ID
33547
Description
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
Keywords
Versions (1)
- 12/12/18 12/12/18 -
Copyright Holder
GlaxoSmithKline
Uploaded on
December 12, 2018
DOI
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License
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
Description
Serious Adverse Events, Section 1
Alias
- UMLS CUI-1
- C1519255
Description
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
Data type
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0347984
- UMLS CUI [1,3]
- C2347804
Description
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.
Data type
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0011900
Description
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.
Data type
date
Alias
- UMLS CUI [1,1]
- C0574845
- UMLS CUI [1,2]
- C1519255
Description
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.
Data type
time
Alias
- UMLS CUI [1,1]
- C0449244
- UMLS CUI [1,2]
- C1519255
Description
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.
Data type
integer
Alias
- UMLS CUI [1]
- C1705586
Description
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'.
Data type
date
Alias
- UMLS CUI [1,1]
- C0806020
- UMLS CUI [1,2]
- C1519255
Description
00:00-23:59. Record the end time of the SAE.
Data type
time
Alias
- UMLS CUI [1,1]
- C1522314
- UMLS CUI [1,2]
- C1519255
Description
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).
Data type
text
Alias
- UMLS CUI [1]
- C1710066
Description
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).
Data type
text
Alias
- UMLS CUI [1,1]
- C1704758
- UMLS CUI [1,2]
- C1519255
Description
Indicate ' Yes' if the event(s) were directly responsible for the subject's withdrawal as indicated on the Study Conclusion page, otherwise indicate 'No'.
Data type
text
Alias
- UMLS CUI [1,1]
- C2349954
- UMLS CUI [1,2]
- C1519255
Description
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.
Data type
text
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0085978
- UMLS CUI [1,3]
- C1519255
Description
If yes, summarise findings in Section 11 Narrative Remarks of thes SAE form.
Data type
text
Alias
- UMLS CUI [1,1]
- C0004398
- UMLS CUI [1,2]
- C1519255
Description
Section 2 Seriousness
Alias
- UMLS CUI-1
- C1710056
Description
Results in death
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0011065
- UMLS CUI [1,2]
- C1519255
Description
Life-threatening
Data type
boolean
Alias
- UMLS CUI [1]
- C1517874
Description
Hospitalization/ prolongation of existing hospitalization
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0019993
- UMLS CUI [1,2]
- C1519255
- UMLS CUI [2,1]
- C0745041
- UMLS CUI [2,2]
- C1519255
Description
Results in disability/incapacity
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0231170
Description
Congenital anomaly/birth defect
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0000768
- UMLS CUI [1,2]
- C1519255
Description
Other seriousness
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1710056
- UMLS CUI [1,2]
- C0205394
Description
Other seriousness, specification
Data type
text
Alias
- UMLS CUI [1,1]
- C1710056
- UMLS CUI [1,2]
- C0205394
Description
Section 3 Demography Data
Alias
- UMLS CUI-1
- C0011298
Description
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
Description
Recurrence of Adverse event after further investigational product
Data type
text
Alias
- UMLS CUI [1,1]
- C0034897
- UMLS CUI [1,2]
- C0877248
- UMLS CUI [1,3]
- C1517331
- UMLS CUI [1,4]
- C0304229
Description
SECTION 5 Possible Causes of SAE other than Investigational Product(s)
Alias
- UMLS CUI-1
- C0015127
- UMLS CUI-2
- C1519255
Description
Disease
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C1519255
- UMLS CUI [1,3]
- C0347984
- UMLS CUI [1,4]
- C0008976
Description
Medical condition(s)
Data type
boolean
Alias
- UMLS CUI [1]
- C0012634
Description
Medical condition(s), specification
Data type
text
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C0348080
