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 @ 12:36 AM
Ignite Modification Date:
2025-12-25 @ 10:44 PM
NCT ID:
NCT04516967
Description:
None
Frequency Threshold:
5
Time Frame:
Up to 12 weeks (Core Phase) and up to 2 years (ongoing Extension Phase)
Study:
NCT04516967
Study Brief:
Avatrombopag for the Treatment of Thrombocytopenia in Pediatric Subjects With Immune Thrombocytopenia for ≥6 Months
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Placebo Comparator:Placebo | Study is 3:1 randomization ratio (avatrombopag to placebo). Investigational product administered orally once daily for 12 weeks Placebo: Placebo comparator tablet or sprinkle capsule | 0 | None | 1 | 21 | 16 | 21 | View |
| Ongoing Open Label Extension Phase | All subjects receive investigational drug for up to 2 years. | 0 | None | 16 | 73 | 62 | 73 | View |
| Experimental: Avatrombopag | Study is 3:1 randomization ratio (avatrombopag to placebo). Investigational product administered orally once daily for 12 weeks Avatrombopag: Oral avatrombopag tablet or sprinkle capsule | 0 | None | 5 | 54 | 50 | 54 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Oral Purpura | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (26.1) | View |
| Headache | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (26.1) | View |
| Bone Marrow Reticulin fibrosis | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (26.1) | View |
| Febrile Neutropenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (26.1) | View |
| Immune Thrombocytopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (26.1) | View |
| Thrombocytosis | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (26.1) | View |
| Mouth Haemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (26.1) | View |
| Rectal Haemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (26.1) | View |
| Epistaxis | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (26.1) | View |
| Skin Haemorrhage | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (26.1) | View |
| Aplastic Anemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (26.1) | View |
| Bone Marrow Disorder | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (26.1) | View |
| Thrombocytopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (26.1) | View |
| Dental Caries | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (26.1) | View |
| Gastritis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (26.1) | View |
| Mucosal Haemorrhage | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (26.1) | View |
| Hypogammaglobulinaemia | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA (26.1) | View |
| Appendicitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (26.1) | View |
| Gastroenteritis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (26.1) | View |
| Abdominal Injury | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (26.1) | View |
| Head Injury | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (26.1) | View |
| Dysarthria | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (26.1) | View |
| Paresthesia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (26.1) | View |
| Vaginal Haemorrhage | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA (26.1) | View |
| Petechiae | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (26.1) | View |
| Urticaria | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (26.1) | View |
| Deep Vein Thrombosis | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (26.1) | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Diarrhoea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (26.1) | View |
| Vomiting | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (26.1) | View |
| Abdominal Pain | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (26.1) | View |
| Gingival Bleeding | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (26.1) | View |
| Rectal Haemorrhage | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (26.1) | View |
| Pyrexia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (26.1) | View |
| Upper Respiratory Tract Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (26.1) | View |
| COVID 19 | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (26.1) | View |
| Nasopharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (26.1) | View |
| Viral Upper Respiratory Tract Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (26.1) | View |
| Contusion | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (26.1) | View |
| Arthralagia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (26.1) | View |
| Pain in Extremity | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (26.1) | View |
| Headache | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (26.1) | View |
| Epistaxis | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (26.1) | View |
| Cough | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (26.1) | View |
| Oropharyngeal Pain | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (26.1) | View |
| Rhinorrhoea | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (26.1) | View |
| Petechiae | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (26.1) | View |
| Ecchymosis | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (26.1) | View |
| Haematoma | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (26.1) | View |
| Nasal Congestion | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (26.1) | View |
| Nausea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (26.1) | View |
| Rhinitis | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (26.1) | View |
| Gastroenteritis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (26.1) | View |
| Influenza | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (26.1) | View |
| Iron Deficiency | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (26.1) | View |
| Pharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (26.1) | View |
| Toothache | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (26.1) | View |