Trial Outcomes & Findings for OASIS-IPF (Idiopathic Pulmonary Fibrosis) Study (NCT NCT03386994)
NCT ID: NCT03386994
Last Updated: 2020-11-09
Results Overview
The total annual IPF-related costs were obtained as the sum of direct health costs, direct non-health costs and indirect costs. IPF-related costs were quantified for each patient over the follow-up period of 12 months. The direct health and direct non-health costs were calculated as the sum of the costs of medical visits, emergency room visits, hospital admissions, outpatient tests, non-pharmacological treatments and pharmacological treatments and the sum of transport costs, paid caregivers costs, orthopedic material costs, financial aid, and structural changes cost. The indirect costs included number of IPF related days off work and time dedicated to patient care with IPF (informal caregiver). The opportunity cost method was used to calculate informal care costs. The indirect costs were estimated by applying salary costs based on the latest data published by the Spanish Instituto Nacional de Estadística from the salary structure survey, adjusted to age.
COMPLETED
204 participants
12 months. (At baseline visit (T0), at 6 months visit (T6) and at 12 month visit (T12)).
2020-11-09
Participant Flow
Non-interventional multicenter study in Spain, based on newly collected data of patients with Idiopathic Pulmonary Fibrosis (IPF) aims to estimate the economic and social Impact of IPF according to the Forced Vital Capacity (FVC) value.
All patients who are diagnosed with IPF and attended to a routine visit during the inclusion period and met all of the inclusion and none of the exclusion criteria and provided informed consent to participate were included in the study. IPF-Patients were reported by subgroup (predicted FVC% at baseline) for baseline characteristics and outcome measures, to make comparisons between groups. Data on caregiver burden was collected from routine clinical care using medical records and patient´s diary.
Participant milestones
| Measure |
All Patients With IPF - Overall Population
All patients with Idiopathic Pulmonary Fibrosis (IPF).
|
|---|---|
|
Overall Study
STARTED
|
204
|
|
Overall Study
COMPLETED
|
166
|
|
Overall Study
NOT COMPLETED
|
38
|
Reasons for withdrawal
| Measure |
All Patients With IPF - Overall Population
All patients with Idiopathic Pulmonary Fibrosis (IPF).
|
|---|---|
|
Overall Study
Lung transplant
|
1
|
|
Overall Study
Adverse Event
|
14
|
|
Overall Study
Lost to Follow-up
|
4
|
|
Overall Study
Withdrawal by Subject
|
3
|
|
Overall Study
Death
|
16
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
IPF Patients With Predicted FVC <50% at T0 - Subgroup
n=22 Participants
All patients diagnosed with Idiopathic Pulmonary Fibrosis (IPF) and predicted Forced Vital Capacity (FVC)% value below 50% at baseline visit (T0).
Patient group (FVC\<50%, FVC 50-80%, FVC\>80%) was calculated based on available patient data: Men: FVC % predicted (%)= 100 FVC/(0.678 T -0.0147 E -6.0548) Women: FVC % predicted (%)= 100 FVC /(0.0454 T -0.0211 E -2.8253) (FVC is FVC in liters, T is height in cm and E is age in years).
|
IPF Patients With Predicted FVC 50-80% at T0 - Subgroup
n=152 Participants
All patients diagnosed with Idiopathic Pulmonary Fibrosis (IPF) and predicted Forced Vital Capacity (FVC)% value between 50 and 80% at baseline visit (T0).
Patient group (FVC\<50%, FVC 50-80%, FVC\>80%) was calculated based on available patient data: Men: FVC % predicted (%)= 100 FVC/(0.0678 T -0.0147 E -6.0548) Women: FVC % predicted (%)= 100 FVC /(0.0454 T -0.0211 E -2.8253) (FVC is FVC in liters, T is height in cm and E is age in years).
|
IPF Patients With Predicted FVC >80% at T0 - Subgroup
n=30 Participants
All patients diagnosed with Idiopathic Pulmonary Fibrosis (IPF) and predicted Forced Vital Capacity (FVC)% value above 80% at baseline visit (T0).
Patient group (FVC\<50%, FVC 50-80%, FVC\>80%) was calculated based on available patient data: Men: FVC % predicted (%)= 100 FVC/(0.0678 T -0.0147 E -6.0548) Women: FVC % predicted (%)= 100 FVC /(0.0454 T -0.0211 E -2.8253) (FVC is FVC in liters, T is height in cm and E is age in years).
|
Total
n=204 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
70.32 Years
STANDARD_DEVIATION 8.52 • n=22 Participants
|
71.36 Years
STANDARD_DEVIATION 7.21 • n=152 Participants
|
68.33 Years
STANDARD_DEVIATION 8.54 • n=30 Participants
|
70.80 Years
STANDARD_DEVIATION 7.60 • n=204 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=22 Participants
|
32 Participants
n=152 Participants
|
11 Participants
n=30 Participants
|
47 Participants
n=204 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=22 Participants
|
120 Participants
n=152 Participants
|
19 Participants
n=30 Participants
|
157 Participants
n=204 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
PRIMARY outcome
Timeframe: 12 months. (At baseline visit (T0), at 6 months visit (T6) and at 12 month visit (T12)).Population: Evaluable Population (cost): Evaluable Population who had data on resource use due to IPF (primary/secondary care/emergency visits, transport, hospitalization, outpatient tests, (non)-pharmacological treatment, caregivers, orthopedic material, structural changes, economic aid, lost work productivity, resource use due to acute exacerbations). IPF-patients were reported by subgroup to make comparisons between groups.
The total annual IPF-related costs were obtained as the sum of direct health costs, direct non-health costs and indirect costs. IPF-related costs were quantified for each patient over the follow-up period of 12 months. The direct health and direct non-health costs were calculated as the sum of the costs of medical visits, emergency room visits, hospital admissions, outpatient tests, non-pharmacological treatments and pharmacological treatments and the sum of transport costs, paid caregivers costs, orthopedic material costs, financial aid, and structural changes cost. The indirect costs included number of IPF related days off work and time dedicated to patient care with IPF (informal caregiver). The opportunity cost method was used to calculate informal care costs. The indirect costs were estimated by applying salary costs based on the latest data published by the Spanish Instituto Nacional de Estadística from the salary structure survey, adjusted to age.
Outcome measures
| Measure |
IPF Patients With Predicted FVC <50% at T0 - Subgroup
n=15 Participants
All patients diagnosed with Idiopathic Pulmonary Fibrosis (IPF) and predicted Forced Vital Capacity (FVC)% value below 50% at baseline visit (T0).
Patient group (FVC\<50%, FVC 50-80%, FVC\>80%) was calculated based on available patient data: Men: FVC % predicted (%)= 100 FVC/(0.678 T -0.0147 E -6.0548) Women: FVC % predicted (%)= 100 FVC /(0.0454 T -0.0211 E -2.8253) (FVC is FVC in liters, T is height in cm and E is age in years).
|
IPF Patients With Predicted FVC 50-80% at T0 - Subgroup
n=152 Participants
All patients diagnosed with Idiopathic Pulmonary Fibrosis (IPF) and predicted Forced Vital Capacity (FVC)% value between 50 and 80% at baseline visit (T0).
Patient group (FVC\<50%, FVC 50-80%, FVC\>80%) was calculated based on available patient data: Men: FVC % predicted (%)= 100 FVC/(0.0678 T -0.0147 E -6.0548) Women: FVC % predicted (%)= 100 FVC /(0.0454 T -0.0211 E -2.8253) (FVC is FVC in liters, T is height in cm and E is age in years).
|
IPF Patients With Predicted FVC >80% at T0 - Subgroup
n=25 Participants
All patients diagnosed with Idiopathic Pulmonary Fibrosis (IPF) and predicted Forced Vital Capacity (FVC)% value above 80% at baseline visit (T0).
Patient group (FVC\<50%, FVC 50-80%, FVC\>80%) was calculated based on available patient data: Men: FVC % predicted (%)= 100 FVC/(0.0678 T -0.0147 E -6.0548) Women: FVC % predicted (%)= 100 FVC /(0.0454 T -0.0211 E -2.8253) (FVC is FVC in liters, T is height in cm and E is age in years).
|
|---|---|---|---|
|
Idiopathic Pulmonary Fibrosis (IPF)-Related Costs
Total annual IPF related costs
|
38923.57 Euro (€)
Standard Deviation 29263.42
|
22613.68 Euro (€)
Standard Deviation 12873.07
|
20369.94 Euro (€)
Standard Deviation 11955.91
|
|
Idiopathic Pulmonary Fibrosis (IPF)-Related Costs
Annual direct health IPF-related costs
|
37183.17 Euro (€)
Standard Deviation 28465.86
|
22425.64 Euro (€)
Standard Deviation 12788.42
|
20195.31 Euro (€)
Standard Deviation 12159.89
|
|
Idiopathic Pulmonary Fibrosis (IPF)-Related Costs
Annual direct non-health related costs
|
1657.63 Euro (€)
Standard Deviation 3148.58
|
149.25 Euro (€)
Standard Deviation 701.58
|
174.63 Euro (€)
Standard Deviation 589.53
|
|
Idiopathic Pulmonary Fibrosis (IPF)-Related Costs
Annual indirect IPF-related costs
|
82.77 Euro (€)
Standard Deviation 320.58
|
38.79 Euro (€)
Standard Deviation 316.50
|
0.00 Euro (€)
Standard Deviation 0.00
|
SECONDARY outcome
Timeframe: 12 months. (At baseline visit (T0), at 6 month visit (T6) and at 12 month visit (T12)).Population: Evaluable Population including participants with available data for SGRQ at T0, T6 and T12. IPF-patients were reported by subgroup to make comparisons between groups.
The Quality of Life of patients with IPF according to Forced Vital Capacity (FVC)% predicted value, is assessed through SGRQ. The SGRQ is a 50-item questionaire developed to quantify the impact of the disease on the health and QoL perceived by patients with respiratory diseases. It consisted of 50 items divided into 3 scales: symptoms (frequency and severity of respiratory symptoms), activity (limitations due to dyspnoea) and impact (psychological and social functioning disorders caused by the disease). The final scores ranged from 0 (best health-related quality of life) to 100 (worse health-related quality of life). The number of participants analysed displays the number of participants with available data at the timepoint of interests.
Outcome measures
| Measure |
IPF Patients With Predicted FVC <50% at T0 - Subgroup
n=22 Participants
All patients diagnosed with Idiopathic Pulmonary Fibrosis (IPF) and predicted Forced Vital Capacity (FVC)% value below 50% at baseline visit (T0).
