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 @ 3:51 PM
Ignite Modification Date:
2025-12-25 @ 1:57 PM
NCT ID:
NCT01761292
Description:
TEAEs by Primary System Organ Class, Preferred Term, and Relationship to Study Drug are reported for each dose separately in Part 1 and Part 2 of the study (i.e. Part 1 25.0 mg, Part 1 37.5 mg, Part 1 50 mg; Part 2 25.0 mg, Part 2 37.5 mg) and are reported to represent all participants and all parts of this study including the extension period altogether (i.e. Part 1 + Part 2 + Extensions 1, 2, and 3). Adverse events were not assessed by dose nor separately for the extension period.
Frequency Threshold:
5
Time Frame:
Adverse events (AE) were assessed throughout the study: in Part 1 (screen, weeks 0, 1, 2, 3, 4, 5); Part 2 (months 0, 1, 2, 3, 4.5, 6, 7.5, 9, 10.5,12); Extension 1 (months 14,16,18, 20, 22, 24, FU); Extension 2 (months 26,28, 30,32, 34, 36, FU); Extension 3 (months 40, 44, 48, 52, FU). Extensions 1, 2 and 3 together represent Part 3 of the study.
Study:
NCT01761292
Study Brief:
A Study to Assess Safety/Tolerability, pk, Effects on Histology, Clinical Parameters of Givinostat in Children With DMD
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 1 - 25 mg | The safety population included all children who received any investigational product. The dose level under which the patient was analyzed was the dose of investigational product that was actually received. 19 patients were included in the safety population of Part 1. | 0 | None | 0 | 4 | 3 | 4 | View |
| Part 2 - 37.5 mg | The safety population included all children who received any investigational product. The dose level under which the patient was analyzed was the dose of investigational product that was actually received. 19 patients were included in the safety population of Part 2. | 0 | None | 1 | 19 | 19 | 19 | View |
| Part 1 - 50 mg | The safety population included all children who received any investigational product. The dose level under which the patient was analyzed was the dose of investigational product that was actually received. 19 patients were included in the safety population of Part 1. | 0 | None | 1 | 12 | 12 | 12 | View |
| Part 1 - 37.5 mg | The safety population included all children who received any investigational product. The dose level under which the patient was analyzed was the dose of investigational product that was actually received. 19 patients were included in the safety population of Part 1. | 0 | None | 0 | 7 | 6 | 7 | View |
| Part 2 - 25 mg | The safety population included all children who received any investigational product. The dose level under which the patient was analyzed was the dose of investigational product that was actually received. 19 patients were included in the safety population of Part 2. | 0 | None | 1 | 12 | 12 | 12 | View |
| Overall (Part 1 + Part 2 + Extensions 1, 2, 3 ) | The safety population included all children who received any investigational product. The dose level under which the patient was analyzed was the dose of investigational product that was actually received. 19 patients were included in the safety population of Part 1 and 19 patients were included in the safety population of Part 2. In all Extensions, the Safety Analysis Population was set up to 20 patients (100%), including all patients who received any investigational product. | 0 | None | 8 | 20 | 20 | 20 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Cushing's syndrome | SYSTEMATIC_ASSESSMENT | Endocrine disorders | MedDRA (17.0) | View |
| Chest pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (17.0) | View |
| Lower limb fracture | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (17.0) | View |
| Platelet count decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (17.0) | View |
| Haematuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (17.0) | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (17.0) | View |
| Cataracts | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (17.0) | View |
| Femural fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (17.0) | View |
| Rhabdomyolysis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (17.0) | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Lens discoloration | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (17.0) | View |
| Lenticular opacity | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (17.0) | View |
| Abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (17.0) | View |
| Colitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (17.0) | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (17.0) | View |
| Faeces soft | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (17.0) | View |
| Legament sprain | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (17.0) | View |
| Limb injury | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (17.0) | View |
| Respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (17.0) | View |
| Rhinitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (17.0) | View |
| Tooth infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (17.0) | View |
| Upper respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (17.0) | View |
| Lymphadenopathy | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (17.0) | View |
| Cardiac discomfort | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (17.0) | View |
| Extrasystoles | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (17.0) | View |
| Left ventricular dilatation | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (17.0) | View |
| Left ventricular disfunction | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (17.0) | View |
| Palpitations | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (17.0) | View |
| Sinus tachycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (17.0) | View |
| Tachycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (17.0) | View |
| Ventricular extrasystoles | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (17.0) | View |
| Gilbert's syndrome | SYSTEMATIC_ASSESSMENT | Congenital, familial and genetic disorders | MedDRA (17.0) | View |
| Ear pain | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA (17.0) | View |
| Adrenal insufficiency | SYSTEMATIC_ASSESSMENT | Endocrine disorders | MedDRA (17.0) | View |
| Autoimmune thyroiditis | SYSTEMATIC_ASSESSMENT | Endocrine disorders | MedDRA (17.0) | View |
