Adverse Events Module

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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 @ 4:52 PM
Ignite Modification Date: 2025-12-25 @ 2:35 PM
NCT ID: NCT00531050
Description: All patients who received at least one dose of treatment were included in the safety and tolerability evaluation.
Frequency Threshold: 3
Time Frame: None
Study: NCT00531050
Study Brief: Safety of Exercise and High-dose Salbutamol in Patients With Chronic Obstructive Pulmonary Disease (COPD) Receiving Therapeutic Doses of Indacaterol (QAB 149) and Salmeterol
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Part 1:Indacaterol 300mcg Patient received a single inhaled dose of indacaterol 300μg capsule via the Concept1 inhaler device. For each treatment period and for each patient, the doses were to be administered at approximately the same time in the morning (i.e. between 8 and 9am). None None 1 26 9 26 View
Part 1:Salmeterol 50mcg Patient received single dose of salmeterol 50μg via Diskus DPI. For each treatment period and for each patient, the doses were to be administered at approximately the same time in the morning (i.e. between 8 and 9am). None None 0 25 4 25 View
Part 1:Placebo Patient received single dose of indacaterol matching placebo via the Concept1 inhaler device. For each treatment period and for each patient, the doses were to be administered at approximately the same time in the morning (i.e. between 8 and 9am). None None 1 26 4 26 View
Part 2:Salmeterol AM 50mcg/Salmeterol PM 50mcg Patients received morning and evening single inhalational dose of salmeterol 50μg via Diskus dry powder inhaler (DPI). For each treatment period and for each patient, the doses were to be administered at approximately the same time in the morning (i.e. between 8 and 9am) and the evening dose between 8 and 9pm. 20 minutes following each dose, patients received three doses of nebulized salbutamol 2.5 mg at 20 minute intervals. None None 0 24 8 24 View
Part 2:Indacaterol 300μg Morning/Placebo Evening Patients received a morning single inhalational dose of indacaterol 300μg and an evening single inhalation dose of indacaterol matching placebo via the Concept1 inhaler device. For each treatment period and for each patient, the doses were to be administered at approximately the same time in the morning (i.e. between 8 and 9am) and the evening dose between 8 and 9pm. 20 minutes following each dose, patients received three doses of nebulized salbutamol 2.5 mg at 20 minute intervals. None None 0 23 8 23 View
Part 2:Placebo Morning/Placebo Evening Patients received single inhalation dose of indacaterol matching placebo in morning and evening via Concept1 device. For each treatment period and for each patient, the doses were to be administered at approximately the same time in the morning (i.e. between 8 and 9am) and the evening dose between 8 and 9pm. 20 minutes following each dose, patients received three doses of nebulized salbutamol 2.5 mg at 20 minute intervals. None None 0 23 6 23 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Chronic obstructive pulmonary disease SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10.X View
Tonsillectomy SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 10.X View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 10.X View
Palpitations SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 10.X View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.X View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.X View
Gingivitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.X View
Toothache SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.X View
Catheter thrombosis SYSTEMATIC_ASSESSMENT General disorders MedDRA 10.X View
Chills SYSTEMATIC_ASSESSMENT General disorders MedDRA 10.X View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 10.X View
Feeling hot SYSTEMATIC_ASSESSMENT General disorders MedDRA 10.X View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 10.X View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.X View
Tooth abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.X View
Procedural dizziness SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 10.X View
Musculoskeletal chest pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 10.X View
Neck pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 10.X View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10.X View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10.X View
Neuropathy peripheral SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10.X View
Tremor SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10.X View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10.X View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10.X View
Pharyngolaryngeal pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10.X View
Productive cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10.X View
Erythema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 10.X View
Hyperhidrosis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 10.X View
Hypoaesthesia facial SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 10.X View
Nail disorder SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 10.X View
Pruritus generalised SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 10.X View
Diastolic hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 10.X View