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 @ 1:14 AM

Ignite Modification Date: 2025-12-25 @ 11:23 PM

NCT ID: NCT01365793

Description: None

Frequency Threshold: 0

Time Frame: None

Study: NCT01365793

Study Brief: Randomized Control Trial of Fluid Therapy for Pediatric Diabetic Ketoacidosis

Event Groups(If Any):

Event Groups

Title	Description	Deaths # Affected	Deaths # At Risk	Serious # Affected	Serious # At Risk	Other # Affected	Other # At Risk	View

Rapid Rehydration Using 0.45% Saline Replacement Fluid	This arm involved more rapid intravenous fluid treatment which included a second 10cc/Kg bolus of 0.9% saline and assumed a 10% fluid deficit. Intravenous fluids were infused to replace half of the estimated fluid deficit over 12 hours and the remaining half over the following 24 hours, in addition to maintenance fluids. 0.45% saline was used as the replacement fluid for this arm.	1	None	5	342	112	342	View
Rapid Rehydration Using 0.9% Saline Replacement Fluid	This arm involved more rapid intravenous fluid treatment which included a second 10cc/Kg bolus of 0.9% saline and assumed a 10% fluid deficit. Intravenous fluids were infused to replace half of the estimated fluid deficit over 12 hours and the remaining half over the following 24 hours, in addition to maintenance fluids. 0.9% saline was used as the replacement fluid for this arm.	0	None	4	344	124	344	View
Slower Rehydration Using 0.9% Saline Replacement Fluid	This arm involved slower rehydration (assumed 5% fluid deficit and no additional fluid bolus). Intravenous fluids were infused to replace the estimated deficit over 48 hours, in addition to maintenance fluids. 0.9% saline was used as the replacement fluid for this arm.	0	None	10	347	129	347	View
Slower Rehydration Using 0.45% Saline Replacement Fluid	This arm involved slower rehydration (assumed 5% fluid deficit and no additional fluid bolus). Intravenous fluids were infused to replace the estimated deficit over 48 hours, in addition to maintenance fluids. 0.45% saline was used as the replacement fluid for this arm.	0	None	11	338	117	338	View

Serious Events(If Any):

Serious Events

Term	Type	Organ System	Vocab	View

Cardiac Arrest	SYSTEMATIC_ASSESSMENT	Cardiac disorders	None	View
Abdominal pain upper	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	None	View
Hepatomegaly	SYSTEMATIC_ASSESSMENT	Hepatobiliary disorders	None	View
Infection	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Acidosis	SYSTEMATIC_ASSESSMENT	Metabolism and nutrition disorders	None	View
Brain oedema	SYSTEMATIC_ASSESSMENT	Nervous system disorders	None	View
Renal injury	SYSTEMATIC_ASSESSMENT	Renal and urinary disorders	None	View
Acute respiratory distress syndrome	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	None	View
Hypovolemic shock	SYSTEMATIC_ASSESSMENT	Vascular disorders	None	View
Pancreatitis	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	None	View
Acidosis hyperchloraemic	SYSTEMATIC_ASSESSMENT	Metabolism and nutrition disorders	None	View
Diabetic ketoacidosis	SYSTEMATIC_ASSESSMENT	Metabolism and nutrition disorders	None	View
Hypoglycaemia	SYSTEMATIC_ASSESSMENT	Metabolism and nutrition disorders	None	View
Cerebral infarction	SYSTEMATIC_ASSESSMENT	Nervous system disorders	None	View
Somnolence	SYSTEMATIC_ASSESSMENT	Nervous system disorders	None	View
Pneumothorax	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	None	View

Other Events(If Any):

