Adverse Events Module

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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 @ 12:21 AM
Ignite Modification Date: 2025-12-25 @ 10:25 PM
NCT ID: NCT01520558
Description: None
Frequency Threshold: 0
Time Frame: None
Study: NCT01520558
Study Brief: CNDO-109-AANK for AML in First Complete Remission (CR1)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
CNDO-109-AANK Cells Dose 1 In stage 1, patients will receive one of three doses of CNDO-109-AANK cells, and the lowest of these three doses (dose 1) is 3×10\^5 cells/kg recipient body weight. In stage 2, the MTD will have been determined and all patients will receive either Dose 1, Dose 2 or Dose 3. CNDO-109-AANK Cells: Single dose, infusion 0 None 1 3 3 3 View
CNDO-109-AANK Cells Dose 3 In stage 1, patients will receive one of three doses of CNDO-109-AANK cells, and the highest dose of these three doses (dose 3) is 3×10\^6 cells/kg recipient body weight. In stage 2, the MTD will have been determined and all patients will receive either Dose 1, Dose 2 or Dose 3. CNDO-109-AANK Cells: Single dose, infusion 1 None 3 6 6 6 View
CNDO-109-AANK Cells Dose 2 In stage 1, patients will receive one of three doses of CNDO-109-AANK cells, and the middle dose of these three doses (dose 2) is 1×10\^6 cells/kg recipient body weight. In stage 2, the MTD will have been determined and all patients will receive either Dose 1, Dose 2 or Dose 3. CNDO-109-AANK Cells: Single dose, infusion 0 None 1 3 3 3 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Neutropenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Atrial fibrillation NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Blood creatinine increased NON_SYSTEMATIC_ASSESSMENT Investigations None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Thrombocytopenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Anemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Fatigue NON_SYSTEMATIC_ASSESSMENT General disorders None View
Pyrexia NON_SYSTEMATIC_ASSESSMENT General disorders None View
Chills NON_SYSTEMATIC_ASSESSMENT General disorders None View
Generalized oedema NON_SYSTEMATIC_ASSESSMENT General disorders None View
Mucosal inflammation NON_SYSTEMATIC_ASSESSMENT General disorders None View
Diarrhoea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dysphagia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Retching NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dry skin NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Rash NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Erythema NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Macule NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Night sweats NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Pain of skin NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Red man syndrome NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Pneumonia NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Septic shock NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Upper respiratory tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Renal injury NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Somnolence NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Vertigo NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Urticaria NON_SYSTEMATIC_ASSESSMENT Immune system disorders None View
Musculoskeletal pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Neutrophil count decreased NON_SYSTEMATIC_ASSESSMENT Investigations None View
Platelet count decreased NON_SYSTEMATIC_ASSESSMENT Investigations None View
WBC count decreased NON_SYSTEMATIC_ASSESSMENT Investigations None View
Lymph count decreased NON_SYSTEMATIC_ASSESSMENT Investigations None View
ALT increased NON_SYSTEMATIC_ASSESSMENT Investigations None View
Blood albumin decreased NON_SYSTEMATIC_ASSESSMENT Investigations None View
Blood Alk Phos increased NON_SYSTEMATIC_ASSESSMENT Investigations None View
Lymph count increased NON_SYSTEMATIC_ASSESSMENT Investigations None View
Weight decreased NON_SYSTEMATIC_ASSESSMENT Investigations None View
Hypoalbuminaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Dehydration NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Oedema peripheral NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypercalcemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypermagnesaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypomagnesaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hyperurecemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypophosphataemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Neutropenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Skin exfoliation NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Rales NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Atelectasis NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Cough NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Dyspnoea NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Nasal congestion NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Upper respiratory tract congestion NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Wheezing NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Hypotension NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Hypertension NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Haematoma NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Anxiety NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Delirium NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Insomnia NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Sinus tachycardia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Oliguria NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Pollakiuria NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Polyuria NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Renal failure NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View