Patient group (FVC\<50%, FVC 50-80%, FVC\>80%) was calculated based on available patient data: Men: FVC % predicted (%)= 100 FVC/(0.678 T -0.0147 E -6.0548) Women: FVC % predicted (%)= 100 FVC /(0.0454 T -0.0211 E -2.8253) (FVC is FVC in liters, T is height in cm and E is age in years).
|
IPF Patients With Predicted FVC 50-80% at T0 - Subgroup
n=152 Participants
All patients diagnosed with Idiopathic Pulmonary Fibrosis (IPF) and predicted Forced Vital Capacity (FVC)% value between 50 and 80% at baseline visit (T0).
Patient group (FVC\<50%, FVC 50-80%, FVC\>80%) was calculated based on available patient data: Men: FVC % predicted (%)= 100 FVC/(0.0678 T -0.0147 E -6.0548) Women: FVC % predicted (%)= 100 FVC /(0.0454 T -0.0211 E -2.8253) (FVC is FVC in liters, T is height in cm and E is age in years).
|
IPF Patients With Predicted FVC >80% at T0 - Subgroup
n=30 Participants
All patients diagnosed with Idiopathic Pulmonary Fibrosis (IPF) and predicted Forced Vital Capacity (FVC)% value above 80% at baseline visit (T0).
Patient group (FVC\<50%, FVC 50-80%, FVC\>80%) was calculated based on available patient data: Men: FVC % predicted (%)= 100 FVC/(0.0678 T -0.0147 E -6.0548) Women: FVC % predicted (%)= 100 FVC /(0.0454 T -0.0211 E -2.8253) (FVC is FVC in liters, T is height in cm and E is age in years).
|
|---|---|---|---|
|
Quality of Life (QoL) of Patients With Idiopathic Pulmonary Fibrosis (IPF) Through Saint George´s Respiratory Questionaire (SGRQ)
T0
|
48.52 Score on a scale
Standard Deviation 17.26
|
33.70 Score on a scale
Standard Deviation 17.17
|
31.97 Score on a scale
Standard Deviation 20.37
|
|
Quality of Life (QoL) of Patients With Idiopathic Pulmonary Fibrosis (IPF) Through Saint George´s Respiratory Questionaire (SGRQ)
T6
|
43.34 Score on a scale
Standard Deviation 20.70
|
33.84 Score on a scale
Standard Deviation 19.15
|
30.68 Score on a scale
Standard Deviation 17.98
|
|
Quality of Life (QoL) of Patients With Idiopathic Pulmonary Fibrosis (IPF) Through Saint George´s Respiratory Questionaire (SGRQ)
T12
|
41.64 Score on a scale
Standard Deviation 21.62
|
36.93 Score on a scale
Standard Deviation 19.27
|
25.38 Score on a scale
Standard Deviation 17.38
|
SECONDARY outcome
Timeframe: 12 months. (At baseline visit (T0), at 6 month visit (T6) and at 12 month visit (T12)).Population: Evaluable Population including participants with available data for EQ-VAS at T0, T6 and T12. IPF-patients were reported by subgroup to make comparisons between groups.
The Quality of Life of patients with IPF according to Forced Vital Capacity (FVC)% predicted value is assessed through the EQ-VAS, which is a self-rated health status using a visual analogue scale (VAS), ranging form 0-100, with 0 = worst state of health imaginable and 100 = best state of health imaginable. The EQ-VAS is part of the EuroQoL five dimensions questionaire 5L (EQ-5D-5L). The number of participants analysed displays the number of participants with available data at the timepoint of interests.
Outcome measures
| Measure |
IPF Patients With Predicted FVC <50% at T0 - Subgroup
n=22 Participants
All patients diagnosed with Idiopathic Pulmonary Fibrosis (IPF) and predicted Forced Vital Capacity (FVC)% value below 50% at baseline visit (T0).
Patient group (FVC\<50%, FVC 50-80%, FVC\>80%) was calculated based on available patient data: Men: FVC % predicted (%)= 100 FVC/(0.678 T -0.0147 E -6.0548) Women: FVC % predicted (%)= 100 FVC /(0.0454 T -0.0211 E -2.8253) (FVC is FVC in liters, T is height in cm and E is age in years).
|
IPF Patients With Predicted FVC 50-80% at T0 - Subgroup
n=152 Participants
All patients diagnosed with Idiopathic Pulmonary Fibrosis (IPF) and predicted Forced Vital Capacity (FVC)% value between 50 and 80% at baseline visit (T0).
Patient group (FVC\<50%, FVC 50-80%, FVC\>80%) was calculated based on available patient data: Men: FVC % predicted (%)= 100 FVC/(0.0678 T -0.0147 E -6.0548) Women: FVC % predicted (%)= 100 FVC /(0.0454 T -0.0211 E -2.8253) (FVC is FVC in liters, T is height in cm and E is age in years).
|
IPF Patients With Predicted FVC >80% at T0 - Subgroup
n=30 Participants
All patients diagnosed with Idiopathic Pulmonary Fibrosis (IPF) and predicted Forced Vital Capacity (FVC)% value above 80% at baseline visit (T0).
Patient group (FVC\<50%, FVC 50-80%, FVC\>80%) was calculated based on available patient data: Men: FVC % predicted (%)= 100 FVC/(0.0678 T -0.0147 E -6.0548) Women: FVC % predicted (%)= 100 FVC /(0.0454 T -0.0211 E -2.8253) (FVC is FVC in liters, T is height in cm and E is age in years).
|
|---|---|---|---|
|
Quality of Life (QoL) of Patients With Idiopathic Pulmonary Fibrosis (IPF) Through EuroQoL Visual Analogue Scale (EQ-VAS)
T0
|
58.41 Score on a scale
Standard Deviation 16.72
|
64.82 Score on a scale
Standard Deviation 20.43
|
66.67 Score on a scale
Standard Deviation 21.39
|
|
Quality of Life (QoL) of Patients With Idiopathic Pulmonary Fibrosis (IPF) Through EuroQoL Visual Analogue Scale (EQ-VAS)
T6
|
59.29 Score on a scale
Standard Deviation 21.11
|
65.16 Score on a scale
Standard Deviation 19.02
|
68.76 Score on a scale
Standard Deviation 19.85
|
|
Quality of Life (QoL) of Patients With Idiopathic Pulmonary Fibrosis (IPF) Through EuroQoL Visual Analogue Scale (EQ-VAS)
T12
|
63.93 Score on a scale
Standard Deviation 23.95
|
62.91 Score on a scale
Standard Deviation 20.34
|
71.36 Score on a scale
Standard Deviation 17.74
|
SECONDARY outcome
Timeframe: 12 months. (At baseline visit (T0), at 6 month visit (T6) and at 12 month visit (T12)).Population: Evaluable Population including participants with available data for Barthel Index at T0, T6 and T12. IPF-patients were reported by subgroup to make comparisons between groups.
The Quality of Life of patients with IPF according to Forced Vital Capacity (FVC)% predicted value is assessed through the Barthel Index. Barthel Index were used to score the ability of a participant to care for himself. It consists of 10 items, the values assigned to each item are based on time and amount of actual physical assistance required if a participant is unable to perform the activity. The final score ranges from 0 and 100. Participant scoring 100 is continent, feeds himself, dresses himself, gets up out of bed and chairs, bathes himself, walks at least a block, and can ascend and descend stairs. The number of participants analysed displays the number of participants with available data at the timepoint of interests.
Outcome measures
| Measure |
IPF Patients With Predicted FVC <50% at T0 - Subgroup
n=22 Participants
All patients diagnosed with Idiopathic Pulmonary Fibrosis (IPF) and predicted Forced Vital Capacity (FVC)% value below 50% at baseline visit (T0).
Patient group (FVC\<50%, FVC 50-80%, FVC\>80%) was calculated based on available patient data: Men: FVC % predicted (%)= 100 FVC/(0.678 T -0.0147 E -6.0548) Women: FVC % predicted (%)= 100 FVC /(0.0454 T -0.0211 E -2.8253) (FVC is FVC in liters, T is height in cm and E is age in years).
|
IPF Patients With Predicted FVC 50-80% at T0 - Subgroup
n=152 Participants
All patients diagnosed with Idiopathic Pulmonary Fibrosis (IPF) and predicted Forced Vital Capacity (FVC)% value between 50 and 80% at baseline visit (T0).
Patient group (FVC\<50%, FVC 50-80%, FVC\>80%) was calculated based on available patient data: Men: FVC % predicted (%)= 100 FVC/(0.0678 T -0.0147 E -6.0548) Women: FVC % predicted (%)= 100 FVC /(0.0454 T -0.0211 E -2.8253) (FVC is FVC in liters, T is height in cm and E is age in years).
|
IPF Patients With Predicted FVC >80% at T0 - Subgroup
n=30 Participants
All patients diagnosed with Idiopathic Pulmonary Fibrosis (IPF) and predicted Forced Vital Capacity (FVC)% value above 80% at baseline visit (T0).
Patient group (FVC\<50%, FVC 50-80%, FVC\>80%) was calculated based on available patient data: Men: FVC % predicted (%)= 100 FVC/(0.0678 T -0.0147 E -6.0548) Women: FVC % predicted (%)= 100 FVC /(0.0454 T -0.0211 E -2.8253) (FVC is FVC in liters, T is height in cm and E is age in years).
|
|---|---|---|---|
|
Quality of Life (QoL) of Patients With Idiopathic Pulmonary Fibrosis (IPF), Through Barthel Index
T0
|
92.95 Score on a scale
Standard Deviation 10.76
|
97.50 Score on a scale
Standard Deviation 7.68
|
97.67 Score on a scale
Standard Deviation 5.68
|
|
Quality of Life (QoL) of Patients With Idiopathic Pulmonary Fibrosis (IPF), Through Barthel Index
T6
|
91.25 Score on a scale
Standard Deviation 12.08
|
95.94 Score on a scale
Standard Deviation 11.21
|
96.35 Score on a scale
Standard Deviation 8.19
|
|
Quality of Life (QoL) of Patients With Idiopathic Pulmonary Fibrosis (IPF), Through Barthel Index
T12
|
91.79 Score on a scale
Standard Deviation 15.76
|
95.74 Score on a scale
Standard Deviation 12.66
|
96.59 Score on a scale
Standard Deviation 12.85
|
SECONDARY outcome
Timeframe: 12 months. (At baseline visit (T0), at 6 month visit (T6) and at 12 month visit (T12)).Population: Evaluable Population: All patients who met the selection criteria (no protocol deviations) and with predicted FVC% classified. IPF-patients were reported by subgroup to make comparisons between groups.
Number of IPF-patients with acute exacerbations according to Forced Vital Capacity (FVC)% that occured along one year. Acute exacerbation is defined as an acute, clinically significant respiratory deterioration characterized by evidence of new widespread alveolar abnormality.
