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 @ 10:41 PM
Ignite Modification Date:
2025-12-25 @ 8:12 PM
NCT ID:
NCT02911935
Description:
None
Frequency Threshold:
0
Time Frame:
Follow up duration of 18-48 months
Study:
NCT02911935
Study Brief:
Azithromycin to Prevent Wheezing Following Severe RSV Bronchiolitis-II
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Azithromycin | Participants orally received azithromycin 10mg/kg/day for 7 days; then oral azithromycin 5mg/kg/day for 7 additional days | 0 | None | 15 | 101 | 73 | 101 | View |
| Placebo | Participants orally received placebo daily for 14 days. | 0 | None | 16 | 99 | 72 | 99 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Accidental drug ingestion | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Acute appendicitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Choking | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| ED visit for gastroenteritis | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| High Fever | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Hospitalization for bone fracutre | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Hospitalization for respiratory distress | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Hospitalization for wheezing | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Hospitalized for observation and video EEG | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Preseptal Cellulitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Respiratory failure/distress | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Scheduled surgery for bilateral myringotomy with tube insertion and bilateral Adenotonsillectomy | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Transferred to PICU during respiratory infection | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Hospitalization with hematoma | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Hospitalized after bronchoscopy | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Hospitalized for a UTI and fever | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Hospitalized for dehydration | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Hospitalized for observation following bronchoscopy, BAL and EGD with biopsies | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Hospitalized for planned right open pyeloplasty and observation | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Hospitalized with respiratory infection | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Hospitalized with bloody diarrhea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Hospitalized with questionable seizurelike activity | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Hospitalized with pneumonia | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Hospitalized for asthma exacerbation | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Abnormal Neutrophil Count | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
| Abnormal platelet count | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
| Acute Otitis Media | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| GERD | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Loose stool | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Skin infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Wheezing | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Blocked tear duct | SYSTEMATIC_ASSESSMENT | Eye disorders | None | View |
| Blood in urine | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Decreased Neutrophil count | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
| Diarrhea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Ear infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Fever | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Fussy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Pink eye | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Rash | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| Severe obstructive sleep apnea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Sleep myoclonus | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Strep infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Upper respiratory infection | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |