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 @ 4:21 PM
Ignite Modification Date:
2025-12-25 @ 2:17 PM
NCT ID:
NCT04545866
Description:
AE onset was monitored from treatment initiation through 7 days after the last dose of study drug (30 days for SIP and PVL). This window includes up to 10 days postnatal age (or 33 days PNA for SIP/PVL). AEs were not monitored for infants who did not initiate treatment.
All-cause mortality was monitored from randomization through 36 weeks PMA or prior study status (discharge, transfer).
Note: Treatment group is reported as randomized. Published analyses may use treatment as received.
Frequency Threshold:
0.00
Time Frame:
Adverse events were monitored from treatment through 7 days (168 hours) post-treatment, or treatment through 30 days (720 hours) post-treatment for SIP and PVL. All-cause mortality was monitored from randomization through 36 weeks PMA.
Study:
NCT04545866
Study Brief:
The Budesonide in Babies (BiB) Trial
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| BUDE | Budesonide (Pulmicort nebulizing suspension) 1 ml/kg + Surfactant (poractant alfa; Curosurf) 2.5 ml/kg | 49 | None | 63 | 323 | 232 | 323 | View |
| SURF | Surfactant (poractant alfa; Curosurf) 2.5 ml/kg | 42 | None | 55 | 318 | 187 | 318 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Atrial flutter | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA Version 24.0 | View |
| Cardio-respiratory arrest neonatal | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA Version 24.0 | View |
| Newborn persistent pulmonary hypertension | NON_SYSTEMATIC_ASSESSMENT | Congenital, familial and genetic disorders | MedDRA Version 24.0 | View |
| Pulmonary hypoplasia | NON_SYSTEMATIC_ASSESSMENT | Congenital, familial and genetic disorders | MedDRA Version 24.0 | View |
| Gastric perforation | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 24.0 | View |
| Intestinal perforation | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 24.0 | View |
| Intra-abdominal haemorrhage | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 24.0 | View |
| Necrotising colitis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 24.0 | View |
| Neonatal intestinal perforation | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 24.0 | View |
| Pneumoperitoneum | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 24.0 | View |
| Sepsis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 24.0 | View |
| Sepsis neonatal | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 24.0 | View |
| Septic shock | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 24.0 | View |
| Endotracheal intubation complication | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 24.0 | View |
| Hyperglycaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Version 24.0 | View |
| Cerebral haemorrhage | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 24.0 | View |
| Haemorrhage intracranial | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 24.0 | View |
| Intraventricular haemorrhage | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 24.0 | View |
| Intraventricular haemorrhage neonatal | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 24.0 | View |
| Device occlusion | NON_SYSTEMATIC_ASSESSMENT | Product Issues | MedDRA Version 24.0 | View |
| Hypoxia | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 24.0 | View |
| Neonatal asphyxia | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 24.0 | View |
| Neonatal pneumothorax | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 24.0 | View |
| Neonatal respiratory distress syndrome | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 24.0 | View |
| Pneumothorax | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 24.0 | View |
| Pulmonary air leakage | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 24.0 | View |
| Pulmonary haemorrhage | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 24.0 | View |
| Pulmonary hypertension | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 24.0 | View |
| Pulmonary hypertensive crisis | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 24.0 | View |
| Respiratory failure | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 24.0 | View |
| Hypertension | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA Version 24.0 | View |
| Hypotension | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA Version 24.0 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Leukocytosis | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA Version 24.0 | View |
| Thrombocytopenia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA Version 24.0 | View |
| Left ventricular dysfunction | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA Version 24.0 | View |
| Newborn persistent pulmonary hypertension | NON_SYSTEMATIC_ASSESSMENT | Congenital, familial and genetic disorders | MedDRA Version 24.0 | View |
| Patent ductus arteriosus | NON_SYSTEMATIC_ASSESSMENT | Congenital, familial and genetic disorders | MedDRA Version 24.0 | View |
| Intestinal perforation | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 24.0 | View |
| Intra-abdominal haemorrhage | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 24.0 | View |
| Necrotising colitis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 24.0 | View |
| Necrotising enterocolitis neonatal | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 24.0 | View |
| Pneumoperitoneum | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA Version 24.0 | View |
| Meningitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 24.0 | View |
| Sepsis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 24.0 | View |
| Sepsis neonatal | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA Version 24.0 | View |
| Endotracheal intubation complication | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA Version 24.0 | View |
| Acidosis | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Version 24.0 | View |
| Hyperammonaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Version 24.0 | View |
| Hyperglycaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Version 24.0 | View |
| Hypoglycaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Version 24.0 | View |
| Hyponatraemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA Version 24.0 | View |
| Haemorrhage intracranial | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 24.0 | View |
| Intraventricular haemorrhage neonatal | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 24.0 | View |
| Periventricular leukomalacia | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA Version 24.0 | View |
| Device occlusion | NON_SYSTEMATIC_ASSESSMENT | Product Issues | MedDRA Version 24.0 | View |
| Oliguria | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA Version 24.0 | View |
| Acute respiratory failure | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 24.0 | View |
| Hypoxia | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 24.0 | View |
| Pneumothorax | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 24.0 | View |
| Pulmonary air leakage | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 24.0 | View |
| Pulmonary haemorrhage | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 24.0 | View |
| Pulmonary haemorrhage neonatal | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 24.0 | View |
| Pulmonary hypertension | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 24.0 | View |
| Pulmonary interstitial emphysema syndrome | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA Version 24.0 | View |
| Hypertension | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA Version 24.0 | View |
| Hypotension | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA Version 24.0 | View |