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ID
45930
Description
The general purpose of this trial is to investigate the efficacy and safety of 4 dose strategies of BIBF 1120 treatment for 12 months, compared to placebo in patients with idiopathic pulmonary fibrosis. The primary objective of this study is to demonstrate whether at least one dose strategy is superior to placebo in patients with IPF, in modifying the rate of decline of Forced Vital Capacity (FVC). As a secondary objective, additional parameters will be assessed in order to differentiate between dose strategies on the basis of safety and efficacy
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Keywords
Versions (3)
- 3/5/24 3/5/24 - Dr. Christian Niklas
- 3/28/24 3/28/24 - Dr. Christian Niklas
- 3/28/24 3/28/24 - Dr. Christian Niklas
Copyright Holder
Boehringer Ingelheim
Uploaded on
March 5, 2024
DOI
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License
Creative Commons BY-NC-SA 4.0
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Safety And Efficacy of BIBF 1120 in Idiopathic Pulmonary Fibrosis
AE
- StudyEvent: CUM_AE
- StudyEvent: CUM_CT
- StudyEvent: TRT CHANGE
- StudyEvent: IVRS
- StudyEvent: VISIT 1
- StudyEvent: VISIT 2
- StudyEvent: VISIT 3
- StudyEvent: VISIT 4
- StudyEvent: VISIT 5
- StudyEvent: VISIT 6
- StudyEvent: VISIT 6A
- StudyEvent: VISIT 7
- StudyEvent: VISIT 7A
- StudyEvent: VISIT 8
- StudyEvent: VISIT 8A
- StudyEvent: VISIT 9
- StudyEvent: END TRT 1
- StudyEvent: VISIT 10
- StudyEvent: VISIT 11
- StudyEvent: VISIT 12
- StudyEvent: VISIT 12A
- StudyEvent: VISIT 13
- StudyEvent: VISIT 13A
- StudyEvent: VISIT 13B
- StudyEvent: VISIT 13C
- StudyEvent: VISIT 14
- StudyEvent: VISIT 14A
- StudyEvent: VISIT 14B
- StudyEvent: VISIT 14C
- StudyEvent: VISIT 15
- StudyEvent: VISIT 15A
- StudyEvent: VISIT 15B
- StudyEvent: VISIT 15C
- StudyEvent: VISIT 16
- StudyEvent: VISIT 16A
- StudyEvent: VISIT 16B
- StudyEvent: VISIT 16C
- StudyEvent: END TRT 2
- StudyEvent: EOT
- StudyEvent: FOLLOWUP
- StudyEvent: DISC V4
- StudyEvent: DISC V5
- StudyEvent: DISC V6
- StudyEvent: DISC V7
- StudyEvent: DISC V8
- StudyEvent: DISC V9
- StudyEvent: COMPLETION
Similar models
AE
- StudyEvent: CUM_AE
- StudyEvent: CUM_CT
- StudyEvent: TRT CHANGE
- StudyEvent: IVRS
- StudyEvent: VISIT 1
- StudyEvent: VISIT 2
- StudyEvent: VISIT 3
- StudyEvent: VISIT 4
- StudyEvent: VISIT 5
- StudyEvent: VISIT 6
- StudyEvent: VISIT 6A
- StudyEvent: VISIT 7
- StudyEvent: VISIT 7A
- StudyEvent: VISIT 8
- StudyEvent: VISIT 8A
- StudyEvent: VISIT 9
- StudyEvent: END TRT 1
- StudyEvent: VISIT 10
- StudyEvent: VISIT 11
- StudyEvent: VISIT 12
- StudyEvent: VISIT 12A
- StudyEvent: VISIT 13
- StudyEvent: VISIT 13A
- StudyEvent: VISIT 13B
- StudyEvent: VISIT 13C
- StudyEvent: VISIT 14
- StudyEvent: VISIT 14A
- StudyEvent: VISIT 14B
- StudyEvent: VISIT 14C
- StudyEvent: VISIT 15
- StudyEvent: VISIT 15A
- StudyEvent: VISIT 15B
- StudyEvent: VISIT 15C
- StudyEvent: VISIT 16
- StudyEvent: VISIT 16A
- StudyEvent: VISIT 16B
- StudyEvent: VISIT 16C
- StudyEvent: END TRT 2
- StudyEvent: EOT
- StudyEvent: FOLLOWUP
- StudyEvent: DISC V4
- StudyEvent: DISC V5
- StudyEvent: DISC V6
- StudyEvent: DISC V7
- StudyEvent: DISC V8
- StudyEvent: DISC V9
