Trial Outcomes & Findings for The Impact of Aspirin Dose Modification on the Innate Immune Response - Will Lower Dose Aspirin Therapy Reduce the Response to Endotoxin (NCT NCT03869268)
NCT ID: NCT03869268
Last Updated: 2025-09-11
Results Overview
plasma TNF-α at 2 hours post-injection of 2 ng/kg endotoxin compared between participants receiving no IMP, aspirin (Aspirin lysine) 20 mg BD, aspirin (Aspirin lysine) 75 mg OD and aspirin (Aspirin lysine) 300 mg OD.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
72 participants
Primary outcome timeframe
2 hours post endotoxin injection
Results posted on
2025-09-11
Participant Flow
Participant milestones
| Measure |
No Drug, no Drug Plus Loading Dose Ticagrelor 180 mg
Patients will be randomised to receive no drug for the first medication period (10 days).
Patient will then be allocated to receive no drug for the second medication period (10 days) and Ticagrelor will be allocated as a single loading dose of 180 mg (2 x 90 mg orodispersible tablets) on the second endotoxin visit.
|
No Drug Plus Loading Dose Ticagrelor 180mg, no Drug
Participants will be randomised to receive loading dose of ticagrelor 180 mg on the last day of the first medication period (10-14 days).
Participants will then be allocated to receive no aspirin and no ticagrelor loading dose for the second medication period (10-14 days).
|
Aspirin 20mg BD, Then Aspirin 20mg BD Plus Loading Dose Ticagrelor 180mg
Participants will be randomised to receive aspirin 20 mg twice daily for the first medication period (10 days).
Participants will then be allocated to receive aspirin 20 mg twice daily for the second medication period (10-14 days), plus a loading dose of ticagrelor 180 mg on the last day of the period.
|
Aspirin 20mg BD & Loading Dose Ticagrelor 180mg, Then Aspirin 20mg BD no Loading Dose
Participants will be randomised to receive aspirin 20 mg twice daily for the first medication period (10-14 days)plus a loading dose of ticagrelor 180 mg on the last day of the period.
Participants will then be allocated to receive aspirin 20 mg twice daily for the second medication period (10-14 days), with no loading dose on endotoxin challenge day.
|
Aspirin 75mg OD no Loading Dose of Ticagrelor, Then Aspirin 75mg & Loading Dose Ticagrelor 180mg
Participants will be randomised to receive aspirin 75 mg once daily for the first medication period (10-14 days).
Participants will then be allocated to receive aspirin 75 mg once daily for the second medication period (10-14 days), plus a loading dose of ticagrelor 180 mg on the last day of the period.
|
Aspirin 75mg OD & Loading Dose Ticagrelor 180mg, Then Aspirin 75mg, no Loading Dose of Ticagrelor
Participants will be randomised to receive aspirin 75 mg once daily for the first medication period (10-14 days),with a loading dose of ticagrelor 180 mg on the last day of the period.
Participants will then be allocated to receive aspirin 75 mg once daily for the second medication period (10-14 days), no loading dose of ticagrelor.
|
Aspirin 300mg OD, Then Aspirin 300mg OD Plus Loading Dose Ticagrelor 180mg
Participants will be randomised to receive aspirin 300 mg once daily for the first medication period (10 days).
Participants will then be allocated to receive aspirin 300 mg once daily for the second medication period (10-14 days), plus a loading dose of ticagrelor 180 mg on the last day of the period.
|
Aspirin 300mg & Ticagrelor 180mg Loading Dose, Then Aspirin 300mg OD no Loading Dose Ticagrelor
Participants will be randomised to receive aspirin 300 mg once daily for the first medication period (10-14 days) plus a loading dose of ticagrelor 180 mg on the last day of the period.
Participants will then be allocated to receive aspirin 300 mg once daily for the second medicaion period (10-14 days).
|
|---|---|---|---|---|---|---|---|---|
|
Intervention + Endotoxin
STARTED
|
9
|
9
|
9
|
9
|
9
|
9
|
9
|
9
|
|
Intervention + Endotoxin
COMPLETED
|
8
|
9
|
9
|
9
|
8
|
8
|
9
|
7
|
|
Intervention + Endotoxin
NOT COMPLETED
|
1
|
0
|
0
|
0
|
1
|
1
|
0
|
2
|
|
Intervention + Endotoxin (Post Washout)
STARTED
|
7
|
9
|
8
|
8
|
5
|
8
|
8
|
7
|
|
Intervention + Endotoxin (Post Washout)
COMPLETED
|
7
|
9
|
8
|
8
|
5
|
8
|
8
|
6
|
|
Intervention + Endotoxin (Post Washout)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The Impact of Aspirin Dose Modification on the Innate Immune Response - Will Lower Dose Aspirin Therapy Reduce the Response to Endotoxin
Baseline characteristics by cohort
| Measure |
No Drug, no Drug Plus Loading Dose Ticagrelor 180 mg
n=9 Participants
Patients will be randomised to receive no drug for the first medication period (10 days).
Patient will then be allocated to receive no drug for the second medication period (10 days) and Ticagrelor will be allocated as a single loading dose of 180 mg (2 x 90 mg orodispersible tablets) on the second endotoxin visit.
|
No Drug Plus Loading Dose Ticagrelor 180mg, no Drug
n=9 Participants
Participants will be randomised to receive loading dose of ticagrelor 180 mg on the last day of the first medication period (10-14 days).
Participants will then be allocated to receive no aspirin and no ticagrelor loading dose for the second medication period (10-14 days).
|
Aspirin 20mg BD, Then Aspirin 20mg BD Plus Loading Dose Ticagrelor 180mg
n=9 Participants
Participants will be randomised to receive aspirin 20 mg twice daily for the first medication period (10 days).
Participants will then be allocated to receive aspirin 20 mg twice daily for the second medication period (10-14 days), plus a loading dose of ticagrelor 180 mg on the last day of the period.
|
Aspirin 20mg BD & Loading Dose Ticagrelor 180mg, Then Aspirin 20mg BD no Loading Dose
n=9 Participants
Participants will be randomised to receive aspirin 20 mg twice daily for the first medication period (10-14 days)plus a loading dose of ticagrelor 180 mg on the last day of the period.
Participants will then be allocated to receive aspirin 20 mg twice daily for the second medication period (10-14 days), with no loading dose on endotoxin challenge day.
|
Aspirin 75mg OD no Loading Dose of Ticagrelor, Then Aspirin 75mg & Loading Dose Ticagrelor 180mg
n=9 Participants
Participants will be randomised to receive aspirin 75 mg once daily for the first medication period (10-14 days).
Participants will then be allocated to receive aspirin 75 mg once daily for the second medication period (10-14 days), plus a loading dose of ticagrelor 180 mg on the last day of the period.
|
Aspirin 75mg OD & Loading Dose Ticagrelor 180mg, Then Aspirin 75mg, no Loading Dose of Ticagrelor
n=9 Participants
Participants will be randomised to receive aspirin 75 mg once daily for the first medication period (10-14 days),with a loading dose of ticagrelor 180 mg on the last day of the period.
Participants will then be allocated to receive aspirin 75 mg once daily for the second medication period (10-14 days), no loading dose of ticagrelor.
|
Aspirin 300mg OD, Then Aspirin 300mg OD Plus Loading Dose Ticagrelor 180mg
n=9 Participants
Participants will be randomised to receive aspirin 300 mg once daily for the first medication period (10 days).
Participants will then be allocated to receive aspirin 300 mg once daily for the second medication period (10-14 days), plus a loading dose of ticagrelor 180 mg on the last day of the period.
|
Aspirin 300mg & Ticagrelor 180mg Loading Dose, Then Aspirin 300mg OD no Loading Dose Ticagrelor
n=9 Participants
Participants will be randomised to receive aspirin 300 mg once daily for the first medication period (10-14 days) plus a loading dose of ticagrelor 180 mg on the last day of the period.
Participants will then be allocated to receive aspirin 300 mg once daily for the second medicaion period (10-14 days).
|
Total
n=72 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
9 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
9 Participants
n=10 Participants
|
9 Participants
n=115 Participants
|
9 Participants
n=24 Participants
|
72 Participants
n=42 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
1 Participants
n=24 Participants
|
6 Participants
n=42 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
9 Participants
n=10 Participants
|
9 Participants
n=115 Participants
|
8 Participants
n=24 Participants
|
66 Participants
n=42 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
2 Participants
n=24 Participants
|
10 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
8 Participants
n=10 Participants
|
7 Participants
n=115 Participants
|
7 Participants
n=24 Participants
|
61 Participants
n=42 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
PRIMARY outcome
Timeframe: 2 hours post endotoxin injectionPopulation: all participants that completed one or both endotoxin challenge days
plasma TNF-α at 2 hours post-injection of 2 ng/kg endotoxin compared between participants receiving no IMP, aspirin (Aspirin lysine) 20 mg BD, aspirin (Aspirin lysine) 75 mg OD and aspirin (Aspirin lysine) 300 mg OD.
Outcome measures
| Measure |
No Drug
n=17 Participants
Patients will be randomised to receive no drug for the first medication period (10 days) and will not receive any drug on the endotoxin challenge day
|
No Drug Plus Loading Dose Ticagrelor 180mg
n=16 Participants
Participants will be randomised to receive loading dose of ticagrelor 180 mg on the last day of the first medication period (10-14 days).
|
Aspirin 20mg BD
n=17 Participants
Participants will be randomised to receive aspirin 20 mg twice daily for the first medication period (10 days) and will not receive study drugs on the endotoxin challenge day
|
Aspirin 20mg BD & Loading Dose Ticagrelor 180mg
n=17 Participants
Participants will be randomised to receive aspirin 20 mg twice daily for the first medication period (10-14 days)plus a loading dose of ticagrelor 180 mg on the last day of the period.
|
Aspirin 75mg OD no Loading Dose of Ticagrelor
n=16 Participants
Participants will be randomised to receive aspirin 75 mg once daily for the first medication period (10-14 days) and no study drug on endotoxin challenge day
|
Aspirin 75mg OD & Loading Dose Ticagrelor 180mg
n=14 Participants
Participants will be randomised to receive aspirin 75 mg once daily for the first medication period (10-14 days),with a loading dose of ticagrelor 180 mg on the last day of the period.
|
Aspirin 300mg OD
n=15 Participants
Participants will be randomised to receive aspirin 300 mg once daily for the first medication period (10 days) and no study drug on endotoxin challenge day
|
Aspirin 300mg & Ticagrelor 180mg Loading Dose
n=15 Participants
Participants will be randomised to receive aspirin 300 mg once daily for the first medication period (10-14 days) plus a loading dose of ticagrelor 180 mg on the last day of the period.
|
|---|---|---|---|---|---|---|---|---|
|
Assess Inflammatory Response to Intravenous Endotoxin
|
167.53 pg/ml
Standard Deviation 186.17
|
111.05 pg/ml
Standard Deviation 154.48
|
254.92 pg/ml
Standard Deviation 236.79
|
128.73 pg/ml
Standard Deviation 162.22
|
103.72 pg/ml
Standard Deviation 141.36
|
72.95 pg/ml
Standard Deviation 77.78
|
156.17 pg/ml
Standard Deviation 141.28
|
126.66 pg/ml
Standard Deviation 194.96
|
SECONDARY outcome
Timeframe: 0 to 6 hours after endotoxin administrationPopulation: all participants that completed one or both endotoxin challenge days.
Change in serum CRP from 0 to 6 hours after endotoxin administration
Outcome measures
| Measure |
No Drug
n=17 Participants
Patients will be randomised to receive no drug for the first medication period (10 days) and will not receive any drug on the endotoxin challenge day
|
No Drug Plus Loading Dose Ticagrelor 180mg
n=17 Participants
Participants will be randomised to receive loading dose of ticagrelor 180 mg on the last day of the first medication period (10-14 days).
|
Aspirin 20mg BD
n=18 Participants
Participants will be randomised to receive aspirin 20 mg twice daily for the first medication period (10 days) and will not receive study drugs on the endotoxin challenge day
|
Aspirin 20mg BD & Loading Dose Ticagrelor 180mg
n=17 Participants
Participants will be randomised to receive aspirin 20 mg twice daily for the first medication period (10-14 days)plus a loading dose of ticagrelor 180 mg on the last day of the period.
|
Aspirin 75mg OD no Loading Dose of Ticagrelor
n=16 Participants
Participants will be randomised to receive aspirin 75 mg once daily for the first medication period (10-14 days) and no study drug on endotoxin challenge day
|
Aspirin 75mg OD & Loading Dose Ticagrelor 180mg
n=16 Participants
Participants will be randomised to receive aspirin 75 mg once daily for the first medication period (10-14 days),with a loading dose of ticagrelor 180 mg on the last day of the period.
|
Aspirin 300mg OD
n=15 Participants
Participants will be randomised to receive aspirin 300 mg once daily for the first medication period (10 days) and no study drug on endotoxin challenge day
|
Aspirin 300mg & Ticagrelor 180mg Loading Dose
n=16 Participants
Participants will be randomised to receive aspirin 300 mg once daily for the first medication period (10-14 days) plus a loading dose of ticagrelor 180 mg on the last day of the period.
|
|---|---|---|---|---|---|---|---|---|
|
Serum CRP Changes
|
2.84 mg/L
Standard Deviation 1.54
|
3.00 mg/L
Standard Deviation 2.30
|
3.61 mg/L
Standard Deviation 2.48
|
3.11 mg/L
Standard Deviation 1.08
|
3.10 mg/L
Standard Deviation 1.40
|
2.52 mg/L
Standard Deviation 1.19
|
2.94 mg/L
Standard Deviation 2.01
|
2.60 mg/L
Standard Deviation 1.83
|
SECONDARY outcome
Timeframe: 0 to 6 hours after endotoxin administrationPopulation: Participants who completed one or both endotoxin challenge days
Leukocyte count, from 0 to 6 hours after endotoxin administration
Outcome measures
| Measure |
No Drug
n=16 Participants
Patients will be randomised to receive no drug for the first medication period (10 days) and will not receive any drug on the endotoxin challenge day
|
No Drug Plus Loading Dose Ticagrelor 180mg
n=17 Participants
Participants will be randomised to receive loading dose of ticagrelor 180 mg on the last day of the first medication period (10-14 days).
|
Aspirin 20mg BD
n=18 Participants
Participants will be randomised to receive aspirin 20 mg twice daily for the first medication period (10 days) and will not receive study drugs on the endotoxin challenge day
|
Aspirin 20mg BD & Loading Dose Ticagrelor 180mg
n=17 Participants
Participants will be randomised to receive aspirin 20 mg twice daily for the first medication period (10-14 days)plus a loading dose of ticagrelor 180 mg on the last day of the period.
|
Aspirin 75mg OD no Loading Dose of Ticagrelor
n=16 Participants
Participants will be randomised to receive aspirin 75 mg once daily for the first medication period (10-14 days) and no study drug on endotoxin challenge day
|
Aspirin 75mg OD & Loading Dose Ticagrelor 180mg
n=16 Participants
Participants will be randomised to receive aspirin 75 mg once daily for the first medication period (10-14 days),with a loading dose of ticagrelor 180 mg on the last day of the period.
|
Aspirin 300mg OD
n=15 Participants
Participants will be randomised to receive aspirin 300 mg once daily for the first medication period (10 days) and no study drug on endotoxin challenge day
|
Aspirin 300mg & Ticagrelor 180mg Loading Dose
n=16 Participants
Participants will be randomised to receive aspirin 300 mg once daily for the first medication period (10-14 days) plus a loading dose of ticagrelor 180 mg on the last day of the period.
|
|---|---|---|---|---|---|---|---|---|
|
Leukocyte Count
|
9.28 10^9 cells per liter
Standard Deviation 2.46
|
9.32 10^9 cells per liter
Standard Deviation 3.38
|
10.77 10^9 cells per liter
Standard Deviation 3.63
|
11.77 10^9 cells per liter
Standard Deviation 2.12
|
11.09 10^9 cells per liter
Standard Deviation 2.98
|
9.99 10^9 cells per liter
Standard Deviation 4.42
|
9.45 10^9 cells per liter
Standard Deviation 3.83
|
8.91 10^9 cells per liter
Standard Deviation 3.30
|
SECONDARY outcome
Timeframe: 0 to 6 hours after endotoxin administrationPopulation: all participants who completed one or both endotoxin challenge days
Serum TXB2 from 0 to 6 hours after endotoxin administration
Outcome measures
| Measure |
No Drug
n=16 Participants
Patients will be randomised to receive no drug for the first medication period (10 days) and will not receive any drug on the endotoxin challenge day
|
No Drug Plus Loading Dose Ticagrelor 180mg
n=15 Participants
Participants will be randomised to receive loading dose of ticagrelor 180 mg on the last day of the first medication period (10-14 days).
|
Aspirin 20mg BD
n=17 Participants
Participants will be randomised to receive aspirin 20 mg twice daily for the first medication period (10 days) and will not receive study drugs on the endotoxin challenge day
|
Aspirin 20mg BD & Loading Dose Ticagrelor 180mg
n=17 Participants
Participants will be randomised to receive aspirin 20 mg twice daily for the first medication period (10-14 days)plus a loading dose of ticagrelor 180 mg on the last day of the period.
|
Aspirin 75mg OD no Loading Dose of Ticagrelor
n=17 Participants
Participants will be randomised to receive aspirin 75 mg once daily for the first medication period (10-14 days) and no study drug on endotoxin challenge day
|
Aspirin 75mg OD & Loading Dose Ticagrelor 180mg
n=14 Participants
Participants will be randomised to receive aspirin 75 mg once daily for the first medication period (10-14 days),with a loading dose of ticagrelor 180 mg on the last day of the period.
|
Aspirin 300mg OD
n=15 Participants
Participants will be randomised to receive aspirin 300 mg once daily for the first medication period (10 days) and no study drug on endotoxin challenge day
|
Aspirin 300mg & Ticagrelor 180mg Loading Dose
n=15 Participants
Participants will be randomised to receive aspirin 300 mg once daily for the first medication period (10-14 days) plus a loading dose of ticagrelor 180 mg on the last day of the period.
