ID
33547
Descripción
Study ID: 107806 Clinical Study ID: RA3107806 Study Title: An open label study to determine the safety, tolerability, excretion balance and pharmacokinetics of Losmapimod, administered as a single dose of an oral solution to healthy adult male subjects Patient Level Data: Clinicaltrials.gov Identifier: NCT00599612 https://clinicaltrials.gov/ct2/show/NCT00599612 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: losmapimod Trade Name: losmapimod Study Indication: Pulmonary Disease, Chronic Obstructive The study consists of a screening, study visit and follow-up. The protocol identifier for all: RA3107806 This document contains the form of SAE. It has to be filled in if the subject has experienced an SAE.
Link
https://clinicaltrials.gov/ct2/show/NCT00599612
Palabras clave
Versiones (1)
- 12/12/18 12/12/18 -
Titular de derechos de autor
GlaxoSmithKline
Subido en
12 de diciembre de 2018
DOI
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Licencia
Creative Commons BY-NC 3.0
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Safety, tolerability, excretion balance and pharmacokinetics of Losmapimod in healthy males, NCT00599612
Serious Adverse Event (SAE)
- StudyEvent: ODM
Descripción
Serious Adverse Events, Section 1
Alias
- UMLS CUI-1
- C1519255
Descripción
If YES, record following items. A serious adverse event is any untoward medical occurrence that, at any dose: a) results in death b) is life-threatening c) requires hospitalization or prolongation of existing hospitalization d) results in disability/incapacity e) a congenital anomaly/birth defect f) other
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0347984
- UMLS CUI [1,3]
- C2347804
Descripción
Diagnosis only (if known) OR Serious signs / symptoms (list one per line). Record one SAE diagnosis per line, or a sign/symptom if the diagnosis is not available. lf a diagnosis subsequently becomes available, this then should be entered and the sign/symptom crossed out, initialled and dated by the investigator. A separate form should be used for each SAE. However, if multiple SAEs which are temporally or c inically related are apparent at the time of initial reporting then these may be reported on the same page. If this was recorded previously as a non-serious event but has progressed to serious, put a line through the Non-Serious AE record and transcribe the details onto the SAE form.
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0011900
Descripción
day month year. Record the date of onset of the first occurrence of the event or signs/symptoms of the serious event, not the date the event became serious.
Tipo de datos
date
Alias
- UMLS CUI [1,1]
- C0574845
- UMLS CUI [1,2]
- C1519255
Descripción
00:00-23:59. Record the time of onset of the first occurrence of the event or signs/symptoms of the serious event, not the time the event became serious.
Tipo de datos
time
Alias
- UMLS CUI [1,1]
- C0449244
- UMLS CUI [1,2]
- C1519255
Descripción
All SAEs must be followed until the events are resolved, the condition stabilizes, the events are otherwise explained, or the subject is lost to follow-up. Indicate if the event was "Recovered/Resolved", "Recovered/Resolved with sequelae". If the SAE is ongoing at the time the subject completes the study or becomes lost to follow-up, the outcome must be recorded as "Not recovered/not resolved" or "Recovering/Resolving". Also enter "Not recovered/not resolved" if the SAE was ongoing at the time of death, but was not the cause of death, enter fatal for the SAE which was the direct cause of death.
Tipo de datos
integer
Alias
- UMLS CUI [1]
- C1705586
Descripción
day month year. Record the end date. This is the date the SAE Recovered/Resolved, or if the outcome was fatal, record the date the subject died. If the event Recovered/Resolved with sequelae, enter the date the subject's medical condition resolved or stabilised. Leave blank if the SAE is 'Not recovered/Not resolved' or 'Recovering/Resolving'.
Tipo de datos
date
Alias
- UMLS CUI [1,1]
- C0806020
- UMLS CUI [1,2]
- C1519255
Descripción
00:00-23:59. Record the end time of the SAE.