Other Events

Term	Type	Organ System	Vocab	View

Musculoskeletal pain	SYSTEMATIC_ASSESSMENT	Musculoskeletal and connective tissue disorders	None	View
Myalgia	SYSTEMATIC_ASSESSMENT	Musculoskeletal and connective tissue disorders	None	View
Neck pain	SYSTEMATIC_ASSESSMENT	Musculoskeletal and connective tissue disorders	None	View
Pain in extremity	SYSTEMATIC_ASSESSMENT	Musculoskeletal and connective tissue disorders	None	View
Trismus	SYSTEMATIC_ASSESSMENT	Musculoskeletal and connective tissue disorders	None	View
Brain oedema	SYSTEMATIC_ASSESSMENT	Nervous system disorders	None	View
Dizziness	SYSTEMATIC_ASSESSMENT	Nervous system disorders	None	View
Dysarthria	SYSTEMATIC_ASSESSMENT	Nervous system disorders	None	View
Headache	SYSTEMATIC_ASSESSMENT	Nervous system disorders	None	View
Seizure	SYSTEMATIC_ASSESSMENT	Nervous system disorders	None	View
Syncope	SYSTEMATIC_ASSESSMENT	Nervous system disorders	None	View
Agitation	SYSTEMATIC_ASSESSMENT	Psychiatric disorders	None	View
Coagulopathy	SYSTEMATIC_ASSESSMENT	Blood and lymphatic system disorders	None	View
Lymphadenopathy	SYSTEMATIC_ASSESSMENT	Blood and lymphatic system disorders	None	View
Bradycardia	SYSTEMATIC_ASSESSMENT	Cardiac disorders	None	View
Nodal Rythm	SYSTEMATIC_ASSESSMENT	Cardiac disorders	None	View
Tachycardia	SYSTEMATIC_ASSESSMENT	Cardiac disorders	None	View
Ventricular Extrasystoles	SYSTEMATIC_ASSESSMENT	Cardiac disorders	None	View
Ear pain	SYSTEMATIC_ASSESSMENT	Ear and labyrinth disorders	None	View
Middle ear effusion	SYSTEMATIC_ASSESSMENT	Ear and labyrinth disorders	None	View
Hypothyroidism	SYSTEMATIC_ASSESSMENT	Endocrine disorders	None	View
Eye irritation	SYSTEMATIC_ASSESSMENT	Eye disorders	None	View
Eye pain	SYSTEMATIC_ASSESSMENT	Eye disorders	None	View
Ocular hyperaemia	SYSTEMATIC_ASSESSMENT	Eye disorders	None	View
Vision blurred	SYSTEMATIC_ASSESSMENT	Eye disorders	None	View
Abdominal distension	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	None	View
Abdominal pain	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	None	View
Abdominal pain lower	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	None	View
Abdominal pain upper	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	None	View
Abdominal tenderness	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	None	View
Constipation	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	None	View
Diarrhoea	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	None	View
Dyspepsia	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	None	View
Dysphagia	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	None	View
Gastrointestinal sounds abnormal	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	None	View
Gastrooesophageal reflux disease	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	None	View
Gingival pain	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	None	View
Glossodynia	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	None	View
Haematemesis	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	None	View
Haematochezia	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	None	View
Mouth ulceration	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	None	View
Nausea	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	None	View
Oesophageal discomfort	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	None	View
Oesophagitis	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	None	View
Oral Pain	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	None	View
Pancreatitis acute	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	None	View
Proctalgia	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	None	View
Stomatitis	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	None	View
Toothache	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	None	View
Vomiting	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	None	View
Catheter site inflammation	SYSTEMATIC_ASSESSMENT	General disorders	None	View
Catheter site pain	SYSTEMATIC_ASSESSMENT	General disorders	None	View
Chest discomfort	SYSTEMATIC_ASSESSMENT	General disorders	None	View
Chest pain	SYSTEMATIC_ASSESSMENT	General disorders	None	View
Chills	SYSTEMATIC_ASSESSMENT	General disorders	None	View
Complication associated with device	SYSTEMATIC_ASSESSMENT	General disorders	None	View
Crying	SYSTEMATIC_ASSESSMENT	General disorders	None	View
Facial pain	SYSTEMATIC_ASSESSMENT	General disorders	None	View
Hypothermia	SYSTEMATIC_ASSESSMENT	General disorders	None	View
Infusion site extravasation	SYSTEMATIC_ASSESSMENT	General disorders	None	View
Infusion site pain	SYSTEMATIC_ASSESSMENT	General disorders	None	View
Injection site pain	SYSTEMATIC_ASSESSMENT	General disorders	None	View
Oedema peripheral	SYSTEMATIC_ASSESSMENT	General disorders	None	View