|
|---|---|---|---|---|---|---|---|---|
|
Serum TXB2
|
389904.00 pg/ml
Standard Deviation 355874.00
|
274473.00 pg/ml
Standard Deviation 212718.00
|
19334.00 pg/ml
Standard Deviation 46071.00
|
3538.00 pg/ml
Standard Deviation 6430.00
|
1824.00 pg/ml
Standard Deviation 2466.00
|
1444.00 pg/ml
Standard Deviation 1375.00
|
346.60 pg/ml
Standard Deviation 495.80
|
301.00 pg/ml
Standard Deviation 429.20
|
Adverse Events
No Drug
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
No Drug Plus Ticagrelor 180mg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Aspirin 20mg BD
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Aspirin 20mg BD & Ticagrelor 180mg
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Aspirin 75mg OD
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Aspirin 75mg OD & Ticagrelor 180mg
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Aspirin 300mg OD
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Aspirin 300mg OD & Ticagrelor 180mg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
No Drug
n=17 participants at risk
Patients will be randomised to receive no drug for the first medication period (10 days) followed by endotoxin challenge
|
No Drug Plus Ticagrelor 180mg
n=16 participants at risk
Participants will be randomised to receive no drug, then a loading dose of ticagrelor 180 mg on the last day of the first medication period (10-14 days) followed by endotoxin challenge
|
Aspirin 20mg BD
n=17 participants at risk
Participants will be randomised to receive aspirin 20 mg twice daily for the first medication period (10 days) followed by endotoxin challenge
|
Aspirin 20mg BD & Ticagrelor 180mg
n=17 participants at risk
Participants will be randomised to receive aspirin 20 mg twice daily for the first medication period (10-14 days) plus a loading dose of ticagrelor 180 mg on the last day of the period followed by endotoxin challenge.
|
Aspirin 75mg OD
n=16 participants at risk
Participants will be randomised to receive aspirin 75 mg once daily for the first medication period (10-14 days).
followed by endotoxin challenge
|
Aspirin 75mg OD & Ticagrelor 180mg
n=14 participants at risk
Participants will be randomised to receive aspirin 75 mg once daily for the first medication period (10-14 days),with a loading dose of ticagrelor 180 mg on the last day of the period followed by endotoxin challenge
|
Aspirin 300mg OD
n=15 participants at risk
Participants will be randomised to receive aspirin 300 mg once daily for the first medication period (10 days) followed by endotoxin challenge
|
Aspirin 300mg OD & Ticagrelor 180mg
n=15 participants at risk
Participants will be randomised to receive aspirin 300 mg once daily for the first medication period (10-14 days) plus a loading dose of ticagrelor 180 mg on the last day of the period followed by endotoxin challenge
|
|---|---|---|---|---|---|---|---|---|
|
Cardiac disorders
bradycardia
|
0.00%
0/17 • Adverse events and reactions will be recorded and reported from randomisation to 10 days after visit 3 (1st endotoxin injection day), and from visit 6 (start of period 2) to 10 days after visit 7 (2nd endotoxin injection day) as described in the protocol. Thus adverse events occurring in the break (wash out period) between the first and second medication periods, excepting those originating in the 10 days after endotoxin injection, will not be recorded or reported as stipulated in the protocol.
Adverse events not reported as they are expected as a normal response to endotoxin: Abnormal body temperature, except if \>39 and \<34oC, unless persists at 6 hours post-endotoxin /meets the criteria of SAE; Change in pulse rate, except\>140 and\<45 bpm/if meets criteria for SAE; Increase/decrease in blood pressure from baseline of\<40 mmHg unless an SAE; Self-limiting symptoms due to endotoxaemia at discretion of investigator, unless an SAE; Changes in leukocyte/platelet count or CRP unless SAE
|
6.2%
1/16 • Number of events 1 • Adverse events and reactions will be recorded and reported from randomisation to 10 days after visit 3 (1st endotoxin injection day), and from visit 6 (start of period 2) to 10 days after visit 7 (2nd endotoxin injection day) as described in the protocol. Thus adverse events occurring in the break (wash out period) between the first and second medication periods, excepting those originating in the 10 days after endotoxin injection, will not be recorded or reported as stipulated in the protocol.
Adverse events not reported as they are expected as a normal response to endotoxin: Abnormal body temperature, except if \>39 and \<34oC, unless persists at 6 hours post-endotoxin /meets the criteria of SAE; Change in pulse rate, except\>140 and\<45 bpm/if meets criteria for SAE; Increase/decrease in blood pressure from baseline of\<40 mmHg unless an SAE; Self-limiting symptoms due to endotoxaemia at discretion of investigator, unless an SAE; Changes in leukocyte/platelet count or CRP unless SAE
|
5.9%
1/17 • Number of events 1 • Adverse events and reactions will be recorded and reported from randomisation to 10 days after visit 3 (1st endotoxin injection day), and from visit 6 (start of period 2) to 10 days after visit 7 (2nd endotoxin injection day) as described in the protocol. Thus adverse events occurring in the break (wash out period) between the first and second medication periods, excepting those originating in the 10 days after endotoxin injection, will not be recorded or reported as stipulated in the protocol.
Adverse events not reported as they are expected as a normal response to endotoxin: Abnormal body temperature, except if \>39 and \<34oC, unless persists at 6 hours post-endotoxin /meets the criteria of SAE; Change in pulse rate, except\>140 and\<45 bpm/if meets criteria for SAE; Increase/decrease in blood pressure from baseline of\<40 mmHg unless an SAE; Self-limiting symptoms due to endotoxaemia at discretion of investigator, unless an SAE; Changes in leukocyte/platelet count or CRP unless SAE
|
5.9%
1/17 • Number of events 1 • Adverse events and reactions will be recorded and reported from randomisation to 10 days after visit 3 (1st endotoxin injection day), and from visit 6 (start of period 2) to 10 days after visit 7 (2nd endotoxin injection day) as described in the protocol. Thus adverse events occurring in the break (wash out period) between the first and second medication periods, excepting those originating in the 10 days after endotoxin injection, will not be recorded or reported as stipulated in the protocol.
Adverse events not reported as they are expected as a normal response to endotoxin: Abnormal body temperature, except if \>39 and \<34oC, unless persists at 6 hours post-endotoxin /meets the criteria of SAE; Change in pulse rate, except\>140 and\<45 bpm/if meets criteria for SAE; Increase/decrease in blood pressure from baseline of\<40 mmHg unless an SAE; Self-limiting symptoms due to endotoxaemia at discretion of investigator, unless an SAE; Changes in leukocyte/platelet count or CRP unless SAE
|
0.00%
0/16 • Adverse events and reactions will be recorded and reported from randomisation to 10 days after visit 3 (1st endotoxin injection day), and from visit 6 (start of period 2) to 10 days after visit 7 (2nd endotoxin injection day) as described in the protocol. Thus adverse events occurring in the break (wash out period) between the first and second medication periods, excepting those originating in the 10 days after endotoxin injection, will not be recorded or reported as stipulated in the protocol.
Adverse events not reported as they are expected as a normal response to endotoxin: Abnormal body temperature, except if \>39 and \<34oC, unless persists at 6 hours post-endotoxin /meets the criteria of SAE; Change in pulse rate, except\>140 and\<45 bpm/if meets criteria for SAE; Increase/decrease in blood pressure from baseline of\<40 mmHg unless an SAE; Self-limiting symptoms due to endotoxaemia at discretion of investigator, unless an SAE; Changes in leukocyte/platelet count or CRP unless SAE
|
0.00%
0/14 • Adverse events and reactions will be recorded and reported from randomisation to 10 days after visit 3 (1st endotoxin injection day), and from visit 6 (start of period 2) to 10 days after visit 7 (2nd endotoxin injection day) as described in the protocol. Thus adverse events occurring in the break (wash out period) between the first and second medication periods, excepting those originating in the 10 days after endotoxin injection, will not be recorded or reported as stipulated in the protocol.
Adverse events not reported as they are expected as a normal response to endotoxin: Abnormal body temperature, except if \>39 and \<34oC, unless persists at 6 hours post-endotoxin /meets the criteria of SAE; Change in pulse rate, except\>140 and\<45 bpm/if meets criteria for SAE; Increase/decrease in blood pressure from baseline of\<40 mmHg unless an SAE; Self-limiting symptoms due to endotoxaemia at discretion of investigator, unless an SAE; Changes in leukocyte/platelet count or CRP unless SAE
|
6.7%
1/15 • Number of events 1 • Adverse events and reactions will be recorded and reported from randomisation to 10 days after visit 3 (1st endotoxin injection day), and from visit 6 (start of period 2) to 10 days after visit 7 (2nd endotoxin injection day) as described in the protocol. Thus adverse events occurring in the break (wash out period) between the first and second medication periods, excepting those originating in the 10 days after endotoxin injection, will not be recorded or reported as stipulated in the protocol.
Adverse events not reported as they are expected as a normal response to endotoxin: Abnormal body temperature, except if \>39 and \<34oC, unless persists at 6 hours post-endotoxin /meets the criteria of SAE; Change in pulse rate, except\>140 and\<45 bpm/if meets criteria for SAE; Increase/decrease in blood pressure from baseline of\<40 mmHg unless an SAE; Self-limiting symptoms due to endotoxaemia at discretion of investigator, unless an SAE; Changes in leukocyte/platelet count or CRP unless SAE
|
0.00%
0/15 • Adverse events and reactions will be recorded and reported from randomisation to 10 days after visit 3 (1st endotoxin injection day), and from visit 6 (start of period 2) to 10 days after visit 7 (2nd endotoxin injection day) as described in the protocol. Thus adverse events occurring in the break (wash out period) between the first and second medication periods, excepting those originating in the 10 days after endotoxin injection, will not be recorded or reported as stipulated in the protocol.
Adverse events not reported as they are expected as a normal response to endotoxin: Abnormal body temperature, except if \>39 and \<34oC, unless persists at 6 hours post-endotoxin /meets the criteria of SAE; Change in pulse rate, except\>140 and\<45 bpm/if meets criteria for SAE; Increase/decrease in blood pressure from baseline of\<40 mmHg unless an SAE; Self-limiting symptoms due to endotoxaemia at discretion of investigator, unless an SAE; Changes in leukocyte/platelet count or CRP unless SAE
|
|
General disorders
Bruise
|
0.00%
0/17 • Adverse events and reactions will be recorded and reported from randomisation to 10 days after visit 3 (1st endotoxin injection day), and from visit 6 (start of period 2) to 10 days after visit 7 (2nd endotoxin injection day) as described in the protocol. Thus adverse events occurring in the break (wash out period) between the first and second medication periods, excepting those originating in the 10 days after endotoxin injection, will not be recorded or reported as stipulated in the protocol.
Adverse events not reported as they are expected as a normal response to endotoxin: Abnormal body temperature, except if \>39 and \<34oC, unless persists at 6 hours post-endotoxin /meets the criteria of SAE; Change in pulse rate, except\>140 and\<45 bpm/if meets criteria for SAE; Increase/decrease in blood pressure from baseline of\<40 mmHg unless an SAE; Self-limiting symptoms due to endotoxaemia at discretion of investigator, unless an SAE; Changes in leukocyte/platelet count or CRP unless SAE
|
0.00%
0/16 • Adverse events and reactions will be recorded and reported from randomisation to 10 days after visit 3 (1st endotoxin injection day), and from visit 6 (start of period 2) to 10 days after visit 7 (2nd endotoxin injection day) as described in the protocol. Thus adverse events occurring in the break (wash out period) between the first and second medication periods, excepting those originating in the 10 days after endotoxin injection, will not be recorded or reported as stipulated in the protocol.
Adverse events not reported as they are expected as a normal response to endotoxin: Abnormal body temperature, except if \>39 and \<34oC, unless persists at 6 hours post-endotoxin /meets the criteria of SAE; Change in pulse rate, except\>140 and\<45 bpm/if meets criteria for SAE; Increase/decrease in blood pressure from baseline of\<40 mmHg unless an SAE; Self-limiting symptoms due to endotoxaemia at discretion of investigator, unless an SAE; Changes in leukocyte/platelet count or CRP unless SAE
|
0.00%
0/17 • Adverse events and reactions will be recorded and reported from randomisation to 10 days after visit 3 (1st endotoxin injection day), and from visit 6 (start of period 2) to 10 days after visit 7 (2nd endotoxin injection day) as described in the protocol. Thus adverse events occurring in the break (wash out period) between the first and second medication periods, excepting those originating in the 10 days after endotoxin injection, will not be recorded or reported as stipulated in the protocol.
Adverse events not reported as they are expected as a normal response to endotoxin: Abnormal body temperature, except if \>39 and \<34oC, unless persists at 6 hours post-endotoxin /meets the criteria of SAE; Change in pulse rate, except\>140 and\<45 bpm/if meets criteria for SAE; Increase/decrease in blood pressure from baseline of\<40 mmHg unless an SAE; Self-limiting symptoms due to endotoxaemia at discretion of investigator, unless an SAE; Changes in leukocyte/platelet count or CRP unless SAE
|
5.9%
1/17 • Number of events 1 • Adverse events and reactions will be recorded and reported from randomisation to 10 days after visit 3 (1st endotoxin injection day), and from visit 6 (start of period 2) to 10 days after visit 7 (2nd endotoxin injection day) as described in the protocol. Thus adverse events occurring in the break (wash out period) between the first and second medication periods, excepting those originating in the 10 days after endotoxin injection, will not be recorded or reported as stipulated in the protocol.
Adverse events not reported as they are expected as a normal response to endotoxin: Abnormal body temperature, except if \>39 and \<34oC, unless persists at 6 hours post-endotoxin /meets the criteria of SAE; Change in pulse rate, except\>140 and\<45 bpm/if meets criteria for SAE; Increase/decrease in blood pressure from baseline of\<40 mmHg unless an SAE; Self-limiting symptoms due to endotoxaemia at discretion of investigator, unless an SAE; Changes in leukocyte/platelet count or CRP unless SAE
|
0.00%
0/16 • Adverse events and reactions will be recorded and reported from randomisation to 10 days after visit 3 (1st endotoxin injection day), and from visit 6 (start of period 2) to 10 days after visit 7 (2nd endotoxin injection day) as described in the protocol. Thus adverse events occurring in the break (wash out period) between the first and second medication periods, excepting those originating in the 10 days after endotoxin injection, will not be recorded or reported as stipulated in the protocol.
Adverse events not reported as they are expected as a normal response to endotoxin: Abnormal body temperature, except if \>39 and \<34oC, unless persists at 6 hours post-endotoxin /meets the criteria of SAE; Change in pulse rate, except\>140 and\<45 bpm/if meets criteria for SAE; Increase/decrease in blood pressure from baseline of\<40 mmHg unless an SAE; Self-limiting symptoms due to endotoxaemia at discretion of investigator, unless an SAE; Changes in leukocyte/platelet count or CRP unless SAE
|
0.00%
0/14 • Adverse events and reactions will be recorded and reported from randomisation to 10 days after visit 3 (1st endotoxin injection day), and from visit 6 (start of period 2) to 10 days after visit 7 (2nd endotoxin injection day) as described in the protocol. Thus adverse events occurring in the break (wash out period) between the first and second medication periods, excepting those originating in the 10 days after endotoxin injection, will not be recorded or reported as stipulated in the protocol.
Adverse events not reported as they are expected as a normal response to endotoxin: Abnormal body temperature, except if \>39 and \<34oC, unless persists at 6 hours post-endotoxin /meets the criteria of SAE; Change in pulse rate, except\>140 and\<45 bpm/if meets criteria for SAE; Increase/decrease in blood pressure from baseline of\<40 mmHg unless an SAE; Self-limiting symptoms due to endotoxaemia at discretion of investigator, unless an SAE; Changes in leukocyte/platelet count or CRP unless SAE
|
0.00%
0/15 • Adverse events and reactions will be recorded and reported from randomisation to 10 days after visit 3 (1st endotoxin injection day), and from visit 6 (start of period 2) to 10 days after visit 7 (2nd endotoxin injection day) as described in the protocol. Thus adverse events occurring in the break (wash out period) between the first and second medication periods, excepting those originating in the 10 days after endotoxin injection, will not be recorded or reported as stipulated in the protocol.
Adverse events not reported as they are expected as a normal response to endotoxin: Abnormal body temperature, except if \>39 and \<34oC, unless persists at 6 hours post-endotoxin /meets the criteria of SAE; Change in pulse rate, except\>140 and\<45 bpm/if meets criteria for SAE; Increase/decrease in blood pressure from baseline of\<40 mmHg unless an SAE; Self-limiting symptoms due to endotoxaemia at discretion of investigator, unless an SAE; Changes in leukocyte/platelet count or CRP unless SAE
|
0.00%
0/15 • Adverse events and reactions will be recorded and reported from randomisation to 10 days after visit 3 (1st endotoxin injection day), and from visit 6 (start of period 2) to 10 days after visit 7 (2nd endotoxin injection day) as described in the protocol. Thus adverse events occurring in the break (wash out period) between the first and second medication periods, excepting those originating in the 10 days after endotoxin injection, will not be recorded or reported as stipulated in the protocol.
Adverse events not reported as they are expected as a normal response to endotoxin: Abnormal body temperature, except if \>39 and \<34oC, unless persists at 6 hours post-endotoxin /meets the criteria of SAE; Change in pulse rate, except\>140 and\<45 bpm/if meets criteria for SAE; Increase/decrease in blood pressure from baseline of\<40 mmHg unless an SAE; Self-limiting symptoms due to endotoxaemia at discretion of investigator, unless an SAE; Changes in leukocyte/platelet count or CRP unless SAE
|
|
Gastrointestinal disorders
epigastric pain
|
0.00%
0/17 • Adverse events and reactions will be recorded and reported from randomisation to 10 days after visit 3 (1st endotoxin injection day), and from visit 6 (start of period 2) to 10 days after visit 7 (2nd endotoxin injection day) as described in the protocol. Thus adverse events occurring in the break (wash out period) between the first and second medication periods, excepting those originating in the 10 days after endotoxin injection, will not be recorded or reported as stipulated in the protocol.
Adverse events not reported as they are expected as a normal response to endotoxin: Abnormal body temperature, except if \>39 and \<34oC, unless persists at 6 hours post-endotoxin /meets the criteria of SAE; Change in pulse rate, except\>140 and\<45 bpm/if meets criteria for SAE; Increase/decrease in blood pressure from baseline of\<40 mmHg unless an SAE; Self-limiting symptoms due to endotoxaemia at discretion of investigator, unless an SAE; Changes in leukocyte/platelet count or CRP unless SAE
|
0.00%
0/16 • Adverse events and reactions will be recorded and reported from randomisation to 10 days after visit 3 (1st endotoxin injection day), and from visit 6 (start of period 2) to 10 days after visit 7 (2nd endotoxin injection day) as described in the protocol. Thus adverse events occurring in the break (wash out period) between the first and second medication periods, excepting those originating in the 10 days after endotoxin injection, will not be recorded or reported as stipulated in the protocol.
