ID
33547
Beschreibung
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
Stichworte
Versionen (1)
- 12.12.18 12.12.18 -
Rechteinhaber
GlaxoSmithKline
Hochgeladen am
12. Dezember 2018
DOI
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Lizenz
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
Beschreibung
Serious Adverse Events, Section 1
Alias
- UMLS CUI-1
- C1519255
Beschreibung
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
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0347984
- UMLS CUI [1,3]
- C2347804
Beschreibung
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.
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0011900
Beschreibung
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.
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0574845
- UMLS CUI [1,2]
- C1519255
Beschreibung
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.
Datentyp
time
Alias
- UMLS CUI [1,1]
- C0449244
- UMLS CUI [1,2]
- C1519255
Beschreibung
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.
Datentyp
integer
Alias
- UMLS CUI [1]
- C1705586
Beschreibung
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'.
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0806020
- UMLS CUI [1,2]
- C1519255
Beschreibung
00:00-23:59. Record the end time of the SAE.
Datentyp
time
Alias
- UMLS CUI [1,1]
- C1522314
- UMLS CUI [1,2]
- C1519255
Beschreibung
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).
Datentyp
text
Alias
- UMLS CUI [1]
- C1710066
Beschreibung
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).
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1704758
- UMLS CUI [1,2]
- C1519255
Beschreibung
Indicate ' Yes' if the event(s) were directly responsible for the subject's withdrawal as indicated on the Study Conclusion page, otherwise indicate 'No'.
Datentyp
text
Alias
- UMLS CUI [1,1]
- C2349954
- UMLS CUI [1,2]
- C1519255
Beschreibung
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.
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0085978
- UMLS CUI [1,3]
- C1519255
Beschreibung
If yes, summarise findings in Section 11 Narrative Remarks of thes SAE form.
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0004398
- UMLS CUI [1,2]
- C1519255
Beschreibung
Section 2 Seriousness
Alias
- UMLS CUI-1
- C1710056
Beschreibung
Results in death
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0011065
- UMLS CUI [1,2]
- C1519255
Beschreibung
Life-threatening
Datentyp
boolean
Alias
- UMLS CUI [1]
- C1517874
Beschreibung
Hospitalization/ prolongation of existing hospitalization
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0019993
- UMLS CUI [1,2]
- C1519255
- UMLS CUI [2,1]
- C0745041
- UMLS CUI [2,2]
- C1519255
Beschreibung
Results in disability/incapacity
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0231170
Beschreibung
Congenital anomaly/birth defect
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0000768
- UMLS CUI [1,2]
- C1519255
Beschreibung
Other seriousness
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C1710056
- UMLS CUI [1,2]
- C0205394
Beschreibung
Other seriousness, specification
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1710056
- UMLS CUI [1,2]
- C0205394
Beschreibung
Section 3 Demography Data
Alias
- UMLS CUI-1
- C0011298
Beschreibung
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
Beschreibung
Recurrence of Adverse event after further investigational product
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0034897
- UMLS CUI [1,2]
- C0877248
- UMLS CUI [1,3]
- C1517331
- UMLS CUI [1,4]
- C0304229
Beschreibung
SECTION 5 Possible Causes of SAE other than Investigational Product(s)
Alias
- UMLS CUI-1
- C0015127
- UMLS CUI-2
- C1519255
Beschreibung
Disease
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C1519255
- UMLS CUI [1,3]
- C0347984
- UMLS CUI [1,4]
- C0008976
Beschreibung
Medical condition(s)
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0012634
Beschreibung
Medical condition(s), specification
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C0348080
