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 @ 4:31 PM
Ignite Modification Date:
2025-12-25 @ 2:23 PM
NCT ID:
NCT00042666
Description:
Study-specific clinical outcomes due to PD were not considered to be a SAE unless the investigator deemed it related to the use of the study drug.
Frequency Threshold:
5
Time Frame:
None
Study:
NCT00042666
Study Brief:
A Study of Oral LY317615 in Relapsed or Refractory Diffuse Large B-Cell Lymphomas.
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Enzastaurin | 500 mg enzastaurin tablets were administered in the morning within 30 minutes of a meal for 28 days (1 cycle) to be continued for up to 6 cycles in the absence of disease progression. | None | None | 21 | 55 | 51 | 55 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Anaemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | 16.0 | View |
| Angina unstable | SYSTEMATIC_ASSESSMENT | Cardiac disorders | 16.0 | View |
| Abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 16.0 | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 16.0 | View |
| Gastritis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 16.0 | View |
| Rectal haemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 16.0 | View |
| Asthenia | SYSTEMATIC_ASSESSMENT | General disorders | 16.0 | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | 16.0 | View |
| Oedema peripheral | SYSTEMATIC_ASSESSMENT | General disorders | 16.0 | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | 16.0 | View |
| Clostridium difficile sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | 16.0 | View |
| Herpes zoster | SYSTEMATIC_ASSESSMENT | Infections and infestations | 16.0 | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | 16.0 | View |
| Pneumonia pneumococcal | SYSTEMATIC_ASSESSMENT | Infections and infestations | 16.0 | View |
| Septic shock | SYSTEMATIC_ASSESSMENT | Infections and infestations | 16.0 | View |
| Urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | 16.0 | View |
| Blood creatinine increased | SYSTEMATIC_ASSESSMENT | Investigations | 16.0 | View |
| Dehydration | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | 16.0 | View |
| Hypercalcaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | 16.0 | View |
| Syncope | SYSTEMATIC_ASSESSMENT | Nervous system disorders | 16.0 | View |
| Confusional state | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | 16.0 | View |
| Azotaemia | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | 16.0 | View |
| Renal failure acute | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | 16.0 | View |
| Ureteric obstruction | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | 16.0 | View |
| Acute respiratory distress syndrome | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 16.0 | View |
| Respiratory failure | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 16.0 | View |
| Hypotension | SYSTEMATIC_ASSESSMENT | Vascular disorders | 16.0 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Anaemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | 16.0 | View |
| Thrombocytopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | 16.0 | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 16.0 | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 16.0 | View |
| Flatulence | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 16.0 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 16.0 | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 16.0 | View |
| Asthenia | SYSTEMATIC_ASSESSMENT | General disorders | 16.0 | View |
| Chills | SYSTEMATIC_ASSESSMENT | General disorders | 16.0 | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | 16.0 | View |
| Oedema | SYSTEMATIC_ASSESSMENT | General disorders | 16.0 | View |
| Oedema peripheral | SYSTEMATIC_ASSESSMENT | General disorders | 16.0 | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | 16.0 | View |
| Upper respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | 16.0 | View |
| Urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | 16.0 | View |
| Blood creatinine increased | SYSTEMATIC_ASSESSMENT | Investigations | 16.0 | View |
| Weight decreased | SYSTEMATIC_ASSESSMENT | Investigations | 16.0 | View |
| Decreased appetite | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | 16.0 | View |
| Dehydration | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | 16.0 | View |
| Hypercalcaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | 16.0 | View |
| Hyperkalaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | 16.0 | View |
| Arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | 16.0 | View |
| Back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | 16.0 | View |
| Myalgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | 16.0 | View |
| Pain in extremity | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | 16.0 | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | 16.0 | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | 16.0 | View |
| Neuropathy peripheral | SYSTEMATIC_ASSESSMENT | Nervous system disorders | 16.0 | View |
| Anxiety | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | 16.0 | View |
| Insomnia | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | 16.0 | View |
| Chromaturia | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | 16.0 | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 16.0 | View |
| Dyspnoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 16.0 | View |
| Night sweats | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | 16.0 | View |
| Rash | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | 16.0 | View |
| Orthostatic hypotension | SYSTEMATIC_ASSESSMENT | Vascular disorders | 16.0 | View |