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 @ 3:53 PM
Ignite Modification Date:
2025-12-25 @ 1:58 PM
NCT ID:
NCT00128492
Description:
A treatment-emergent AE was any physical or clinical worsening in symptoms or disease experienced by the participant at any time during the course of the study, whether or not the event was considered related to study participation or study procedures. An SAE was any adverse experience that resulted in death or hospitalization.
Frequency Threshold:
5
Time Frame:
Participants were monitored for AEs and SAEs during all on-treatment and off-treatment intervals. Participants could receive up to 9 courses of AZLI, with total time on study of up to 18 months. Events occurring during the 18-month period are reported.
Study:
NCT00128492
Study Brief:
Safety and Efficacy Study of Aztreonam for Inhalation Solution (AZLI) in Cystic Fibrosis (CF) Patients With Pseudomonas Aeruginosa (PA)
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| 75 mg AZLI Two Times a Day (BID) | Participants received up to 9 treatment courses of open-label 75 mg AZLI BID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy. BID = twice daily | None | None | 38 | 85 | 83 | 85 | View |
| 75 mg AZLI Three Times a Day (TID) | Participants received up to 9 treatment courses of open-label 75 mg AZLI TID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy. TID = three times daily | None | None | 100 | 189 | 185 | 189 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Abdominal pain | None | Gastrointestinal disorders | MedDRA 8.0 | View |
| Abdominal pain lower | None | Gastrointestinal disorders | MedDRA 8.0 | View |
| Abdominal pain upper | None | Gastrointestinal disorders | MedDRA 8.0 | View |
| Abdominal tenderness | None | Gastrointestinal disorders | MedDRA 8.0 | View |
| Abortion spontaneous | None | Pregnancy, puerperium and perinatal conditions | MedDRA 8.0 | View |
| Anaemia | None | Blood and lymphatic system disorders | MedDRA 8.0 | View |
| Anorexia | None | Metabolism and nutrition disorders | MedDRA 8.0 | View |
| Antibacterial prophylaxis | None | Surgical and medical procedures | MedDRA 8.0 | View |
| Arthralgia | None | Musculoskeletal and connective tissue disorders | MedDRA 8.0 | View |
| Asthenia | None | General disorders | MedDRA 8.0 | View |
| Atelectasis | None | Respiratory, thoracic and mediastinal disorders | MedDRA 8.0 | View |
| Back pain | None | Musculoskeletal and connective tissue disorders | MedDRA 8.0 | View |
| Blood chloride decreased | None | Investigations | MedDRA 8.0 | View |
| Blood creatinine increased | None | Investigations | MedDRA 8.0 | View |
| Blood culture positive | None | Investigations | MedDRA 8.0 | View |
| Blood potassium decreased | None | Investigations | MedDRA 8.0 | View |
| Breath sounds decreased | None | Respiratory, thoracic and mediastinal disorders | MedDRA 8.0 | View |
| Bronchiectasis | None | Respiratory, thoracic and mediastinal disorders | MedDRA 8.0 | View |
| Bronchopneumonia | None | Respiratory, thoracic and mediastinal disorders | MedDRA 8.0 | View |
| Chest discomfort | None | Respiratory, thoracic and mediastinal disorders | MedDRA 8.0 | View |
| Constipation | None | Gastrointestinal 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 |
| Cyanosis | None | Cardiac 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 |
| Diarrhoea | None | Gastrointestinal disorders | MedDRA 8.0 | View |
| Distal intestinal obstruction syndrome | None | Gastrointestinal disorders | MedDRA 8.0 | View |
| Dizziness | None | Nervous system disorders | MedDRA 8.0 | View |
| Dyspepsia | None | Gastrointestinal 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 |
| Dyspnoea exertional | None | Respiratory, thoracic and mediastinal disorders | MedDRA 8.0 | View |
| Electrolyte imbalance | None | Metabolism and nutrition disorders | MedDRA 8.0 | View |
| Exercise tolerance decreased | None | General disorders | MedDRA 8.0 | View |
| Fatigue | None | General disorders | MedDRA 8.0 | View |
| Fluid retention | None | Renal and urinary disorders | MedDRA 8.0 | View |
| Forced expiratory volume decreased | None | Investigations | MedDRA 8.0 | View |
| Gastrointestinal disorder | None | Gastrointestinal disorders | MedDRA 8.0 | View |
| Gastrostomy tube insertion | None | Surgical and medical procedures | MedDRA 8.0 | View |