Pain	SYSTEMATIC_ASSESSMENT	General disorders	None	View
Peripheral swelling	SYSTEMATIC_ASSESSMENT	General disorders	None	View
Pyrexia	SYSTEMATIC_ASSESSMENT	General disorders	None	View
Abscess	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Bacteraemia	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Candida infection	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Candiduria	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Cellulitis	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Clostridium difficile colitis	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Fungal infection	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Lice infestation	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Metapneumovirus infection	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Oral candidiasis	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Otitits media	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Periorbital cellulitis	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Pharyngitis	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Pharyngitis streptococcal	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Pneumonia	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Pyuria	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Sinusitis	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Skin candida	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Tooth infection	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Upper respiratory tract infection	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Urethritis	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Urinary tract infection	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Vaginal infection	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Vulvovaginal candidiasis	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Vulvovaginal mycotic infection	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Vuvlovaginitis	SYSTEMATIC_ASSESSMENT	Infections and infestations	None	View
Heart injury	SYSTEMATIC_ASSESSMENT	Injury, poisoning and procedural complications	None	View
Medication error	SYSTEMATIC_ASSESSMENT	Injury, poisoning and procedural complications	None	View
Post procedural haemorrhage	SYSTEMATIC_ASSESSMENT	Injury, poisoning and procedural complications	None	View
Amylase increased	SYSTEMATIC_ASSESSMENT	Investigations	None	View
Blood bicarbonate decreased	SYSTEMATIC_ASSESSMENT	Investigations	None	View
Blood chloride increased	SYSTEMATIC_ASSESSMENT	Investigations	None	View
Blood creatinine phosphokinase decreased	SYSTEMATIC_ASSESSMENT	Investigations	None	View
Blood glucose decreased	SYSTEMATIC_ASSESSMENT	Investigations	None	View
Blood glucose increased	SYSTEMATIC_ASSESSMENT	Investigations	None	View
Blood immunoglobulin A increased	SYSTEMATIC_ASSESSMENT	Investigations	None	View
Blood ketone body increased	SYSTEMATIC_ASSESSMENT	Investigations	None	View
Blood magnesium decreased	SYSTEMATIC_ASSESSMENT	Investigations	None	View
Blood osmolarity decreased	SYSTEMATIC_ASSESSMENT	Investigations	None	View
Blood phosphorus decreased	SYSTEMATIC_ASSESSMENT	Investigations	None	View
Blood potassium decreased	SYSTEMATIC_ASSESSMENT	Investigations	None	View
Blood potassium increased	SYSTEMATIC_ASSESSMENT	Investigations	None	View
Blood pressure increased	SYSTEMATIC_ASSESSMENT	Investigations	None	View
Blood sodium decreased	SYSTEMATIC_ASSESSMENT	Investigations	None	View
Blood sodium increased	SYSTEMATIC_ASSESSMENT	Investigations	None	View
Blood thyroid stimulating hormone increased	SYSTEMATIC_ASSESSMENT	Investigations	None	View
Blood urea decreased	SYSTEMATIC_ASSESSMENT	Investigations	None	View
Cardiac murmur	SYSTEMATIC_ASSESSMENT	Investigations	None	View
Coma scale abnormal	SYSTEMATIC_ASSESSMENT	Investigations	None	View
Crystal urine present	SYSTEMATIC_ASSESSMENT	Investigations	None	View
Electrocardiogram QT prolonged	SYSTEMATIC_ASSESSMENT	Investigations	None	View
Electrocardiogram T wave peaked	SYSTEMATIC_ASSESSMENT	Investigations	None	View
Influenza A virus test positive	SYSTEMATIC_ASSESSMENT	Investigations	None	View
Lipase increased	SYSTEMATIC_ASSESSMENT	Investigations	None	View
Liver function test increased	SYSTEMATIC_ASSESSMENT	Investigations	None	View
Streptococcus test positive	SYSTEMATIC_ASSESSMENT	Investigations	None	View
Urinary casts	SYSTEMATIC_ASSESSMENT	Investigations	None	View
Urine analysis abnormal	SYSTEMATIC_ASSESSMENT	Investigations	None	View
Urine output decreased	SYSTEMATIC_ASSESSMENT	Investigations	None	View
White blood cell count increased	SYSTEMATIC_ASSESSMENT	Investigations	None	View
Acidosis	SYSTEMATIC_ASSESSMENT	Metabolism and nutrition disorders	None	View
Acidosis hyperchloraemic	SYSTEMATIC_ASSESSMENT	Metabolism and nutrition disorders	None	View
