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 @ 12:14 AM
Ignite Modification Date:
2025-12-25 @ 10:16 PM
NCT ID:
NCT00565058
Description:
None
Frequency Threshold:
0
Time Frame:
310 days
Study:
NCT00565058
Study Brief:
Combination of GTI-2040 and Cytarabine in the Treatment of Refractory and Relapsed Acute Myeloid Leukemia (AML)
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Phase II Arm | Phase II PD Study (Early GTI-2040) Group: In the Phase II PD Study Group, GTI-2040 is given 24 hours prior to addition of HiDAC. | None | None | 2 | 15 | 15 | 15 | View |
| Pilot | Pilot PD Study (Delayed GTI-2040) Group: In the Pilot PD Study Group, addition of GTI-2040 is delayed until 24 hours after initiation of HiDAC. | None | None | 2 | 10 | 10 | 10 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Febrile Neutropenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (Unspecified) | View |
| Disease Progression | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (Unspecified) | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (Unspecified) | View |
| Sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (Unspecified) | View |
| Acute Respiratory Failure | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | View |
| Hypoxia | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | View |
| Pulmonary oedema | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Anemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (Unspecified) | View |
| Febrile neutropenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (Unspecified) | View |
| Leukocytosis | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (Unspecified) | View |
| Leukopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (Unspecified) | View |
| Lymphopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (Unspecified) | View |
| Neutropenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (Unspecified) | View |
| Thrombocytopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (Unspecified) | View |
| Tachycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (Unspecified) | View |
| Conjunctival haemorrhage | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (Unspecified) | View |
| Dry eye | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (Unspecified) | View |
| Keratitis | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (Unspecified) | View |
| Retinal haemorrhage | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (Unspecified) | View |
| Vision blurred | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (Unspecified) | View |
| Visual disturbance | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (Unspecified) | View |
| Abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (Unspecified) | View |
| Abdominal pain upper | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (Unspecified) | View |
| Abdominal tenderness | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (Unspecified) | View |
| Colitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (Unspecified) | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (Unspecified) | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (Unspecified) | View |
| Dry mouth | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (Unspecified) | View |
| Dyspepsia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (Unspecified) | View |
| Flatulence | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (Unspecified) | View |
| Gingival bleeding | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (Unspecified) | View |
| Lip swelling | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (Unspecified) | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (Unspecified) | View |
| Oral mucosal petechiae | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (Unspecified) | View |
| Stomach discomfort | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (Unspecified) | View |
| Stomatitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (Unspecified) | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (Unspecified) | View |
| Asthenia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (Unspecified) | View |
| Catheter site discharge | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (Unspecified) | View |
| Chills | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (Unspecified) | View |
| Disease progression | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (Unspecified) | View |
| Facial pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (Unspecified) | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (Unspecified) | View |
| Generalised oedema | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (Unspecified) | View |
| Infusion site erythema | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (Unspecified) | View |
| Infusion site haemorrhage | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (Unspecified) | View |
| Infusion site pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (Unspecified) | View |
| Mucosal inflammation | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (Unspecified) | View |
| Oedema | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (Unspecified) | View |
| Oedema peripheral | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (Unspecified) | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (Unspecified) | View |
| Cholelithiasis | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (Unspecified) | View |
| Hyperbilirubinaemia | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (Unspecified) | View |
| Bacteraemia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (Unspecified) | View |
| Candidiasis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (Unspecified) | View |
| Catheter related infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (Unspecified) | View |
| Cellulitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (Unspecified) | View |
| Central line infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (Unspecified) | View |
| Chronic sinusitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (Unspecified) | View |
| Clostridium difficile colitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (Unspecified) | View |
| Enterococcal infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (Unspecified) | View |
| Folliculitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (Unspecified) | View |
| Lung infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (Unspecified) | View |
| Neutropenic sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (Unspecified) | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (Unspecified) | View |
| Rash pustular | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (Unspecified) | View |
| Sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (Unspecified) | View |
| Sinusitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (Unspecified) | View |
| Staphylococcal infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (Unspecified) | View |
| Streptococcal infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (Unspecified) | View |
| Urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (Unspecified) | View |
| Post lumbar puncture syndrome | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (Unspecified) | View |
| Procedural pain | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (Unspecified) | View |
| Wound | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (Unspecified) | View |
| Activated partial thromboplastin time prolonged | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (Unspecified) | View |