| Delayed puberty | SYSTEMATIC_ASSESSMENT | Endocrine disorders | MedDRA (17.0) | View |
| Hypothyroidism | SYSTEMATIC_ASSESSMENT | Endocrine disorders | MedDRA (17.0) | View |
| Secondary adrenocartical insufficiency | SYSTEMATIC_ASSESSMENT | Endocrine disorders | MedDRA (17.0) | View |
| Cataract | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (17.0) | View |
| Frequent bowel movements | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (17.0) | View |
| Haemorrhoids | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (17.0) | View |
| Stomatitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (17.0) | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (17.0) | View |
| Chest pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (17.0) | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (17.0) | View |
| Gait disturbance | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (17.0) | View |
| Non cardiac chest pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (17.0) | View |
| Peripheral swelling | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (17.0) | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (17.0) | View |
| Bronchitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (17.0) | View |
| Ear infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (17.0) | View |
| Gastroenteritis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (17.0) | View |
| Gastrointestinal viral infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (17.0) | View |
| Influenza | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (17.0) | View |
| Molluscum contagiosum | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (17.0) | View |
| Nasopharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (17.0) | View |
| Paronychia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (17.0) | View |
| Pharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (17.0) | View |
| Urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (17.0) | View |
| Varicella | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (17.0) | View |
| Contusion | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (17.0) | View |
| Fall | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (17.0) | View |
| Femur fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (17.0) | View |
| Foot fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (17.0) | View |
| Head injury | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (17.0) | View |
| Joint injury | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (17.0) | View |
| Laceration | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (17.0) | View |
| Legament injury | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (17.0) | View |
| Lower limb fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (17.0) | View |
| Muscle strain | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (17.0) | View |
| Spinal compression fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (17.0) | View |
| Spinal cord injury sacral | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (17.0) | View |
| Tendon injury | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (17.0) | View |
| Tibia fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (17.0) | View |
| Blood bilirubin increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (17.0) | View |
| Intraocular pressure increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (17.0) | View |
| Neutrophil count decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (17.0) | View |
| Platelet count decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (17.0) | View |
| White blood cell count decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (17.0) | View |
| Decreased appetite | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (17.0) | View |
| Hypertryglyceridaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (17.0) | View |
| Arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (17.0) | View |
| Back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (17.0) | View |
| Fracture pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (17.0) | View |
| Muscular weakness | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (17.0) | View |
| Myalgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (17.0) | View |
| Neck pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (17.0) | View |
| Osteopenia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (17.0) | View |
| Pain in extremity | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (17.0) | View |
| Tendinous contracture | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (17.0) | View |
| Tendon pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (17.0) | View |
| Tendonitis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (17.0) | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (17.0) | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (17.0) | View |
| Haematuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (17.0) | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | View |
| Dyspnoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | View |
| Epistaxis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | View |
| Laryngeal inflammation | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | View |
| Nasal congestion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | View |
| Oropharyngeal pain | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | View |
| Pharyngeal erythema | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | View |
| Dermatosis | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (17.0) | View |
| Ecchymosis | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (17.0) | View |
| Erythema | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (17.0) | View |
| Erythema annulare | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (17.0) | View |
| Intertrigo | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (17.0) | View |
| Nail dystrophy | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (17.0) | View |
| Rash | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (17.0) | View |
| Seborrhoeic dermatitis | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (17.0) | View |
| Skin lesion | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (17.0) | View |
| Solar dermatitis | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (17.0) | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (17.0) | View |