Tipo de datos
time
Alias
- UMLS CUI [1,1]
- C1522314
- UMLS CUI [1,2]
- C1519255
Descripción
Record the maximum intensity that occurred over the duration of the SAE. Amend the intensity if it increases. Mild = An event that is easily tolerated by the subject, causing minimal discomfort and not interfering with everyday activities. Moderate = An event that is sufficientlydiscomforitng to interfere with everyday activities. Severe = An event that prevents normal everyday activities. Not applicable = Those event(s) where intensity is meaningless or impossible to determine (i.e., blindness and coma).
Tipo de datos
text
Alias
- UMLS CUI [1]
- C1710066
Descripción
lnvestigationalproduct(s) withdrawn = Admin istration of investigational product(s) was permanently discontinued. Dose reduced = Dose is reduced for one or more investigational product(s). Dose increased = Dose increased for one or more investigational product(s). Dose not changed = lnvestigational product(s) continues even though an adverse event has occurred. Dose interrupted = Administration of one or more investigational product(s) was temporarily interrupted but then restarted. Not applicable = Subject was not receiving nvestigational product(s) when the event occurred (e.g., pre-or post-dosing) or the subject died and there was no prior decision to discontinue IP(s).
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C1704758
- UMLS CUI [1,2]
- C1519255
Descripción
Indicate ' Yes' if the event(s) were directly responsible for the subject's withdrawal as indicated on the Study Conclusion page, otherwise indicate 'No'.
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C2349954
- UMLS CUI [1,2]
- C1519255
Descripción
It is a regulatory requirement for investigators to assess relationship to investigational product(s) based on information available. The assessment should be reviewed on receipt of any new information and amended if necessary. "A reasonable possibility" is meant to convey that there are facts/evidence or arguments to suggest a causal relationship. Facts/evidence/arguments that may support "A reasonable possibility'' include, for example, a temporal relationship, a pharmacologically-predicted event, or positive dechallenge or rechallenge. Confounding factors, such as concomitant medication, a concomitant illness, or relevant medical history, should also be considered.
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0085978
- UMLS CUI [1,3]
- C1519255
Descripción
If yes, summarise findings in Section 11 Narrative Remarks of thes SAE form.
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0004398
- UMLS CUI [1,2]
- C1519255
Descripción
Section 2 Seriousness
Alias
- UMLS CUI-1
- C1710056
Descripción
Results in death
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0011065
- UMLS CUI [1,2]
- C1519255
Descripción
Life-threatening
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C1517874
Descripción
Hospitalization/ prolongation of existing hospitalization
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0019993
- UMLS CUI [1,2]
- C1519255
- UMLS CUI [2,1]
- C0745041
- UMLS CUI [2,2]
- C1519255
Descripción
Results in disability/incapacity
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0231170
Descripción
Congenital anomaly/birth defect
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0000768
- UMLS CUI [1,2]
- C1519255
Descripción
Other seriousness
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C1710056
- UMLS CUI [1,2]
- C0205394
Descripción
Other seriousness, specification
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C1710056
- UMLS CUI [1,2]
- C0205394
Descripción
Section 3 Demography Data
Alias
- UMLS CUI-1
- C0011298
Descripción
Section 4 Recurrence of Adverse event after further investigational product
Alias
- UMLS CUI-1
- C0034897
- UMLS CUI-2
- C0877248
- UMLS CUI-3
- C1517331
- UMLS CUI-4
- C0304229
Descripción
Recurrence of Adverse event after further investigational product
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0034897
- UMLS CUI [1,2]
- C0877248
- UMLS CUI [1,3]
- C1517331
- UMLS CUI [1,4]
- C0304229
Descripción
SECTION 5 Possible Causes of SAE other than Investigational Product(s)
Alias
- UMLS CUI-1
- C0015127
- UMLS CUI-2
- C1519255
Descripción
Disease
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C1519255
- UMLS CUI [1,3]
- C0347984
- UMLS CUI [1,4]
- C0008976
Descripción
Medical condition(s)