| Alanine aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (Unspecified) | View |
| Aspartate aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (Unspecified) | View |
| Blood albumin decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (Unspecified) | View |
| Blood albumin increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (Unspecified) | View |
| Blood alkaline phosphatase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (Unspecified) | View |
| Blood bilirubin increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (Unspecified) | View |
| Blood calcium decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (Unspecified) | View |
| Blood creatinine increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (Unspecified) | View |
| Blood glucose increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (Unspecified) | View |
| Blood potassium decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (Unspecified) | View |
| Blood sodium decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (Unspecified) | View |
| Blood uric acid increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (Unspecified) | View |
| Cardiac murmur | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (Unspecified) | View |
| Clostridium difficile toxin test positive | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (Unspecified) | View |
| Haemoglobin decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (Unspecified) | View |
| International normalised ratio increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (Unspecified) | View |
| Neutrophil count decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (Unspecified) | View |
| Platelet count decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (Unspecified) | View |
| Protein total decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (Unspecified) | View |
| Weight decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (Unspecified) | View |
| White blood cell count decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (Unspecified) | View |
| Anorexia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (Unspecified) | View |
| Decreased appetite | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (Unspecified) | View |
| Hyperchloraemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (Unspecified) | View |
| Hyperglycaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (Unspecified) | View |
| Hyperphosphataemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (Unspecified) | View |
| Hypoalbuminaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (Unspecified) | View |
| Hypocalcaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (Unspecified) | View |
| Hypokalaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (Unspecified) | View |
| Hypomagnesaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (Unspecified) | View |
| Hyponatraemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (Unspecified) | View |
| Hypophosphataemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (Unspecified) | View |
| Arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | View |
| Back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | View |
| Bone pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | View |
| Myalgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | View |
| Pain in extremity | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | View |
| Pain in jaw | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | View |
| Pubic pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | View |
| Coordination abnormal | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (Unspecified) | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (Unspecified) | View |
| Dysarthria | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (Unspecified) | View |
| Dysgeusia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (Unspecified) | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (Unspecified) | View |
| Neuropathy peripheral | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (Unspecified) | View |
| Paraesthesia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (Unspecified) | View |
| Somnolence | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (Unspecified) | View |
| Anxiety | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (Unspecified) | View |
| Confusional state | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (Unspecified) | View |
| Depression | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (Unspecified) | View |
| Insomnia | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (Unspecified) | View |
| Mood altered | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (Unspecified) | View |
| Haematuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (Unspecified) | View |
| Renal failure acute | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (Unspecified) | View |
| Metrorrhagia | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA (Unspecified) | View |
| Acute respiratory failure | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | View |
| Dyspnoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | View |
| Epistaxis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | View |
| Hiccups | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | View |
| Hypoxia | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | View |
| Lung infiltration | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | View |
| Pharyngeal erythema | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | View |
| Pharyngolaryngeal pain | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | View |
| Pleural effusion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | View |
| Pulmonary oedema | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | View |
| Rales | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | View |
| Respiratory failure | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | View |
| Wheezing | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | View |
| Alopecia | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | View |
| Blister | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | View |
| Ecchymosis | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | View |
| Erythema | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | View |
| Hyperhidrosis | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | View |
| Petechiae | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | View |
| Pruritus | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | View |
| Rash | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | View |
| Rash erythematous | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | View |
| Rash pruritic | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | View |
| Skin disorder | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | View |
| Skin lesion | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | View |
| Skin nodule | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | View |
| Swelling face | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | View |
| Urticaria | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | View |
| Deep vein thrombosis | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (Unspecified) | View |
| Hypotension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (Unspecified) | View |
| Thrombophlebitis superficial | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (Unspecified) | View |