Outcome measures
| Measure |
IPF Patients With Predicted FVC <50% at T0 - Subgroup
n=22 Participants
All patients diagnosed with Idiopathic Pulmonary Fibrosis (IPF) and predicted Forced Vital Capacity (FVC)% value below 50% at baseline visit (T0).
Patient group (FVC\<50%, FVC 50-80%, FVC\>80%) was calculated based on available patient data: Men: FVC % predicted (%)= 100 FVC/(0.678 T -0.0147 E -6.0548) Women: FVC % predicted (%)= 100 FVC /(0.0454 T -0.0211 E -2.8253) (FVC is FVC in liters, T is height in cm and E is age in years).
|
IPF Patients With Predicted FVC 50-80% at T0 - Subgroup
n=152 Participants
All patients diagnosed with Idiopathic Pulmonary Fibrosis (IPF) and predicted Forced Vital Capacity (FVC)% value between 50 and 80% at baseline visit (T0).
Patient group (FVC\<50%, FVC 50-80%, FVC\>80%) was calculated based on available patient data: Men: FVC % predicted (%)= 100 FVC/(0.0678 T -0.0147 E -6.0548) Women: FVC % predicted (%)= 100 FVC /(0.0454 T -0.0211 E -2.8253) (FVC is FVC in liters, T is height in cm and E is age in years).
|
IPF Patients With Predicted FVC >80% at T0 - Subgroup
n=30 Participants
All patients diagnosed with Idiopathic Pulmonary Fibrosis (IPF) and predicted Forced Vital Capacity (FVC)% value above 80% at baseline visit (T0).
Patient group (FVC\<50%, FVC 50-80%, FVC\>80%) was calculated based on available patient data: Men: FVC % predicted (%)= 100 FVC/(0.0678 T -0.0147 E -6.0548) Women: FVC % predicted (%)= 100 FVC /(0.0454 T -0.0211 E -2.8253) (FVC is FVC in liters, T is height in cm and E is age in years).
|
|---|---|---|---|
|
Number of Idiopathic Pulmonary Fibrosis (IPF)-Patients With Acute Exacerbations Along One Year
|
6 Participants
|
13 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: 12 months. (At baseline visit (T0), at 6 months visit (T6) at 12 month visit (T12)).Population: Evaluable Population (cost): Evaluable Population who had data on resource use due to IPF (primary/secondary care/emergency visits, transport, hospitalization, outpatient tests, (non)-pharmacological treatment, caregivers, orthopedic material, structural changes, economic aid, lost work productivity, resource use due to acute exacerbations). IPF-patients were reported by subgroup to make comparisons between groups.
The total annual acute exacerbation-related costs were obtained as the sum of direct and indirect costs for each patient over the follow-up period of 12 months. For estimation of costs the following variables were used: Acute exacerbation related resource use for direct cost estimation: primary and secondary care visits, emergency visits (primary care and hospital), hospitalizations, ICU with and without intubation (qualitative analysis), outpatient tests and other examinations, use of transport, use of formal caregiver, pharmacological and non-pharmacological treatments (except treatments administered in hospitalization), orthopedic material, formal social services, economic aid and structural adaptations. Acute exacerbation related resource use for indirect cost estimation: patients' days off work and informal caregiver.
Outcome measures
| Measure |
IPF Patients With Predicted FVC <50% at T0 - Subgroup
n=15 Participants
All patients diagnosed with Idiopathic Pulmonary Fibrosis (IPF) and predicted Forced Vital Capacity (FVC)% value below 50% at baseline visit (T0).
Patient group (FVC\<50%, FVC 50-80%, FVC\>80%) was calculated based on available patient data: Men: FVC % predicted (%)= 100 FVC/(0.678 T -0.0147 E -6.0548) Women: FVC % predicted (%)= 100 FVC /(0.0454 T -0.0211 E -2.8253) (FVC is FVC in liters, T is height in cm and E is age in years).
|
IPF Patients With Predicted FVC 50-80% at T0 - Subgroup
n=140 Participants
All patients diagnosed with Idiopathic Pulmonary Fibrosis (IPF) and predicted Forced Vital Capacity (FVC)% value between 50 and 80% at baseline visit (T0).
Patient group (FVC\<50%, FVC 50-80%, FVC\>80%) was calculated based on available patient data: Men: FVC % predicted (%)= 100 FVC/(0.0678 T -0.0147 E -6.0548) Women: FVC % predicted (%)= 100 FVC /(0.0454 T -0.0211 E -2.8253) (FVC is FVC in liters, T is height in cm and E is age in years).
|
IPF Patients With Predicted FVC >80% at T0 - Subgroup
n=25 Participants
All patients diagnosed with Idiopathic Pulmonary Fibrosis (IPF) and predicted Forced Vital Capacity (FVC)% value above 80% at baseline visit (T0).
Patient group (FVC\<50%, FVC 50-80%, FVC\>80%) was calculated based on available patient data: Men: FVC % predicted (%)= 100 FVC/(0.0678 T -0.0147 E -6.0548) Women: FVC % predicted (%)= 100 FVC /(0.0454 T -0.0211 E -2.8253) (FVC is FVC in liters, T is height in cm and E is age in years).
|
|---|---|---|---|
|
Total Annual Acute Exacerbation-related Costs
|
600.40 Euro (€)
Standard Deviation 1586.20
|
819.28 Euro (€)
Standard Deviation 3827.04
|
142.17 Euro (€)
Standard Deviation 703.24
|
SECONDARY outcome
Timeframe: 12 months. (At baseline visit (T0) and at 12 month visit (T12)).Population: Evaluable Population (cost) including participants with FVC decline between T0 and T12 (paired data) - Overall FVC Patient Group.
Economic Impact of IPF in adult patients through the estimation annual direct and indirect costs associated with the disease (€/year) from a social perspective by FVC decline according to predicted FVC%. FVC decline is calculated: FVC% (T12)- FVC%(T0)). In order to estimate the direct and indirect costs according to FVC decline the following variable were described: FVC predicted along the study. Men: FVC % predicted (%) = 100 FVC / (0.0678 T - 0.0147 E - 6.0548) Women: FVC % predicted (%) = 100 FVC / (0.0454 T - 0.0211 E - 2.8253) (FVC is FVC in liters, T is height in cm and E is age in years) The calculated variable was stratified into the following subgroups between T0 and T12: ≤-10%; from -10% to -5%; \>-5%
Outcome measures
| Measure |
IPF Patients With Predicted FVC <50% at T0 - Subgroup
n=24 Participants
All patients diagnosed with Idiopathic Pulmonary Fibrosis (IPF) and predicted Forced Vital Capacity (FVC)% value below 50% at baseline visit (T0).
Patient group (FVC\<50%, FVC 50-80%, FVC\>80%) was calculated based on available patient data: Men: FVC % predicted (%)= 100 FVC/(0.678 T -0.0147 E -6.0548) Women: FVC % predicted (%)= 100 FVC /(0.0454 T -0.0211 E -2.8253) (FVC is FVC in liters, T is height in cm and E is age in years).
|
IPF Patients With Predicted FVC 50-80% at T0 - Subgroup
n=31 Participants
All patients diagnosed with Idiopathic Pulmonary Fibrosis (IPF) and predicted Forced Vital Capacity (FVC)% value between 50 and 80% at baseline visit (T0).
Patient group (FVC\<50%, FVC 50-80%, FVC\>80%) was calculated based on available patient data: Men: FVC % predicted (%)= 100 FVC/(0.0678 T -0.0147 E -6.0548) Women: FVC % predicted (%)= 100 FVC /(0.0454 T -0.0211 E -2.8253) (FVC is FVC in liters, T is height in cm and E is age in years).
|
IPF Patients With Predicted FVC >80% at T0 - Subgroup
n=85 Participants
All patients diagnosed with Idiopathic Pulmonary Fibrosis (IPF) and predicted Forced Vital Capacity (FVC)% value above 80% at baseline visit (T0).
Patient group (FVC\<50%, FVC 50-80%, FVC\>80%) was calculated based on available patient data: Men: FVC % predicted (%)= 100 FVC/(0.0678 T -0.0147 E -6.0548) Women: FVC % predicted (%)= 100 FVC /(0.0454 T -0.0211 E -2.8253) (FVC is FVC in liters, T is height in cm and E is age in years).
|
|---|---|---|---|
|
Idiopathic Pulmonary Fibrosis (IPF)-Related Costs by Forced Vital Capacity (FVC) Decline - Overall FVC Patient Group
Annual indirect IPF-related costs
|
2.99 Euro (€)
Standard Deviation 14.63
|
46.68 Euro (€)
Standard Deviation 185.74
|
3.65 Euro (€)
Standard Deviation 24.86
|
|
Idiopathic Pulmonary Fibrosis (IPF)-Related Costs by Forced Vital Capacity (FVC) Decline - Overall FVC Patient Group
Total annual IPF-related costs
|
22261.30 Euro (€)
Standard Deviation 14568.38
|
20986.06 Euro (€)
Standard Deviation 10864.08
|
26171.47 Euro (€)
Standard Deviation 17009.81
|
|
Idiopathic Pulmonary Fibrosis (IPF)-Related Costs by Forced Vital Capacity (FVC) Decline - Overall FVC Patient Group
Annual direct health IPF-related costs
|
21926.97 Euro (€)
Standard Deviation 14418.41
|
20939.38 Euro (€)
Standard Deviation 10847.61
|
25818.15 Euro (€)
Standard Deviation 16606.63
|
|
Idiopathic Pulmonary Fibrosis (IPF)-Related Costs by Forced Vital Capacity (FVC) Decline - Overall FVC Patient Group
Annual direct non-health IPF-related costs
|
331.35 Euro (€)
Standard Deviation 918.61
|
0.00 Euro (€)
Standard Deviation 0.00
|
349.66 Euro (€)
Standard Deviation 1511.20
|
SECONDARY outcome
Timeframe: 12 months. (At baseline visit (T0) and at 12 month visit (T12)).Population: Evaluable Population (cost) including participants with FVC decline between T0 and T12 (paired data) - Subgroup with predicted FVC \<50% at T0.
Economic Impact of IPF in adult patients through the estimation annual direct and indirect costs associated with the disease (€/year) from a social perspective by FVC decline according to predicted FVC%. FVC decline is calculated: FVC% (T12)- FVC%(T0)). In order to estimate the direct and indirect costs according to FVC decline the following variable were described: FVC predicted along the study. Men: FVC % predicted (%) = 100 FVC / (0.0678 T - 0.0147 E - 6.0548) Women: FVC % predicted (%) = 100 FVC / (0.0454 T - 0.0211 E - 2.8253) (FVC is FVC in liters, T is height in cm and E is age in years) The calculated variable was stratified into the following subgroups between T0 and T12: ≤-10%; from -10% to -5%; \>-5% Results are reported for participants with predicted FVC \<50% at baseline.