Alkalosis	SYSTEMATIC_ASSESSMENT	Metabolism and nutrition disorders	None	View
Dehydration	SYSTEMATIC_ASSESSMENT	Metabolism and nutrition disorders	None	View
Hyperchloraemia	SYSTEMATIC_ASSESSMENT	Metabolism and nutrition disorders	None	View
Hyperglycaemia	SYSTEMATIC_ASSESSMENT	Metabolism and nutrition disorders	None	View
Hyperkalaemia	SYSTEMATIC_ASSESSMENT	Metabolism and nutrition disorders	None	View
Hypernatraemia	SYSTEMATIC_ASSESSMENT	Metabolism and nutrition disorders	None	View
Hyperphosphataemia	SYSTEMATIC_ASSESSMENT	Metabolism and nutrition disorders	None	View
Hypertriglyceridaemia	SYSTEMATIC_ASSESSMENT	Metabolism and nutrition disorders	None	View
Hypocalcaemia	SYSTEMATIC_ASSESSMENT	Metabolism and nutrition disorders	None	View
Hypoglycaemia	SYSTEMATIC_ASSESSMENT	Metabolism and nutrition disorders	None	View
Hypokalaemia	SYSTEMATIC_ASSESSMENT	Metabolism and nutrition disorders	None	View
Hypomagnesaemia	SYSTEMATIC_ASSESSMENT	Metabolism and nutrition disorders	None	View
Hyponatraemia	SYSTEMATIC_ASSESSMENT	Metabolism and nutrition disorders	None	View
Hypophagia	SYSTEMATIC_ASSESSMENT	Metabolism and nutrition disorders	None	View
Hypophosphataemia	SYSTEMATIC_ASSESSMENT	Metabolism and nutrition disorders	None	View
Arthralgia	SYSTEMATIC_ASSESSMENT	Musculoskeletal and connective tissue disorders	None	View
Back pain	SYSTEMATIC_ASSESSMENT	Musculoskeletal and connective tissue disorders	None	View
Musculoskeletal chest pain	SYSTEMATIC_ASSESSMENT	Musculoskeletal and connective tissue disorders	None	View
Anxiety	SYSTEMATIC_ASSESSMENT	Psychiatric disorders	None	View
Confusional state	SYSTEMATIC_ASSESSMENT	Psychiatric disorders	None	View
Insomnia	SYSTEMATIC_ASSESSMENT	Psychiatric disorders	None	View
Irritability	SYSTEMATIC_ASSESSMENT	Psychiatric disorders	None	View
Mental status changes	SYSTEMATIC_ASSESSMENT	Psychiatric disorders	None	View
Suicidal ideation	SYSTEMATIC_ASSESSMENT	Psychiatric disorders	None	View
Haematuria	SYSTEMATIC_ASSESSMENT	Renal and urinary disorders	None	View
Incontinence	SYSTEMATIC_ASSESSMENT	Renal and urinary disorders	None	View
Urinary incontinence	SYSTEMATIC_ASSESSMENT	Renal and urinary disorders	None	View
Vaginal discharge	SYSTEMATIC_ASSESSMENT	Reproductive system and breast disorders	None	View
Vulvovaginal pruritis	SYSTEMATIC_ASSESSMENT	Reproductive system and breast disorders	None	View
Cough	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	None	View
Dyspnoea	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	None	View
Epistaxis	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	None	View
Hypoxia	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	None	View
Nasal congestion	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	None	View
Oropharyngeal pain	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	None	View
Pharyngeal erythema	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	None	View
Pneumonia aspiration	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	None	View
Pulmonary oedema	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	None	View
Rhinorrhoea	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	None	View
Stridor	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	None	View
Tachypnoea	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	None	View
Throat irritation	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	None	View
Wheezing	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	None	View
Decubitus ulcer	SYSTEMATIC_ASSESSMENT	Skin and subcutaneous tissue disorders	None	View
Dry skin	SYSTEMATIC_ASSESSMENT	Skin and subcutaneous tissue disorders	None	View
Pruritis	SYSTEMATIC_ASSESSMENT	Skin and subcutaneous tissue disorders	None	View
Rash	SYSTEMATIC_ASSESSMENT	Skin and subcutaneous tissue disorders	None	View
Rash erythematous	SYSTEMATIC_ASSESSMENT	Skin and subcutaneous tissue disorders	None	View
Rash pruritic	SYSTEMATIC_ASSESSMENT	Skin and subcutaneous tissue disorders	None	View
Skin disorder	SYSTEMATIC_ASSESSMENT	Skin and subcutaneous tissue disorders	None	View
Skin warm	SYSTEMATIC_ASSESSMENT	Skin and subcutaneous tissue disorders	None	View
Swelling face	SYSTEMATIC_ASSESSMENT	Skin and subcutaneous tissue disorders	None	View
Urticaria	SYSTEMATIC_ASSESSMENT	Skin and subcutaneous tissue disorders	None	View
Flushing	SYSTEMATIC_ASSESSMENT	Vascular disorders	None	View
Hypertension	SYSTEMATIC_ASSESSMENT	Vascular disorders	None	View
Hypotension	SYSTEMATIC_ASSESSMENT	Vascular disorders	None	View
Orthostatic hypotension	SYSTEMATIC_ASSESSMENT	Vascular disorders	None	View
Peripheral coldness	SYSTEMATIC_ASSESSMENT	Vascular disorders	None	View
Phlebitis	SYSTEMATIC_ASSESSMENT	Vascular disorders	None	View
Poor peripheral circulation	SYSTEMATIC_ASSESSMENT	Vascular disorders	None	View