Adverse events not reported as they are expected as a normal response to endotoxin: Abnormal body temperature, except if \>39 and \<34oC, unless persists at 6 hours post-endotoxin /meets the criteria of SAE; Change in pulse rate, except\>140 and\<45 bpm/if meets criteria for SAE; Increase/decrease in blood pressure from baseline of\<40 mmHg unless an SAE; Self-limiting symptoms due to endotoxaemia at discretion of investigator, unless an SAE; Changes in leukocyte/platelet count or CRP unless SAE
|
0.00%
0/17 • Adverse events and reactions will be recorded and reported from randomisation to 10 days after visit 3 (1st endotoxin injection day), and from visit 6 (start of period 2) to 10 days after visit 7 (2nd endotoxin injection day) as described in the protocol. Thus adverse events occurring in the break (wash out period) between the first and second medication periods, excepting those originating in the 10 days after endotoxin injection, will not be recorded or reported as stipulated in the protocol.
Adverse events not reported as they are expected as a normal response to endotoxin: Abnormal body temperature, except if \>39 and \<34oC, unless persists at 6 hours post-endotoxin /meets the criteria of SAE; Change in pulse rate, except\>140 and\<45 bpm/if meets criteria for SAE; Increase/decrease in blood pressure from baseline of\<40 mmHg unless an SAE; Self-limiting symptoms due to endotoxaemia at discretion of investigator, unless an SAE; Changes in leukocyte/platelet count or CRP unless SAE
|
0.00%
0/17 • Adverse events and reactions will be recorded and reported from randomisation to 10 days after visit 3 (1st endotoxin injection day), and from visit 6 (start of period 2) to 10 days after visit 7 (2nd endotoxin injection day) as described in the protocol. Thus adverse events occurring in the break (wash out period) between the first and second medication periods, excepting those originating in the 10 days after endotoxin injection, will not be recorded or reported as stipulated in the protocol.
Adverse events not reported as they are expected as a normal response to endotoxin: Abnormal body temperature, except if \>39 and \<34oC, unless persists at 6 hours post-endotoxin /meets the criteria of SAE; Change in pulse rate, except\>140 and\<45 bpm/if meets criteria for SAE; Increase/decrease in blood pressure from baseline of\<40 mmHg unless an SAE; Self-limiting symptoms due to endotoxaemia at discretion of investigator, unless an SAE; Changes in leukocyte/platelet count or CRP unless SAE
|
0.00%
0/16 • Adverse events and reactions will be recorded and reported from randomisation to 10 days after visit 3 (1st endotoxin injection day), and from visit 6 (start of period 2) to 10 days after visit 7 (2nd endotoxin injection day) as described in the protocol. Thus adverse events occurring in the break (wash out period) between the first and second medication periods, excepting those originating in the 10 days after endotoxin injection, will not be recorded or reported as stipulated in the protocol.
Adverse events not reported as they are expected as a normal response to endotoxin: Abnormal body temperature, except if \>39 and \<34oC, unless persists at 6 hours post-endotoxin /meets the criteria of SAE; Change in pulse rate, except\>140 and\<45 bpm/if meets criteria for SAE; Increase/decrease in blood pressure from baseline of\<40 mmHg unless an SAE; Self-limiting symptoms due to endotoxaemia at discretion of investigator, unless an SAE; Changes in leukocyte/platelet count or CRP unless SAE
|
0.00%
0/14 • Adverse events and reactions will be recorded and reported from randomisation to 10 days after visit 3 (1st endotoxin injection day), and from visit 6 (start of period 2) to 10 days after visit 7 (2nd endotoxin injection day) as described in the protocol. Thus adverse events occurring in the break (wash out period) between the first and second medication periods, excepting those originating in the 10 days after endotoxin injection, will not be recorded or reported as stipulated in the protocol.
Adverse events not reported as they are expected as a normal response to endotoxin: Abnormal body temperature, except if \>39 and \<34oC, unless persists at 6 hours post-endotoxin /meets the criteria of SAE; Change in pulse rate, except\>140 and\<45 bpm/if meets criteria for SAE; Increase/decrease in blood pressure from baseline of\<40 mmHg unless an SAE; Self-limiting symptoms due to endotoxaemia at discretion of investigator, unless an SAE; Changes in leukocyte/platelet count or CRP unless SAE
|
0.00%
0/15 • Adverse events and reactions will be recorded and reported from randomisation to 10 days after visit 3 (1st endotoxin injection day), and from visit 6 (start of period 2) to 10 days after visit 7 (2nd endotoxin injection day) as described in the protocol. Thus adverse events occurring in the break (wash out period) between the first and second medication periods, excepting those originating in the 10 days after endotoxin injection, will not be recorded or reported as stipulated in the protocol.
Adverse events not reported as they are expected as a normal response to endotoxin: Abnormal body temperature, except if \>39 and \<34oC, unless persists at 6 hours post-endotoxin /meets the criteria of SAE; Change in pulse rate, except\>140 and\<45 bpm/if meets criteria for SAE; Increase/decrease in blood pressure from baseline of\<40 mmHg unless an SAE; Self-limiting symptoms due to endotoxaemia at discretion of investigator, unless an SAE; Changes in leukocyte/platelet count or CRP unless SAE
|
6.7%
1/15 • Number of events 1 • Adverse events and reactions will be recorded and reported from randomisation to 10 days after visit 3 (1st endotoxin injection day), and from visit 6 (start of period 2) to 10 days after visit 7 (2nd endotoxin injection day) as described in the protocol. Thus adverse events occurring in the break (wash out period) between the first and second medication periods, excepting those originating in the 10 days after endotoxin injection, will not be recorded or reported as stipulated in the protocol.
Adverse events not reported as they are expected as a normal response to endotoxin: Abnormal body temperature, except if \>39 and \<34oC, unless persists at 6 hours post-endotoxin /meets the criteria of SAE; Change in pulse rate, except\>140 and\<45 bpm/if meets criteria for SAE; Increase/decrease in blood pressure from baseline of\<40 mmHg unless an SAE; Self-limiting symptoms due to endotoxaemia at discretion of investigator, unless an SAE; Changes in leukocyte/platelet count or CRP unless SAE
|
|
General disorders
pyrexia
|
17.6%
3/17 • Number of events 3 • Adverse events and reactions will be recorded and reported from randomisation to 10 days after visit 3 (1st endotoxin injection day), and from visit 6 (start of period 2) to 10 days after visit 7 (2nd endotoxin injection day) as described in the protocol. Thus adverse events occurring in the break (wash out period) between the first and second medication periods, excepting those originating in the 10 days after endotoxin injection, will not be recorded or reported as stipulated in the protocol.
Adverse events not reported as they are expected as a normal response to endotoxin: Abnormal body temperature, except if \>39 and \<34oC, unless persists at 6 hours post-endotoxin /meets the criteria of SAE; Change in pulse rate, except\>140 and\<45 bpm/if meets criteria for SAE; Increase/decrease in blood pressure from baseline of\<40 mmHg unless an SAE; Self-limiting symptoms due to endotoxaemia at discretion of investigator, unless an SAE; Changes in leukocyte/platelet count or CRP unless SAE
|
12.5%
2/16 • Number of events 2 • Adverse events and reactions will be recorded and reported from randomisation to 10 days after visit 3 (1st endotoxin injection day), and from visit 6 (start of period 2) to 10 days after visit 7 (2nd endotoxin injection day) as described in the protocol. Thus adverse events occurring in the break (wash out period) between the first and second medication periods, excepting those originating in the 10 days after endotoxin injection, will not be recorded or reported as stipulated in the protocol.
Adverse events not reported as they are expected as a normal response to endotoxin: Abnormal body temperature, except if \>39 and \<34oC, unless persists at 6 hours post-endotoxin /meets the criteria of SAE; Change in pulse rate, except\>140 and\<45 bpm/if meets criteria for SAE; Increase/decrease in blood pressure from baseline of\<40 mmHg unless an SAE; Self-limiting symptoms due to endotoxaemia at discretion of investigator, unless an SAE; Changes in leukocyte/platelet count or CRP unless SAE
|
0.00%
0/17 • Adverse events and reactions will be recorded and reported from randomisation to 10 days after visit 3 (1st endotoxin injection day), and from visit 6 (start of period 2) to 10 days after visit 7 (2nd endotoxin injection day) as described in the protocol. Thus adverse events occurring in the break (wash out period) between the first and second medication periods, excepting those originating in the 10 days after endotoxin injection, will not be recorded or reported as stipulated in the protocol.
Adverse events not reported as they are expected as a normal response to endotoxin: Abnormal body temperature, except if \>39 and \<34oC, unless persists at 6 hours post-endotoxin /meets the criteria of SAE; Change in pulse rate, except\>140 and\<45 bpm/if meets criteria for SAE; Increase/decrease in blood pressure from baseline of\<40 mmHg unless an SAE; Self-limiting symptoms due to endotoxaemia at discretion of investigator, unless an SAE; Changes in leukocyte/platelet count or CRP unless SAE
|
5.9%
1/17 • Number of events 1 • Adverse events and reactions will be recorded and reported from randomisation to 10 days after visit 3 (1st endotoxin injection day), and from visit 6 (start of period 2) to 10 days after visit 7 (2nd endotoxin injection day) as described in the protocol. Thus adverse events occurring in the break (wash out period) between the first and second medication periods, excepting those originating in the 10 days after endotoxin injection, will not be recorded or reported as stipulated in the protocol.
Adverse events not reported as they are expected as a normal response to endotoxin: Abnormal body temperature, except if \>39 and \<34oC, unless persists at 6 hours post-endotoxin /meets the criteria of SAE; Change in pulse rate, except\>140 and\<45 bpm/if meets criteria for SAE; Increase/decrease in blood pressure from baseline of\<40 mmHg unless an SAE; Self-limiting symptoms due to endotoxaemia at discretion of investigator, unless an SAE; Changes in leukocyte/platelet count or CRP unless SAE
|
12.5%
2/16 • Number of events 2 • Adverse events and reactions will be recorded and reported from randomisation to 10 days after visit 3 (1st endotoxin injection day), and from visit 6 (start of period 2) to 10 days after visit 7 (2nd endotoxin injection day) as described in the protocol. Thus adverse events occurring in the break (wash out period) between the first and second medication periods, excepting those originating in the 10 days after endotoxin injection, will not be recorded or reported as stipulated in the protocol.
Adverse events not reported as they are expected as a normal response to endotoxin: Abnormal body temperature, except if \>39 and \<34oC, unless persists at 6 hours post-endotoxin /meets the criteria of SAE; Change in pulse rate, except\>140 and\<45 bpm/if meets criteria for SAE; Increase/decrease in blood pressure from baseline of\<40 mmHg unless an SAE; Self-limiting symptoms due to endotoxaemia at discretion of investigator, unless an SAE; Changes in leukocyte/platelet count or CRP unless SAE
|
14.3%
2/14 • Number of events 2 • Adverse events and reactions will be recorded and reported from randomisation to 10 days after visit 3 (1st endotoxin injection day), and from visit 6 (start of period 2) to 10 days after visit 7 (2nd endotoxin injection day) as described in the protocol. Thus adverse events occurring in the break (wash out period) between the first and second medication periods, excepting those originating in the 10 days after endotoxin injection, will not be recorded or reported as stipulated in the protocol.
Adverse events not reported as they are expected as a normal response to endotoxin: Abnormal body temperature, except if \>39 and \<34oC, unless persists at 6 hours post-endotoxin /meets the criteria of SAE; Change in pulse rate, except\>140 and\<45 bpm/if meets criteria for SAE; Increase/decrease in blood pressure from baseline of\<40 mmHg unless an SAE; Self-limiting symptoms due to endotoxaemia at discretion of investigator, unless an SAE; Changes in leukocyte/platelet count or CRP unless SAE
|
6.7%
1/15 • Number of events 1 • Adverse events and reactions will be recorded and reported from randomisation to 10 days after visit 3 (1st endotoxin injection day), and from visit 6 (start of period 2) to 10 days after visit 7 (2nd endotoxin injection day) as described in the protocol. Thus adverse events occurring in the break (wash out period) between the first and second medication periods, excepting those originating in the 10 days after endotoxin injection, will not be recorded or reported as stipulated in the protocol.
Adverse events not reported as they are expected as a normal response to endotoxin: Abnormal body temperature, except if \>39 and \<34oC, unless persists at 6 hours post-endotoxin /meets the criteria of SAE; Change in pulse rate, except\>140 and\<45 bpm/if meets criteria for SAE; Increase/decrease in blood pressure from baseline of\<40 mmHg unless an SAE; Self-limiting symptoms due to endotoxaemia at discretion of investigator, unless an SAE; Changes in leukocyte/platelet count or CRP unless SAE
|
6.7%
1/15 • Number of events 1 • Adverse events and reactions will be recorded and reported from randomisation to 10 days after visit 3 (1st endotoxin injection day), and from visit 6 (start of period 2) to 10 days after visit 7 (2nd endotoxin injection day) as described in the protocol. Thus adverse events occurring in the break (wash out period) between the first and second medication periods, excepting those originating in the 10 days after endotoxin injection, will not be recorded or reported as stipulated in the protocol.
Adverse events not reported as they are expected as a normal response to endotoxin: Abnormal body temperature, except if \>39 and \<34oC, unless persists at 6 hours post-endotoxin /meets the criteria of SAE; Change in pulse rate, except\>140 and\<45 bpm/if meets criteria for SAE; Increase/decrease in blood pressure from baseline of\<40 mmHg unless an SAE; Self-limiting symptoms due to endotoxaemia at discretion of investigator, unless an SAE; Changes in leukocyte/platelet count or CRP unless SAE
|
|
Endocrine disorders
hypokalaemia
|
0.00%
0/17 • Adverse events and reactions will be recorded and reported from randomisation to 10 days after visit 3 (1st endotoxin injection day), and from visit 6 (start of period 2) to 10 days after visit 7 (2nd endotoxin injection day) as described in the protocol. Thus adverse events occurring in the break (wash out period) between the first and second medication periods, excepting those originating in the 10 days after endotoxin injection, will not be recorded or reported as stipulated in the protocol.
Adverse events not reported as they are expected as a normal response to endotoxin: Abnormal body temperature, except if \>39 and \<34oC, unless persists at 6 hours post-endotoxin /meets the criteria of SAE; Change in pulse rate, except\>140 and\<45 bpm/if meets criteria for SAE; Increase/decrease in blood pressure from baseline of\<40 mmHg unless an SAE; Self-limiting symptoms due to endotoxaemia at discretion of investigator, unless an SAE; Changes in leukocyte/platelet count or CRP unless SAE
|
0.00%
0/16 • Adverse events and reactions will be recorded and reported from randomisation to 10 days after visit 3 (1st endotoxin injection day), and from visit 6 (start of period 2) to 10 days after visit 7 (2nd endotoxin injection day) as described in the protocol. Thus adverse events occurring in the break (wash out period) between the first and second medication periods, excepting those originating in the 10 days after endotoxin injection, will not be recorded or reported as stipulated in the protocol.
Adverse events not reported as they are expected as a normal response to endotoxin: Abnormal body temperature, except if \>39 and \<34oC, unless persists at 6 hours post-endotoxin /meets the criteria of SAE; Change in pulse rate, except\>140 and\<45 bpm/if meets criteria for SAE; Increase/decrease in blood pressure from baseline of\<40 mmHg unless an SAE; Self-limiting symptoms due to endotoxaemia at discretion of investigator, unless an SAE; Changes in leukocyte/platelet count or CRP unless SAE
|
5.9%
1/17 • Number of events 1 • Adverse events and reactions will be recorded and reported from randomisation to 10 days after visit 3 (1st endotoxin injection day), and from visit 6 (start of period 2) to 10 days after visit 7 (2nd endotoxin injection day) as described in the protocol. Thus adverse events occurring in the break (wash out period) between the first and second medication periods, excepting those originating in the 10 days after endotoxin injection, will not be recorded or reported as stipulated in the protocol.
Adverse events not reported as they are expected as a normal response to endotoxin: Abnormal body temperature, except if \>39 and \<34oC, unless persists at 6 hours post-endotoxin /meets the criteria of SAE; Change in pulse rate, except\>140 and\<45 bpm/if meets criteria for SAE; Increase/decrease in blood pressure from baseline of\<40 mmHg unless an SAE; Self-limiting symptoms due to endotoxaemia at discretion of investigator, unless an SAE; Changes in leukocyte/platelet count or CRP unless SAE
|
0.00%
0/17 • Adverse events and reactions will be recorded and reported from randomisation to 10 days after visit 3 (1st endotoxin injection day), and from visit 6 (start of period 2) to 10 days after visit 7 (2nd endotoxin injection day) as described in the protocol. Thus adverse events occurring in the break (wash out period) between the first and second medication periods, excepting those originating in the 10 days after endotoxin injection, will not be recorded or reported as stipulated in the protocol.
Adverse events not reported as they are expected as a normal response to endotoxin: Abnormal body temperature, except if \>39 and \<34oC, unless persists at 6 hours post-endotoxin /meets the criteria of SAE; Change in pulse rate, except\>140 and\<45 bpm/if meets criteria for SAE; Increase/decrease in blood pressure from baseline of\<40 mmHg unless an SAE; Self-limiting symptoms due to endotoxaemia at discretion of investigator, unless an SAE; Changes in leukocyte/platelet count or CRP unless SAE
|
0.00%
0/16 • Adverse events and reactions will be recorded and reported from randomisation to 10 days after visit 3 (1st endotoxin injection day), and from visit 6 (start of period 2) to 10 days after visit 7 (2nd endotoxin injection day) as described in the protocol. Thus adverse events occurring in the break (wash out period) between the first and second medication periods, excepting those originating in the 10 days after endotoxin injection, will not be recorded or reported as stipulated in the protocol.