Outcome measures
| Measure |
IPF Patients With Predicted FVC <50% at T0 - Subgroup
All patients diagnosed with Idiopathic Pulmonary Fibrosis (IPF) and predicted Forced Vital Capacity (FVC)% value below 50% at baseline visit (T0).
Patient group (FVC\<50%, FVC 50-80%, FVC\>80%) was calculated based on available patient data: Men: FVC % predicted (%)= 100 FVC/(0.678 T -0.0147 E -6.0548) Women: FVC % predicted (%)= 100 FVC /(0.0454 T -0.0211 E -2.8253) (FVC is FVC in liters, T is height in cm and E is age in years).
|
IPF Patients With Predicted FVC 50-80% at T0 - Subgroup
All patients diagnosed with Idiopathic Pulmonary Fibrosis (IPF) and predicted Forced Vital Capacity (FVC)% value between 50 and 80% at baseline visit (T0).
Patient group (FVC\<50%, FVC 50-80%, FVC\>80%) was calculated based on available patient data: Men: FVC % predicted (%)= 100 FVC/(0.0678 T -0.0147 E -6.0548) Women: FVC % predicted (%)= 100 FVC /(0.0454 T -0.0211 E -2.8253) (FVC is FVC in liters, T is height in cm and E is age in years).
|
IPF Patients With Predicted FVC >80% at T0 - Subgroup
n=9 Participants
All patients diagnosed with Idiopathic Pulmonary Fibrosis (IPF) and predicted Forced Vital Capacity (FVC)% value above 80% at baseline visit (T0).
Patient group (FVC\<50%, FVC 50-80%, FVC\>80%) was calculated based on available patient data: Men: FVC % predicted (%)= 100 FVC/(0.0678 T -0.0147 E -6.0548) Women: FVC % predicted (%)= 100 FVC /(0.0454 T -0.0211 E -2.8253) (FVC is FVC in liters, T is height in cm and E is age in years).
|
|---|---|---|---|
|
Idiopathic Pulmonary Fibrosis (IPF)-Related Costs by Forced Vital Capacity (FVC) Decline - Subgroup: Predicted FVC<50% at T0
Total annual IPF-related costs
|
—
|
—
|
48035.14 Euro (€)
Standard Deviation 32937.16
|
|
Idiopathic Pulmonary Fibrosis (IPF)-Related Costs by Forced Vital Capacity (FVC) Decline - Subgroup: Predicted FVC<50% at T0
Annual direct health IPF-related costs
|
—
|
—
|
45646.56 Euro (€)
Standard Deviation 32130.57
|
|
Idiopathic Pulmonary Fibrosis (IPF)-Related Costs by Forced Vital Capacity (FVC) Decline - Subgroup: Predicted FVC<50% at T0
Annual direct non-health related costs
|
—
|
—
|
2388.58 Euro (€)
Standard Deviation 3902.02
|
|
Idiopathic Pulmonary Fibrosis (IPF)-Related Costs by Forced Vital Capacity (FVC) Decline - Subgroup: Predicted FVC<50% at T0
Annual indirect IPF-related costs
|
—
|
—
|
0.00 Euro (€)
Standard Deviation 0.00
|
SECONDARY outcome
Timeframe: 12 months. (At baseline visit (T0) and at 12 month visit (T12)).Population: Evaluable Population (cost) including participants with FVC decline between T0 and T12 (paired data) - Subgroup predicted FVC 50-80% at T0.
Economic Impact of IPF in adult patients through the estimation annual direct and indirect costs associated with the disease (€/year) from a social perspective by FVC decline according to predicted FVC%. FVC decline is calculated: FVC% (T12)- FVC%(T0)). In order to estimate the direct and indirect costs according to FVC decline the following variable were described: Men: FVC % predicted (%) = 100 FVC / (0.0678 T - 0.0147 E - 6.0548) Women: FVC % predicted (%) = 100 FVC / (0.0454 T - 0.0211 E - 2.8253) (FVC is FVC in liters, T is height in cm and E is age in years) The calculated variable was stratified into the following subgroups between T0 and T12: ≤-10%; from -10% to -5%; \>-5% Results are reported for participants with predicted FVC 50-80% at baseline.
Outcome measures
| Measure |
IPF Patients With Predicted FVC <50% at T0 - Subgroup
n=21 Participants
All patients diagnosed with Idiopathic Pulmonary Fibrosis (IPF) and predicted Forced Vital Capacity (FVC)% value below 50% at baseline visit (T0).
Patient group (FVC\<50%, FVC 50-80%, FVC\>80%) was calculated based on available patient data: Men: FVC % predicted (%)= 100 FVC/(0.678 T -0.0147 E -6.0548) Women: FVC % predicted (%)= 100 FVC /(0.0454 T -0.0211 E -2.8253) (FVC is FVC in liters, T is height in cm and E is age in years).
|
IPF Patients With Predicted FVC 50-80% at T0 - Subgroup
n=26 Participants
All patients diagnosed with Idiopathic Pulmonary Fibrosis (IPF) and predicted Forced Vital Capacity (FVC)% value between 50 and 80% at baseline visit (T0).
Patient group (FVC\<50%, FVC 50-80%, FVC\>80%) was calculated based on available patient data: Men: FVC % predicted (%)= 100 FVC/(0.0678 T -0.0147 E -6.0548) Women: FVC % predicted (%)= 100 FVC /(0.0454 T -0.0211 E -2.8253) (FVC is FVC in liters, T is height in cm and E is age in years).
|
IPF Patients With Predicted FVC >80% at T0 - Subgroup
n=64 Participants
All patients diagnosed with Idiopathic Pulmonary Fibrosis (IPF) and predicted Forced Vital Capacity (FVC)% value above 80% at baseline visit (T0).
Patient group (FVC\<50%, FVC 50-80%, FVC\>80%) was calculated based on available patient data: Men: FVC % predicted (%)= 100 FVC/(0.0678 T -0.0147 E -6.0548) Women: FVC % predicted (%)= 100 FVC /(0.0454 T -0.0211 E -2.8253) (FVC is FVC in liters, T is height in cm and E is age in years).
|
|---|---|---|---|
|
Idiopathic Pulmonary Fibrosis (IPF)-Related Costs by Forced Vital Capacity (FVC) Decline - Subgroup: Predicted FVC 50-80% at T0
Total annual IPF-related costs
|
24208.51 Euro (€)
Standard Deviation 14372.38
|
20546.19 Euro (€)
Standard Deviation 11062.92
|
23539.60 Euro (€)
Standard Deviation 11999.95
|
|
Idiopathic Pulmonary Fibrosis (IPF)-Related Costs by Forced Vital Capacity (FVC) Decline - Subgroup: Predicted FVC 50-80% at T0
Annual direct health IPF-related costs
|
23826.41 Euro (€)
Standard Deviation 14251.63
|
20490.53 Euro (€)
Standard Deviation 11041.18
|
23450.00 Euro (€)
Standard Deviation 12009.78
|
|
Idiopathic Pulmonary Fibrosis (IPF)-Related Costs by Forced Vital Capacity (FVC) Decline - Subgroup: Predicted FVC 50-80% at T0
Annual direct non-healt IPF-related costs
|
378.68 Euro (€)
Standard Deviation 975.49
|
0.00 Euro (€)
Standard Deviation 0.00
|
84.75 Euro (€)
Standard Deviation 574.20
|
|
Idiopathic Pulmonary Fibrosis (IPF)-Related Costs by Forced Vital Capacity (FVC) Decline - Subgroup: Predicted FVC 50-80% at T0
Annual indirect IPF-related costs
|
3.41 Euro (€)
Standard Deviation 15.64
|
55.66 Euro (€)
Standard Deviation 202.19
|
4.85 Euro (€)
Standard Deviation 28.60
|
SECONDARY outcome
Timeframe: 12 months. (At baseline visit (T0) and at 12 month visit (T12)).Population: Evaluable Population (cost) including participants with FVC decline between T0 and T12 (paired data) - Subgroup with predicted FVC \>80% at T0.
Economic Impact of IPF in adult patients through the estimation annual direct and indirect costs associated with the disease (€/year) from a social perspective by FVC decline according to predicted FVC%. FVC decline is calculated: FVC% (T12)- FVC%(T0)). In order to estimate the direct and indirect costs according to FVC decline the following variable were described: Men: FVC % predicted (%) = 100 FVC / (0.0678 T - 0.0147 E - 6.0548) Women: FVC % predicted (%) = 100 FVC / (0.0454 T - 0.0211 E - 2.8253) (FVC is FVC in liters, T is height in cm and E is age in years) The calculated variable was stratified into the following subgroups between T0 and T12: ≤-10%; from -10% to -5%; \>-5% Results are reported for participants with predicted FVC \> 80% at baseline.
Outcome measures
| Measure |
IPF Patients With Predicted FVC <50% at T0 - Subgroup
n=3 Participants
All patients diagnosed with Idiopathic Pulmonary Fibrosis (IPF) and predicted Forced Vital Capacity (FVC)% value below 50% at baseline visit (T0).
Patient group (FVC\<50%, FVC 50-80%, FVC\>80%) was calculated based on available patient data: Men: FVC % predicted (%)= 100 FVC/(0.678 T -0.0147 E -6.0548) Women: FVC % predicted (%)= 100 FVC /(0.0454 T -0.0211 E -2.8253) (FVC is FVC in liters, T is height in cm and E is age in years).
|
IPF Patients With Predicted FVC 50-80% at T0 - Subgroup
n=5 Participants
All patients diagnosed with Idiopathic Pulmonary Fibrosis (IPF) and predicted Forced Vital Capacity (FVC)% value between 50 and 80% at baseline visit (T0).
Patient group (FVC\<50%, FVC 50-80%, FVC\>80%) was calculated based on available patient data: Men: FVC % predicted (%)= 100 FVC/(0.0678 T -0.0147 E -6.0548) Women: FVC % predicted (%)= 100 FVC /(0.0454 T -0.0211 E -2.8253) (FVC is FVC in liters, T is height in cm and E is age in years).
|
IPF Patients With Predicted FVC >80% at T0 - Subgroup
n=12 Participants
All patients diagnosed with Idiopathic Pulmonary Fibrosis (IPF) and predicted Forced Vital Capacity (FVC)% value above 80% at baseline visit (T0).