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C0012634
Descripción
Medical condition(s), specification
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C0348080
Descripción
Lack of efficacy
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C0235828
Descripción
Withdrawal of investigational product(s)
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C2349954
- UMLS CUI [1,2]
- C0304229
- UMLS CUI [1,3]
- C1519255
Descripción
Concomitant medication
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C1519255
Descripción
Concomitant medication, specify
Tipo de datos
text
Alias
- UMLS CUI [1]
- C2347852
Descripción
(e.g., procedures)
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C2348568
Descripción
Other causation
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0205394
- UMLS CUI [1,2]
- C0015127
- UMLS CUI [1,3]
- C1519255
Descripción
Other, specify
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0205394
- UMLS CUI [1,2]
- C0015127
Descripción
Section 6 Relevant Medical Conditions
Alias
- UMLS CUI-1
- C0012634
- UMLS CUI-2
- C0262926
Descripción
Past or current medical disorders, allergies, surgeries
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C1444637
- UMLS CUI [1,2]
- C0012634
- UMLS CUI [2,1]
- C0521116
- UMLS CUI [2,2]
- C0012634
- UMLS CUI [3]
- C0020517
- UMLS CUI [4]
- C0543467
Descripción
day month year
Tipo de datos
date
Alias
- UMLS CUI [1]
- C0574845
Descripción
Condition present at time of SAE
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C0150312
- UMLS CUI [1,3]
- C1519255
Descripción
day month year
Tipo de datos
date
Alias
- UMLS CUI [1,1]
- C2745955
- UMLS CUI [1,2]
- C0012634
- UMLS CUI [1,3]
- C0011008
- UMLS CUI [1,4]
- C1519255
Descripción
SECTION 7 Other Relevant Risk Factors
Alias
- UMLS CUI-1
- C0205394
- UMLS CUI-2
- C0035648
- UMLS CUI-3
- C1519255
Descripción
SECTION 8 Relevant Concomitant Medications
Alias
- UMLS CUI-1
- C2347852
Descripción
(Trade name preferred)
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0013227
Descripción
Drug Dose
Tipo de datos
integer
Alias
- UMLS CUI [1]
- C0678766
Descripción
Dose unit
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0869039
Descripción
Frequency
Tipo de datos
text
Alias
- UMLS CUI [1]
- C3476109
Descripción
Route
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0013153
Descripción
Started pre-study
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0808070
- UMLS CUI [1,2]
- C0332152
- UMLS CUI [1,3]
- C2347804
Descripción
day month year
Tipo de datos
date
Alias
- UMLS CUI [1]
- C0808070
Descripción
day month year
Tipo de datos
date
Alias
- UMLS CUI [1]
- C0806020
Descripción
Ongoing medication
Tipo de datos
text
Alias
- UMLS CUI [1]
- C2826666
Descripción
Reason for medication
Tipo de datos
text
Alias
- UMLS CUI [1]
- C2826696
Descripción
SECTION 9 Details of Investigational Product(s)
Alias
- UMLS CUI-1
- C0013230
- UMLS CUI-2
- C1522508
Descripción
SECTION 10 Details of Relevant Assessments
Alias
- UMLS CUI-1
- C1261322
- UMLS CUI-2
- C1519255
Descripción
Provide details of any other assessments or supplementary investigations/examinations that were conducted as part of the subject’s care and/or based on clinical judgment of the likely causative factors of the SAE. This may include, but not be limited to: • Laboratory data. Always provide the reference range and baseline values (fax or mail pages if extensive supporting data) • Findings of ECGs, X-rays, etc. • Results of other diagnostic tests or assays • Key findings from hospital discharge or pathology reports
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C1522508
- UMLS CUI [1,2]
- C0220825
Descripción
SECTION 11 Narrative Remarks
Alias
- UMLS CUI-1
- C0947611
- UMLS CUI-2
- C1519255
Descripción
This should include but not be limited to the following: • Any previous occurrences of this type of event • Any relevant non-serious adverse events that occurred prior to the SAE • The full clinical presentation and sequelae/evolution of the SAE • Any associated signs and symptoms of the SAE • Explain any possible causes of the SAE • Treatment for the SAE (including any specific medications administered or non-drug treatment) • Any other action taken for the management of the SAE or the subject • Duration and outcome of the SAE • If the SAE is associated with an overdose of investigational product(s), details of the amount of overdose and whether it was intentional or accidental.