Beschreibung
Lack of efficacy
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0235828
Beschreibung
Withdrawal of investigational product(s)
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C2349954
- UMLS CUI [1,2]
- C0304229
- UMLS CUI [1,3]
- C1519255
Beschreibung
Concomitant medication
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C1519255
Beschreibung
Concomitant medication, specify
Datentyp
text
Alias
- UMLS CUI [1]
- C2347852
Beschreibung
(e.g., procedures)
Datentyp
boolean
Alias
- UMLS CUI [1]
- C2348568
Beschreibung
Other causation
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0205394
- UMLS CUI [1,2]
- C0015127
- UMLS CUI [1,3]
- C1519255
Beschreibung
Other, specify
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0205394
- UMLS CUI [1,2]
- C0015127
Beschreibung
Section 6 Relevant Medical Conditions
Alias
- UMLS CUI-1
- C0012634
- UMLS CUI-2
- C0262926
Beschreibung
Past or current medical disorders, allergies, surgeries
Datentyp
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
Beschreibung
day month year
Datentyp
date
Alias
- UMLS CUI [1]
- C0574845
Beschreibung
Condition present at time of SAE
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C0150312
- UMLS CUI [1,3]
- C1519255
Beschreibung
day month year
Datentyp
date
Alias
- UMLS CUI [1,1]
- C2745955
- UMLS CUI [1,2]
- C0012634
- UMLS CUI [1,3]
- C0011008
- UMLS CUI [1,4]
- C1519255
Beschreibung
SECTION 7 Other Relevant Risk Factors
Alias
- UMLS CUI-1
- C0205394
- UMLS CUI-2
- C0035648
- UMLS CUI-3
- C1519255
Beschreibung
SECTION 8 Relevant Concomitant Medications
Alias
- UMLS CUI-1
- C2347852
Beschreibung
(Trade name preferred)
Datentyp
text
Alias
- UMLS CUI [1]
- C0013227
Beschreibung
Drug Dose
Datentyp
integer
Alias
- UMLS CUI [1]
- C0678766
Beschreibung
Dose unit
Datentyp
text
Alias
- UMLS CUI [1]
- C0869039
Beschreibung
Frequency
Datentyp
text
Alias
- UMLS CUI [1]
- C3476109
Beschreibung
Route
Datentyp
text
Alias
- UMLS CUI [1]
- C0013153
Beschreibung
Started pre-study
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0808070
- UMLS CUI [1,2]
- C0332152
- UMLS CUI [1,3]
- C2347804
Beschreibung
day month year
Datentyp
date
Alias
- UMLS CUI [1]
- C0808070
Beschreibung
day month year
Datentyp
date
Alias
- UMLS CUI [1]
- C0806020
Beschreibung
Ongoing medication
Datentyp
text
Alias
- UMLS CUI [1]
- C2826666
Beschreibung
Reason for medication
Datentyp
text
Alias
- UMLS CUI [1]
- C2826696
Beschreibung
SECTION 9 Details of Investigational Product(s)
Alias
- UMLS CUI-1
- C0013230
- UMLS CUI-2
- C1522508
Beschreibung
SECTION 10 Details of Relevant Assessments
Alias
- UMLS CUI-1
- C1261322
- UMLS CUI-2
- C1519255
Beschreibung
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
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1522508
- UMLS CUI [1,2]
- C0220825
Beschreibung
SECTION 11 Narrative Remarks
Alias
- UMLS CUI-1
- C0947611
- UMLS CUI-2
- C1519255
Beschreibung
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.
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0678257
Beschreibung
Confirm that the data on the SAE pages are accurate and complete.
Datentyp
text
Alias
- UMLS CUI [1]
- C2826892
Beschreibung
Invetigator Signature
Datentyp
text
Alias
- UMLS CUI [1]
- C2346576
Beschreibung
day month year
Datentyp
date
Alias
- UMLS CUI [1]
- C0011008
Beschreibung
Section 12 Additional/Follow-up information
Alias
- UMLS CUI-1
- C1524062
- UMLS CUI-2
- C1533716
- UMLS CUI-3
- C1519255
- UMLS CUI-4
- C1522577
Beschreibung
use this itemg to provide any additional details on the SAE not already captured on the previous items
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1524062
- UMLS CUI [1,2]
- C1533716
- UMLS CUI [1,3]
- C1519255
- UMLS CUI [1,4]
- C1522577
Beschreibung
Invetigator Signature
Datentyp
text
Alias
- UMLS CUI [1]
- C2346576
Beschreibung
Reporting investigator - Name
Datentyp
text
Alias
- UMLS CUI [1]
- C2826892
Beschreibung
day month year
Datentyp
date
Alias
- UMLS CUI [1]
- C0011008
Ähnliche Modelle
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])