| Haemoptysis | None | Respiratory, thoracic and mediastinal disorders | MedDRA 8.0 | View |
| Headache | None | Nervous system disorders | MedDRA 8.0 | View |
| Hepatitis acute | None | Hepatobiliary disorders | MedDRA 8.0 | View |
| Hyperglycaemia | None | Metabolism and nutrition disorders | MedDRA 8.0 | View |
| Hypoxia | None | Respiratory, thoracic and mediastinal disorders | MedDRA 8.0 | View |
| Increased viscosity of bronchial secretion | None | Respiratory, thoracic and mediastinal disorders | MedDRA 8.0 | View |
| Infrequent bowel movements | None | Gastrointestinal disorders | MedDRA 8.0 | View |
| Inguinal hernia | None | Gastrointestinal disorders | MedDRA 8.0 | View |
| Joint swelling | None | Musculoskeletal and connective tissue disorders | MedDRA 8.0 | View |
| Lethargy | None | General disorders | MedDRA 8.0 | View |
| Lipase increased | None | Investigations | MedDRA 8.0 | View |
| Lung infiltration | None | Respiratory, thoracic and mediastinal disorders | MedDRA 8.0 | View |
| Malaise | None | General disorders | MedDRA 8.0 | View |
| Musculoskeletal chest pain | None | Musculoskeletal and connective tissue disorders | MedDRA 8.0 | View |
| Nasal congestion | None | Respiratory, thoracic and mediastinal disorders | MedDRA 8.0 | View |
| Nausea | None | Gastrointestinal disorders | MedDRA 8.0 | View |
| Nephrolithiasis | None | Renal and urinary disorders | MedDRA 8.0 | View |
| Non-cardiac chest pain | None | Respiratory, thoracic and mediastinal disorders | MedDRA 8.0 | View |
| Oxygen saturation decreased | None | Investigations | MedDRA 8.0 | View |
| Oxygen supplementation | None | Surgical and medical procedures | MedDRA 8.0 | View |
| Pain | None | General disorders | MedDRA 8.0 | View |
| Pancreatitis | None | Gastrointestinal disorders | MedDRA 8.0 | View |
| Pelvic pain | None | Reproductive system and breast disorders | MedDRA 8.0 | View |
| Peripheral ischaemia | None | Vascular disorders | MedDRA 8.0 | View |
| Pharyngolaryngeal pain | None | Respiratory, thoracic and mediastinal disorders | MedDRA 8.0 | View |
| Pleuritic pain | None | Respiratory, thoracic and mediastinal disorders | MedDRA 8.0 | View |
| Pneumonia | None | Respiratory, thoracic and mediastinal disorders | MedDRA 8.0 | View |
| Pneumonia bacterial | None | Respiratory, thoracic and mediastinal disorders | MedDRA 8.0 | View |
| Pneumothorax | 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 |
| Rales | None | Respiratory, thoracic and mediastinal disorders | MedDRA 8.0 | View |
| Rash | None | Skin and subcutaneous tissue disorders | MedDRA 8.0 | View |
| Respiratory distress | None | Respiratory, thoracic and mediastinal disorders | MedDRA 8.0 | View |
| Respiratory tract congestion | None | Respiratory, thoracic and mediastinal disorders | MedDRA 8.0 | View |
| Respiratory tract infection | None | Respiratory, thoracic and mediastinal disorders | MedDRA 8.0 | View |
| Rhinorrhoea | None | Respiratory, thoracic and mediastinal disorders | MedDRA 8.0 | View |
| Rhonchi | None | Respiratory, thoracic and mediastinal disorders | MedDRA 8.0 | View |
| Sinus congestion | None | Respiratory, thoracic and mediastinal disorders | MedDRA 8.0 | View |
| Sputum discoloured | None | Respiratory, thoracic and mediastinal disorders | MedDRA 8.0 | View |
| Sputum purulent | None | Respiratory, thoracic and mediastinal disorders | MedDRA 8.0 | View |
| Staphylococcal infection | None | Infections and infestations | MedDRA 8.0 | View |
| Tachycardia | None | Cardiac disorders | MedDRA 8.0 | View |
| Tachypnoea | None | Respiratory, thoracic and mediastinal disorders | MedDRA 8.0 | View |
| Urine output decreased | None | Investigations | MedDRA 8.0 | View |
| Uterine leiomyoma | None | Reproductive system and breast disorders | MedDRA 8.0 | View |
| Vocal cord paralysis | None | Nervous system disorders | MedDRA 8.0 | View |
| Vomiting | None | Gastrointestinal disorders | MedDRA 8.0 | View |
| Weight decreased | None | Investigations | MedDRA 8.0 | View |
| Wheezing | None | Respiratory, thoracic and mediastinal disorders | MedDRA 8.0 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Abdominal distension | None | Gastrointestinal disorders | MedDRA 8.0 | View |
| Abdominal pain | None | Gastrointestinal disorders | MedDRA 8.0 | View |