Adverse events not reported as they are expected as a normal response to endotoxin: Abnormal body temperature, except if \>39 and \<34oC, unless persists at 6 hours post-endotoxin /meets the criteria of SAE; Change in pulse rate, except\>140 and\<45 bpm/if meets criteria for SAE; Increase/decrease in blood pressure from baseline of\<40 mmHg unless an SAE; Self-limiting symptoms due to endotoxaemia at discretion of investigator, unless an SAE; Changes in leukocyte/platelet count or CRP unless SAE
|
0.00%
0/14 • Adverse events and reactions will be recorded and reported from randomisation to 10 days after visit 3 (1st endotoxin injection day), and from visit 6 (start of period 2) to 10 days after visit 7 (2nd endotoxin injection day) as described in the protocol. Thus adverse events occurring in the break (wash out period) between the first and second medication periods, excepting those originating in the 10 days after endotoxin injection, will not be recorded or reported as stipulated in the protocol.
Adverse events not reported as they are expected as a normal response to endotoxin: Abnormal body temperature, except if \>39 and \<34oC, unless persists at 6 hours post-endotoxin /meets the criteria of SAE; Change in pulse rate, except\>140 and\<45 bpm/if meets criteria for SAE; Increase/decrease in blood pressure from baseline of\<40 mmHg unless an SAE; Self-limiting symptoms due to endotoxaemia at discretion of investigator, unless an SAE; Changes in leukocyte/platelet count or CRP unless SAE
|
0.00%
0/15 • Adverse events and reactions will be recorded and reported from randomisation to 10 days after visit 3 (1st endotoxin injection day), and from visit 6 (start of period 2) to 10 days after visit 7 (2nd endotoxin injection day) as described in the protocol. Thus adverse events occurring in the break (wash out period) between the first and second medication periods, excepting those originating in the 10 days after endotoxin injection, will not be recorded or reported as stipulated in the protocol.
Adverse events not reported as they are expected as a normal response to endotoxin: Abnormal body temperature, except if \>39 and \<34oC, unless persists at 6 hours post-endotoxin /meets the criteria of SAE; Change in pulse rate, except\>140 and\<45 bpm/if meets criteria for SAE; Increase/decrease in blood pressure from baseline of\<40 mmHg unless an SAE; Self-limiting symptoms due to endotoxaemia at discretion of investigator, unless an SAE; Changes in leukocyte/platelet count or CRP unless SAE
|
0.00%
0/15 • Adverse events and reactions will be recorded and reported from randomisation to 10 days after visit 3 (1st endotoxin injection day), and from visit 6 (start of period 2) to 10 days after visit 7 (2nd endotoxin injection day) as described in the protocol. Thus adverse events occurring in the break (wash out period) between the first and second medication periods, excepting those originating in the 10 days after endotoxin injection, will not be recorded or reported as stipulated in the protocol.
Adverse events not reported as they are expected as a normal response to endotoxin: Abnormal body temperature, except if \>39 and \<34oC, unless persists at 6 hours post-endotoxin /meets the criteria of SAE; Change in pulse rate, except\>140 and\<45 bpm/if meets criteria for SAE; Increase/decrease in blood pressure from baseline of\<40 mmHg unless an SAE; Self-limiting symptoms due to endotoxaemia at discretion of investigator, unless an SAE; Changes in leukocyte/platelet count or CRP unless SAE
|
|
Blood and lymphatic system disorders
Bleeding
|
0.00%
0/17 • Adverse events and reactions will be recorded and reported from randomisation to 10 days after visit 3 (1st endotoxin injection day), and from visit 6 (start of period 2) to 10 days after visit 7 (2nd endotoxin injection day) as described in the protocol. Thus adverse events occurring in the break (wash out period) between the first and second medication periods, excepting those originating in the 10 days after endotoxin injection, will not be recorded or reported as stipulated in the protocol.
Adverse events not reported as they are expected as a normal response to endotoxin: Abnormal body temperature, except if \>39 and \<34oC, unless persists at 6 hours post-endotoxin /meets the criteria of SAE; Change in pulse rate, except\>140 and\<45 bpm/if meets criteria for SAE; Increase/decrease in blood pressure from baseline of\<40 mmHg unless an SAE; Self-limiting symptoms due to endotoxaemia at discretion of investigator, unless an SAE; Changes in leukocyte/platelet count or CRP unless SAE
|
0.00%
0/16 • Adverse events and reactions will be recorded and reported from randomisation to 10 days after visit 3 (1st endotoxin injection day), and from visit 6 (start of period 2) to 10 days after visit 7 (2nd endotoxin injection day) as described in the protocol. Thus adverse events occurring in the break (wash out period) between the first and second medication periods, excepting those originating in the 10 days after endotoxin injection, will not be recorded or reported as stipulated in the protocol.
Adverse events not reported as they are expected as a normal response to endotoxin: Abnormal body temperature, except if \>39 and \<34oC, unless persists at 6 hours post-endotoxin /meets the criteria of SAE; Change in pulse rate, except\>140 and\<45 bpm/if meets criteria for SAE; Increase/decrease in blood pressure from baseline of\<40 mmHg unless an SAE; Self-limiting symptoms due to endotoxaemia at discretion of investigator, unless an SAE; Changes in leukocyte/platelet count or CRP unless SAE
|
5.9%
1/17 • Number of events 1 • Adverse events and reactions will be recorded and reported from randomisation to 10 days after visit 3 (1st endotoxin injection day), and from visit 6 (start of period 2) to 10 days after visit 7 (2nd endotoxin injection day) as described in the protocol. Thus adverse events occurring in the break (wash out period) between the first and second medication periods, excepting those originating in the 10 days after endotoxin injection, will not be recorded or reported as stipulated in the protocol.
Adverse events not reported as they are expected as a normal response to endotoxin: Abnormal body temperature, except if \>39 and \<34oC, unless persists at 6 hours post-endotoxin /meets the criteria of SAE; Change in pulse rate, except\>140 and\<45 bpm/if meets criteria for SAE; Increase/decrease in blood pressure from baseline of\<40 mmHg unless an SAE; Self-limiting symptoms due to endotoxaemia at discretion of investigator, unless an SAE; Changes in leukocyte/platelet count or CRP unless SAE
|
0.00%
0/17 • Adverse events and reactions will be recorded and reported from randomisation to 10 days after visit 3 (1st endotoxin injection day), and from visit 6 (start of period 2) to 10 days after visit 7 (2nd endotoxin injection day) as described in the protocol. Thus adverse events occurring in the break (wash out period) between the first and second medication periods, excepting those originating in the 10 days after endotoxin injection, will not be recorded or reported as stipulated in the protocol.
Adverse events not reported as they are expected as a normal response to endotoxin: Abnormal body temperature, except if \>39 and \<34oC, unless persists at 6 hours post-endotoxin /meets the criteria of SAE; Change in pulse rate, except\>140 and\<45 bpm/if meets criteria for SAE; Increase/decrease in blood pressure from baseline of\<40 mmHg unless an SAE; Self-limiting symptoms due to endotoxaemia at discretion of investigator, unless an SAE; Changes in leukocyte/platelet count or CRP unless SAE
|
0.00%
0/16 • Adverse events and reactions will be recorded and reported from randomisation to 10 days after visit 3 (1st endotoxin injection day), and from visit 6 (start of period 2) to 10 days after visit 7 (2nd endotoxin injection day) as described in the protocol. Thus adverse events occurring in the break (wash out period) between the first and second medication periods, excepting those originating in the 10 days after endotoxin injection, will not be recorded or reported as stipulated in the protocol.
Adverse events not reported as they are expected as a normal response to endotoxin: Abnormal body temperature, except if \>39 and \<34oC, unless persists at 6 hours post-endotoxin /meets the criteria of SAE; Change in pulse rate, except\>140 and\<45 bpm/if meets criteria for SAE; Increase/decrease in blood pressure from baseline of\<40 mmHg unless an SAE; Self-limiting symptoms due to endotoxaemia at discretion of investigator, unless an SAE; Changes in leukocyte/platelet count or CRP unless SAE
|
0.00%
0/14 • Adverse events and reactions will be recorded and reported from randomisation to 10 days after visit 3 (1st endotoxin injection day), and from visit 6 (start of period 2) to 10 days after visit 7 (2nd endotoxin injection day) as described in the protocol. Thus adverse events occurring in the break (wash out period) between the first and second medication periods, excepting those originating in the 10 days after endotoxin injection, will not be recorded or reported as stipulated in the protocol.
Adverse events not reported as they are expected as a normal response to endotoxin: Abnormal body temperature, except if \>39 and \<34oC, unless persists at 6 hours post-endotoxin /meets the criteria of SAE; Change in pulse rate, except\>140 and\<45 bpm/if meets criteria for SAE; Increase/decrease in blood pressure from baseline of\<40 mmHg unless an SAE; Self-limiting symptoms due to endotoxaemia at discretion of investigator, unless an SAE; Changes in leukocyte/platelet count or CRP unless SAE
|
0.00%
0/15 • Adverse events and reactions will be recorded and reported from randomisation to 10 days after visit 3 (1st endotoxin injection day), and from visit 6 (start of period 2) to 10 days after visit 7 (2nd endotoxin injection day) as described in the protocol. Thus adverse events occurring in the break (wash out period) between the first and second medication periods, excepting those originating in the 10 days after endotoxin injection, will not be recorded or reported as stipulated in the protocol.
Adverse events not reported as they are expected as a normal response to endotoxin: Abnormal body temperature, except if \>39 and \<34oC, unless persists at 6 hours post-endotoxin /meets the criteria of SAE; Change in pulse rate, except\>140 and\<45 bpm/if meets criteria for SAE; Increase/decrease in blood pressure from baseline of\<40 mmHg unless an SAE; Self-limiting symptoms due to endotoxaemia at discretion of investigator, unless an SAE; Changes in leukocyte/platelet count or CRP unless SAE
|
0.00%
0/15 • Adverse events and reactions will be recorded and reported from randomisation to 10 days after visit 3 (1st endotoxin injection day), and from visit 6 (start of period 2) to 10 days after visit 7 (2nd endotoxin injection day) as described in the protocol. Thus adverse events occurring in the break (wash out period) between the first and second medication periods, excepting those originating in the 10 days after endotoxin injection, will not be recorded or reported as stipulated in the protocol.
Adverse events not reported as they are expected as a normal response to endotoxin: Abnormal body temperature, except if \>39 and \<34oC, unless persists at 6 hours post-endotoxin /meets the criteria of SAE; Change in pulse rate, except\>140 and\<45 bpm/if meets criteria for SAE; Increase/decrease in blood pressure from baseline of\<40 mmHg unless an SAE; Self-limiting symptoms due to endotoxaemia at discretion of investigator, unless an SAE; Changes in leukocyte/platelet count or CRP unless SAE
|
|
Injury, poisoning and procedural complications
pinpoint pain
|
0.00%
0/17 • Adverse events and reactions will be recorded and reported from randomisation to 10 days after visit 3 (1st endotoxin injection day), and from visit 6 (start of period 2) to 10 days after visit 7 (2nd endotoxin injection day) as described in the protocol. Thus adverse events occurring in the break (wash out period) between the first and second medication periods, excepting those originating in the 10 days after endotoxin injection, will not be recorded or reported as stipulated in the protocol.
Adverse events not reported as they are expected as a normal response to endotoxin: Abnormal body temperature, except if \>39 and \<34oC, unless persists at 6 hours post-endotoxin /meets the criteria of SAE; Change in pulse rate, except\>140 and\<45 bpm/if meets criteria for SAE; Increase/decrease in blood pressure from baseline of\<40 mmHg unless an SAE; Self-limiting symptoms due to endotoxaemia at discretion of investigator, unless an SAE; Changes in leukocyte/platelet count or CRP unless SAE
|
0.00%
0/16 • Adverse events and reactions will be recorded and reported from randomisation to 10 days after visit 3 (1st endotoxin injection day), and from visit 6 (start of period 2) to 10 days after visit 7 (2nd endotoxin injection day) as described in the protocol. Thus adverse events occurring in the break (wash out period) between the first and second medication periods, excepting those originating in the 10 days after endotoxin injection, will not be recorded or reported as stipulated in the protocol.
Adverse events not reported as they are expected as a normal response to endotoxin: Abnormal body temperature, except if \>39 and \<34oC, unless persists at 6 hours post-endotoxin /meets the criteria of SAE; Change in pulse rate, except\>140 and\<45 bpm/if meets criteria for SAE; Increase/decrease in blood pressure from baseline of\<40 mmHg unless an SAE; Self-limiting symptoms due to endotoxaemia at discretion of investigator, unless an SAE; Changes in leukocyte/platelet count or CRP unless SAE
|
5.9%
1/17 • Number of events 1 • Adverse events and reactions will be recorded and reported from randomisation to 10 days after visit 3 (1st endotoxin injection day), and from visit 6 (start of period 2) to 10 days after visit 7 (2nd endotoxin injection day) as described in the protocol. Thus adverse events occurring in the break (wash out period) between the first and second medication periods, excepting those originating in the 10 days after endotoxin injection, will not be recorded or reported as stipulated in the protocol.
Adverse events not reported as they are expected as a normal response to endotoxin: Abnormal body temperature, except if \>39 and \<34oC, unless persists at 6 hours post-endotoxin /meets the criteria of SAE; Change in pulse rate, except\>140 and\<45 bpm/if meets criteria for SAE; Increase/decrease in blood pressure from baseline of\<40 mmHg unless an SAE; Self-limiting symptoms due to endotoxaemia at discretion of investigator, unless an SAE; Changes in leukocyte/platelet count or CRP unless SAE
|
0.00%
0/17 • Adverse events and reactions will be recorded and reported from randomisation to 10 days after visit 3 (1st endotoxin injection day), and from visit 6 (start of period 2) to 10 days after visit 7 (2nd endotoxin injection day) as described in the protocol. Thus adverse events occurring in the break (wash out period) between the first and second medication periods, excepting those originating in the 10 days after endotoxin injection, will not be recorded or reported as stipulated in the protocol.
Adverse events not reported as they are expected as a normal response to endotoxin: Abnormal body temperature, except if \>39 and \<34oC, unless persists at 6 hours post-endotoxin /meets the criteria of SAE; Change in pulse rate, except\>140 and\<45 bpm/if meets criteria for SAE; Increase/decrease in blood pressure from baseline of\<40 mmHg unless an SAE; Self-limiting symptoms due to endotoxaemia at discretion of investigator, unless an SAE; Changes in leukocyte/platelet count or CRP unless SAE
|
0.00%
0/16 • Adverse events and reactions will be recorded and reported from randomisation to 10 days after visit 3 (1st endotoxin injection day), and from visit 6 (start of period 2) to 10 days after visit 7 (2nd endotoxin injection day) as described in the protocol. Thus adverse events occurring in the break (wash out period) between the first and second medication periods, excepting those originating in the 10 days after endotoxin injection, will not be recorded or reported as stipulated in the protocol.
Adverse events not reported as they are expected as a normal response to endotoxin: Abnormal body temperature, except if \>39 and \<34oC, unless persists at 6 hours post-endotoxin /meets the criteria of SAE; Change in pulse rate, except\>140 and\<45 bpm/if meets criteria for SAE; Increase/decrease in blood pressure from baseline of\<40 mmHg unless an SAE; Self-limiting symptoms due to endotoxaemia at discretion of investigator, unless an SAE; Changes in leukocyte/platelet count or CRP unless SAE
|
0.00%
0/14 • Adverse events and reactions will be recorded and reported from randomisation to 10 days after visit 3 (1st endotoxin injection day), and from visit 6 (start of period 2) to 10 days after visit 7 (2nd endotoxin injection day) as described in the protocol. Thus adverse events occurring in the break (wash out period) between the first and second medication periods, excepting those originating in the 10 days after endotoxin injection, will not be recorded or reported as stipulated in the protocol.
Adverse events not reported as they are expected as a normal response to endotoxin: Abnormal body temperature, except if \>39 and \<34oC, unless persists at 6 hours post-endotoxin /meets the criteria of SAE; Change in pulse rate, except\>140 and\<45 bpm/if meets criteria for SAE; Increase/decrease in blood pressure from baseline of\<40 mmHg unless an SAE; Self-limiting symptoms due to endotoxaemia at discretion of investigator, unless an SAE; Changes in leukocyte/platelet count or CRP unless SAE
|
0.00%
0/15 • Adverse events and reactions will be recorded and reported from randomisation to 10 days after visit 3 (1st endotoxin injection day), and from visit 6 (start of period 2) to 10 days after visit 7 (2nd endotoxin injection day) as described in the protocol. Thus adverse events occurring in the break (wash out period) between the first and second medication periods, excepting those originating in the 10 days after endotoxin injection, will not be recorded or reported as stipulated in the protocol.
Adverse events not reported as they are expected as a normal response to endotoxin: Abnormal body temperature, except if \>39 and \<34oC, unless persists at 6 hours post-endotoxin /meets the criteria of SAE; Change in pulse rate, except\>140 and\<45 bpm/if meets criteria for SAE; Increase/decrease in blood pressure from baseline of\<40 mmHg unless an SAE; Self-limiting symptoms due to endotoxaemia at discretion of investigator, unless an SAE; Changes in leukocyte/platelet count or CRP unless SAE
|
0.00%
0/15 • Adverse events and reactions will be recorded and reported from randomisation to 10 days after visit 3 (1st endotoxin injection day), and from visit 6 (start of period 2) to 10 days after visit 7 (2nd endotoxin injection day) as described in the protocol. Thus adverse events occurring in the break (wash out period) between the first and second medication periods, excepting those originating in the 10 days after endotoxin injection, will not be recorded or reported as stipulated in the protocol.
Adverse events not reported as they are expected as a normal response to endotoxin: Abnormal body temperature, except if \>39 and \<34oC, unless persists at 6 hours post-endotoxin /meets the criteria of SAE; Change in pulse rate, except\>140 and\<45 bpm/if meets criteria for SAE; Increase/decrease in blood pressure from baseline of\<40 mmHg unless an SAE; Self-limiting symptoms due to endotoxaemia at discretion of investigator, unless an SAE; Changes in leukocyte/platelet count or CRP unless SAE
|
|
Infections and infestations
cold sores
|
0.00%
0/17 • Adverse events and reactions will be recorded and reported from randomisation to 10 days after visit 3 (1st endotoxin injection day), and from visit 6 (start of period 2) to 10 days after visit 7 (2nd endotoxin injection day) as described in the protocol. Thus adverse events occurring in the break (wash out period) between the first and second medication periods, excepting those originating in the 10 days after endotoxin injection, will not be recorded or reported as stipulated in the protocol.
