Trial · NCT04172701
Registered outcomes49
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 49
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Incidence Rate for the First Pneumonia Event | From the index date (i.e. between 01 January 2005 and 30 April 2015) up to the earliest of discontinuation of the index drug (i.e. LAMA or ICS/LABA), death, or 30 April 2016 (i.e. cut-off date for data retrieving), up to 136 months. | Pneumonia was defined as ≥1 inpatient or outpatient claims 1) with ICD-10 codes for pneumonia recorded as any diagnosis in inpatient claims or primary \~ 4th secondary diagnosis in outpatient claims, AND 2) with diagnostic test code for chest-X ray or chest- computed tomography (CT), AND 3) with antibiotics prescription during the following period after the index date. To assess the incidence of pneumonia event, the first pneumonia event observed during the follow-up period was considered. Incidence rate for the first pneumonia event was calculated as below: Incidence rate per 1000 person-years= Number of patients with event/ sum of event-free period during the follow-up period (1000 person-years) |
| Primary | Incidence Rate of Pneumonia Events | From the index date (i.e. between 01 January 2005 and 30 April 2015) up to the earliest of discontinuation of the index drug (i.e. LAMA or ICS/LABA), death, or 30 April 2016 (i.e. cut-off date for data retrieving), up to 136 months. | Pneumonia was defined as ≥1 inpatient or outpatient claims 1) with ICD-10 codes for pneumonia recorded as any diagnosis in inpatient claims or primary \~ 4th secondary diagnosis in outpatient claims, AND 2) with diagnostic test code for chest-X ray or chest- computed tomography (CT), AND 3) with antibiotics prescription during the following period after the index date. This outcome measure reports: Total number of pneumonia events/ sum of follow-up duration (person-years) for all participants |
| Primary | Time to First Pneumonia Event From the Index Date | From the index date (i.e. between 01 January 2005 and 30 April 2015) up to the earliest of discontinuation of the index drug (i.e. LAMA or ICS/LABA), death, or 30 April 2016 (i.e. cut-off date for data retrieving), up to 136 months. | Pneumonia was defined as ≥1 inpatient or outpatient claims 1) with ICD-10 codes for pneumonia recorded as any diagnosis in inpatient claims or primary \~ 4th secondary diagnosis in outpatient claims, AND 2) with diagnostic test code for chest-X ray or chest- computed tomography (CT), AND 3) with antibiotics prescription during the following period after the index date. Date of pneumonia event was defined as the starting date of outpatient claim, or as the admission date of inpatient claim with the above 3 conditions to define pneumonia event. Mean and Standard Deviation of time to first pneumonia event from the index date was estimated using the Kaplan-Meier curve. |
| Primary | Number of Patients With Pneumonia Event | From the index date (i.e. between 01 January 2005 and 30 April 2015) up to the earliest of discontinuation of the index drug (i.e. LAMA or ICS/LABA), death, or 30 April 2016 (i.e. cut-off date for data retrieving), up to 136 months. | Pneumonia was defined as ≥1 inpatient or outpatient claims 1) with ICD-10 codes for pneumonia recorded as any diagnosis in inpatient claims or primary \~ 4th secondary diagnosis in outpatient claims, AND 2) with diagnostic test code for chest-X ray or chest- computed tomography (CT), AND 3) with antibiotics prescription during the following period after the index date. Number of patients with pneumonia event is reported. |
| Primary | Incidence Rate of the First Chronic Obstructive Pulmonary Disease (COPD) Exacerbation Event (All Types) | Up to 12 months from the index date. Index date was between 01 January 2005 and 30 April 2015. | To assess the incidence of COPD exacerbation event (all types), the first COPD exacerbation event among pre-defined moderate COPD exacerbation and severe COPD exacerbation event observed within the 12-month period after the index date was considered. Moderate COPD exacerbation was defined as ≥ 1 outpatient claims 1) with ICD-10 codes for COPD recorded as primary \~ 4th secondary diagnosis, AND 2) with systemic steroids and/or antibiotics prescription within 12 months after the index date. Severe COPD exacerbation was defined as ≥ 1 Emergency Room (ER) visit or inpatient claims 1) with ICD-10 codes for COPD or diseases due to COPD worsening as any diagnosis, AND 2) with systemic steroids and/or antibiotics prescription. Incidence rate of COPD exacerbation events (all types) was calculated as below: Incidence rate per 1000 person-years= Number of patients with event/sum of event-free period during the follow-up period (1000 person-years) |