| Abdominal pain upper | None | Gastrointestinal disorders | MedDRA 8.0 | View |
| Arthralgia | None | Musculoskeletal and connective tissue disorders | MedDRA 8.0 | View |
| Asthenia | None | General disorders | MedDRA 8.0 | View |
| Back pain | None | Musculoskeletal and connective tissue 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 |
| Chest discomfort | None | Respiratory, thoracic and mediastinal disorders | MedDRA 8.0 | View |
| Chest wall pain | None | Musculoskeletal and connective tissue disorders | MedDRA 8.0 | View |
| Chills | None | General disorders | MedDRA 8.0 | View |
| Constipation | None | Gastrointestinal 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 |
| Decreased appetite | None | Metabolism and nutrition disorders | MedDRA 8.0 | View |
| Diarrhoea | None | Gastrointestinal disorders | MedDRA 8.0 | View |
| Dizziness | None | Nervous system disorders | MedDRA 8.0 | View |
| Dysphonia | 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 |
| Dyspnoea exertional | None | Respiratory, thoracic and mediastinal disorders | MedDRA 8.0 | View |
| Ear pain | None | Ear and labyrinth disorders | MedDRA 8.0 | View |
| Epistaxis | None | Respiratory, thoracic and mediastinal disorders | MedDRA 8.0 | View |
| Exercise tolerance decreased | None | General disorders | MedDRA 8.0 | View |
| Fatigue | None | General disorders | MedDRA 8.0 | View |
| Forced expiratory volume decreased | None | Investigations | MedDRA 8.0 | View |
| Haemoptysis | None | Respiratory, thoracic and mediastinal disorders | MedDRA 8.0 | View |
| Headache | None | Nervous system disorders | MedDRA 8.0 | View |
| Musculoskeletal chest pain | None | Musculoskeletal and connective tissue disorders | MedDRA 8.0 | View |
| Myalgia | None | Musculoskeletal and connective tissue disorders | MedDRA 8.0 | View |
| Nasal congestion | None | Respiratory, thoracic and mediastinal disorders | MedDRA 8.0 | View |
| Nasal mucosal disorder | None | Respiratory, thoracic and mediastinal disorders | MedDRA 8.0 | View |
| Nasal oedema | None | Respiratory, thoracic and mediastinal disorders | MedDRA 8.0 | View |
| Nasal polyps | None | Respiratory, thoracic and mediastinal disorders | MedDRA 8.0 | View |
| Nasopharyngitis | None | Respiratory, thoracic and mediastinal 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 |
| Pain | None | General disorders | MedDRA 8.0 | View |
| Pain in extremity | None | Musculoskeletal and connective tissue disorders | MedDRA 8.0 | View |
| Paranasal sinus hypersecretion | None | Respiratory, thoracic and mediastinal disorders | MedDRA 8.0 | View |
| Pharyngeal erythema | None | Respiratory, thoracic and mediastinal disorders | MedDRA 8.0 | View |
| Pharyngolaryngeal pain | None | Respiratory, thoracic and mediastinal disorders | MedDRA 8.0 | View |
| Postnasal drip | None | Respiratory, thoracic and mediastinal disorders | MedDRA 8.0 | View |
| Productive cough | None | Respiratory, thoracic and mediastinal disorders | MedDRA 8.0 | View |
| Pruritus | None | Skin and subcutaneous tissue disorders | MedDRA 8.0 | View |
| Pulmonary function test decreased | None | Investigations | MedDRA 8.0 | View |
| Pyrexia | None | General disorders | MedDRA 8.0 | View |
| Rales | None | Respiratory, thoracic and mediastinal disorders | MedDRA 8.0 | View |
| Rash | None | Skin and subcutaneous tissue disorders | MedDRA 8.0 | View |
| Respiratory tract congestion | None | Respiratory, thoracic and mediastinal disorders | MedDRA 8.0 | View |
| Rhinitis | None | Respiratory, thoracic and mediastinal disorders | MedDRA 8.0 | View |
| Rhinorrhoea | None | Respiratory, thoracic and mediastinal disorders | MedDRA 8.0 | View |
| Rhonchi | None | Respiratory, thoracic and mediastinal disorders | MedDRA 8.0 | View |
| Sinus congestion | None | Respiratory, thoracic and mediastinal disorders | MedDRA 8.0 | View |
| Sinus headache | None | Respiratory, thoracic and mediastinal disorders | MedDRA 8.0 | View |
| Sneezing | None | Respiratory, thoracic and mediastinal disorders | MedDRA 8.0 | View |
| Sputum discoloured | None | Respiratory, thoracic and mediastinal disorders | MedDRA 8.0 | View |
| Vomiting | None | Gastrointestinal disorders | MedDRA 8.0 | View |
| Weight decreased | None | Investigations | MedDRA 8.0 | View |
| Wheezing | None | Respiratory, thoracic and mediastinal disorders | MedDRA 8.0 | View |