Patient group (FVC\<50%, FVC 50-80%, FVC\>80%) was calculated based on available patient data: Men: FVC % predicted (%)= 100 FVC/(0.0678 T -0.0147 E -6.0548) Women: FVC % predicted (%)= 100 FVC /(0.0454 T -0.0211 E -2.8253) (FVC is FVC in liters, T is height in cm and E is age in years).
|
|---|---|---|---|
|
Idiopathic Pulmonary Fibrosis (IPF)-Related Costs by Forced Vital Capacity (FVC) Decline - Subgroup: Predicted FVC>80% at T0
Total annual IPF-related costs
|
8630.88 Euro (€)
Standard Deviation 7522.53
|
23273.38 Euro (€)
Standard Deviation 10606.04
|
23810.32 Euro (€)
Standard Deviation 12580.11
|
|
Idiopathic Pulmonary Fibrosis (IPF)-Related Costs by Forced Vital Capacity (FVC) Decline - Subgroup: Predicted FVC>80% at T0
Annual direct health IPF-related costs
|
8630.88 Euro (€)
Standard Deviation 7522.53
|
23273.38 Euro (€)
Standard Deviation 10606.04
|
23576.99 Euro (€)
Standard Deviation 13010.66
|
|
Idiopathic Pulmonary Fibrosis (IPF)-Related Costs by Forced Vital Capacity (FVC) Decline - Subgroup: Predicted FVC>80% at T0
Annual direct non-health IPF-related costs
|
0.00 Euro (€)
Standard Deviation 0.00
|
0.00 Euro (€)
Standard Deviation 0.00
|
233.33 Euro (€)
Standard Deviation 808.29
|
|
Idiopathic Pulmonary Fibrosis (IPF)-Related Costs by Forced Vital Capacity (FVC) Decline - Subgroup: Predicted FVC>80% at T0
Annual indirect IPF-related costs
|
0.00 Euro (€)
Standard Deviation 0.00
|
0.00 Euro (€)
Standard Deviation 0.00
|
0.00 Euro (€)
Standard Deviation 0.00
|
SECONDARY outcome
Timeframe: 12 months. (At baseline visit (T0) and at 12 month visit (T12)).Population: Evaluable Population including participants with FVC decline between T0 and T12 (paired data) and with SGRQ values at T0 and T12 - Overall FVC patient group.
Absolute Change in SGRQ score by FVC decline according to predicted FVC% from baseline visit (T0) to 12 month visit (T12). The SGRQ is a 50-item questionaire developed to quantify the impact of the disease on the health and QoL perceived by patients with respiratory diseases. It consisted of 50 items divided into 3 scales: symptoms, activity and impact. The final scores ranged from 0 (best health-related quality of life) to 100 (worse health-related quality of life). FVC decline: FVC% (T12)- FVC%(T0) In order to estimate the Quality of Life according to FVC decline the following variable were described: FVC % predicted along the study:. Men: FVC % predicted (%) = 100 FVC / (0.0678 T - 0.0147 E - 6.0548) Women: FVC % predicted (%) = 100 FVC / (0.0454 T - 0.0211 E - 2.8253) (FVC is FVC in liters, T is height in cm and E is age in years). The calculated variable was stratified into the following subgroups between T0 and T12: ≤-10%; from -10% to -5%; \>-5%
Outcome measures
| Measure |
IPF Patients With Predicted FVC <50% at T0 - Subgroup
n=18 Participants
All patients diagnosed with Idiopathic Pulmonary Fibrosis (IPF) and predicted Forced Vital Capacity (FVC)% value below 50% at baseline visit (T0).
Patient group (FVC\<50%, FVC 50-80%, FVC\>80%) was calculated based on available patient data: Men: FVC % predicted (%)= 100 FVC/(0.678 T -0.0147 E -6.0548) Women: FVC % predicted (%)= 100 FVC /(0.0454 T -0.0211 E -2.8253) (FVC is FVC in liters, T is height in cm and E is age in years).
|
IPF Patients With Predicted FVC 50-80% at T0 - Subgroup
n=25 Participants
All patients diagnosed with Idiopathic Pulmonary Fibrosis (IPF) and predicted Forced Vital Capacity (FVC)% value between 50 and 80% at baseline visit (T0).
Patient group (FVC\<50%, FVC 50-80%, FVC\>80%) was calculated based on available patient data: Men: FVC % predicted (%)= 100 FVC/(0.0678 T -0.0147 E -6.0548) Women: FVC % predicted (%)= 100 FVC /(0.0454 T -0.0211 E -2.8253) (FVC is FVC in liters, T is height in cm and E is age in years).
|
IPF Patients With Predicted FVC >80% at T0 - Subgroup
n=72 Participants
All patients diagnosed with Idiopathic Pulmonary Fibrosis (IPF) and predicted Forced Vital Capacity (FVC)% value above 80% at baseline visit (T0).
Patient group (FVC\<50%, FVC 50-80%, FVC\>80%) was calculated based on available patient data: Men: FVC % predicted (%)= 100 FVC/(0.0678 T -0.0147 E -6.0548) Women: FVC % predicted (%)= 100 FVC /(0.0454 T -0.0211 E -2.8253) (FVC is FVC in liters, T is height in cm and E is age in years).
|
|---|---|---|---|
|
Absolute Change in Saint George´s Respiratory Questionaire (SGRQ) Score From Baseline Visit (T0) to 12 Month Visit (T12) by Forced Vital Capacity (FVC) Decline - Overall FVC Patient Group
|
8.49 Score on a scale
Standard Deviation 17.16
|
3.20 Score on a scale
Standard Deviation 11.71
|
0.23 Score on a scale
Standard Deviation 13.11
|
SECONDARY outcome
Timeframe: 12 months. (At baseline visit (T0) and at 12 month visit (T12)).Population: Evaluable Population including participants with FVC decline between T0 and T12 (paired data) and with SGRQ values at T0 and T12 - Subgroup with predicted FVC \<50% at T0.
Absolute Change in SGRQ score by FVC decline according to predicted FVC% from baseline visit (T0) to 12 month visit (T12). The SGRQ is a 50-item questionaire developed to quantify the impact of the disease on the health and QoL perceived by patients with respiratory diseases. It consisted of 50 items divided into 3 scales: symptoms, activity and impact. The final scores ranged from 0 (best health-related quality of life) to 100 (worse health-related quality of life). FVC decline: FVC% (T12)- FVC%(T0) In order to estimate SGRQ according to FVC decline the following variable were described: Men: FVC % predicted (%) = 100 FVC / (0.0678 T - 0.0147 E - 6.0548) Women: FVC % predicted (%) = 100 FVC / (0.0454 T - 0.0211 E - 2.8253) (FVC is FVC in liters, T is height in cm and E is age in years). The calculated variable was stratified into the following subgroups between T0 and T12: ≤-10%; from -10% to -5%; \>-5% Results are reported for participants with predicted FVC\<50% at baseline.
Outcome measures
| Measure |
IPF Patients With Predicted FVC <50% at T0 - Subgroup
All patients diagnosed with Idiopathic Pulmonary Fibrosis (IPF) and predicted Forced Vital Capacity (FVC)% value below 50% at baseline visit (T0).
Patient group (FVC\<50%, FVC 50-80%, FVC\>80%) was calculated based on available patient data: Men: FVC % predicted (%)= 100 FVC/(0.678 T -0.0147 E -6.0548) Women: FVC % predicted (%)= 100 FVC /(0.0454 T -0.0211 E -2.8253) (FVC is FVC in liters, T is height in cm and E is age in years).
|
IPF Patients With Predicted FVC 50-80% at T0 - Subgroup
All patients diagnosed with Idiopathic Pulmonary Fibrosis (IPF) and predicted Forced Vital Capacity (FVC)% value between 50 and 80% at baseline visit (T0).
Patient group (FVC\<50%, FVC 50-80%, FVC\>80%) was calculated based on available patient data: Men: FVC % predicted (%)= 100 FVC/(0.0678 T -0.0147 E -6.0548) Women: FVC % predicted (%)= 100 FVC /(0.0454 T -0.0211 E -2.8253) (FVC is FVC in liters, T is height in cm and E is age in years).
|
IPF Patients With Predicted FVC >80% at T0 - Subgroup
n=7 Participants
All patients diagnosed with Idiopathic Pulmonary Fibrosis (IPF) and predicted Forced Vital Capacity (FVC)% value above 80% at baseline visit (T0).
Patient group (FVC\<50%, FVC 50-80%, FVC\>80%) was calculated based on available patient data: Men: FVC % predicted (%)= 100 FVC/(0.0678 T -0.0147 E -6.0548) Women: FVC % predicted (%)= 100 FVC /(0.0454 T -0.0211 E -2.8253) (FVC is FVC in liters, T is height in cm and E is age in years).
|
|---|---|---|---|
|
Absolute Change in Saint George´s Respiratory Questionaire (SGRQ) Score From Baseline Visit (T0) to 12 Month Visit (T12) by Forced Vital Capacity (FVC) Decline - Subgroup: Predicted FVC<50% at T0
|
—
|
—
|
-14.93 Score on a scale
Standard Deviation 29.03
|
SECONDARY outcome
Timeframe: 12 months (At baseline visit (T0) and at 12 month visit (T12)).Population: Evaluable Population including participants with FVC decline between T0 and T12 (paired data) and with SGRQ values at T0 and T12 - Subgroup with predicted FVC 50-80% at T0.
Absolute Change in SGRQ score by FVC decline according to predicted FVC% from baseline visit (T0) to 12 month visit (T12). The SGRQ is a 50-item questionaire developed to quantify the impact of the disease on the health and QoL perceived by patients with respiratory diseases. It consisted of 50 items divided into 3 scales: symptoms (frequency and severity of respiratory symptoms), activity (limitations due to dyspnoea) and impact (psychological and social functioning disorders caused by the disease). The final scores ranged from 0 (best health-related quality of life) to 100 (worse health-related quality of life). FVC decline: FVC% (T12)- FVC%(T0) Results are reported for participants with predicted FVC 50-80% at baseline.
Outcome measures
| Measure |
IPF Patients With Predicted FVC <50% at T0 - Subgroup
n=15 Participants
All patients diagnosed with Idiopathic Pulmonary Fibrosis (IPF) and predicted Forced Vital Capacity (FVC)% value below 50% at baseline visit (T0).
Patient group (FVC\<50%, FVC 50-80%, FVC\>80%) was calculated based on available patient data: Men: FVC % predicted (%)= 100 FVC/(0.678 T -0.0147 E -6.0548) Women: FVC % predicted (%)= 100 FVC /(0.0454 T -0.0211 E -2.8253) (FVC is FVC in liters, T is height in cm and E is age in years).
|
IPF Patients With Predicted FVC 50-80% at T0 - Subgroup
n=21 Participants
All patients diagnosed with Idiopathic Pulmonary Fibrosis (IPF) and predicted Forced Vital Capacity (FVC)% value between 50 and 80% at baseline visit (T0).