| Primary | Incidence Rate of Chronic Obstructive Pulmonary Disease (COPD) Exacerbation Events (All Types) | Up to 12 months from the index date. Index date was between 01 January 2005 and 30 April 2015. | To assess the frequency of all types (moderate and severe) COPD exacerbation events, any events observed within the 12-month period after the index date was considered. Moderate COPD exacerbation was defined as ≥ 1 outpatient claims 1) with ICD-10 codes for COPD recorded as primary \~ 4th secondary diagnosis, AND 2) with systemic steroids and/or antibiotics prescription within 12 months after the index date. Severe COPD exacerbation was defined as ≥ 1 Emergency Room (ER) visit or inpatient claims 1) with ICD-10 codes for COPD or diseases due to COPD worsening as any diagnosis, AND 2) with systemic steroids and/or antibiotics prescription. Outcome measure reports: Total number of COPD exacerbation events (all types)/sum of follow-up duration (person-years) for all participants |
| Primary | Number of Patients With Chronic Obstructive Pulmonary Disease (COPD) Exacerbation Events | Up to 12 months from the index date. Index date was between 01 January 2005 and 30 April 2015. | Number of patients with Chronic Obstructive Pulmonary Disease (COPD) exacerbation (moderate or severe) events is reported. Moderate COPD exacerbation was defined as ≥ 1 outpatient claims 1) with ICD-10 codes for COPD recorded as primary \~ 4th secondary diagnosis, AND 2) with systemic steroids and/or antibiotics prescription within 12 months after the index date. Severe COPD exacerbation was defined as ≥ 1 Emergency Room (ER) visit or inpatient claims 1) with ICD-10 codes for COPD or diseases due to COPD worsening as any diagnosis, AND 2) with systemic steroids and/or antibiotics prescription. |
| Primary | Time to First Chronic Obstructive Pulmonary Disease (COPD) Exacerbation Event From the Index Date | Up to 12 months from the index date. Index date was between 01 January 2005 and 30 April 2015. | Mean and Standard Deviation of time to first COPD exacerbation (moderate or severe) event from the index date was estimated using the Kaplan-Meier curve. Moderate COPD exacerbation was defined as ≥ 1 outpatient claims 1) with ICD-10 codes for COPD recorded as primary \~ 4th secondary diagnosis, AND 2) with systemic steroids and/or antibiotics prescription within 12 months after the index date. Severe COPD exacerbation was defined as ≥ 1 Emergency Room (ER) visit or inpatient claims 1) with ICD-10 codes for COPD or diseases due to COPD worsening as any diagnosis, AND 2) with systemic steroids and/or antibiotics prescription. Date of severe COPD exacerbation event was defined as the starting date of ER claims or admission date of inpatient claims with the above 2 conditions to define moderate COPD exacerbation event. |
| Primary | Incidence Rate of Initiating Triple Combination Therapy | From the index date (i.e. between 01 January 2005 and 30 April 2015) up to the earliest of discontinuation of the index drug (i.e. LAMA or ICS/LABA), death, or 30 April 2016 (i.e. cut-off date for data retrieving), up to 136 months. | To assess the incidence rate of initiating triple combination therapy, the first triple combination therapy observed during the follow-up period was considered. Triple combination therapy of inhaled corticosteroids (ICS), long-acting beta agonists (LABA) and long-acting muscarinic antagonists (LAMA) was defined as ≥ 1 outpatient or inpatient claims with a combination of ICS, LABA, and LAMA. Three components of ICS, LABA and LAMA MUST have been prescribed together in a same prescription issued on same date to be considered as triple combination therapy (i.e. ICS/LABA fixed dose combination (FDC) and LAMA, ICS and LABA/LAMA FDC, ICS/LABA FDC and LABA/LAMA FDC, ICS and LABA and LAMA are all considered as triple combination therapy). Incidence rate of initiating triple combination therapy is reported as: Incidence rate per 1000 person-years= Number of patients with event/ sum of event-free period during the follow-up period (1000 person-years) |
| Primary | Number of Patients Who Initiated a Triple Combination Therapy | From the index date (i.e. between 01 January 2005 and 30 April 2015) up to the earliest of discontinuation of the index drug (i.e. LAMA or ICS/LABA), death, or 30 April 2016 (i.e. cut-off date for data retrieving), up to 136 months. | Number of patients who initiated a triple combination therapy is reported. Triple combination therapy of inhaled corticosteroids (ICS), long-acting beta agonists (LABA) and long-acting muscarinic antagonists (LAMA) was defined as ≥ 1 outpatient or inpatient claims with a combination of ICS, LABA, and LAMA. Three components of ICS, LABA and LAMA MUST have been prescribed together in a same prescription issued on same date to be considered as triple combination therapy (i.e. ICS/LABA fixed dose combination (FDC) and LAMA, ICS and LABA/LAMA FDC, ICS/LABA FDC and LABA/LAMA FDC, ICS and LABA and LAMA are all considered as triple combination therapy). |
