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 @ 5:19 AM
Ignite Modification Date:
2025-12-26 @ 4:26 AM
NCT ID:
NCT04328727
Description:
No adverse events where collected during the long term follow up
Frequency Threshold:
5
Time Frame:
All-cause mortality: from first dose of study treatment up to 2 years after last dose including post-treatment long term follow up period up to 3.1 years approximately. Serious and Other Adverse Events: from first dose of study treatment until 30 days after last dose up to 1.1 years approximately.
Study:
NCT04328727
Study Brief:
Combination of Eltrombopag With Immunosuppressive Therapy in East-Asian Patients With Severe Aplastic Anemia
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Eltrombopag | Participants received eltrombopag in combination with r-ATG and CsA. | 1 | None | 14 | 36 | 36 | 36 | View |
| Eltrombopag (Post-treatment Long Term Follow-up) | Deaths collected in the post- treatment long term follow-up period (starting from day 31 after last dose). No AEs were collected during this period | 2 | None | 0 | 0 | 0 | 0 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Blood bilirubin increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (27.1) | View |
| Gamma-glutamyltransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (27.1) | View |
| Neutrophil count decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (27.1) | View |
| Hyperuricaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (27.1) | View |
| Hypokalaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (27.1) | View |
| Hyponatraemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (27.1) | View |
| Uterine leiomyoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (27.1) | View |
| Hydronephrosis | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (27.1) | View |
| Breast hyperplasia | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA (27.1) | View |
| Heavy menstrual bleeding | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA (27.1) | View |
| Drug-induced liver injury | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (27.1) | View |
| Hepatic function abnormal | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (27.1) | View |
| Herpes zoster | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (27.1) | View |
| Sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (27.1) | View |
| Urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (27.1) | View |
| Alanine aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (27.1) | View |
| Aspartate aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (27.1) | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Rhinitis allergic | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (27.1) | View |
| Acne | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (27.1) | View |
| Dry skin | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (27.1) | View |
| Rash | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (27.1) | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (27.1) | View |
| Cataract | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (27.1) | View |
| Abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (27.1) | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (27.1) | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (27.1) | View |
| Dyspepsia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (27.1) | View |
| Gastrointestinal disorder | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (27.1) | View |
| Gastrointestinal haemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (27.1) | View |
| Gastrooesophageal reflux disease | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (27.1) | View |
| Haemorrhoids | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (27.1) | View |
| Mouth ulceration | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (27.1) | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (27.1) | View |
| Hepatic function abnormal | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (27.1) | View |
| Hypersensitivity | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA (27.1) | View |
| Immunodeficiency | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA (27.1) | View |
| Serum sickness | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA (27.1) | View |
| Neutropenic infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (27.1) | View |
| Oral infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (27.1) | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (27.1) | View |
| Upper respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (27.1) | View |
| Urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (27.1) | View |
| Allergic transfusion reaction | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (27.1) | View |
| Alanine aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (27.1) | View |
| Blood bilirubin increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (27.1) | View |
| Decreased appetite | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (27.1) | View |
| Hypercholesterolaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (27.1) | View |
| Hyperglycaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (27.1) | View |
| Hyperlipidaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (27.1) | View |
| Hypertriglyceridaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (27.1) | View |
| Hyperuricaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (27.1) | View |
| Hypoproteinaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (27.1) | View |
| Sodium retention | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (27.1) | View |
| Pain in extremity | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (27.1) | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (27.1) | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (27.1) | View |
| Acute kidney injury | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (27.1) | View |
| Renal failure | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (27.1) | View |
| Renal impairment | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (27.1) | View |
| Productive cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (27.1) | View |
| Stomatitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (27.1) | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (27.1) | View |
| Chest discomfort | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (27.1) | View |
| Chest pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (27.1) | View |
| Oedema peripheral | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (27.1) | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (27.1) | View |
| Hyperbilirubinaemia | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (27.1) | View |
| Allergy to immunoglobulin therapy | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA (27.1) | View |
| Cytomegalovirus infection reactivation | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (27.1) | View |
| Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (27.1) | View |
| Aspartate aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (27.1) | View |
| Bilirubin conjugated increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (27.1) | View |
| Blood alkaline phosphatase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (27.1) | View |
| Blood creatinine increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (27.1) | View |
| Blood glucose increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (27.1) | View |
| Blood pressure increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (27.1) | View |
| Blood urea increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (27.1) | View |
| Gamma-glutamyltransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (27.1) | View |
| Fluid retention | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (27.1) | View |
| Hypoalbuminaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (27.1) | View |
| Hypocalcaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (27.1) | View |
| Hypokalaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (27.1) | View |
| Hypomagnesaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (27.1) | View |
| Hyponatraemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (27.1) | View |
| Febrile neutropenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (27.1) | View |
| Cardiac failure | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (27.1) | View |