Patient group (FVC\<50%, FVC 50-80%, FVC\>80%) was calculated based on available patient data: Men: FVC % predicted (%)= 100 FVC/(0.0678 T -0.0147 E -6.0548) Women: FVC % predicted (%)= 100 FVC /(0.0454 T -0.0211 E -2.8253) (FVC is FVC in liters, T is height in cm and E is age in years).
|
IPF Patients With Predicted FVC >80% at T0 - Subgroup
n=53 Participants
All patients diagnosed with Idiopathic Pulmonary Fibrosis (IPF) and predicted Forced Vital Capacity (FVC)% value above 80% at baseline visit (T0).
Patient group (FVC\<50%, FVC 50-80%, FVC\>80%) was calculated based on available patient data: Men: FVC % predicted (%)= 100 FVC/(0.0678 T -0.0147 E -6.0548) Women: FVC % predicted (%)= 100 FVC /(0.0454 T -0.0211 E -2.8253) (FVC is FVC in liters, T is height in cm and E is age in years).
|
|---|---|---|---|
|
Absolute Change in Saint George´s Respiratory Questionaire (SGRQ) Score From Baseline Visit (T0) to 12 Month Visit (T12) by Forced Vital Capacity (FVC) Decline - Subgroup: Predicted FVC 50-80% at T0
|
12.58 Score on a scale
Standard Deviation 14.02
|
2.20 Score on a scale
Standard Deviation 12.16
|
2.16 Score on a scale
Standard Deviation 9.62
|
SECONDARY outcome
Timeframe: 12 months. (At baseline visit (T0) and at 12 month visit (T12)).Population: Evaluable Population including participants with FVC decline between T0 and T12 (paired data) and with SGRQ values at T0 and T12 - Subgroup with predicted FVC \>80% at T0.
Absolute Change in SGRQ score by FVC decline according to predicted FVC% from baseline visit (T0) to 12 month visit (T12). The SGRQ is a 50-item questionaire developed to quantify the impact of the disease on the health and QoL perceived by patients with respiratory diseases. It consisted of 50 items divided into 3 scales: symptoms (frequency and severity of respiratory symptoms), activity (limitations due to dyspnoea) and impact (psychological and social functioning disorders caused by the disease). The final scores ranged from 0 (best health-related quality of life) to 100 (worse health-related quality of life). FVC decline: FVC% (T12)- FVC%(T0) Results are reported for participants with predicted FVC \>80% at baseline.
Outcome measures
| Measure |
IPF Patients With Predicted FVC <50% at T0 - Subgroup
n=3 Participants
All patients diagnosed with Idiopathic Pulmonary Fibrosis (IPF) and predicted Forced Vital Capacity (FVC)% value below 50% at baseline visit (T0).
Patient group (FVC\<50%, FVC 50-80%, FVC\>80%) was calculated based on available patient data: Men: FVC % predicted (%)= 100 FVC/(0.678 T -0.0147 E -6.0548) Women: FVC % predicted (%)= 100 FVC /(0.0454 T -0.0211 E -2.8253) (FVC is FVC in liters, T is height in cm and E is age in years).
|
IPF Patients With Predicted FVC 50-80% at T0 - Subgroup
n=4 Participants
All patients diagnosed with Idiopathic Pulmonary Fibrosis (IPF) and predicted Forced Vital Capacity (FVC)% value between 50 and 80% at baseline visit (T0).
Patient group (FVC\<50%, FVC 50-80%, FVC\>80%) was calculated based on available patient data: Men: FVC % predicted (%)= 100 FVC/(0.0678 T -0.0147 E -6.0548) Women: FVC % predicted (%)= 100 FVC /(0.0454 T -0.0211 E -2.8253) (FVC is FVC in liters, T is height in cm and E is age in years).
|
IPF Patients With Predicted FVC >80% at T0 - Subgroup
n=12 Participants
All patients diagnosed with Idiopathic Pulmonary Fibrosis (IPF) and predicted Forced Vital Capacity (FVC)% value above 80% at baseline visit (T0).
Patient group (FVC\<50%, FVC 50-80%, FVC\>80%) was calculated based on available patient data: Men: FVC % predicted (%)= 100 FVC/(0.0678 T -0.0147 E -6.0548) Women: FVC % predicted (%)= 100 FVC /(0.0454 T -0.0211 E -2.8253) (FVC is FVC in liters, T is height in cm and E is age in years).
|
|---|---|---|---|
|
Absolute Change in Saint George´s Respiratory Questionaire (SGRQ) Score From Baseline Visit (T0) to 12 Month Visit (T12) by Forced Vital Capacity (FVC) Decline - Subgroup: Predicted FVC>80% at T0
|
-11.97 Score on a scale
Standard Deviation 19.38
|
8.43 Score on a scale
Standard Deviation 8.32
|
0.56 Score on a scale
Standard Deviation 6.93
|
SECONDARY outcome
Timeframe: 12 months. (At baseline visit (T0) and at 12 month visit (T12)).Population: Evaluable Population including participants with FVC decline between T0 and T12 (paired data) and with EQ-VAS values at T0 and T12 - Overall FVC Patient Group.
Absolute Change in EQ-VAS score by FVC decline according to predicted FVC% from baseline visit (T0) to 12 month visit (T12). The EQVAS is a self-rated health status using a VAS (0-100), with 0= worst state of health imaginable and 100= best state of health imaginable. The EQ-VAS records the subject's perceptions of their own current overall health. FVC decline: FVC% (T12)- FVC%(T0) In order to estimate the EQ-VAS according to FVC decline the following variable were described: FVC % predicted along the study: Men: FVC % predicted (%) = 100 FVC / (0.0678 T - 0.0147 E - 6.0548) Women: FVC % predicted (%) = 100 FVC / (0.0454 T - 0.0211 E - 2.8253) (FVC is FVC in liters, T is height in cm and E is age in years) The calculated variable was stratified into the following subgroups between T0 and T12: ≤-10%; from -10% to -5%; \>-5%
Outcome measures
| Measure |
IPF Patients With Predicted FVC <50% at T0 - Subgroup
n=24 Participants
All patients diagnosed with Idiopathic Pulmonary Fibrosis (IPF) and predicted Forced Vital Capacity (FVC)% value below 50% at baseline visit (T0).
Patient group (FVC\<50%, FVC 50-80%, FVC\>80%) was calculated based on available patient data: Men: FVC % predicted (%)= 100 FVC/(0.678 T -0.0147 E -6.0548) Women: FVC % predicted (%)= 100 FVC /(0.0454 T -0.0211 E -2.8253) (FVC is FVC in liters, T is height in cm and E is age in years).
|
IPF Patients With Predicted FVC 50-80% at T0 - Subgroup
n=31 Participants
All patients diagnosed with Idiopathic Pulmonary Fibrosis (IPF) and predicted Forced Vital Capacity (FVC)% value between 50 and 80% at baseline visit (T0).
Patient group (FVC\<50%, FVC 50-80%, FVC\>80%) was calculated based on available patient data: Men: FVC % predicted (%)= 100 FVC/(0.0678 T -0.0147 E -6.0548) Women: FVC % predicted (%)= 100 FVC /(0.0454 T -0.0211 E -2.8253) (FVC is FVC in liters, T is height in cm and E is age in years).
|
IPF Patients With Predicted FVC >80% at T0 - Subgroup
n=85 Participants
All patients diagnosed with Idiopathic Pulmonary Fibrosis (IPF) and predicted Forced Vital Capacity (FVC)% value above 80% at baseline visit (T0).
Patient group (FVC\<50%, FVC 50-80%, FVC\>80%) was calculated based on available patient data: Men: FVC % predicted (%)= 100 FVC/(0.0678 T -0.0147 E -6.0548) Women: FVC % predicted (%)= 100 FVC /(0.0454 T -0.0211 E -2.8253) (FVC is FVC in liters, T is height in cm and E is age in years).
|
|---|---|---|---|
|
Absolute Change in EuroQoL Visual Analogue Scale (EQ-VAS) From Baseline Visit (T0) to 12 Month Visit (T12) by Forced Vital Capacity (FVC) Decline- Overall FVC Patient Group
|
-8.96 Score on scale
Standard Deviation 17.74
|
-6.16 Score on scale
Standard Deviation 18.69
|
-0.04 Score on scale
Standard Deviation 14.79
|
SECONDARY outcome
Timeframe: 12 months. (At baseline visit (T0) and at 12 month visit (T12)).Population: Evaluable Population including participants with FVC decline between T0 and T12 (paired data) and with EQ-VAS values at T0 and T12 - Subgroup with predicted FVC \<50% at T0.
Absolute Change in EQ-VAS score by FVC decline according to predicted FVC% from baseline visit (T0) to 12 month visit (T12). The EQVAS is a self-rated health status using a VAS (0-100), with 0= worst state of health imaginable and 100= best state of health imaginable. The EQ-VAS records the subject's perceptions of their own current overall health. FVC decline: FVC% (T12)- FVC%(T0) In order to estimate the EQ-VAS according to FVC decline the following variable were described: FVC % predicted along the study: Men: FVC % predicted (%) = 100 FVC / (0.0678 T - 0.0147 E - 6.0548) Women: FVC % predicted (%) = 100 FVC / (0.0454 T - 0.0211 E - 2.8253) (FVC is FVC in liters, T is height in cm and E is age in years) The calculated variable was stratified into the following subgroups between T0 and T12: ≤-10%; from -10% to -5%; \>-5% Results are reported for participants with predicted FVC\<50% at baseline.
Outcome measures
| Measure |
IPF Patients With Predicted FVC <50% at T0 - Subgroup
All patients diagnosed with Idiopathic Pulmonary Fibrosis (IPF) and predicted Forced Vital Capacity (FVC)% value below 50% at baseline visit (T0).
Patient group (FVC\<50%, FVC 50-80%, FVC\>80%) was calculated based on available patient data: Men: FVC % predicted (%)= 100 FVC/(0.678 T -0.0147 E -6.0548) Women: FVC % predicted (%)= 100 FVC /(0.0454 T -0.0211 E -2.8253) (FVC is FVC in liters, T is height in cm and E is age in years).
|
IPF Patients With Predicted FVC 50-80% at T0 - Subgroup
All patients diagnosed with Idiopathic Pulmonary Fibrosis (IPF) and predicted Forced Vital Capacity (FVC)% value between 50 and 80% at baseline visit (T0).