Adverse events not reported as they are expected as a normal response to endotoxin: Abnormal body temperature, except if \>39 and \<34oC, unless persists at 6 hours post-endotoxin /meets the criteria of SAE; Change in pulse rate, except\>140 and\<45 bpm/if meets criteria for SAE; Increase/decrease in blood pressure from baseline of\<40 mmHg unless an SAE; Self-limiting symptoms due to endotoxaemia at discretion of investigator, unless an SAE; Changes in leukocyte/platelet count or CRP unless SAE
|
0.00%
0/16 • Adverse events and reactions will be recorded and reported from randomisation to 10 days after visit 3 (1st endotoxin injection day), and from visit 6 (start of period 2) to 10 days after visit 7 (2nd endotoxin injection day) as described in the protocol. Thus adverse events occurring in the break (wash out period) between the first and second medication periods, excepting those originating in the 10 days after endotoxin injection, will not be recorded or reported as stipulated in the protocol.
Adverse events not reported as they are expected as a normal response to endotoxin: Abnormal body temperature, except if \>39 and \<34oC, unless persists at 6 hours post-endotoxin /meets the criteria of SAE; Change in pulse rate, except\>140 and\<45 bpm/if meets criteria for SAE; Increase/decrease in blood pressure from baseline of\<40 mmHg unless an SAE; Self-limiting symptoms due to endotoxaemia at discretion of investigator, unless an SAE; Changes in leukocyte/platelet count or CRP unless SAE
|
0.00%
0/17 • Adverse events and reactions will be recorded and reported from randomisation to 10 days after visit 3 (1st endotoxin injection day), and from visit 6 (start of period 2) to 10 days after visit 7 (2nd endotoxin injection day) as described in the protocol. Thus adverse events occurring in the break (wash out period) between the first and second medication periods, excepting those originating in the 10 days after endotoxin injection, will not be recorded or reported as stipulated in the protocol.
Adverse events not reported as they are expected as a normal response to endotoxin: Abnormal body temperature, except if \>39 and \<34oC, unless persists at 6 hours post-endotoxin /meets the criteria of SAE; Change in pulse rate, except\>140 and\<45 bpm/if meets criteria for SAE; Increase/decrease in blood pressure from baseline of\<40 mmHg unless an SAE; Self-limiting symptoms due to endotoxaemia at discretion of investigator, unless an SAE; Changes in leukocyte/platelet count or CRP unless SAE
|
5.9%
1/17 • Number of events 1 • Adverse events and reactions will be recorded and reported from randomisation to 10 days after visit 3 (1st endotoxin injection day), and from visit 6 (start of period 2) to 10 days after visit 7 (2nd endotoxin injection day) as described in the protocol. Thus adverse events occurring in the break (wash out period) between the first and second medication periods, excepting those originating in the 10 days after endotoxin injection, will not be recorded or reported as stipulated in the protocol.
Adverse events not reported as they are expected as a normal response to endotoxin: Abnormal body temperature, except if \>39 and \<34oC, unless persists at 6 hours post-endotoxin /meets the criteria of SAE; Change in pulse rate, except\>140 and\<45 bpm/if meets criteria for SAE; Increase/decrease in blood pressure from baseline of\<40 mmHg unless an SAE; Self-limiting symptoms due to endotoxaemia at discretion of investigator, unless an SAE; Changes in leukocyte/platelet count or CRP unless SAE
|
0.00%
0/16 • Adverse events and reactions will be recorded and reported from randomisation to 10 days after visit 3 (1st endotoxin injection day), and from visit 6 (start of period 2) to 10 days after visit 7 (2nd endotoxin injection day) as described in the protocol. Thus adverse events occurring in the break (wash out period) between the first and second medication periods, excepting those originating in the 10 days after endotoxin injection, will not be recorded or reported as stipulated in the protocol.
Adverse events not reported as they are expected as a normal response to endotoxin: Abnormal body temperature, except if \>39 and \<34oC, unless persists at 6 hours post-endotoxin /meets the criteria of SAE; Change in pulse rate, except\>140 and\<45 bpm/if meets criteria for SAE; Increase/decrease in blood pressure from baseline of\<40 mmHg unless an SAE; Self-limiting symptoms due to endotoxaemia at discretion of investigator, unless an SAE; Changes in leukocyte/platelet count or CRP unless SAE
|
0.00%
0/14 • Adverse events and reactions will be recorded and reported from randomisation to 10 days after visit 3 (1st endotoxin injection day), and from visit 6 (start of period 2) to 10 days after visit 7 (2nd endotoxin injection day) as described in the protocol. Thus adverse events occurring in the break (wash out period) between the first and second medication periods, excepting those originating in the 10 days after endotoxin injection, will not be recorded or reported as stipulated in the protocol.
Adverse events not reported as they are expected as a normal response to endotoxin: Abnormal body temperature, except if \>39 and \<34oC, unless persists at 6 hours post-endotoxin /meets the criteria of SAE; Change in pulse rate, except\>140 and\<45 bpm/if meets criteria for SAE; Increase/decrease in blood pressure from baseline of\<40 mmHg unless an SAE; Self-limiting symptoms due to endotoxaemia at discretion of investigator, unless an SAE; Changes in leukocyte/platelet count or CRP unless SAE
|
0.00%
0/15 • Adverse events and reactions will be recorded and reported from randomisation to 10 days after visit 3 (1st endotoxin injection day), and from visit 6 (start of period 2) to 10 days after visit 7 (2nd endotoxin injection day) as described in the protocol. Thus adverse events occurring in the break (wash out period) between the first and second medication periods, excepting those originating in the 10 days after endotoxin injection, will not be recorded or reported as stipulated in the protocol.
Adverse events not reported as they are expected as a normal response to endotoxin: Abnormal body temperature, except if \>39 and \<34oC, unless persists at 6 hours post-endotoxin /meets the criteria of SAE; Change in pulse rate, except\>140 and\<45 bpm/if meets criteria for SAE; Increase/decrease in blood pressure from baseline of\<40 mmHg unless an SAE; Self-limiting symptoms due to endotoxaemia at discretion of investigator, unless an SAE; Changes in leukocyte/platelet count or CRP unless SAE
|
0.00%
0/15 • Adverse events and reactions will be recorded and reported from randomisation to 10 days after visit 3 (1st endotoxin injection day), and from visit 6 (start of period 2) to 10 days after visit 7 (2nd endotoxin injection day) as described in the protocol. Thus adverse events occurring in the break (wash out period) between the first and second medication periods, excepting those originating in the 10 days after endotoxin injection, will not be recorded or reported as stipulated in the protocol.
Adverse events not reported as they are expected as a normal response to endotoxin: Abnormal body temperature, except if \>39 and \<34oC, unless persists at 6 hours post-endotoxin /meets the criteria of SAE; Change in pulse rate, except\>140 and\<45 bpm/if meets criteria for SAE; Increase/decrease in blood pressure from baseline of\<40 mmHg unless an SAE; Self-limiting symptoms due to endotoxaemia at discretion of investigator, unless an SAE; Changes in leukocyte/platelet count or CRP unless SAE
|
|
Cardiac disorders
hypertension
|
0.00%
0/17 • Adverse events and reactions will be recorded and reported from randomisation to 10 days after visit 3 (1st endotoxin injection day), and from visit 6 (start of period 2) to 10 days after visit 7 (2nd endotoxin injection day) as described in the protocol. Thus adverse events occurring in the break (wash out period) between the first and second medication periods, excepting those originating in the 10 days after endotoxin injection, will not be recorded or reported as stipulated in the protocol.
Adverse events not reported as they are expected as a normal response to endotoxin: Abnormal body temperature, except if \>39 and \<34oC, unless persists at 6 hours post-endotoxin /meets the criteria of SAE; Change in pulse rate, except\>140 and\<45 bpm/if meets criteria for SAE; Increase/decrease in blood pressure from baseline of\<40 mmHg unless an SAE; Self-limiting symptoms due to endotoxaemia at discretion of investigator, unless an SAE; Changes in leukocyte/platelet count or CRP unless SAE
|
0.00%
0/16 • Adverse events and reactions will be recorded and reported from randomisation to 10 days after visit 3 (1st endotoxin injection day), and from visit 6 (start of period 2) to 10 days after visit 7 (2nd endotoxin injection day) as described in the protocol. Thus adverse events occurring in the break (wash out period) between the first and second medication periods, excepting those originating in the 10 days after endotoxin injection, will not be recorded or reported as stipulated in the protocol.
Adverse events not reported as they are expected as a normal response to endotoxin: Abnormal body temperature, except if \>39 and \<34oC, unless persists at 6 hours post-endotoxin /meets the criteria of SAE; Change in pulse rate, except\>140 and\<45 bpm/if meets criteria for SAE; Increase/decrease in blood pressure from baseline of\<40 mmHg unless an SAE; Self-limiting symptoms due to endotoxaemia at discretion of investigator, unless an SAE; Changes in leukocyte/platelet count or CRP unless SAE
|
0.00%
0/17 • Adverse events and reactions will be recorded and reported from randomisation to 10 days after visit 3 (1st endotoxin injection day), and from visit 6 (start of period 2) to 10 days after visit 7 (2nd endotoxin injection day) as described in the protocol. Thus adverse events occurring in the break (wash out period) between the first and second medication periods, excepting those originating in the 10 days after endotoxin injection, will not be recorded or reported as stipulated in the protocol.
Adverse events not reported as they are expected as a normal response to endotoxin: Abnormal body temperature, except if \>39 and \<34oC, unless persists at 6 hours post-endotoxin /meets the criteria of SAE; Change in pulse rate, except\>140 and\<45 bpm/if meets criteria for SAE; Increase/decrease in blood pressure from baseline of\<40 mmHg unless an SAE; Self-limiting symptoms due to endotoxaemia at discretion of investigator, unless an SAE; Changes in leukocyte/platelet count or CRP unless SAE
|
0.00%
0/17 • Adverse events and reactions will be recorded and reported from randomisation to 10 days after visit 3 (1st endotoxin injection day), and from visit 6 (start of period 2) to 10 days after visit 7 (2nd endotoxin injection day) as described in the protocol. Thus adverse events occurring in the break (wash out period) between the first and second medication periods, excepting those originating in the 10 days after endotoxin injection, will not be recorded or reported as stipulated in the protocol.
Adverse events not reported as they are expected as a normal response to endotoxin: Abnormal body temperature, except if \>39 and \<34oC, unless persists at 6 hours post-endotoxin /meets the criteria of SAE; Change in pulse rate, except\>140 and\<45 bpm/if meets criteria for SAE; Increase/decrease in blood pressure from baseline of\<40 mmHg unless an SAE; Self-limiting symptoms due to endotoxaemia at discretion of investigator, unless an SAE; Changes in leukocyte/platelet count or CRP unless SAE
|
0.00%
0/16 • Adverse events and reactions will be recorded and reported from randomisation to 10 days after visit 3 (1st endotoxin injection day), and from visit 6 (start of period 2) to 10 days after visit 7 (2nd endotoxin injection day) as described in the protocol. Thus adverse events occurring in the break (wash out period) between the first and second medication periods, excepting those originating in the 10 days after endotoxin injection, will not be recorded or reported as stipulated in the protocol.
Adverse events not reported as they are expected as a normal response to endotoxin: Abnormal body temperature, except if \>39 and \<34oC, unless persists at 6 hours post-endotoxin /meets the criteria of SAE; Change in pulse rate, except\>140 and\<45 bpm/if meets criteria for SAE; Increase/decrease in blood pressure from baseline of\<40 mmHg unless an SAE; Self-limiting symptoms due to endotoxaemia at discretion of investigator, unless an SAE; Changes in leukocyte/platelet count or CRP unless SAE
|
7.1%
1/14 • Number of events 1 • Adverse events and reactions will be recorded and reported from randomisation to 10 days after visit 3 (1st endotoxin injection day), and from visit 6 (start of period 2) to 10 days after visit 7 (2nd endotoxin injection day) as described in the protocol. Thus adverse events occurring in the break (wash out period) between the first and second medication periods, excepting those originating in the 10 days after endotoxin injection, will not be recorded or reported as stipulated in the protocol.
Adverse events not reported as they are expected as a normal response to endotoxin: Abnormal body temperature, except if \>39 and \<34oC, unless persists at 6 hours post-endotoxin /meets the criteria of SAE; Change in pulse rate, except\>140 and\<45 bpm/if meets criteria for SAE; Increase/decrease in blood pressure from baseline of\<40 mmHg unless an SAE; Self-limiting symptoms due to endotoxaemia at discretion of investigator, unless an SAE; Changes in leukocyte/platelet count or CRP unless SAE
|
0.00%
0/15 • Adverse events and reactions will be recorded and reported from randomisation to 10 days after visit 3 (1st endotoxin injection day), and from visit 6 (start of period 2) to 10 days after visit 7 (2nd endotoxin injection day) as described in the protocol. Thus adverse events occurring in the break (wash out period) between the first and second medication periods, excepting those originating in the 10 days after endotoxin injection, will not be recorded or reported as stipulated in the protocol.
Adverse events not reported as they are expected as a normal response to endotoxin: Abnormal body temperature, except if \>39 and \<34oC, unless persists at 6 hours post-endotoxin /meets the criteria of SAE; Change in pulse rate, except\>140 and\<45 bpm/if meets criteria for SAE; Increase/decrease in blood pressure from baseline of\<40 mmHg unless an SAE; Self-limiting symptoms due to endotoxaemia at discretion of investigator, unless an SAE; Changes in leukocyte/platelet count or CRP unless SAE
|
0.00%
0/15 • Adverse events and reactions will be recorded and reported from randomisation to 10 days after visit 3 (1st endotoxin injection day), and from visit 6 (start of period 2) to 10 days after visit 7 (2nd endotoxin injection day) as described in the protocol. Thus adverse events occurring in the break (wash out period) between the first and second medication periods, excepting those originating in the 10 days after endotoxin injection, will not be recorded or reported as stipulated in the protocol.
Adverse events not reported as they are expected as a normal response to endotoxin: Abnormal body temperature, except if \>39 and \<34oC, unless persists at 6 hours post-endotoxin /meets the criteria of SAE; Change in pulse rate, except\>140 and\<45 bpm/if meets criteria for SAE; Increase/decrease in blood pressure from baseline of\<40 mmHg unless an SAE; Self-limiting symptoms due to endotoxaemia at discretion of investigator, unless an SAE; Changes in leukocyte/platelet count or CRP unless SAE
|
|
Infections and infestations
Covid-19 infection
|
0.00%
0/17 • Adverse events and reactions will be recorded and reported from randomisation to 10 days after visit 3 (1st endotoxin injection day), and from visit 6 (start of period 2) to 10 days after visit 7 (2nd endotoxin injection day) as described in the protocol. Thus adverse events occurring in the break (wash out period) between the first and second medication periods, excepting those originating in the 10 days after endotoxin injection, will not be recorded or reported as stipulated in the protocol.
Adverse events not reported as they are expected as a normal response to endotoxin: Abnormal body temperature, except if \>39 and \<34oC, unless persists at 6 hours post-endotoxin /meets the criteria of SAE; Change in pulse rate, except\>140 and\<45 bpm/if meets criteria for SAE; Increase/decrease in blood pressure from baseline of\<40 mmHg unless an SAE; Self-limiting symptoms due to endotoxaemia at discretion of investigator, unless an SAE; Changes in leukocyte/platelet count or CRP unless SAE
|
0.00%
0/16 • Adverse events and reactions will be recorded and reported from randomisation to 10 days after visit 3 (1st endotoxin injection day), and from visit 6 (start of period 2) to 10 days after visit 7 (2nd endotoxin injection day) as described in the protocol. Thus adverse events occurring in the break (wash out period) between the first and second medication periods, excepting those originating in the 10 days after endotoxin injection, will not be recorded or reported as stipulated in the protocol.
Adverse events not reported as they are expected as a normal response to endotoxin: Abnormal body temperature, except if \>39 and \<34oC, unless persists at 6 hours post-endotoxin /meets the criteria of SAE; Change in pulse rate, except\>140 and\<45 bpm/if meets criteria for SAE; Increase/decrease in blood pressure from baseline of\<40 mmHg unless an SAE; Self-limiting symptoms due to endotoxaemia at discretion of investigator, unless an SAE; Changes in leukocyte/platelet count or CRP unless SAE
|
0.00%
0/17 • Adverse events and reactions will be recorded and reported from randomisation to 10 days after visit 3 (1st endotoxin injection day), and from visit 6 (start of period 2) to 10 days after visit 7 (2nd endotoxin injection day) as described in the protocol. Thus adverse events occurring in the break (wash out period) between the first and second medication periods, excepting those originating in the 10 days after endotoxin injection, will not be recorded or reported as stipulated in the protocol.
Adverse events not reported as they are expected as a normal response to endotoxin: Abnormal body temperature, except if \>39 and \<34oC, unless persists at 6 hours post-endotoxin /meets the criteria of SAE; Change in pulse rate, except\>140 and\<45 bpm/if meets criteria for SAE; Increase/decrease in blood pressure from baseline of\<40 mmHg unless an SAE; Self-limiting symptoms due to endotoxaemia at discretion of investigator, unless an SAE; Changes in leukocyte/platelet count or CRP unless SAE
|
0.00%
0/17 • Adverse events and reactions will be recorded and reported from randomisation to 10 days after visit 3 (1st endotoxin injection day), and from visit 6 (start of period 2) to 10 days after visit 7 (2nd endotoxin injection day) as described in the protocol. Thus adverse events occurring in the break (wash out period) between the first and second medication periods, excepting those originating in the 10 days after endotoxin injection, will not be recorded or reported as stipulated in the protocol.
Adverse events not reported as they are expected as a normal response to endotoxin: Abnormal body temperature, except if \>39 and \<34oC, unless persists at 6 hours post-endotoxin /meets the criteria of SAE; Change in pulse rate, except\>140 and\<45 bpm/if meets criteria for SAE; Increase/decrease in blood pressure from baseline of\<40 mmHg unless an SAE; Self-limiting symptoms due to endotoxaemia at discretion of investigator, unless an SAE; Changes in leukocyte/platelet count or CRP unless SAE
|
6.2%
1/16 • Number of events 1 • Adverse events and reactions will be recorded and reported from randomisation to 10 days after visit 3 (1st endotoxin injection day), and from visit 6 (start of period 2) to 10 days after visit 7 (2nd endotoxin injection day) as described in the protocol. Thus adverse events occurring in the break (wash out period) between the first and second medication periods, excepting those originating in the 10 days after endotoxin injection, will not be recorded or reported as stipulated in the protocol.
