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 @ 3:40 PM
Ignite Modification Date:
2025-12-25 @ 1:50 PM
NCT ID:
NCT01934192
Description:
AE and SAE analysis was based on Safety Population consisting of all participants who received at least one dose of study treatment.
Frequency Threshold:
0
Time Frame:
Adverse events (AEs) and Serious adverse events (SAEs) were collected for approximately 23 days from start of study treatment until follow up 14 days post last-dose.
Study:
NCT01934192
Study Brief:
Nutritional Adequacy Therapeutic Enhancement in the Critically Ill. The NUTRIATE Study
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Baseline EN Tolerant: Camicinal 50 mg | Participants who were tolerant to EN feeding at Baseline received up to 7 doses of Camicinal (GSK962040) 50 mg once daily via NG tube. participants who developed intolerance did not switch the treatment. | None | None | 4 | 39 | 13 | 39 | View |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Participants who were tolerant to EN feeding at Baseline received up to 7 doses of either Camicinal (GSK962040) 50 mg once daily via NG tube. Participants who developed intolerance to EN feeding at any point up to dose 5 were switched to receive Metoclopramide 10 mg every 6 Hrs via IV route. | None | None | 0 | 3 | 2 | 3 | View |
| Baseline EN Intolerant: Camicinal 50 mg | Participant who were intolerant to EN feeding at Baseline received Camicinal (GSK962040) 50 mg once daily via NG tube. | None | None | 0 | 4 | 0 | 4 | View |
| Baseline EN Intolerant: Metoclopramide 10 mg | Participant who were intolerant to EN feeding at Baseline received metoclopramide 10 mg every 6 Hrs. via IV route. | None | None | 2 | 4 | 3 | 4 | View |
| Baseline EN Tolerant: Placebo | Participants who were tolerant to EN feeding at Baseline received up to 7 doses of placebo drug once daily via NG tube. Participants who developed intolerance did not switch the treatment. | None | None | 1 | 35 | 9 | 35 | View |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Participants who were tolerant to EN feeding at Baseline received up to 7 doses of placebo drug once daily via NG tube. Participants who developed intolerance to EN feeding at any point up to dose 5 were switched to receive Camicinal 50 mg once daily. | None | None | 0 | 3 | 2 | 3 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Acute respiratory distress syndrome | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | View |
| Pulmonary haemorrhage | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | View |
| Intestinal ischaemia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 16.1 | View |
| Sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 16.1 | View |
| Head injury | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 16.1 | View |
| Alanine aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 16.1 | View |
| Hypoalbuminaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 16.1 | View |
| Acute kidney injury | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 16.1 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 16.1 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 16.1 | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 16.1 | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 16.1 | View |
| Diverticulum | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 16.1 | View |
| Dry mouth | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 16.1 | View |
| Dysphagia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 16.1 | View |
| Gastric dilatation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 16.1 | View |
| Gastritis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 16.1 | View |
| Haematochezia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 16.1 | View |
| Impaired gastric emptying | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 16.1 | View |
| Intestinal ischaemia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 16.1 | View |
| Upper gastrointestinal haemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 16.1 | View |
| Cellulitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 16.1 | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 16.1 | View |
| Enterococcal infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 16.1 | View |
| Escherichia infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 16.1 | View |
| Klebsiella sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 16.1 | View |
| Lower respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 16.1 | View |
| Oral candidiasis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 16.1 | View |
| Oral herpes | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 16.1 | View |
| Pneumonia haemophilus | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 16.1 | View |
| Pulmonary sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 16.1 | View |
| Respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 16.1 | View |
| Sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 16.1 | View |
| Staphylococcal sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 16.1 | View |
| Streptococcal infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 16.1 | View |
| Wound infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 16.1 | View |
| Alanine aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 16.1 | View |
| Blood glucose increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 16.1 | View |
| Blood potassium decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 16.1 | View |
| Blood urea increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 16.1 | View |
| Body temperature increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 16.1 | View |
| Electrocardiogram ST segment depression | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 16.1 | View |
| Electrocardiogram T wave inversion | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 16.1 | View |
| Gamma-glutamyltransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 16.1 | View |
| Haemoglobin decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 16.1 | View |
| Liver function test increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 16.1 | View |
| Acute respiratory distress syndrome | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | View |
| Atelectasis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | View |
| Cheyne-Stokes respiration | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | View |
| Increased bronchial secretion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | View |
| Pulmonary embolism | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | View |
| Pulmonary haemorrhage | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | View |
| Tachypnoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | View |
| Atrial fibrillation | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 16.1 | View |
| Atrial flutter | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 16.1 | View |
| Atrial tachycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 16.1 | View |
| Bundle branch block right | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 16.1 | View |
| Tachycardia paroxysmal | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 16.1 | View |
| Ventricular tachycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 16.1 | View |
| Fluid overload | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 16.1 | View |
| Hyperglycaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 16.1 | View |
| Hyperkalaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 16.1 | View |
| Hypoalbuminaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 16.1 | View |
| Hypokalaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 16.1 | View |
| Hypomagnesaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 16.1 | View |
| Hyponatraemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 16.1 | View |
| Delirium | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 16.1 | View |
| Head injury | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 16.1 | View |
| Post procedural haemorrhage | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 16.1 | View |
| Postoperative wound complication | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 16.1 | View |
| Procedural haemorrhage | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 16.1 | View |
| Skin graft failure | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 16.1 | View |
| Anaemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 16.1 | View |
| Erythema | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 16.1 | View |
| Dermatitis allergic | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 16.1 | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 16.1 | View |
| Deep vein thrombosis | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 16.1 | View |
| Hypotension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 16.1 | View |
| Cholestasis | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 16.1 | View |
| Device dislocation | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA 16.1 | View |
| Acute kidney injury | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 16.1 | View |