Patient group (FVC\<50%, FVC 50-80%, FVC\>80%) was calculated based on available patient data: Men: FVC % predicted (%)= 100 FVC/(0.0678 T -0.0147 E -6.0548) Women: FVC % predicted (%)= 100 FVC /(0.0454 T -0.0211 E -2.8253) (FVC is FVC in liters, T is height in cm and E is age in years).
|
IPF Patients With Predicted FVC >80% at T0 - Subgroup
n=9 Participants
All patients diagnosed with Idiopathic Pulmonary Fibrosis (IPF) and predicted Forced Vital Capacity (FVC)% value above 80% at baseline visit (T0).
Patient group (FVC\<50%, FVC 50-80%, FVC\>80%) was calculated based on available patient data: Men: FVC % predicted (%)= 100 FVC/(0.0678 T -0.0147 E -6.0548) Women: FVC % predicted (%)= 100 FVC /(0.0454 T -0.0211 E -2.8253) (FVC is FVC in liters, T is height in cm and E is age in years).
|
|---|---|---|---|
|
Absolute Change in EuroQoL Visual Analogue Scale (EQ-VAS) From Baseline Visit (T0) to 12 Month Visit (T12) by Forced Vital Capacity (FVC) Decline - Subgroup: Predicted FVC<50% at T0
|
—
|
—
|
13.89 Score on scale
Standard Deviation 13.41
|
SECONDARY outcome
Timeframe: 12 months. (At baseline visit (T0) and at 12 month visit (T12)).Population: Evaluable Population including participants with FVC decline between T0 and T12 (paired data) and with EQ-VAS values at T0 and T12 - Subgroup with predicted FVC 50-80% at T0.
Absolute Change in EQ-VAS score by FVC decline according to predicted FVC% from baseline visit (T0) to 12 month visit (T12). The EQVAS is a self-rated health status using a VAS (0-100), with 0= worst state of health imaginable and 100= best state of health imaginable. The EQ-VAS records the subject's perceptions of their own current overall health. FVC decline: FVC% (T12)- FVC%(T0) In order to estimate the EQ-VAS according to FVC decline the following variable were described: FVC % predicted along the study:. Men: FVC % predicted (%) = 100 FVC / (0.0678 T - 0.0147 E - 6.0548) Women: FVC % predicted (%) = 100 FVC / (0.0454 T - 0.0211 E - 2.8253) (FVC is FVC in liters, T is height in cm and E is age in years) The calculated variable was stratified into the following subgroups between T0 and T12: ≤-10%; from -10% to -5%; \>-5% Results are reported for participants with predicted FVC 50-80% at baseline.
Outcome measures
| Measure |
IPF Patients With Predicted FVC <50% at T0 - Subgroup
n=21 Participants
All patients diagnosed with Idiopathic Pulmonary Fibrosis (IPF) and predicted Forced Vital Capacity (FVC)% value below 50% at baseline visit (T0).
Patient group (FVC\<50%, FVC 50-80%, FVC\>80%) was calculated based on available patient data: Men: FVC % predicted (%)= 100 FVC/(0.678 T -0.0147 E -6.0548) Women: FVC % predicted (%)= 100 FVC /(0.0454 T -0.0211 E -2.8253) (FVC is FVC in liters, T is height in cm and E is age in years).
|
IPF Patients With Predicted FVC 50-80% at T0 - Subgroup
n=26 Participants
All patients diagnosed with Idiopathic Pulmonary Fibrosis (IPF) and predicted Forced Vital Capacity (FVC)% value between 50 and 80% at baseline visit (T0).
Patient group (FVC\<50%, FVC 50-80%, FVC\>80%) was calculated based on available patient data: Men: FVC % predicted (%)= 100 FVC/(0.0678 T -0.0147 E -6.0548) Women: FVC % predicted (%)= 100 FVC /(0.0454 T -0.0211 E -2.8253) (FVC is FVC in liters, T is height in cm and E is age in years).
|
IPF Patients With Predicted FVC >80% at T0 - Subgroup
n=64 Participants
All patients diagnosed with Idiopathic Pulmonary Fibrosis (IPF) and predicted Forced Vital Capacity (FVC)% value above 80% at baseline visit (T0).
Patient group (FVC\<50%, FVC 50-80%, FVC\>80%) was calculated based on available patient data: Men: FVC % predicted (%)= 100 FVC/(0.0678 T -0.0147 E -6.0548) Women: FVC % predicted (%)= 100 FVC /(0.0454 T -0.0211 E -2.8253) (FVC is FVC in liters, T is height in cm and E is age in years).
|
|---|---|---|---|
|
Absolute Change in EuroQoL Visual Analogue Scale (EQ-VAS) From Baseline Visit (T0) to 12 Month Visit (T12) by Forced Vital Capacity (FVC) Decline- Subgroup: Predicted FVC 50-80% at T0
|
-10.48 Score on scale
Standard Deviation 18.21
|
-6.96 Score on scale
Standard Deviation 20.15
|
-1.45 Score on scale
Standard Deviation 14.77
|
SECONDARY outcome
Timeframe: 12 months. (At baseline visit (T0) and at 12 month visit (T12)).Population: Evaluable Population including participants with FVC decline between T0 and T12 (paired data) and with EQ-VAS values at T0 and T12 - Subgroup with predicted FVC \>80% at T0.
Absolute Change in EQ-VAS score by FVC decline according to predicted FVC% from baseline visit (T0) to 12 month visit (T12). The EQVAS is a self-rated health status using a VAS (0-100), with 0= worst state of health imaginable and 100= best state of health imaginable. The EQ-VAS records the subject's perceptions of their own current overall health. FVC decline: FVC% (T12)- FVC%(T0) In order to estimate the EQ-VAS according to FVC decline the following variable were described: FVC % predicted along the study:. Men: FVC % predicted (%) = 100 FVC / (0.0678 T - 0.0147 E - 6.0548) Women: FVC % predicted (%) = 100 FVC / (0.0454 T - 0.0211 E - 2.8253) (FVC is FVC in liters, T is height in cm and E is age in years) The calculated variable was stratified into the following subgroups between T0 and T12: ≤-10%; from -10% to -5%; \>-5% Results are reported for participants with predicted FVC\>80% at baseline.
Outcome measures
| Measure |
IPF Patients With Predicted FVC <50% at T0 - Subgroup
n=3 Participants
All patients diagnosed with Idiopathic Pulmonary Fibrosis (IPF) and predicted Forced Vital Capacity (FVC)% value below 50% at baseline visit (T0).
Patient group (FVC\<50%, FVC 50-80%, FVC\>80%) was calculated based on available patient data: Men: FVC % predicted (%)= 100 FVC/(0.678 T -0.0147 E -6.0548) Women: FVC % predicted (%)= 100 FVC /(0.0454 T -0.0211 E -2.8253) (FVC is FVC in liters, T is height in cm and E is age in years).
|
IPF Patients With Predicted FVC 50-80% at T0 - Subgroup
n=5 Participants
All patients diagnosed with Idiopathic Pulmonary Fibrosis (IPF) and predicted Forced Vital Capacity (FVC)% value between 50 and 80% at baseline visit (T0).
Patient group (FVC\<50%, FVC 50-80%, FVC\>80%) was calculated based on available patient data: Men: FVC % predicted (%)= 100 FVC/(0.0678 T -0.0147 E -6.0548) Women: FVC % predicted (%)= 100 FVC /(0.0454 T -0.0211 E -2.8253) (FVC is FVC in liters, T is height in cm and E is age in years).
|
IPF Patients With Predicted FVC >80% at T0 - Subgroup
n=12 Participants
All patients diagnosed with Idiopathic Pulmonary Fibrosis (IPF) and predicted Forced Vital Capacity (FVC)% value above 80% at baseline visit (T0).
Patient group (FVC\<50%, FVC 50-80%, FVC\>80%) was calculated based on available patient data: Men: FVC % predicted (%)= 100 FVC/(0.0678 T -0.0147 E -6.0548) Women: FVC % predicted (%)= 100 FVC /(0.0454 T -0.0211 E -2.8253) (FVC is FVC in liters, T is height in cm and E is age in years).
|
|---|---|---|---|
|
Absolute Change in EuroQoL Visual Analogue Scale (EQ-VAS) From Baseline Visit (T0) to 12 Month Visit (T12) by Forced Vital Capacity (FVC) Decline - Subgroup: Predicted FVC>80% at T0
|
1.67 Score on scale
Standard Deviation 10.41
|
-2.00 Score on scale
Standard Deviation 7.58
|
-2.92 Score on scale
Standard Deviation 10.54
|
SECONDARY outcome
Timeframe: 12 months. (At baseline visit (T0), at 6 month visit (T6), at 12 month visit (T12)).Population: Caregivers who have signed the specific written informed consent.
Caregivers of IPF patients were asked to complete the Zarit Burden Interview. It is a self-report measure. The revised version contains 22 items. Each item on the interview is a statement which the caregiver is asked to endorse using a 5-point scale. Response options, in the Spanish version, range from 0 (never) to 4 (nearly always). The final score ranges from 0 to 88. A higher score implies a greater burden (≤ 21: Little or no burden; 22-40: mild to moderate burden; 41-60: moderate to severe burden; ≥ 61: severe burden).
Outcome measures
| Measure |
IPF Patients With Predicted FVC <50% at T0 - Subgroup
n=37 Participants
All patients diagnosed with Idiopathic Pulmonary Fibrosis (IPF) and predicted Forced Vital Capacity (FVC)% value below 50% at baseline visit (T0).
Patient group (FVC\<50%, FVC 50-80%, FVC\>80%) was calculated based on available patient data: Men: FVC % predicted (%)= 100 FVC/(0.678 T -0.0147 E -6.0548) Women: FVC % predicted (%)= 100 FVC /(0.0454 T -0.0211 E -2.8253) (FVC is FVC in liters, T is height in cm and E is age in years).
|
IPF Patients With Predicted FVC 50-80% at T0 - Subgroup
All patients diagnosed with Idiopathic Pulmonary Fibrosis (IPF) and predicted Forced Vital Capacity (FVC)% value between 50 and 80% at baseline visit (T0).
Patient group (FVC\<50%, FVC 50-80%, FVC\>80%) was calculated based on available patient data: Men: FVC % predicted (%)= 100 FVC/(0.0678 T -0.0147 E -6.0548) Women: FVC % predicted (%)= 100 FVC /(0.0454 T -0.0211 E -2.8253) (FVC is FVC in liters, T is height in cm and E is age in years).
|
IPF Patients With Predicted FVC >80% at T0 - Subgroup
All patients diagnosed with Idiopathic Pulmonary Fibrosis (IPF) and predicted Forced Vital Capacity (FVC)% value above 80% at baseline visit (T0).