Adverse events not reported as they are expected as a normal response to endotoxin: Abnormal body temperature, except if \>39 and \<34oC, unless persists at 6 hours post-endotoxin /meets the criteria of SAE; Change in pulse rate, except\>140 and\<45 bpm/if meets criteria for SAE; Increase/decrease in blood pressure from baseline of\<40 mmHg unless an SAE; Self-limiting symptoms due to endotoxaemia at discretion of investigator, unless an SAE; Changes in leukocyte/platelet count or CRP unless SAE
|
0.00%
0/14 • Adverse events and reactions will be recorded and reported from randomisation to 10 days after visit 3 (1st endotoxin injection day), and from visit 6 (start of period 2) to 10 days after visit 7 (2nd endotoxin injection day) as described in the protocol. Thus adverse events occurring in the break (wash out period) between the first and second medication periods, excepting those originating in the 10 days after endotoxin injection, will not be recorded or reported as stipulated in the protocol.
Adverse events not reported as they are expected as a normal response to endotoxin: Abnormal body temperature, except if \>39 and \<34oC, unless persists at 6 hours post-endotoxin /meets the criteria of SAE; Change in pulse rate, except\>140 and\<45 bpm/if meets criteria for SAE; Increase/decrease in blood pressure from baseline of\<40 mmHg unless an SAE; Self-limiting symptoms due to endotoxaemia at discretion of investigator, unless an SAE; Changes in leukocyte/platelet count or CRP unless SAE
|
0.00%
0/15 • Adverse events and reactions will be recorded and reported from randomisation to 10 days after visit 3 (1st endotoxin injection day), and from visit 6 (start of period 2) to 10 days after visit 7 (2nd endotoxin injection day) as described in the protocol. Thus adverse events occurring in the break (wash out period) between the first and second medication periods, excepting those originating in the 10 days after endotoxin injection, will not be recorded or reported as stipulated in the protocol.
Adverse events not reported as they are expected as a normal response to endotoxin: Abnormal body temperature, except if \>39 and \<34oC, unless persists at 6 hours post-endotoxin /meets the criteria of SAE; Change in pulse rate, except\>140 and\<45 bpm/if meets criteria for SAE; Increase/decrease in blood pressure from baseline of\<40 mmHg unless an SAE; Self-limiting symptoms due to endotoxaemia at discretion of investigator, unless an SAE; Changes in leukocyte/platelet count or CRP unless SAE
|
0.00%
0/15 • Adverse events and reactions will be recorded and reported from randomisation to 10 days after visit 3 (1st endotoxin injection day), and from visit 6 (start of period 2) to 10 days after visit 7 (2nd endotoxin injection day) as described in the protocol. Thus adverse events occurring in the break (wash out period) between the first and second medication periods, excepting those originating in the 10 days after endotoxin injection, will not be recorded or reported as stipulated in the protocol.
Adverse events not reported as they are expected as a normal response to endotoxin: Abnormal body temperature, except if \>39 and \<34oC, unless persists at 6 hours post-endotoxin /meets the criteria of SAE; Change in pulse rate, except\>140 and\<45 bpm/if meets criteria for SAE; Increase/decrease in blood pressure from baseline of\<40 mmHg unless an SAE; Self-limiting symptoms due to endotoxaemia at discretion of investigator, unless an SAE; Changes in leukocyte/platelet count or CRP unless SAE
|
|
Gastrointestinal disorders
dyspepsia
|
0.00%
0/17 • Adverse events and reactions will be recorded and reported from randomisation to 10 days after visit 3 (1st endotoxin injection day), and from visit 6 (start of period 2) to 10 days after visit 7 (2nd endotoxin injection day) as described in the protocol. Thus adverse events occurring in the break (wash out period) between the first and second medication periods, excepting those originating in the 10 days after endotoxin injection, will not be recorded or reported as stipulated in the protocol.
Adverse events not reported as they are expected as a normal response to endotoxin: Abnormal body temperature, except if \>39 and \<34oC, unless persists at 6 hours post-endotoxin /meets the criteria of SAE; Change in pulse rate, except\>140 and\<45 bpm/if meets criteria for SAE; Increase/decrease in blood pressure from baseline of\<40 mmHg unless an SAE; Self-limiting symptoms due to endotoxaemia at discretion of investigator, unless an SAE; Changes in leukocyte/platelet count or CRP unless SAE
|
0.00%
0/16 • Adverse events and reactions will be recorded and reported from randomisation to 10 days after visit 3 (1st endotoxin injection day), and from visit 6 (start of period 2) to 10 days after visit 7 (2nd endotoxin injection day) as described in the protocol. Thus adverse events occurring in the break (wash out period) between the first and second medication periods, excepting those originating in the 10 days after endotoxin injection, will not be recorded or reported as stipulated in the protocol.
Adverse events not reported as they are expected as a normal response to endotoxin: Abnormal body temperature, except if \>39 and \<34oC, unless persists at 6 hours post-endotoxin /meets the criteria of SAE; Change in pulse rate, except\>140 and\<45 bpm/if meets criteria for SAE; Increase/decrease in blood pressure from baseline of\<40 mmHg unless an SAE; Self-limiting symptoms due to endotoxaemia at discretion of investigator, unless an SAE; Changes in leukocyte/platelet count or CRP unless SAE
|
0.00%
0/17 • Adverse events and reactions will be recorded and reported from randomisation to 10 days after visit 3 (1st endotoxin injection day), and from visit 6 (start of period 2) to 10 days after visit 7 (2nd endotoxin injection day) as described in the protocol. Thus adverse events occurring in the break (wash out period) between the first and second medication periods, excepting those originating in the 10 days after endotoxin injection, will not be recorded or reported as stipulated in the protocol.
Adverse events not reported as they are expected as a normal response to endotoxin: Abnormal body temperature, except if \>39 and \<34oC, unless persists at 6 hours post-endotoxin /meets the criteria of SAE; Change in pulse rate, except\>140 and\<45 bpm/if meets criteria for SAE; Increase/decrease in blood pressure from baseline of\<40 mmHg unless an SAE; Self-limiting symptoms due to endotoxaemia at discretion of investigator, unless an SAE; Changes in leukocyte/platelet count or CRP unless SAE
|
0.00%
0/17 • Adverse events and reactions will be recorded and reported from randomisation to 10 days after visit 3 (1st endotoxin injection day), and from visit 6 (start of period 2) to 10 days after visit 7 (2nd endotoxin injection day) as described in the protocol. Thus adverse events occurring in the break (wash out period) between the first and second medication periods, excepting those originating in the 10 days after endotoxin injection, will not be recorded or reported as stipulated in the protocol.
Adverse events not reported as they are expected as a normal response to endotoxin: Abnormal body temperature, except if \>39 and \<34oC, unless persists at 6 hours post-endotoxin /meets the criteria of SAE; Change in pulse rate, except\>140 and\<45 bpm/if meets criteria for SAE; Increase/decrease in blood pressure from baseline of\<40 mmHg unless an SAE; Self-limiting symptoms due to endotoxaemia at discretion of investigator, unless an SAE; Changes in leukocyte/platelet count or CRP unless SAE
|
0.00%
0/16 • Adverse events and reactions will be recorded and reported from randomisation to 10 days after visit 3 (1st endotoxin injection day), and from visit 6 (start of period 2) to 10 days after visit 7 (2nd endotoxin injection day) as described in the protocol. Thus adverse events occurring in the break (wash out period) between the first and second medication periods, excepting those originating in the 10 days after endotoxin injection, will not be recorded or reported as stipulated in the protocol.
Adverse events not reported as they are expected as a normal response to endotoxin: Abnormal body temperature, except if \>39 and \<34oC, unless persists at 6 hours post-endotoxin /meets the criteria of SAE; Change in pulse rate, except\>140 and\<45 bpm/if meets criteria for SAE; Increase/decrease in blood pressure from baseline of\<40 mmHg unless an SAE; Self-limiting symptoms due to endotoxaemia at discretion of investigator, unless an SAE; Changes in leukocyte/platelet count or CRP unless SAE
|
7.1%
1/14 • Number of events 1 • Adverse events and reactions will be recorded and reported from randomisation to 10 days after visit 3 (1st endotoxin injection day), and from visit 6 (start of period 2) to 10 days after visit 7 (2nd endotoxin injection day) as described in the protocol. Thus adverse events occurring in the break (wash out period) between the first and second medication periods, excepting those originating in the 10 days after endotoxin injection, will not be recorded or reported as stipulated in the protocol.
Adverse events not reported as they are expected as a normal response to endotoxin: Abnormal body temperature, except if \>39 and \<34oC, unless persists at 6 hours post-endotoxin /meets the criteria of SAE; Change in pulse rate, except\>140 and\<45 bpm/if meets criteria for SAE; Increase/decrease in blood pressure from baseline of\<40 mmHg unless an SAE; Self-limiting symptoms due to endotoxaemia at discretion of investigator, unless an SAE; Changes in leukocyte/platelet count or CRP unless SAE
|
0.00%
0/15 • Adverse events and reactions will be recorded and reported from randomisation to 10 days after visit 3 (1st endotoxin injection day), and from visit 6 (start of period 2) to 10 days after visit 7 (2nd endotoxin injection day) as described in the protocol. Thus adverse events occurring in the break (wash out period) between the first and second medication periods, excepting those originating in the 10 days after endotoxin injection, will not be recorded or reported as stipulated in the protocol.
Adverse events not reported as they are expected as a normal response to endotoxin: Abnormal body temperature, except if \>39 and \<34oC, unless persists at 6 hours post-endotoxin /meets the criteria of SAE; Change in pulse rate, except\>140 and\<45 bpm/if meets criteria for SAE; Increase/decrease in blood pressure from baseline of\<40 mmHg unless an SAE; Self-limiting symptoms due to endotoxaemia at discretion of investigator, unless an SAE; Changes in leukocyte/platelet count or CRP unless SAE
|
0.00%
0/15 • Adverse events and reactions will be recorded and reported from randomisation to 10 days after visit 3 (1st endotoxin injection day), and from visit 6 (start of period 2) to 10 days after visit 7 (2nd endotoxin injection day) as described in the protocol. Thus adverse events occurring in the break (wash out period) between the first and second medication periods, excepting those originating in the 10 days after endotoxin injection, will not be recorded or reported as stipulated in the protocol.
Adverse events not reported as they are expected as a normal response to endotoxin: Abnormal body temperature, except if \>39 and \<34oC, unless persists at 6 hours post-endotoxin /meets the criteria of SAE; Change in pulse rate, except\>140 and\<45 bpm/if meets criteria for SAE; Increase/decrease in blood pressure from baseline of\<40 mmHg unless an SAE; Self-limiting symptoms due to endotoxaemia at discretion of investigator, unless an SAE; Changes in leukocyte/platelet count or CRP unless SAE
|
|
Gastrointestinal disorders
nausea
|
0.00%
0/17 • Adverse events and reactions will be recorded and reported from randomisation to 10 days after visit 3 (1st endotoxin injection day), and from visit 6 (start of period 2) to 10 days after visit 7 (2nd endotoxin injection day) as described in the protocol. Thus adverse events occurring in the break (wash out period) between the first and second medication periods, excepting those originating in the 10 days after endotoxin injection, will not be recorded or reported as stipulated in the protocol.
Adverse events not reported as they are expected as a normal response to endotoxin: Abnormal body temperature, except if \>39 and \<34oC, unless persists at 6 hours post-endotoxin /meets the criteria of SAE; Change in pulse rate, except\>140 and\<45 bpm/if meets criteria for SAE; Increase/decrease in blood pressure from baseline of\<40 mmHg unless an SAE; Self-limiting symptoms due to endotoxaemia at discretion of investigator, unless an SAE; Changes in leukocyte/platelet count or CRP unless SAE
|
0.00%
0/16 • Adverse events and reactions will be recorded and reported from randomisation to 10 days after visit 3 (1st endotoxin injection day), and from visit 6 (start of period 2) to 10 days after visit 7 (2nd endotoxin injection day) as described in the protocol. Thus adverse events occurring in the break (wash out period) between the first and second medication periods, excepting those originating in the 10 days after endotoxin injection, will not be recorded or reported as stipulated in the protocol.
Adverse events not reported as they are expected as a normal response to endotoxin: Abnormal body temperature, except if \>39 and \<34oC, unless persists at 6 hours post-endotoxin /meets the criteria of SAE; Change in pulse rate, except\>140 and\<45 bpm/if meets criteria for SAE; Increase/decrease in blood pressure from baseline of\<40 mmHg unless an SAE; Self-limiting symptoms due to endotoxaemia at discretion of investigator, unless an SAE; Changes in leukocyte/platelet count or CRP unless SAE
|
0.00%
0/17 • Adverse events and reactions will be recorded and reported from randomisation to 10 days after visit 3 (1st endotoxin injection day), and from visit 6 (start of period 2) to 10 days after visit 7 (2nd endotoxin injection day) as described in the protocol. Thus adverse events occurring in the break (wash out period) between the first and second medication periods, excepting those originating in the 10 days after endotoxin injection, will not be recorded or reported as stipulated in the protocol.
Adverse events not reported as they are expected as a normal response to endotoxin: Abnormal body temperature, except if \>39 and \<34oC, unless persists at 6 hours post-endotoxin /meets the criteria of SAE; Change in pulse rate, except\>140 and\<45 bpm/if meets criteria for SAE; Increase/decrease in blood pressure from baseline of\<40 mmHg unless an SAE; Self-limiting symptoms due to endotoxaemia at discretion of investigator, unless an SAE; Changes in leukocyte/platelet count or CRP unless SAE
|
0.00%
0/17 • Adverse events and reactions will be recorded and reported from randomisation to 10 days after visit 3 (1st endotoxin injection day), and from visit 6 (start of period 2) to 10 days after visit 7 (2nd endotoxin injection day) as described in the protocol. Thus adverse events occurring in the break (wash out period) between the first and second medication periods, excepting those originating in the 10 days after endotoxin injection, will not be recorded or reported as stipulated in the protocol.
Adverse events not reported as they are expected as a normal response to endotoxin: Abnormal body temperature, except if \>39 and \<34oC, unless persists at 6 hours post-endotoxin /meets the criteria of SAE; Change in pulse rate, except\>140 and\<45 bpm/if meets criteria for SAE; Increase/decrease in blood pressure from baseline of\<40 mmHg unless an SAE; Self-limiting symptoms due to endotoxaemia at discretion of investigator, unless an SAE; Changes in leukocyte/platelet count or CRP unless SAE
|
0.00%
0/16 • Adverse events and reactions will be recorded and reported from randomisation to 10 days after visit 3 (1st endotoxin injection day), and from visit 6 (start of period 2) to 10 days after visit 7 (2nd endotoxin injection day) as described in the protocol. Thus adverse events occurring in the break (wash out period) between the first and second medication periods, excepting those originating in the 10 days after endotoxin injection, will not be recorded or reported as stipulated in the protocol.
Adverse events not reported as they are expected as a normal response to endotoxin: Abnormal body temperature, except if \>39 and \<34oC, unless persists at 6 hours post-endotoxin /meets the criteria of SAE; Change in pulse rate, except\>140 and\<45 bpm/if meets criteria for SAE; Increase/decrease in blood pressure from baseline of\<40 mmHg unless an SAE; Self-limiting symptoms due to endotoxaemia at discretion of investigator, unless an SAE; Changes in leukocyte/platelet count or CRP unless SAE
|
0.00%
0/14 • Adverse events and reactions will be recorded and reported from randomisation to 10 days after visit 3 (1st endotoxin injection day), and from visit 6 (start of period 2) to 10 days after visit 7 (2nd endotoxin injection day) as described in the protocol. Thus adverse events occurring in the break (wash out period) between the first and second medication periods, excepting those originating in the 10 days after endotoxin injection, will not be recorded or reported as stipulated in the protocol.
Adverse events not reported as they are expected as a normal response to endotoxin: Abnormal body temperature, except if \>39 and \<34oC, unless persists at 6 hours post-endotoxin /meets the criteria of SAE; Change in pulse rate, except\>140 and\<45 bpm/if meets criteria for SAE; Increase/decrease in blood pressure from baseline of\<40 mmHg unless an SAE; Self-limiting symptoms due to endotoxaemia at discretion of investigator, unless an SAE; Changes in leukocyte/platelet count or CRP unless SAE
|
6.7%
1/15 • Number of events 1 • Adverse events and reactions will be recorded and reported from randomisation to 10 days after visit 3 (1st endotoxin injection day), and from visit 6 (start of period 2) to 10 days after visit 7 (2nd endotoxin injection day) as described in the protocol. Thus adverse events occurring in the break (wash out period) between the first and second medication periods, excepting those originating in the 10 days after endotoxin injection, will not be recorded or reported as stipulated in the protocol.
Adverse events not reported as they are expected as a normal response to endotoxin: Abnormal body temperature, except if \>39 and \<34oC, unless persists at 6 hours post-endotoxin /meets the criteria of SAE; Change in pulse rate, except\>140 and\<45 bpm/if meets criteria for SAE; Increase/decrease in blood pressure from baseline of\<40 mmHg unless an SAE; Self-limiting symptoms due to endotoxaemia at discretion of investigator, unless an SAE; Changes in leukocyte/platelet count or CRP unless SAE
|
0.00%
0/15 • Adverse events and reactions will be recorded and reported from randomisation to 10 days after visit 3 (1st endotoxin injection day), and from visit 6 (start of period 2) to 10 days after visit 7 (2nd endotoxin injection day) as described in the protocol. Thus adverse events occurring in the break (wash out period) between the first and second medication periods, excepting those originating in the 10 days after endotoxin injection, will not be recorded or reported as stipulated in the protocol.
Adverse events not reported as they are expected as a normal response to endotoxin: Abnormal body temperature, except if \>39 and \<34oC, unless persists at 6 hours post-endotoxin /meets the criteria of SAE; Change in pulse rate, except\>140 and\<45 bpm/if meets criteria for SAE; Increase/decrease in blood pressure from baseline of\<40 mmHg unless an SAE; Self-limiting symptoms due to endotoxaemia at discretion of investigator, unless an SAE; Changes in leukocyte/platelet count or CRP unless SAE
|
|
Injury, poisoning and procedural complications
foot injury
|
0.00%
0/17 • Adverse events and reactions will be recorded and reported from randomisation to 10 days after visit 3 (1st endotoxin injection day), and from visit 6 (start of period 2) to 10 days after visit 7 (2nd endotoxin injection day) as described in the protocol. Thus adverse events occurring in the break (wash out period) between the first and second medication periods, excepting those originating in the 10 days after endotoxin injection, will not be recorded or reported as stipulated in the protocol.
