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 @ 2:46 PM
Ignite Modification Date:
2025-12-25 @ 1:14 PM
NCT ID:
NCT00112359
Description:
An AE was any physical or clinical worsening in symptoms or disease (including clinically significant change in lab values) experienced by participant at any time during the study, whether or not the event was considered related to study participation or study procedures.
Participants were only counted once within an SOC and preferred term.
Frequency Threshold:
5
Time Frame:
AEs that first occurred or worsened after the first dose of study drug through 30 days after the last dose are summarized.
Study:
NCT00112359
Study Brief:
International Safety and Efficacy Study of Aztreonam for Inhalation Solution (AZLI) in Cystic Fibrosis Patients With 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 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 three times a day by inhalation using the investigational nebulizer. | None | None | 12 | 84 | 67 | 84 | View |
| 75 mg AZLI 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 three times a day using the investigational nebulizer. | None | None | 5 | 80 | 63 | 80 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Asthenia | None | General disorders | MedDRA 8.0 | View |
| Blood glucose increased | None | Investigations | MedDRA 8.0 | View |
| Breath sounds decreased | None | Respiratory, thoracic and mediastinal disorders | MedDRA 8.0 | View |
| C-reactive protein increased | None | Investigations | MedDRA 8.0 | View |
| Cough | None | Respiratory, thoracic and mediastinal disorders | MedDRA 8.0 | View |
| Crackles lung | None | Respiratory, thoracic and mediastinal disorders | MedDRA 8.0 | View |
| Decreased appetite | None | Metabolism and nutrition disorders | MedDRA 8.0 | View |
| Dehydration | None | Metabolism and nutrition disorders | MedDRA 8.0 | View |
| Dyspnoea | None | Respiratory, thoracic and mediastinal disorders | MedDRA 8.0 | View |
| Dyspnoea exacerbated | None | Respiratory, thoracic and mediastinal disorders | MedDRA 8.0 | View |
| Erythema | None | Skin and subcutaneous tissue disorders | MedDRA 8.0 | View |
| Exercise tolerance decreased | None | General disorders | MedDRA 8.0 | View |
| Fatigue | None | General disorders | MedDRA 8.0 | View |
| Haemoptysis | None | Respiratory, thoracic and mediastinal disorders | MedDRA 8.0 | View |
| Hypovolaemia | None | Metabolism and nutrition disorders | MedDRA 8.0 | View |
| Hypoxia | None | Respiratory, thoracic and mediastinal disorders | MedDRA 8.0 | View |
| Intercostal retraction | None | Respiratory, thoracic and mediastinal disorders | MedDRA 8.0 | View |
| Intestinal obstruction | None | Gastrointestinal disorders | MedDRA 8.0 | View |
| Malnutrition | None | Metabolism and nutrition disorders | MedDRA 8.0 | View |
| Musculoskeletal chest pain | None | Musculoskeletal and connective tissue disorders | MedDRA 8.0 | View |
| Nausea | None | Gastrointestinal disorders | MedDRA 8.0 | View |
| Non-cardiac chest pain | None | Respiratory, thoracic and mediastinal disorders | MedDRA 8.0 | View |
| Oedema peripheral | None | General disorders | MedDRA 8.0 | View |
| Oxygen saturation decreased | None | Investigations | MedDRA 8.0 | View |
| Pain | None | General disorders | MedDRA 8.0 | View |
| Pain in extremity | None | Musculoskeletal and connective tissue disorders | MedDRA 8.0 | View |
| Pleural effusion | None | Respiratory, thoracic and mediastinal disorders | MedDRA 8.0 | View |
| Pneumonia | None | Respiratory, thoracic and mediastinal disorders | MedDRA 8.0 | View |
| Productive cough | None | Respiratory, thoracic and mediastinal disorders | MedDRA 8.0 | View |
| Pulmonary function test decreased | None | Investigations | MedDRA 8.0 | View |
| Pyrexia | None | General disorders | MedDRA 8.0 | View |
| Respiratory tract congestion | None | Respiratory, thoracic and mediastinal disorders | MedDRA 8.0 | View |
| Sinus congestion | None | Respiratory, thoracic and mediastinal disorders | MedDRA 8.0 | View |
| Small intestinal obstruction | None | Gastrointestinal disorders | MedDRA 8.0 | View |
| Sputum discoloured | None | Respiratory, thoracic and mediastinal disorders | MedDRA 8.0 | View |
| Tachypnoea | None | Respiratory, thoracic and mediastinal disorders | MedDRA 8.0 | View |
| Thrombosis | None | Vascular disorders | MedDRA 8.0 | View |
| Umbilical hernia | None | Gastrointestinal disorders | MedDRA 8.0 | View |
| Weight decreased | None | Investigations | MedDRA 8.0 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Abdominal pain | None | Gastrointestinal disorders | MedDRA 8.0 | View |
| Arthralgia | None | Musculoskeletal and connective tissue disorders | MedDRA 8.0 | View |
| Chest discomfort | None | Respiratory, thoracic and mediastinal disorders | MedDRA 8.0 | View |
| Cough | None | Respiratory, thoracic and mediastinal disorders | MedDRA 8.0 | View |
| Crackles lung | None | Respiratory, thoracic and mediastinal disorders | MedDRA 8.0 | View |
| Dyspnoea | None | Respiratory, thoracic and mediastinal disorders | MedDRA 8.0 | View |
| Dyspnoea exacerbated | None | Respiratory, thoracic and mediastinal disorders | MedDRA 8.0 | View |
| Fatigue | None | General disorders | MedDRA 8.0 | View |
| Haemoptysis | None | Respiratory, thoracic and mediastinal disorders | MedDRA 8.0 | View |
| Headache | None | Nervous system disorders | MedDRA 8.0 | View |
| Nasal congestion | None | Respiratory, thoracic and mediastinal disorders | MedDRA 8.0 | View |
| Pharyngolaryngeal pain | None | Respiratory, thoracic and mediastinal disorders | MedDRA 8.0 | View |
| Productive cough | None | Respiratory, thoracic and mediastinal disorders | MedDRA 8.0 | View |
| Pulmonary function test decreased | None | Investigations | MedDRA 8.0 | View |
| Pyrexia | None | General disorders | MedDRA 8.0 | View |
| Rhinorrhoea | None | Respiratory, thoracic and mediastinal disorders | MedDRA 8.0 | View |
| Sinus congestion | None | Respiratory, thoracic and mediastinal disorders | MedDRA 8.0 | View |
| Throat irritation | None | Respiratory, thoracic and mediastinal disorders | MedDRA 8.0 | View |
| Wheezing | None | Respiratory, thoracic and mediastinal disorders | MedDRA 8.0 | View |