| Primary | Time to Initiating Triple Combination Therapy From the Index Date | From the index date (i.e. between 01 January 2005 and 30 April 2015) up to the earliest of discontinuation of the index drug (i.e. LAMA or ICS/LABA), death, or 30 April 2016 (i.e. cut-off date for data retrieving), up to 136 months. | Median and Inter-Quartile Range of time to initiating triple combination therapy from the index date was estimated using the Kaplan-Meier curve. Triple combination therapy of inhaled corticosteroids (ICS), long-acting beta agonists (LABA) and long-acting muscarinic antagonists (LAMA) was defined as ≥ 1 outpatient or inpatient claims with a combination of ICS, LABA, and LAMA. Three components of ICS, LABA and LAMA MUST have been prescribed together in a same prescription issued on same date to be considered as triple combination therapy (i.e. ICS/LABA fixed dose combination (FDC) and LAMA, ICS and LABA/LAMA FDC, ICS/LABA FDC and LABA/LAMA FDC, ICS and LABA and LAMA are all considered as triple combination therapy). Date of triple combination therapy was defined as the starting date of outpatient claim or admission date of inpatient claim with a combination of ICS/LABA and LAMA. |
| Secondary | All-cause Healthcare Resource Utilization (HCRU): Number of Any Medical Visit (Per Person Per Month) | Up to 36 months from the index date. Index date was between 01 January 2005 and 30 April 2015. | Mean and Standard Deviation of any medical visit per person per month is reported. Medical visits were calculated as the sum of inpatient and outpatient visits assuming that emergency room (ER) visits, intensive care unit (ICU) visits and visit for pharmacy dispensation would be counted with the inclusion of inpatient and outpatient visit. |
| Secondary | All-cause Healthcare Resource Utilization (HCRU): Number of Outpatient Visits (Per Person Per Month) | Up to 36 months from the index date. Index date was between 01 January 2005 and 30 April 2015. | Mean and Standard Deviation of outpatient visits per person per month is reported. Outpatient visit was defined as clinic, hospital, or other medical institution (e.g. public health, etc.) visit as an outpatient. |
| Secondary | All-cause Healthcare Resource Utilization (HCRU): Number of Inpatient Visits (Per Person Per Month) | Up to 36 months from the index date. Index date was between 01 January 2005 and 30 April 2015. | Mean and Standard Deviation of inpatient visits per person per month is reported. Inpatient visit was defined as at least 1 overnight stay in a hospital as an inpatient. |
| Secondary | All-cause Healthcare Resource Utilization (HCRU): Number of Emergency Room (ER) Visits (Per Person Per Month) | Up to 36 months from the index date. Index date was between 01 January 2005 and 30 April 2015. | Mean and Standard Deviation of ER visits per person per month is reported. |
| Secondary | All-cause Healthcare Resource Utilization (HCRU): Number of Intensive Care Unit (ICU) Visits (Per Person Per Month) | Up to 36 months from the index date. Index date was between 01 January 2005 and 30 April 2015. | Mean and Standard Deviation of ICU visits per person per month is reported. |
| Secondary | Chronic Obstructive Pulmonary Disease (COPD)-Related Healthcare Resource Utilization (HCRU): Number of Any Medical Visit (Per Person Per Month) | Up to 36 months from the index date. Index date was between 01 January 2005 and 30 April 2015. | COPD-related HCRU was defined as medical claims with ICD-10 codes for COPD and/or COPD-related diseases. Mean and Standard Deviation of any medical visit (inpatient and outpatient visits which include emergency room (ER) and intensive care unit (ICU) visits) per person per month is reported. For outpatient claims, COPD-related HCRU was defined as claims with ICD-10 codes for COPD as primary \~ 4th secondary diagnosis. For inpatient claims, COPD-related HCRU was defined as claims with ICD-10 codes for COPD and/or for diseases due to COPD worsening as any diagnosis. |
| Secondary | Chronic Obstructive Pulmonary Disease (COPD)-Related Healthcare Resource Utilization (HCRU): Number of Outpatient Visits (Per Person Per Month) | Up to 36 months from the index date. Index date was between 01 January 2005 and 30 April 2015. | Mean and Standard Deviation of outpatient visits per person per month is reported. For outpatient claims, COPD-related HCRU was defined as claims with ICD-10 codes for COPD as primary \~ 4th secondary diagnosis. |
| Secondary | Chronic Obstructive Pulmonary Disease (COPD)-Related Healthcare Resource Utilization (HCRU): Number of Inpatient Visits (Per Person Per Month) | Up to 36 months from the index date. Index date was between 01 January 2005 and 30 April 2015. | Mean and Standard Deviation of inpatient visits per person per month is reported. For inpatient claims, COPD-related HCRU was defined as claims with ICD-10 codes for COPD and/or for diseases due to COPD worsening as any diagnosis. |
| Secondary | Chronic Obstructive Pulmonary Disease (COPD)-Related Healthcare Resource Utilization (HCRU): Number of Emergency Room (ER) (Visits Per Person Per Month) | Up to 36 months from the index date. Index date was between 01 January 2005 and 30 April 2015. | Mean and Standard Deviation of ER visits per person per month is reported. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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