Adverse events not reported as they are expected as a normal response to endotoxin: Abnormal body temperature, except if \>39 and \<34oC, unless persists at 6 hours post-endotoxin /meets the criteria of SAE; Change in pulse rate, except\>140 and\<45 bpm/if meets criteria for SAE; Increase/decrease in blood pressure from baseline of\<40 mmHg unless an SAE; Self-limiting symptoms due to endotoxaemia at discretion of investigator, unless an SAE; Changes in leukocyte/platelet count or CRP unless SAE
|
0.00%
0/16 • Adverse events and reactions will be recorded and reported from randomisation to 10 days after visit 3 (1st endotoxin injection day), and from visit 6 (start of period 2) to 10 days after visit 7 (2nd endotoxin injection day) as described in the protocol. Thus adverse events occurring in the break (wash out period) between the first and second medication periods, excepting those originating in the 10 days after endotoxin injection, will not be recorded or reported as stipulated in the protocol.
Adverse events not reported as they are expected as a normal response to endotoxin: Abnormal body temperature, except if \>39 and \<34oC, unless persists at 6 hours post-endotoxin /meets the criteria of SAE; Change in pulse rate, except\>140 and\<45 bpm/if meets criteria for SAE; Increase/decrease in blood pressure from baseline of\<40 mmHg unless an SAE; Self-limiting symptoms due to endotoxaemia at discretion of investigator, unless an SAE; Changes in leukocyte/platelet count or CRP unless SAE
|
0.00%
0/17 • Adverse events and reactions will be recorded and reported from randomisation to 10 days after visit 3 (1st endotoxin injection day), and from visit 6 (start of period 2) to 10 days after visit 7 (2nd endotoxin injection day) as described in the protocol. Thus adverse events occurring in the break (wash out period) between the first and second medication periods, excepting those originating in the 10 days after endotoxin injection, will not be recorded or reported as stipulated in the protocol.
Adverse events not reported as they are expected as a normal response to endotoxin: Abnormal body temperature, except if \>39 and \<34oC, unless persists at 6 hours post-endotoxin /meets the criteria of SAE; Change in pulse rate, except\>140 and\<45 bpm/if meets criteria for SAE; Increase/decrease in blood pressure from baseline of\<40 mmHg unless an SAE; Self-limiting symptoms due to endotoxaemia at discretion of investigator, unless an SAE; Changes in leukocyte/platelet count or CRP unless SAE
|
0.00%
0/17 • Adverse events and reactions will be recorded and reported from randomisation to 10 days after visit 3 (1st endotoxin injection day), and from visit 6 (start of period 2) to 10 days after visit 7 (2nd endotoxin injection day) as described in the protocol. Thus adverse events occurring in the break (wash out period) between the first and second medication periods, excepting those originating in the 10 days after endotoxin injection, will not be recorded or reported as stipulated in the protocol.
Adverse events not reported as they are expected as a normal response to endotoxin: Abnormal body temperature, except if \>39 and \<34oC, unless persists at 6 hours post-endotoxin /meets the criteria of SAE; Change in pulse rate, except\>140 and\<45 bpm/if meets criteria for SAE; Increase/decrease in blood pressure from baseline of\<40 mmHg unless an SAE; Self-limiting symptoms due to endotoxaemia at discretion of investigator, unless an SAE; Changes in leukocyte/platelet count or CRP unless SAE
|
0.00%
0/16 • Adverse events and reactions will be recorded and reported from randomisation to 10 days after visit 3 (1st endotoxin injection day), and from visit 6 (start of period 2) to 10 days after visit 7 (2nd endotoxin injection day) as described in the protocol. Thus adverse events occurring in the break (wash out period) between the first and second medication periods, excepting those originating in the 10 days after endotoxin injection, will not be recorded or reported as stipulated in the protocol.
Adverse events not reported as they are expected as a normal response to endotoxin: Abnormal body temperature, except if \>39 and \<34oC, unless persists at 6 hours post-endotoxin /meets the criteria of SAE; Change in pulse rate, except\>140 and\<45 bpm/if meets criteria for SAE; Increase/decrease in blood pressure from baseline of\<40 mmHg unless an SAE; Self-limiting symptoms due to endotoxaemia at discretion of investigator, unless an SAE; Changes in leukocyte/platelet count or CRP unless SAE
|
0.00%
0/14 • Adverse events and reactions will be recorded and reported from randomisation to 10 days after visit 3 (1st endotoxin injection day), and from visit 6 (start of period 2) to 10 days after visit 7 (2nd endotoxin injection day) as described in the protocol. Thus adverse events occurring in the break (wash out period) between the first and second medication periods, excepting those originating in the 10 days after endotoxin injection, will not be recorded or reported as stipulated in the protocol.
Adverse events not reported as they are expected as a normal response to endotoxin: Abnormal body temperature, except if \>39 and \<34oC, unless persists at 6 hours post-endotoxin /meets the criteria of SAE; Change in pulse rate, except\>140 and\<45 bpm/if meets criteria for SAE; Increase/decrease in blood pressure from baseline of\<40 mmHg unless an SAE; Self-limiting symptoms due to endotoxaemia at discretion of investigator, unless an SAE; Changes in leukocyte/platelet count or CRP unless SAE
|
6.7%
1/15 • Number of events 1 • Adverse events and reactions will be recorded and reported from randomisation to 10 days after visit 3 (1st endotoxin injection day), and from visit 6 (start of period 2) to 10 days after visit 7 (2nd endotoxin injection day) as described in the protocol. Thus adverse events occurring in the break (wash out period) between the first and second medication periods, excepting those originating in the 10 days after endotoxin injection, will not be recorded or reported as stipulated in the protocol.
Adverse events not reported as they are expected as a normal response to endotoxin: Abnormal body temperature, except if \>39 and \<34oC, unless persists at 6 hours post-endotoxin /meets the criteria of SAE; Change in pulse rate, except\>140 and\<45 bpm/if meets criteria for SAE; Increase/decrease in blood pressure from baseline of\<40 mmHg unless an SAE; Self-limiting symptoms due to endotoxaemia at discretion of investigator, unless an SAE; Changes in leukocyte/platelet count or CRP unless SAE
|
0.00%
0/15 • Adverse events and reactions will be recorded and reported from randomisation to 10 days after visit 3 (1st endotoxin injection day), and from visit 6 (start of period 2) to 10 days after visit 7 (2nd endotoxin injection day) as described in the protocol. Thus adverse events occurring in the break (wash out period) between the first and second medication periods, excepting those originating in the 10 days after endotoxin injection, will not be recorded or reported as stipulated in the protocol.
Adverse events not reported as they are expected as a normal response to endotoxin: Abnormal body temperature, except if \>39 and \<34oC, unless persists at 6 hours post-endotoxin /meets the criteria of SAE; Change in pulse rate, except\>140 and\<45 bpm/if meets criteria for SAE; Increase/decrease in blood pressure from baseline of\<40 mmHg unless an SAE; Self-limiting symptoms due to endotoxaemia at discretion of investigator, unless an SAE; Changes in leukocyte/platelet count or CRP unless SAE
|
|
Respiratory, thoracic and mediastinal disorders
excess phleghm
|
0.00%
0/17 • Adverse events and reactions will be recorded and reported from randomisation to 10 days after visit 3 (1st endotoxin injection day), and from visit 6 (start of period 2) to 10 days after visit 7 (2nd endotoxin injection day) as described in the protocol. Thus adverse events occurring in the break (wash out period) between the first and second medication periods, excepting those originating in the 10 days after endotoxin injection, will not be recorded or reported as stipulated in the protocol.
Adverse events not reported as they are expected as a normal response to endotoxin: Abnormal body temperature, except if \>39 and \<34oC, unless persists at 6 hours post-endotoxin /meets the criteria of SAE; Change in pulse rate, except\>140 and\<45 bpm/if meets criteria for SAE; Increase/decrease in blood pressure from baseline of\<40 mmHg unless an SAE; Self-limiting symptoms due to endotoxaemia at discretion of investigator, unless an SAE; Changes in leukocyte/platelet count or CRP unless SAE
|
0.00%
0/16 • Adverse events and reactions will be recorded and reported from randomisation to 10 days after visit 3 (1st endotoxin injection day), and from visit 6 (start of period 2) to 10 days after visit 7 (2nd endotoxin injection day) as described in the protocol. Thus adverse events occurring in the break (wash out period) between the first and second medication periods, excepting those originating in the 10 days after endotoxin injection, will not be recorded or reported as stipulated in the protocol.
Adverse events not reported as they are expected as a normal response to endotoxin: Abnormal body temperature, except if \>39 and \<34oC, unless persists at 6 hours post-endotoxin /meets the criteria of SAE; Change in pulse rate, except\>140 and\<45 bpm/if meets criteria for SAE; Increase/decrease in blood pressure from baseline of\<40 mmHg unless an SAE; Self-limiting symptoms due to endotoxaemia at discretion of investigator, unless an SAE; Changes in leukocyte/platelet count or CRP unless SAE
|
0.00%
0/17 • Adverse events and reactions will be recorded and reported from randomisation to 10 days after visit 3 (1st endotoxin injection day), and from visit 6 (start of period 2) to 10 days after visit 7 (2nd endotoxin injection day) as described in the protocol. Thus adverse events occurring in the break (wash out period) between the first and second medication periods, excepting those originating in the 10 days after endotoxin injection, will not be recorded or reported as stipulated in the protocol.
Adverse events not reported as they are expected as a normal response to endotoxin: Abnormal body temperature, except if \>39 and \<34oC, unless persists at 6 hours post-endotoxin /meets the criteria of SAE; Change in pulse rate, except\>140 and\<45 bpm/if meets criteria for SAE; Increase/decrease in blood pressure from baseline of\<40 mmHg unless an SAE; Self-limiting symptoms due to endotoxaemia at discretion of investigator, unless an SAE; Changes in leukocyte/platelet count or CRP unless SAE
|
0.00%
0/17 • Adverse events and reactions will be recorded and reported from randomisation to 10 days after visit 3 (1st endotoxin injection day), and from visit 6 (start of period 2) to 10 days after visit 7 (2nd endotoxin injection day) as described in the protocol. Thus adverse events occurring in the break (wash out period) between the first and second medication periods, excepting those originating in the 10 days after endotoxin injection, will not be recorded or reported as stipulated in the protocol.
Adverse events not reported as they are expected as a normal response to endotoxin: Abnormal body temperature, except if \>39 and \<34oC, unless persists at 6 hours post-endotoxin /meets the criteria of SAE; Change in pulse rate, except\>140 and\<45 bpm/if meets criteria for SAE; Increase/decrease in blood pressure from baseline of\<40 mmHg unless an SAE; Self-limiting symptoms due to endotoxaemia at discretion of investigator, unless an SAE; Changes in leukocyte/platelet count or CRP unless SAE
|
0.00%
0/16 • Adverse events and reactions will be recorded and reported from randomisation to 10 days after visit 3 (1st endotoxin injection day), and from visit 6 (start of period 2) to 10 days after visit 7 (2nd endotoxin injection day) as described in the protocol. Thus adverse events occurring in the break (wash out period) between the first and second medication periods, excepting those originating in the 10 days after endotoxin injection, will not be recorded or reported as stipulated in the protocol.
Adverse events not reported as they are expected as a normal response to endotoxin: Abnormal body temperature, except if \>39 and \<34oC, unless persists at 6 hours post-endotoxin /meets the criteria of SAE; Change in pulse rate, except\>140 and\<45 bpm/if meets criteria for SAE; Increase/decrease in blood pressure from baseline of\<40 mmHg unless an SAE; Self-limiting symptoms due to endotoxaemia at discretion of investigator, unless an SAE; Changes in leukocyte/platelet count or CRP unless SAE
|
0.00%
0/14 • Adverse events and reactions will be recorded and reported from randomisation to 10 days after visit 3 (1st endotoxin injection day), and from visit 6 (start of period 2) to 10 days after visit 7 (2nd endotoxin injection day) as described in the protocol. Thus adverse events occurring in the break (wash out period) between the first and second medication periods, excepting those originating in the 10 days after endotoxin injection, will not be recorded or reported as stipulated in the protocol.
Adverse events not reported as they are expected as a normal response to endotoxin: Abnormal body temperature, except if \>39 and \<34oC, unless persists at 6 hours post-endotoxin /meets the criteria of SAE; Change in pulse rate, except\>140 and\<45 bpm/if meets criteria for SAE; Increase/decrease in blood pressure from baseline of\<40 mmHg unless an SAE; Self-limiting symptoms due to endotoxaemia at discretion of investigator, unless an SAE; Changes in leukocyte/platelet count or CRP unless SAE
|
6.7%
1/15 • Number of events 1 • Adverse events and reactions will be recorded and reported from randomisation to 10 days after visit 3 (1st endotoxin injection day), and from visit 6 (start of period 2) to 10 days after visit 7 (2nd endotoxin injection day) as described in the protocol. Thus adverse events occurring in the break (wash out period) between the first and second medication periods, excepting those originating in the 10 days after endotoxin injection, will not be recorded or reported as stipulated in the protocol.
Adverse events not reported as they are expected as a normal response to endotoxin: Abnormal body temperature, except if \>39 and \<34oC, unless persists at 6 hours post-endotoxin /meets the criteria of SAE; Change in pulse rate, except\>140 and\<45 bpm/if meets criteria for SAE; Increase/decrease in blood pressure from baseline of\<40 mmHg unless an SAE; Self-limiting symptoms due to endotoxaemia at discretion of investigator, unless an SAE; Changes in leukocyte/platelet count or CRP unless SAE
|
0.00%
0/15 • Adverse events and reactions will be recorded and reported from randomisation to 10 days after visit 3 (1st endotoxin injection day), and from visit 6 (start of period 2) to 10 days after visit 7 (2nd endotoxin injection day) as described in the protocol. Thus adverse events occurring in the break (wash out period) between the first and second medication periods, excepting those originating in the 10 days after endotoxin injection, will not be recorded or reported as stipulated in the protocol.
Adverse events not reported as they are expected as a normal response to endotoxin: Abnormal body temperature, except if \>39 and \<34oC, unless persists at 6 hours post-endotoxin /meets the criteria of SAE; Change in pulse rate, except\>140 and\<45 bpm/if meets criteria for SAE; Increase/decrease in blood pressure from baseline of\<40 mmHg unless an SAE; Self-limiting symptoms due to endotoxaemia at discretion of investigator, unless an SAE; Changes in leukocyte/platelet count or CRP unless SAE
|
|
Nervous system disorders
migraine
|
0.00%
0/17 • Adverse events and reactions will be recorded and reported from randomisation to 10 days after visit 3 (1st endotoxin injection day), and from visit 6 (start of period 2) to 10 days after visit 7 (2nd endotoxin injection day) as described in the protocol. Thus adverse events occurring in the break (wash out period) between the first and second medication periods, excepting those originating in the 10 days after endotoxin injection, will not be recorded or reported as stipulated in the protocol.
Adverse events not reported as they are expected as a normal response to endotoxin: Abnormal body temperature, except if \>39 and \<34oC, unless persists at 6 hours post-endotoxin /meets the criteria of SAE; Change in pulse rate, except\>140 and\<45 bpm/if meets criteria for SAE; Increase/decrease in blood pressure from baseline of\<40 mmHg unless an SAE; Self-limiting symptoms due to endotoxaemia at discretion of investigator, unless an SAE; Changes in leukocyte/platelet count or CRP unless SAE
|
0.00%
0/16 • Adverse events and reactions will be recorded and reported from randomisation to 10 days after visit 3 (1st endotoxin injection day), and from visit 6 (start of period 2) to 10 days after visit 7 (2nd endotoxin injection day) as described in the protocol. Thus adverse events occurring in the break (wash out period) between the first and second medication periods, excepting those originating in the 10 days after endotoxin injection, will not be recorded or reported as stipulated in the protocol.
Adverse events not reported as they are expected as a normal response to endotoxin: Abnormal body temperature, except if \>39 and \<34oC, unless persists at 6 hours post-endotoxin /meets the criteria of SAE; Change in pulse rate, except\>140 and\<45 bpm/if meets criteria for SAE; Increase/decrease in blood pressure from baseline of\<40 mmHg unless an SAE; Self-limiting symptoms due to endotoxaemia at discretion of investigator, unless an SAE; Changes in leukocyte/platelet count or CRP unless SAE
|
0.00%
0/17 • Adverse events and reactions will be recorded and reported from randomisation to 10 days after visit 3 (1st endotoxin injection day), and from visit 6 (start of period 2) to 10 days after visit 7 (2nd endotoxin injection day) as described in the protocol. Thus adverse events occurring in the break (wash out period) between the first and second medication periods, excepting those originating in the 10 days after endotoxin injection, will not be recorded or reported as stipulated in the protocol.
Adverse events not reported as they are expected as a normal response to endotoxin: Abnormal body temperature, except if \>39 and \<34oC, unless persists at 6 hours post-endotoxin /meets the criteria of SAE; Change in pulse rate, except\>140 and\<45 bpm/if meets criteria for SAE; Increase/decrease in blood pressure from baseline of\<40 mmHg unless an SAE; Self-limiting symptoms due to endotoxaemia at discretion of investigator, unless an SAE; Changes in leukocyte/platelet count or CRP unless SAE
|
0.00%
0/17 • Adverse events and reactions will be recorded and reported from randomisation to 10 days after visit 3 (1st endotoxin injection day), and from visit 6 (start of period 2) to 10 days after visit 7 (2nd endotoxin injection day) as described in the protocol. Thus adverse events occurring in the break (wash out period) between the first and second medication periods, excepting those originating in the 10 days after endotoxin injection, will not be recorded or reported as stipulated in the protocol.
Adverse events not reported as they are expected as a normal response to endotoxin: Abnormal body temperature, except if \>39 and \<34oC, unless persists at 6 hours post-endotoxin /meets the criteria of SAE; Change in pulse rate, except\>140 and\<45 bpm/if meets criteria for SAE; Increase/decrease in blood pressure from baseline of\<40 mmHg unless an SAE; Self-limiting symptoms due to endotoxaemia at discretion of investigator, unless an SAE; Changes in leukocyte/platelet count or CRP unless SAE
|
6.2%
1/16 • Number of events 1 • Adverse events and reactions will be recorded and reported from randomisation to 10 days after visit 3 (1st endotoxin injection day), and from visit 6 (start of period 2) to 10 days after visit 7 (2nd endotoxin injection day) as described in the protocol. Thus adverse events occurring in the break (wash out period) between the first and second medication periods, excepting those originating in the 10 days after endotoxin injection, will not be recorded or reported as stipulated in the protocol.
