occlusive Crisis (VOC) | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (23.1) | View |
| Viral Upper Respiratory Tract Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (23.1) | View |
| Pain in extremity | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (23.1) | View |
| Acute Chest Syndrome (ACS) | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (23.1) | View |
| Hypereosinophilic Syndrome | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (23.1) | View |
| Splenomegaly | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (23.1) | View |
| Ear Pain | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA (23.1) | View |
| Abdominal Discomfort | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (23.1) | View |
| Abdominal Pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (23.1) | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (23.1) | View |
| Gastritis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (23.1) | View |
| Gastrointestinal Haemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (23.1) | View |
| Mouth Ulceration | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (23.1) | View |
| Salivary Gland Enlargement | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (23.1) | View |
| Teething | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (23.1) | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (23.1) | View |
| Feeling Abnormal | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (23.1) | View |
| Influenza Like Illness | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (23.1) | View |
| Injection Site Pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (23.1) | View |
| Injection Site Swelling | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (23.1) | View |
| Peripheral Swelling | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (23.1) | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (23.1) | View |
| Swelling Face | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (23.1) | View |
| Ulcer | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (23.1) | View |
| Cholecystitis | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (23.1) | View |
| Hepatomegaly | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (23.1) | View |
| Drug Hypersensitivity | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA (23.1) | View |
| Body Tinea | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (23.1) | View |
| Chronic Sinusitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (23.1) | View |
| Conjunctivitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (23.1) | View |
| Conjunctivitis Viral | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (23.1) | View |
| COVID-19 | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (23.1) | View |
| Croup Infectious | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (23.1) | View |
| Ear Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (23.1) | View |
| Fungal Skin Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (23.1) | View |
| Gastroenteritis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (23.1) | View |
| Gingival Abscess | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (23.1) | View |
| Gingivitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (23.1) | View |
| Hand-Foot-And-Mouth Disease | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (23.1) | View |
| Localised Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (23.1) | View |
| Lower Respiratory Tract Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (23.1) | View |
| Nasopharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (23.1) | View |
| Otitis Media | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (23.1) | View |
| Pharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (23.1) | View |
| Pharyngotonsillitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (23.1) | View |
| Rhinitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (23.1) | View |
| Sinusitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (23.1) | View |
| Tinea Capitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (23.1) | View |
| Tonsilitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (23.1) | View |
| Upper Respiratory Tract Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (23.1) | View |
| Urinary Tract Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (23.1) | View |
| Viral Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (23.1) | View |
| Viral Pharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (23.1) | View |
| Viral Rash | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (23.1) | View |
| Arthropod Bite | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (23.1) | View |
| Contusion | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (23.1) | View |
| Forearm Fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (23.1) | View |
| Lip Injury | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (23.1) | View |
| Procedural Pain | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (23.1) | View |
| Skin Abrasion | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (23.1) | View |
| Skin Laceration | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (23.1) | View |
| Soft Tissue Injury | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (23.1) | View |
| Wound Complication | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (23.1) | View |
| Alanine Aminotransferase Increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (23.1) | View |
| Aspartate Aminotransferase Increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (23.1) | View |
| Blood Iron Decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (23.1) | View |
| Body Temperature Increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (23.1) | View |
| Platelet Count Increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (23.1) | View |
| Vitamin D Decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (23.1) | View |
| Decreased Appetite | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (23.1) | View |
| Vitamin D Deficiency | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (23.1) | View |
| Arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (23.1) | View |
| Back Pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (23.1) | View |
| Bone Pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (23.1) | View |
| Muscle Tightness | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (23.1) | View |
| Soft Tissue Swelling | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (23.1) | View |
| Trismus | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (23.1) | View |
| Benign Rolandic Epilepsy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (23.1) | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (23.1) | View |
| Lethargy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (23.1) | View |
| Pica | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (23.1) | View |
| Balanoposthitis | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA (23.1) | View |
| Priapism | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA (23.1) | View |
| Allergic Respiratory Disease | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (23.1) | View |
| Allergic Sinusitis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (23.1) | View |
| Asthma | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (23.1) | View |
| Bronchial Hyperreactivity | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (23.1) | View |
| Bronchospasm | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (23.1) | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (23.1) | View |
| Rhinitis Allergic | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (23.1) | View |
| Rhinorrhoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (23.1) | View |
| Sneezing | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (23.1) | View |
| Wheezing | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (23.1) | View |
| Eczema | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (23.1) | View |
| Pruritus | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (23.1) | View |
| Skin Erosion | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (23.1) | View |
| Urticaria Papular | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (23.1) | View |
| Tooth Extraction | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA (23.1) | View |
| Toothache | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (23.1) | View |