Patient group (FVC\<50%, FVC 50-80%, FVC\>80%) was calculated based on available patient data: Men: FVC % predicted (%)= 100 FVC/(0.0678 T -0.0147 E -6.0548) Women: FVC % predicted (%)= 100 FVC /(0.0454 T -0.0211 E -2.8253) (FVC is FVC in liters, T is height in cm and E is age in years).
|
|---|---|---|---|
|
Impact of Disease on the Patients Caregiver Through Zarit Burden Interview Questionaire
T0
|
23.59 Score an a scale
Standard Deviation 15.81
|
—
|
—
|
|
Impact of Disease on the Patients Caregiver Through Zarit Burden Interview Questionaire
T6
|
22.50 Score an a scale
Standard Deviation 17.99
|
—
|
—
|
|
Impact of Disease on the Patients Caregiver Through Zarit Burden Interview Questionaire
T12
|
22.08 Score an a scale
Standard Deviation 19.45
|
—
|
—
|
Adverse Events
All Patients With IPF - Overall Population
Serious adverse events
| Measure |
All Patients With IPF - Overall Population
n=89 participants at risk；n=204 participants at risk
All patients with Idiopathic Pulmonary Fibrosis (IPF).
|
|---|---|
|
Cardiac disorders
Acute myocardial infarction
|
0.49%
1/204 • From signing informed consent until end of study, up to 12 months.
For all-cause mortality and serious adverse events the safety population (All screened patients with informed consent prior to participation) was used. Other Adverse events were reported only for patients with at least one dose of OFEV® (OFEV® Population), as defined in the study report. Please note that the number of deaths reported in all-cause mortality is higher than reported in the participant flow due to a number of participants dying after discontinuing the study.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.49%
1/204 • From signing informed consent until end of study, up to 12 months.
For all-cause mortality and serious adverse events the safety population (All screened patients with informed consent prior to participation) was used. Other Adverse events were reported only for patients with at least one dose of OFEV® (OFEV® Population), as defined in the study report. Please note that the number of deaths reported in all-cause mortality is higher than reported in the participant flow due to a number of participants dying after discontinuing the study.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
2.5%
5/204 • From signing informed consent until end of study, up to 12 months.
For all-cause mortality and serious adverse events the safety population (All screened patients with informed consent prior to participation) was used. Other Adverse events were reported only for patients with at least one dose of OFEV® (OFEV® Population), as defined in the study report. Please note that the number of deaths reported in all-cause mortality is higher than reported in the participant flow due to a number of participants dying after discontinuing the study.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.49%
1/204 • From signing informed consent until end of study, up to 12 months.
For all-cause mortality and serious adverse events the safety population (All screened patients with informed consent prior to participation) was used. Other Adverse events were reported only for patients with at least one dose of OFEV® (OFEV® Population), as defined in the study report. Please note that the number of deaths reported in all-cause mortality is higher than reported in the participant flow due to a number of participants dying after discontinuing the study.
|
|
General disorders
Asthenia
|
0.49%
1/204 • From signing informed consent until end of study, up to 12 months.
For all-cause mortality and serious adverse events the safety population (All screened patients with informed consent prior to participation) was used. Other Adverse events were reported only for patients with at least one dose of OFEV® (OFEV® Population), as defined in the study report. Please note that the number of deaths reported in all-cause mortality is higher than reported in the participant flow due to a number of participants dying after discontinuing the study.
|
|
General disorders
Death
|
1.5%
3/204 • From signing informed consent until end of study, up to 12 months.
For all-cause mortality and serious adverse events the safety population (All screened patients with informed consent prior to participation) was used. Other Adverse events were reported only for patients with at least one dose of OFEV® (OFEV® Population), as defined in the study report. Please note that the number of deaths reported in all-cause mortality is higher than reported in the participant flow due to a number of participants dying after discontinuing the study.
|
|
General disorders
Disease progression
|
1.5%
3/204 • From signing informed consent until end of study, up to 12 months.
For all-cause mortality and serious adverse events the safety population (All screened patients with informed consent prior to participation) was used. Other Adverse events were reported only for patients with at least one dose of OFEV® (OFEV® Population), as defined in the study report. Please note that the number of deaths reported in all-cause mortality is higher than reported in the participant flow due to a number of participants dying after discontinuing the study.
|
|
Infections and infestations
Bronchitis
|
0.49%
1/204 • From signing informed consent until end of study, up to 12 months.
For all-cause mortality and serious adverse events the safety population (All screened patients with informed consent prior to participation) was used. Other Adverse events were reported only for patients with at least one dose of OFEV® (OFEV® Population), as defined in the study report. Please note that the number of deaths reported in all-cause mortality is higher than reported in the participant flow due to a number of participants dying after discontinuing the study.
|
|
Infections and infestations
Pneumonia bacterial
|
0.49%
1/204 • From signing informed consent until end of study, up to 12 months.
For all-cause mortality and serious adverse events the safety population (All screened patients with informed consent prior to participation) was used. Other Adverse events were reported only for patients with at least one dose of OFEV® (OFEV® Population), as defined in the study report. Please note that the number of deaths reported in all-cause mortality is higher than reported in the participant flow due to a number of participants dying after discontinuing the study.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.49%
1/204 • From signing informed consent until end of study, up to 12 months.
For all-cause mortality and serious adverse events the safety population (All screened patients with informed consent prior to participation) was used. Other Adverse events were reported only for patients with at least one dose of OFEV® (OFEV® Population), as defined in the study report. Please note that the number of deaths reported in all-cause mortality is higher than reported in the participant flow due to a number of participants dying after discontinuing the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm
|
0.49%
1/204 • From signing informed consent until end of study, up to 12 months.
For all-cause mortality and serious adverse events the safety population (All screened patients with informed consent prior to participation) was used. Other Adverse events were reported only for patients with at least one dose of OFEV® (OFEV® Population), as defined in the study report. Please note that the number of deaths reported in all-cause mortality is higher than reported in the participant flow due to a number of participants dying after discontinuing the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small cell lung cancer
|
0.49%
1/204 • From signing informed consent until end of study, up to 12 months.
For all-cause mortality and serious adverse events the safety population (All screened patients with informed consent prior to participation) was used. Other Adverse events were reported only for patients with at least one dose of OFEV® (OFEV® Population), as defined in the study report. Please note that the number of deaths reported in all-cause mortality is higher than reported in the participant flow due to a number of participants dying after discontinuing the study.
|
|
Psychiatric disorders
Completed suicide
|
0.49%
1/204 • From signing informed consent until end of study, up to 12 months.
For all-cause mortality and serious adverse events the safety population (All screened patients with informed consent prior to participation) was used. Other Adverse events were reported only for patients with at least one dose of OFEV® (OFEV® Population), as defined in the study report. Please note that the number of deaths reported in all-cause mortality is higher than reported in the participant flow due to a number of participants dying after discontinuing the study.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.49%
1/204 • From signing informed consent until end of study, up to 12 months.
For all-cause mortality and serious adverse events the safety population (All screened patients with informed consent prior to participation) was used. Other Adverse events were reported only for patients with at least one dose of OFEV® (OFEV® Population), as defined in the study report. Please note that the number of deaths reported in all-cause mortality is higher than reported in the participant flow due to a number of participants dying after discontinuing the study.
|
|
Renal and urinary disorders
Haematuria
|
0.49%
1/204 • From signing informed consent until end of study, up to 12 months.
For all-cause mortality and serious adverse events the safety population (All screened patients with informed consent prior to participation) was used. Other Adverse events were reported only for patients with at least one dose of OFEV® (OFEV® Population), as defined in the study report. Please note that the number of deaths reported in all-cause mortality is higher than reported in the participant flow due to a number of participants dying after discontinuing the study.
|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
|
0.49%
1/204 • From signing informed consent until end of study, up to 12 months.
For all-cause mortality and serious adverse events the safety population (All screened patients with informed consent prior to participation) was used. Other Adverse events were reported only for patients with at least one dose of OFEV® (OFEV® Population), as defined in the study report. Please note that the number of deaths reported in all-cause mortality is higher than reported in the participant flow due to a number of participants dying after discontinuing the study.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.49%
1/204 • From signing informed consent until end of study, up to 12 months.
For all-cause mortality and serious adverse events the safety population (All screened patients with informed consent prior to participation) was used. Other Adverse events were reported only for patients with at least one dose of OFEV® (OFEV® Population), as defined in the study report. Please note that the number of deaths reported in all-cause mortality is higher than reported in the participant flow due to a number of participants dying after discontinuing the study.
|
|
Respiratory, thoracic and mediastinal disorders
Idiopathic pulmonary fibrosis
|
2.9%
6/204 • From signing informed consent until end of study, up to 12 months.
For all-cause mortality and serious adverse events the safety population (All screened patients with informed consent prior to participation) was used. Other Adverse events were reported only for patients with at least one dose of OFEV® (OFEV® Population), as defined in the study report. Please note that the number of deaths reported in all-cause mortality is higher than reported in the participant flow due to a number of participants dying after discontinuing the study.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.49%
1/204 • From signing informed consent until end of study, up to 12 months.
For all-cause mortality and serious adverse events the safety population (All screened patients with informed consent prior to participation) was used. Other Adverse events were reported only for patients with at least one dose of OFEV® (OFEV® Population), as defined in the study report. Please note that the number of deaths reported in all-cause mortality is higher than reported in the participant flow due to a number of participants dying after discontinuing the study.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.98%
2/204 • From signing informed consent until end of study, up to 12 months.
For all-cause mortality and serious adverse events the safety population (All screened patients with informed consent prior to participation) was used. Other Adverse events were reported only for patients with at least one dose of OFEV® (OFEV® Population), as defined in the study report. Please note that the number of deaths reported in all-cause mortality is higher than reported in the participant flow due to a number of participants dying after discontinuing the study.
|
|
Surgical and medical procedures
Solid organ transplant
|
0.49%
1/204 • From signing informed consent until end of study, up to 12 months.
For all-cause mortality and serious adverse events the safety population (All screened patients with informed consent prior to participation) was used. Other Adverse events were reported only for patients with at least one dose of OFEV® (OFEV® Population), as defined in the study report. Please note that the number of deaths reported in all-cause mortality is higher than reported in the participant flow due to a number of participants dying after discontinuing the study.
|
Other adverse events
| Measure |
All Patients With IPF - Overall Population
n=89 participants at risk；n=204 participants at risk
All patients with Idiopathic Pulmonary Fibrosis (IPF).
|
|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
13.5%
12/89 • From signing informed consent until end of study, up to 12 months.
For all-cause mortality and serious adverse events the safety population (All screened patients with informed consent prior to participation) was used. Other Adverse events were reported only for patients with at least one dose of OFEV® (OFEV® Population), as defined in the study report. Please note that the number of deaths reported in all-cause mortality is higher than reported in the participant flow due to a number of participants dying after discontinuing the study.
|
Additional Information
Boehringer Ingelheim, Call Centre
Boehringer Ingelheim
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place