Adverse events not reported as they are expected as a normal response to endotoxin: Abnormal body temperature, except if \>39 and \<34oC, unless persists at 6 hours post-endotoxin /meets the criteria of SAE; Change in pulse rate, except\>140 and\<45 bpm/if meets criteria for SAE; Increase/decrease in blood pressure from baseline of\<40 mmHg unless an SAE; Self-limiting symptoms due to endotoxaemia at discretion of investigator, unless an SAE; Changes in leukocyte/platelet count or CRP unless SAE
|
0.00%
0/14 • Adverse events and reactions will be recorded and reported from randomisation to 10 days after visit 3 (1st endotoxin injection day), and from visit 6 (start of period 2) to 10 days after visit 7 (2nd endotoxin injection day) as described in the protocol. Thus adverse events occurring in the break (wash out period) between the first and second medication periods, excepting those originating in the 10 days after endotoxin injection, will not be recorded or reported as stipulated in the protocol.
Adverse events not reported as they are expected as a normal response to endotoxin: Abnormal body temperature, except if \>39 and \<34oC, unless persists at 6 hours post-endotoxin /meets the criteria of SAE; Change in pulse rate, except\>140 and\<45 bpm/if meets criteria for SAE; Increase/decrease in blood pressure from baseline of\<40 mmHg unless an SAE; Self-limiting symptoms due to endotoxaemia at discretion of investigator, unless an SAE; Changes in leukocyte/platelet count or CRP unless SAE
|
0.00%
0/15 • Adverse events and reactions will be recorded and reported from randomisation to 10 days after visit 3 (1st endotoxin injection day), and from visit 6 (start of period 2) to 10 days after visit 7 (2nd endotoxin injection day) as described in the protocol. Thus adverse events occurring in the break (wash out period) between the first and second medication periods, excepting those originating in the 10 days after endotoxin injection, will not be recorded or reported as stipulated in the protocol.
Adverse events not reported as they are expected as a normal response to endotoxin: Abnormal body temperature, except if \>39 and \<34oC, unless persists at 6 hours post-endotoxin /meets the criteria of SAE; Change in pulse rate, except\>140 and\<45 bpm/if meets criteria for SAE; Increase/decrease in blood pressure from baseline of\<40 mmHg unless an SAE; Self-limiting symptoms due to endotoxaemia at discretion of investigator, unless an SAE; Changes in leukocyte/platelet count or CRP unless SAE
|
0.00%
0/15 • Adverse events and reactions will be recorded and reported from randomisation to 10 days after visit 3 (1st endotoxin injection day), and from visit 6 (start of period 2) to 10 days after visit 7 (2nd endotoxin injection day) as described in the protocol. Thus adverse events occurring in the break (wash out period) between the first and second medication periods, excepting those originating in the 10 days after endotoxin injection, will not be recorded or reported as stipulated in the protocol.
Adverse events not reported as they are expected as a normal response to endotoxin: Abnormal body temperature, except if \>39 and \<34oC, unless persists at 6 hours post-endotoxin /meets the criteria of SAE; Change in pulse rate, except\>140 and\<45 bpm/if meets criteria for SAE; Increase/decrease in blood pressure from baseline of\<40 mmHg unless an SAE; Self-limiting symptoms due to endotoxaemia at discretion of investigator, unless an SAE; Changes in leukocyte/platelet count or CRP unless SAE
|
|
Injury, poisoning and procedural complications
fall
|
0.00%
0/17 • Adverse events and reactions will be recorded and reported from randomisation to 10 days after visit 3 (1st endotoxin injection day), and from visit 6 (start of period 2) to 10 days after visit 7 (2nd endotoxin injection day) as described in the protocol. Thus adverse events occurring in the break (wash out period) between the first and second medication periods, excepting those originating in the 10 days after endotoxin injection, will not be recorded or reported as stipulated in the protocol.
Adverse events not reported as they are expected as a normal response to endotoxin: Abnormal body temperature, except if \>39 and \<34oC, unless persists at 6 hours post-endotoxin /meets the criteria of SAE; Change in pulse rate, except\>140 and\<45 bpm/if meets criteria for SAE; Increase/decrease in blood pressure from baseline of\<40 mmHg unless an SAE; Self-limiting symptoms due to endotoxaemia at discretion of investigator, unless an SAE; Changes in leukocyte/platelet count or CRP unless SAE
|
0.00%
0/16 • Adverse events and reactions will be recorded and reported from randomisation to 10 days after visit 3 (1st endotoxin injection day), and from visit 6 (start of period 2) to 10 days after visit 7 (2nd endotoxin injection day) as described in the protocol. Thus adverse events occurring in the break (wash out period) between the first and second medication periods, excepting those originating in the 10 days after endotoxin injection, will not be recorded or reported as stipulated in the protocol.
Adverse events not reported as they are expected as a normal response to endotoxin: Abnormal body temperature, except if \>39 and \<34oC, unless persists at 6 hours post-endotoxin /meets the criteria of SAE; Change in pulse rate, except\>140 and\<45 bpm/if meets criteria for SAE; Increase/decrease in blood pressure from baseline of\<40 mmHg unless an SAE; Self-limiting symptoms due to endotoxaemia at discretion of investigator, unless an SAE; Changes in leukocyte/platelet count or CRP unless SAE
|
5.9%
1/17 • Number of events 1 • Adverse events and reactions will be recorded and reported from randomisation to 10 days after visit 3 (1st endotoxin injection day), and from visit 6 (start of period 2) to 10 days after visit 7 (2nd endotoxin injection day) as described in the protocol. Thus adverse events occurring in the break (wash out period) between the first and second medication periods, excepting those originating in the 10 days after endotoxin injection, will not be recorded or reported as stipulated in the protocol.
Adverse events not reported as they are expected as a normal response to endotoxin: Abnormal body temperature, except if \>39 and \<34oC, unless persists at 6 hours post-endotoxin /meets the criteria of SAE; Change in pulse rate, except\>140 and\<45 bpm/if meets criteria for SAE; Increase/decrease in blood pressure from baseline of\<40 mmHg unless an SAE; Self-limiting symptoms due to endotoxaemia at discretion of investigator, unless an SAE; Changes in leukocyte/platelet count or CRP unless SAE
|
0.00%
0/17 • Adverse events and reactions will be recorded and reported from randomisation to 10 days after visit 3 (1st endotoxin injection day), and from visit 6 (start of period 2) to 10 days after visit 7 (2nd endotoxin injection day) as described in the protocol. Thus adverse events occurring in the break (wash out period) between the first and second medication periods, excepting those originating in the 10 days after endotoxin injection, will not be recorded or reported as stipulated in the protocol.
Adverse events not reported as they are expected as a normal response to endotoxin: Abnormal body temperature, except if \>39 and \<34oC, unless persists at 6 hours post-endotoxin /meets the criteria of SAE; Change in pulse rate, except\>140 and\<45 bpm/if meets criteria for SAE; Increase/decrease in blood pressure from baseline of\<40 mmHg unless an SAE; Self-limiting symptoms due to endotoxaemia at discretion of investigator, unless an SAE; Changes in leukocyte/platelet count or CRP unless SAE
|
0.00%
0/16 • Adverse events and reactions will be recorded and reported from randomisation to 10 days after visit 3 (1st endotoxin injection day), and from visit 6 (start of period 2) to 10 days after visit 7 (2nd endotoxin injection day) as described in the protocol. Thus adverse events occurring in the break (wash out period) between the first and second medication periods, excepting those originating in the 10 days after endotoxin injection, will not be recorded or reported as stipulated in the protocol.
Adverse events not reported as they are expected as a normal response to endotoxin: Abnormal body temperature, except if \>39 and \<34oC, unless persists at 6 hours post-endotoxin /meets the criteria of SAE; Change in pulse rate, except\>140 and\<45 bpm/if meets criteria for SAE; Increase/decrease in blood pressure from baseline of\<40 mmHg unless an SAE; Self-limiting symptoms due to endotoxaemia at discretion of investigator, unless an SAE; Changes in leukocyte/platelet count or CRP unless SAE
|
0.00%
0/14 • Adverse events and reactions will be recorded and reported from randomisation to 10 days after visit 3 (1st endotoxin injection day), and from visit 6 (start of period 2) to 10 days after visit 7 (2nd endotoxin injection day) as described in the protocol. Thus adverse events occurring in the break (wash out period) between the first and second medication periods, excepting those originating in the 10 days after endotoxin injection, will not be recorded or reported as stipulated in the protocol.
Adverse events not reported as they are expected as a normal response to endotoxin: Abnormal body temperature, except if \>39 and \<34oC, unless persists at 6 hours post-endotoxin /meets the criteria of SAE; Change in pulse rate, except\>140 and\<45 bpm/if meets criteria for SAE; Increase/decrease in blood pressure from baseline of\<40 mmHg unless an SAE; Self-limiting symptoms due to endotoxaemia at discretion of investigator, unless an SAE; Changes in leukocyte/platelet count or CRP unless SAE
|
0.00%
0/15 • Adverse events and reactions will be recorded and reported from randomisation to 10 days after visit 3 (1st endotoxin injection day), and from visit 6 (start of period 2) to 10 days after visit 7 (2nd endotoxin injection day) as described in the protocol. Thus adverse events occurring in the break (wash out period) between the first and second medication periods, excepting those originating in the 10 days after endotoxin injection, will not be recorded or reported as stipulated in the protocol.
Adverse events not reported as they are expected as a normal response to endotoxin: Abnormal body temperature, except if \>39 and \<34oC, unless persists at 6 hours post-endotoxin /meets the criteria of SAE; Change in pulse rate, except\>140 and\<45 bpm/if meets criteria for SAE; Increase/decrease in blood pressure from baseline of\<40 mmHg unless an SAE; Self-limiting symptoms due to endotoxaemia at discretion of investigator, unless an SAE; Changes in leukocyte/platelet count or CRP unless SAE
|
0.00%
0/15 • Adverse events and reactions will be recorded and reported from randomisation to 10 days after visit 3 (1st endotoxin injection day), and from visit 6 (start of period 2) to 10 days after visit 7 (2nd endotoxin injection day) as described in the protocol. Thus adverse events occurring in the break (wash out period) between the first and second medication periods, excepting those originating in the 10 days after endotoxin injection, will not be recorded or reported as stipulated in the protocol.
Adverse events not reported as they are expected as a normal response to endotoxin: Abnormal body temperature, except if \>39 and \<34oC, unless persists at 6 hours post-endotoxin /meets the criteria of SAE; Change in pulse rate, except\>140 and\<45 bpm/if meets criteria for SAE; Increase/decrease in blood pressure from baseline of\<40 mmHg unless an SAE; Self-limiting symptoms due to endotoxaemia at discretion of investigator, unless an SAE; Changes in leukocyte/platelet count or CRP unless SAE
|
|
Nervous system disorders
vasovagal episode
|
0.00%
0/17 • Adverse events and reactions will be recorded and reported from randomisation to 10 days after visit 3 (1st endotoxin injection day), and from visit 6 (start of period 2) to 10 days after visit 7 (2nd endotoxin injection day) as described in the protocol. Thus adverse events occurring in the break (wash out period) between the first and second medication periods, excepting those originating in the 10 days after endotoxin injection, will not be recorded or reported as stipulated in the protocol.
Adverse events not reported as they are expected as a normal response to endotoxin: Abnormal body temperature, except if \>39 and \<34oC, unless persists at 6 hours post-endotoxin /meets the criteria of SAE; Change in pulse rate, except\>140 and\<45 bpm/if meets criteria for SAE; Increase/decrease in blood pressure from baseline of\<40 mmHg unless an SAE; Self-limiting symptoms due to endotoxaemia at discretion of investigator, unless an SAE; Changes in leukocyte/platelet count or CRP unless SAE
|
0.00%
0/16 • Adverse events and reactions will be recorded and reported from randomisation to 10 days after visit 3 (1st endotoxin injection day), and from visit 6 (start of period 2) to 10 days after visit 7 (2nd endotoxin injection day) as described in the protocol. Thus adverse events occurring in the break (wash out period) between the first and second medication periods, excepting those originating in the 10 days after endotoxin injection, will not be recorded or reported as stipulated in the protocol.
Adverse events not reported as they are expected as a normal response to endotoxin: Abnormal body temperature, except if \>39 and \<34oC, unless persists at 6 hours post-endotoxin /meets the criteria of SAE; Change in pulse rate, except\>140 and\<45 bpm/if meets criteria for SAE; Increase/decrease in blood pressure from baseline of\<40 mmHg unless an SAE; Self-limiting symptoms due to endotoxaemia at discretion of investigator, unless an SAE; Changes in leukocyte/platelet count or CRP unless SAE
|
0.00%
0/17 • Adverse events and reactions will be recorded and reported from randomisation to 10 days after visit 3 (1st endotoxin injection day), and from visit 6 (start of period 2) to 10 days after visit 7 (2nd endotoxin injection day) as described in the protocol. Thus adverse events occurring in the break (wash out period) between the first and second medication periods, excepting those originating in the 10 days after endotoxin injection, will not be recorded or reported as stipulated in the protocol.
Adverse events not reported as they are expected as a normal response to endotoxin: Abnormal body temperature, except if \>39 and \<34oC, unless persists at 6 hours post-endotoxin /meets the criteria of SAE; Change in pulse rate, except\>140 and\<45 bpm/if meets criteria for SAE; Increase/decrease in blood pressure from baseline of\<40 mmHg unless an SAE; Self-limiting symptoms due to endotoxaemia at discretion of investigator, unless an SAE; Changes in leukocyte/platelet count or CRP unless SAE
|
0.00%
0/17 • Adverse events and reactions will be recorded and reported from randomisation to 10 days after visit 3 (1st endotoxin injection day), and from visit 6 (start of period 2) to 10 days after visit 7 (2nd endotoxin injection day) as described in the protocol. Thus adverse events occurring in the break (wash out period) between the first and second medication periods, excepting those originating in the 10 days after endotoxin injection, will not be recorded or reported as stipulated in the protocol.
Adverse events not reported as they are expected as a normal response to endotoxin: Abnormal body temperature, except if \>39 and \<34oC, unless persists at 6 hours post-endotoxin /meets the criteria of SAE; Change in pulse rate, except\>140 and\<45 bpm/if meets criteria for SAE; Increase/decrease in blood pressure from baseline of\<40 mmHg unless an SAE; Self-limiting symptoms due to endotoxaemia at discretion of investigator, unless an SAE; Changes in leukocyte/platelet count or CRP unless SAE
|
0.00%
0/16 • Adverse events and reactions will be recorded and reported from randomisation to 10 days after visit 3 (1st endotoxin injection day), and from visit 6 (start of period 2) to 10 days after visit 7 (2nd endotoxin injection day) as described in the protocol. Thus adverse events occurring in the break (wash out period) between the first and second medication periods, excepting those originating in the 10 days after endotoxin injection, will not be recorded or reported as stipulated in the protocol.
Adverse events not reported as they are expected as a normal response to endotoxin: Abnormal body temperature, except if \>39 and \<34oC, unless persists at 6 hours post-endotoxin /meets the criteria of SAE; Change in pulse rate, except\>140 and\<45 bpm/if meets criteria for SAE; Increase/decrease in blood pressure from baseline of\<40 mmHg unless an SAE; Self-limiting symptoms due to endotoxaemia at discretion of investigator, unless an SAE; Changes in leukocyte/platelet count or CRP unless SAE
|
7.1%
1/14 • Number of events 1 • Adverse events and reactions will be recorded and reported from randomisation to 10 days after visit 3 (1st endotoxin injection day), and from visit 6 (start of period 2) to 10 days after visit 7 (2nd endotoxin injection day) as described in the protocol. Thus adverse events occurring in the break (wash out period) between the first and second medication periods, excepting those originating in the 10 days after endotoxin injection, will not be recorded or reported as stipulated in the protocol.
Adverse events not reported as they are expected as a normal response to endotoxin: Abnormal body temperature, except if \>39 and \<34oC, unless persists at 6 hours post-endotoxin /meets the criteria of SAE; Change in pulse rate, except\>140 and\<45 bpm/if meets criteria for SAE; Increase/decrease in blood pressure from baseline of\<40 mmHg unless an SAE; Self-limiting symptoms due to endotoxaemia at discretion of investigator, unless an SAE; Changes in leukocyte/platelet count or CRP unless SAE
|
0.00%
0/15 • Adverse events and reactions will be recorded and reported from randomisation to 10 days after visit 3 (1st endotoxin injection day), and from visit 6 (start of period 2) to 10 days after visit 7 (2nd endotoxin injection day) as described in the protocol. Thus adverse events occurring in the break (wash out period) between the first and second medication periods, excepting those originating in the 10 days after endotoxin injection, will not be recorded or reported as stipulated in the protocol.
Adverse events not reported as they are expected as a normal response to endotoxin: Abnormal body temperature, except if \>39 and \<34oC, unless persists at 6 hours post-endotoxin /meets the criteria of SAE; Change in pulse rate, except\>140 and\<45 bpm/if meets criteria for SAE; Increase/decrease in blood pressure from baseline of\<40 mmHg unless an SAE; Self-limiting symptoms due to endotoxaemia at discretion of investigator, unless an SAE; Changes in leukocyte/platelet count or CRP unless SAE
|
0.00%
0/15 • Adverse events and reactions will be recorded and reported from randomisation to 10 days after visit 3 (1st endotoxin injection day), and from visit 6 (start of period 2) to 10 days after visit 7 (2nd endotoxin injection day) as described in the protocol. Thus adverse events occurring in the break (wash out period) between the first and second medication periods, excepting those originating in the 10 days after endotoxin injection, will not be recorded or reported as stipulated in the protocol.
Adverse events not reported as they are expected as a normal response to endotoxin: Abnormal body temperature, except if \>39 and \<34oC, unless persists at 6 hours post-endotoxin /meets the criteria of SAE; Change in pulse rate, except\>140 and\<45 bpm/if meets criteria for SAE; Increase/decrease in blood pressure from baseline of\<40 mmHg unless an SAE; Self-limiting symptoms due to endotoxaemia at discretion of investigator, unless an SAE; Changes in leukocyte/platelet count or CRP unless SAE
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place