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0678257
Descripción
Confirm that the data on the SAE pages are accurate and complete.
Tipo de datos
text
Alias
- UMLS CUI [1]
- C2826892
Descripción
Invetigator Signature
Tipo de datos
text
Alias
- UMLS CUI [1]
- C2346576
Descripción
day month year
Tipo de datos
date
Alias
- UMLS CUI [1]
- C0011008
Descripción
Section 12 Additional/Follow-up information
Alias
- UMLS CUI-1
- C1524062
- UMLS CUI-2
- C1533716
- UMLS CUI-3
- C1519255
- UMLS CUI-4
- C1522577
Descripción
use this itemg to provide any additional details on the SAE not already captured on the previous items
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C1524062
- UMLS CUI [1,2]
- C1533716
- UMLS CUI [1,3]
- C1519255
- UMLS CUI [1,4]
- C1522577
Descripción
Invetigator Signature
Tipo de datos
text
Alias
- UMLS CUI [1]
- C2346576
Descripción
Reporting investigator - Name
Tipo de datos
text
Alias
- UMLS CUI [1]
- C2826892
Descripción
day month year
Tipo de datos
date
Alias
- UMLS CUI [1]
- C0011008
Similar models
Serious Adverse Event (SAE)
- StudyEvent: ODM
C0019994 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,2])
C0347984 (UMLS CUI [1,2])
C2347804 (UMLS CUI [1,3])
C0011900 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
C0085978 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
C1519255 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
C0745041 (UMLS CUI [2,1])
C1519255 (UMLS CUI [2,2])
C0231170 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,2])
C0877248 (UMLS CUI-2)
C1517331 (UMLS CUI-3)
C0304229 (UMLS CUI-4)
C0877248 (UMLS CUI [1,2])
C1517331 (UMLS CUI [1,3])
C0304229 (UMLS CUI [1,4])
C1519255 (UMLS CUI-2)
C1519255 (UMLS CUI [1,2])
C0347984 (UMLS CUI [1,3])
C0008976 (UMLS CUI [1,4])
C0348080 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
C1519255 (UMLS CUI [1,2])
C0015127 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
C0015127 (UMLS CUI [1,2])
C0262926 (UMLS CUI-2)
C0012634 (UMLS CUI [1,2])
C0521116 (UMLS CUI [2,1])
C0012634 (UMLS CUI [2,2])
C0020517 (UMLS CUI [3])
C0543467 (UMLS CUI [4])
C0150312 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
C0012634 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C1519255 (UMLS CUI [1,4])
C0035648 (UMLS CUI-2)
C1519255 (UMLS CUI-3)
C3714536 (UMLS CUI [1,2])
C0332152 (UMLS CUI [1,2])
C2347804 (UMLS CUI [1,3])
C1522508 (UMLS CUI-2)
C1522508 (UMLS CUI [1,2])
C1519255 (UMLS CUI-2)
C0220825 (UMLS CUI [1,2])
C1519255 (UMLS CUI-2)
C0678257 (UMLS CUI [1,2])
C1533716 (UMLS CUI-2)
C1519255 (UMLS CUI-3)
C1522577 (UMLS CUI-4)
C1533716 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
C1522577 (UMLS CUI [1,4])