- StudyEvent: COMPLETION
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
LOCKED
Item
text
C3244297 (UMLS CUI [1, 1])
LAB
Item
text
C0022877 (UMLS CUI [1,1])
C0022877 (UMLS CUI [2,1])
C1514721 (UMLS CUI [2,2])
C1515021 (UMLS CUI [2,3])
C0022877 (UMLS CUI [2,1])
C1514721 (UMLS CUI [2,2])
C1515021 (UMLS CUI [2,3])
QUALVAL
Item
text
C1514624,C1522609 (UMLS CUI [1, 1])
HEADCMT
Item
text
C0947611 (UMLS CUI [1, 1])
INV
Item
text
C0035173 (UMLS CUI [1, 1])
SITE
Item
text
C0205145 (UMLS CUI [1, 1])
SUBVISIT
Item
text
C2983704 (UMLS CUI [1,1])
C0441471 (UMLS CUI [1,2])
C0441471 (UMLS CUI [1,2])
VISIT
Item
text
C0205210 C0441471 C1301732 (UMLS CUI [1, 1])
BLANK
Item
text
C1708067 (UMLS CUI [1, 1])
DCMDATE
Item
date
C1302413 (UMLS CUI [1, 1])
DOCNUM
Item
text
C2986015 (UMLS CUI [1, 1])
PATIENT
Item
text
C0030705 (UMLS CUI [1, 1])
CL Item
(0)
C1298908 (UMLS CUI [1,1])
CL Item
(1)
C1705108 (UMLS CUI [1,1])
AEMNM
Item
text
C0441471 (UMLS CUI [1, 1])
AEONYMD
Item
date
C0808070,C0877248 (UMLS CUI [1, 1])
CL Item
(C)
C0439598 (UMLS CUI [1,1])
AEENDYMD
Item
date
C0806020,C0877248 (UMLS CUI [1, 1])
CL Item
(1)
C1513302 (UMLS CUI [1,1])
CL Item
(2)
C1513374 (UMLS CUI [1,1])
CL Item
(3)
C1519275 (UMLS CUI [1,1])
CL Item
(0)
C1298908 (UMLS CUI [1,1])
CL Item
(1)
C1705108 (UMLS CUI [1,1])
CL Item
(1)
C1709863 (UMLS CUI [1,1])
CL Item
(2)
C1709277 (UMLS CUI [1,1])
CL Item
(3)
C1709862 (UMLS CUI [1,1])
CL Item
(4)
C1302234 (UMLS CUI [1,1])
CL Item
(5)
C0439673 (UMLS CUI [1,1])
CL Item
(0)
C1298908 (UMLS CUI [1,1])
CL Item
(1)
C1705108 (UMLS CUI [1,1])
CL Item
(3)
C1298908 (UMLS CUI [1,1])
C0750502 (UMLS CUI [1,2])
C0750502 (UMLS CUI [1,2])
CL Item
(1)
CL Item
(2)
CL Item
(3)
CL Item
(4)
CL Item
(5)
CL Item
(6)
CL Item
(7)
CL Item
(1)
CL Item
(2)
CL Item
(3)
CL Item
(4)
CL Item
(5)
CL Item
(6)
CL Item
(7)
CL Item
(1)
CL Item
(2)
CL Item
(3)
CL Item
(4)
CL Item
(5)
CL Item
(6)
CL Item
(7)
CL Item
(1)
CL Item
(2)
CL Item
(3)
CL Item
(4)
CL Item
(5)
CL Item
(6)
CL Item
(7)
CL Item
(0)
C1298908 (UMLS CUI [1,1])
CL Item
(1)
C1705108 (UMLS CUI [1,1])
CL Item
(0)
C1298908 (UMLS CUI [1,1])
CL Item
(1)
C1705108 (UMLS CUI [1,1])
CL Item
(1)
CL Item
(2)
ENTRYDT1
Item
date
C1978797 (UMLS CUI [1,1])
ENTRYDT2
Item
date
C1978797 (UMLS CUI [1, 1])
AEX
Item
text
C0947611 (UMLS CUI [1, 1])
AEONDT
Item
date
C2985916 (UMLS CUI [1,1])
AEONIMP
Item
integer
C2985916,C2699638 (UMLS CUI [1, 1])
AEENDDT
Item
date
C2697886 (UMLS CUI [1,1])
AEENDIMP
Item
integer
C2697886,C2699638 (UMLS CUI [1, 1])
AEENDCEN
Item
integer
C2697886 (UMLS CUI [1, 1])
CL Item
(1)
CL Item
(2)
CL Item
(3)
CL Item
(4)
CL Item
(5)
CL Item
(6)
CL Item
(7)
CL Item
(8)
CL Item
(9)
CL Item
(10)
CL Item
(15)
CL Item
(16)
CL Item
(17)
CL Item
(19)
CL Item
(1)
C2986497 (UMLS CUI [1,1])
CL Item
(2)
C2986497 (UMLS CUI [1,1])
CL Item
(3)
C2985822 (UMLS CUI [1,1])
CL Item
(4)
C2985822 (UMLS CUI [1,1])
AECMSIG
Item
integer
C1521743,C0877248 (UMLS CUI [1, 1])
AELLT
Item
text
C3900085 (UMLS CUI [1, 1])
AELLTCD
Item
text
C3897027 (UMLS CUI [1, 1])
CL Item
(1)
CL Item
(2)
CL Item
(3)
CL Item
(4)
CL Item
(5)
CL Item
(6)
CL Item
(7)
AEOX
Item
text
C0877248 (UMLS CUI [1,1])
AEOTHSIG
Item
integer
C0205394,C0750502,C0877248 (UMLS CUI [1, 1])
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