Description
Lack of efficacy
Data type
boolean
Alias
- UMLS CUI [1]
- C0235828
Description
Withdrawal of investigational product(s)
Data type
boolean
Alias
- UMLS CUI [1,1]
- C2349954
- UMLS CUI [1,2]
- C0304229
- UMLS CUI [1,3]
- C1519255
Description
Concomitant medication
Data type
boolean
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C1519255
Description
Concomitant medication, specify
Data type
text
Alias
- UMLS CUI [1]
- C2347852
Description
(e.g., procedures)
Data type
boolean
Alias
- UMLS CUI [1]
- C2348568
Description
Other causation
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0205394
- UMLS CUI [1,2]
- C0015127
- UMLS CUI [1,3]
- C1519255
Description
Other, specify
Data type
text
Alias
- UMLS CUI [1,1]
- C0205394
- UMLS CUI [1,2]
- C0015127
Description
Section 6 Relevant Medical Conditions
Alias
- UMLS CUI-1
- C0012634
- UMLS CUI-2
- C0262926
Description
Past or current medical disorders, allergies, surgeries
Data type
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
Description
day month year
Data type
date
Alias
- UMLS CUI [1]
- C0574845
Description
Condition present at time of SAE
Data type
text
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C0150312
- UMLS CUI [1,3]
- C1519255
Description
day month year
Data type
date
Alias
- UMLS CUI [1,1]
- C2745955
- UMLS CUI [1,2]
- C0012634
- UMLS CUI [1,3]
- C0011008
- UMLS CUI [1,4]
- C1519255
Description
SECTION 7 Other Relevant Risk Factors
Alias
- UMLS CUI-1
- C0205394
- UMLS CUI-2
- C0035648
- UMLS CUI-3
- C1519255
Description
SECTION 8 Relevant Concomitant Medications
Alias
- UMLS CUI-1
- C2347852
Description
(Trade name preferred)
Data type
text
Alias
- UMLS CUI [1]
- C0013227
Description
Drug Dose
Data type
integer
Alias
- UMLS CUI [1]
- C0678766
Description
Dose unit
Data type
text
Alias
- UMLS CUI [1]
- C0869039
Description
Frequency
Data type
text
Alias
- UMLS CUI [1]
- C3476109
Description
Route
Data type
text
Alias
- UMLS CUI [1]
- C0013153
Description
Started pre-study
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0808070
- UMLS CUI [1,2]
- C0332152
- UMLS CUI [1,3]
- C2347804
Description
day month year
Data type
date
Alias
- UMLS CUI [1]
- C0808070
Description
day month year
Data type
date
Alias
- UMLS CUI [1]
- C0806020
Description
Ongoing medication
Data type
text
Alias
- UMLS CUI [1]
- C2826666
Description
Reason for medication
Data type
text
Alias
- UMLS CUI [1]
- C2826696
Description
SECTION 9 Details of Investigational Product(s)
Alias
- UMLS CUI-1
- C0013230
- UMLS CUI-2
- C1522508
Description
SECTION 10 Details of Relevant Assessments
Alias
- UMLS CUI-1
- C1261322
- UMLS CUI-2
- C1519255
Description
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
Data type
text
Alias
- UMLS CUI [1,1]
- C1522508
- UMLS CUI [1,2]
- C0220825
Description
SECTION 11 Narrative Remarks
Alias
- UMLS CUI-1
- C0947611
- UMLS CUI-2
- C1519255
Description
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.
Data type
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0678257
Description
Confirm that the data on the SAE pages are accurate and complete.
Data type
text
Alias
- UMLS CUI [1]
- C2826892
Description
Invetigator Signature
Data type
text
Alias
- UMLS CUI [1]
- C2346576
Description
day month year
Data type
date
Alias
- UMLS CUI [1]
- C0011008
Description
Section 12 Additional/Follow-up information
Alias
- UMLS CUI-1
- C1524062
- UMLS CUI-2
- C1533716
- UMLS CUI-3
- C1519255
- UMLS CUI-4
- C1522577
Description
use this itemg to provide any additional details on the SAE not already captured on the previous items
Data type
text
Alias
- UMLS CUI [1,1]
- C1524062
- UMLS CUI [1,2]
- C1533716
- UMLS CUI [1,3]
- C1519255
- UMLS CUI [1,4]
- C1522577
Description
Invetigator Signature
Data type
text
Alias
- UMLS CUI [1]
- C2346576
Description
Reporting investigator - Name
Data type
text
Alias
- UMLS CUI [1]
- C2826892
Description
day month year
Data type
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])