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 @ 4:39 PM
Ignite Modification Date:
2025-12-25 @ 2:29 PM
NCT ID:
NCT00712166
Description:
An AE was any physical/clinical worsening in symptoms/disease (including clinically significant change in lab values) experienced by participant at any time during study, whether or not event was considered related to study participation or study procedures. Participants were only counted once within a System Organ Class (SOC) and preferred term.
Frequency Threshold:
5
Time Frame:
Treatment-emergent AEs were collected continuously from the first dose (Day 0) until 14 days after last AZLI/placebo dose (typically Day 42). Participants who discontinued were evaluated for at least 14 days after last dose of study drug.
Study:
NCT00712166
Study Brief:
Safety and Efficacy Study of Aztreonam for Inhalation Solution (AZLI) in Patients With Cystic Fibrosis, Mild Lung Disease, and P. Aeruginosa
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Placebo Three Times Daily (TID) | Placebo (5 mg/mL lactose when reconstituted in diluent \[0.17% saline\]; sterile, pH 4.2 to 7.5, and osmolality 200 to 400 mOsmol/kg). Placebo was self-administered TID by inhalation using the investigational nebulizer. | None | None | 3 | 81 | 62 | 81 | View |
| AZLI 75 mg Three Times Daily (TID) | AZLI (75 mg/mL aztreonam lysine when reconstituted in diluent \[0.17% saline\]; sterile, pH 4.2 to 7.0, and osmolality 300 to 550 mOsmol/kg). AZLI was self-administered by inhalation TID using the investigational nebulizer. | None | None | 9 | 76 | 58 | 76 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Abdominal pain | None | Gastrointestinal disorders | MedDRA (11.1) | View |
| Abdominal pain upper | None | Gastrointestinal disorders | MedDRA (11.1) | View |
| Breath sounds abnormal | None | Investigations | MedDRA (11.1) | View |
| Cough | None | Respiratory, thoracic and mediastinal disorders | MedDRA (11.1) | View |
| Dyspnoea | None | Respiratory, thoracic and mediastinal disorders | MedDRA (11.1) | View |
| Gastrooesophageal reflux disease | None | Gastrointestinal disorders | MedDRA (11.1) | View |
| Haemoptysis | None | Respiratory, thoracic and mediastinal disorders | MedDRA (11.1) | View |
| Malnutrition | None | Metabolism and nutrition disorders | MedDRA (11.1) | View |
| Melaena | None | Gastrointestinal disorders | MedDRA (11.1) | View |
| Pain | None | General disorders | MedDRA (11.1) | View |
| Pseudomonas bronchitis | None | Respiratory, thoracic and mediastinal disorders | MedDRA (11.1) | View |
| Pulmonary function test decreased | None | Investigations | MedDRA (11.1) | View |
| Pyrexia | None | General disorders | MedDRA (11.1) | View |
| Sinusitis | None | Respiratory, thoracic and mediastinal disorders | MedDRA (11.1) | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Abdominal pain | None | Gastrointestinal disorders | MedDRA (11.1) | View |
| Abdominal pain upper | None | Gastrointestinal disorders | MedDRA (11.1) | View |
| Chest discomfort | None | Respiratory, thoracic and mediastinal disorders | MedDRA (11.1) | View |
| Chest pain | None | Musculoskeletal and connective tissue disorders | MedDRA (11.1) | View |
| Cough | None | Respiratory, thoracic and mediastinal disorders | MedDRA (11.1) | View |
| Decreased appetite | None | Metabolism and nutrition disorders | MedDRA (11.1) | View |
| Diarrhoea | None | Gastrointestinal disorders | MedDRA (11.1) | View |
| Dizziness | None | Nervous system disorders | MedDRA (11.1) | View |
| Dyspnoea | None | Respiratory, thoracic and mediastinal disorders | MedDRA (11.1) | View |
| Fatigue | None | General disorders | MedDRA (11.1) | View |
| Headache | None | Nervous system disorders | MedDRA (11.1) | View |
| Nasal congestion | None | Respiratory, thoracic and mediastinal disorders | MedDRA (11.1) | View |
| Nausea | None | Gastrointestinal disorders | MedDRA (11.1) | View |
| Oropharyngeal pain | None | Respiratory, thoracic and mediastinal disorders | MedDRA (11.1) | View |
| Pleuritic pain | None | Respiratory, thoracic and mediastinal disorders | MedDRA (11.1) | View |
| Postnasal drip | None | Respiratory, thoracic and mediastinal disorders | MedDRA (11.1) | View |
| Productive cough | None | Respiratory, thoracic and mediastinal disorders | MedDRA (11.1) | View |
| Pulmonary function test decreased | None | Investigations | MedDRA (11.1) | View |
| Pyrexia | None | General disorders | MedDRA (11.1) | View |
| Rales | None | Respiratory, thoracic and mediastinal disorders | MedDRA (11.1) | View |
| Respiratory tract congestion | None | Respiratory, thoracic and mediastinal disorders | MedDRA (11.1) | View |
| Rhinitis | None | Respiratory, thoracic and mediastinal disorders | MedDRA (11.1) | View |
| Rhinorrhoea | None | Respiratory, thoracic and mediastinal disorders | MedDRA (11.1) | View |
| Sinus headache | None | Respiratory, thoracic and mediastinal disorders | MedDRA (11.1) | View |
| Sputum discolored | None | Respiratory, thoracic and mediastinal disorders | MedDRA (11.1) | View |
| Wheezing | None | Respiratory, thoracic and mediastinal disorders | MedDRA (11.1) | View |