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 @ 2:09 AM
Ignite Modification Date:
2025-12-26 @ 12:37 AM
NCT ID:
NCT00717860
Description:
None
Frequency Threshold:
5
Time Frame:
None
Study:
NCT00717860
Study Brief:
A Clinical Study of MK0991 (Caspofungin) in Japanese Patients With Deep-seated Candida or Aspergillus Infections (0991-062)(COMPLETED)
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Caspofungin | Caspofungin acetate (50 mg/day for participants with esophageal candidiasis and 50 mg/day for participants with invasive candidiasis or aspergillosis after a 70 mg loading dose on Day 1), once daily intravenously (IV) for 1-4 weeks for esophageal candidiasis, 2-8 weeks for invasive candidiasis, 2-12 weeks for aspergillosis. | None | None | 12 | 60 | 44 | 60 | View |
| Micafungin | Micafungin sodium 150 mg/day, once daily IV for 1-4 weeks for esophageal candidiasis, 2-8 weeks for invasive candidiasis, 2-12 weeks for aspergillosis. | None | None | 14 | 60 | 40 | 60 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Disseminated intravascular coagulation | None | Blood and lymphatic system disorders | MedDRA (11.0) | View |
| Inappropriate antidiuretic hormone secretion | None | Endocrine disorders | MedDRA (11.0) | View |
| Ileus paralytic | None | Gastrointestinal disorders | MedDRA (11.0) | View |
| Death | None | General disorders | MedDRA (11.0) | View |
| Cholelithiasis | None | Hepatobiliary disorders | MedDRA (11.0) | View |
| Bacteraemia | None | Infections and infestations | MedDRA (11.0) | View |
| Bronchopulmonary aspergillosis | None | Infections and infestations | MedDRA (11.0) | View |
| Infection | None | Infections and infestations | MedDRA (11.0) | View |
| Pneumonia | None | Infections and infestations | MedDRA (11.0) | View |
| Sepsis | None | Infections and infestations | MedDRA (11.0) | View |
| Septic shock | None | Infections and infestations | MedDRA (11.0) | View |
| Alanine aminotransferase increased | None | Investigations | MedDRA (11.0) | View |
| Aspartate aminotransferase increased | None | Investigations | MedDRA (11.0) | View |
| Acute myeloid leukaemia | None | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (11.0) | View |
| Lung neoplasm malignant | None | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (11.0) | View |
| Mesothelioma | None | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (11.0) | View |
| Myelodysplastic syndrome | None | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (11.0) | View |
| Peritoneal mesothelioma malignant advanced | None | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (11.0) | View |
| Cerebral infarction | None | Nervous system disorders | MedDRA (11.0) | View |
| Cerebrovascular disorder | None | Nervous system disorders | MedDRA (11.0) | View |
| Renal failure acute | None | Renal and urinary disorders | MedDRA (11.0) | View |
| Chronic obstructive pulmonary disease | None | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | View |
| Haemoptysis | None | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | View |
| Interstitial lung disease | None | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | View |
| Pneumothorax | None | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | View |
| Rash | None | Skin and subcutaneous tissue disorders | MedDRA (11.0) | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Constipation | None | Gastrointestinal disorders | MedDRA (11.0) | View |
| Malaise | None | General disorders | MedDRA (11.0) | View |
| Alanine aminotransferase increased | None | Investigations | MedDRA (11.0) | View |
| Blood potassium decreased | None | Investigations | MedDRA (11.0) | View |
| Insomnia | None | Psychiatric disorders | MedDRA (11.0) | View |
| Diarrhoea | None | Gastrointestinal disorders | MedDRA (11.0) | View |
| Nausea | None | Gastrointestinal disorders | MedDRA (11.0) | View |
| Vomiting | None | Gastrointestinal disorders | MedDRA (11.0) | View |
| Injection site pain | None | General disorders | MedDRA (11.0) | View |
| Oedema | None | General disorders | MedDRA (11.0) | View |
| Pyrexia | None | General disorders | MedDRA (11.0) | View |
| Nasopharyngitis | None | Infections and infestations | MedDRA (11.0) | View |
| Pneumonia | None | Infections and infestations | MedDRA (11.0) | View |
| Aspartate aminotransferase increased | None | Investigations | MedDRA (11.0) | View |
| Blood alkaline phosphatase increased | None | Investigations | MedDRA (11.0) | View |
| Blood glucose increased | None | Investigations | MedDRA (11.0) | View |
| Blood lactate dehydrogenase increased | None | Investigations | MedDRA (11.0) | View |
| Blood potassium increased | None | Investigations | MedDRA (11.0) | View |
| Blood pressure increased | None | Investigations | MedDRA (11.0) | View |
| C-reactive protein increased | None | Investigations | MedDRA (11.0) | View |
| Eosinophil count increased | None | Investigations | MedDRA (11.0) | View |
| Gamma-glutamyltransferase increased | None | Investigations | MedDRA (11.0) | View |
| Whtie blood cell count increased | None | Investigations | MedDRA (11.0) | View |
| Anorexia | None | Metabolism and nutrition disorders | MedDRA (11.0) | View |
| Headache | None | Nervous system disorders | MedDRA (11.0) | View |
| Pruritus | None | Skin and subcutaneous tissue disorders | MedDRA (11.0) | View |
| Rash | None | Skin and subcutaneous tissue disorders | MedDRA (11.0) | View |