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GR270773 In The Treatment Of Suspected Or Confirmed Gram-Negative Severe Sepsis In Adults

Sponsor
GlaxoSmithKline (Industry)
Overall Status
Completed
CT.gov ID
NCT00089986
Collaborator
(none)
1,415
Enrollment
390
Locations
31.4
Duration (Months)
3.6
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The primary objective is to estimate the size of the GR270773 treatment effect on 28-day all-cause mortality for two doses of GR270773 versus placebo in adult subjects with suspected or confirmed Gram-negative severe sepsis. GR270773 will be administered as a three-day continuous intravenous infusion.

Condition or Disease Intervention/Treatment Phase
  • Drug: Intravenous GR270773- Phospholipid Emulsion
  • Other: Placebo
 Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
1415 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Primary Purpose:
Treatment
Official Title:
A Prospective, Randomized, Double-blind, Placebo Controlled, Dose Ranging, Multi-Center Study of the Safety and Efficacy of Three Days Continuous Intravenous Infusion of GR270773 in the Treatment of Suspected or Confirmed Gram-negative Severe Sepsis in Adults
Study Start Date :
Sep 1, 2004
Actual Primary Completion Date :
Apr 1, 2007
Actual Study Completion Date :
Apr 15, 2007

Outcome Measures

Primary Outcome Measures

  1. Percentage of Participants With 28-Day All Cause Mortality [Day 1 (post-infusion) up to Day 28 Follow-up]

    Mortality was assessed by the number of participants who died between days 1 and 28. A summary of death details was given which included whether the participant died between days 1 and 28, whether the death was related sepsis, cause of death, the source of the information, and whether the cause of death was verified by a death record. Participants who had withdrawn from study and all study assessments and for whom survival at day 28 could not be confirmed was treated as deaths for the primary endpoint. The difference in all-cause 28-day mortality rates for each treatment group versus the placebo group in the ITT Population was calculated as placebo - treatment.

Secondary Outcome Measures

  1. Number of Participants With New Onset Organ Failure, Regardless of Cause, Occurring During the 28 Days Post Enrollment in an Organ Not in Failure at Enrolment [Baseline (Day 1, pre-infusion) up to Day 28 Follow-up]

    The new onset organ failure was defined as first time each of the following criteria were met after start of study medication up to Day 28. Respiratory failure: defined by requiring mechanical ventilation not less than 24 hours due to surgery. Renal failure: defined by requiring the initiation of hemodialysis or hemofiltration. Coagulopathy: defined by disseminated intravascular coagulation (DIC) requiring transfusion with platelets or fresh frozen plasma or anticoagulant therapy. Cardiovascular failure: defined by sustained hypotension requiring vasopressor support of dopamine >5 microgram per kilogram per minute (µg/kg/min), epinephrine, norepinephrine, phenylephrine or vasopressin at any dose if used to increase blood pressure for >=6 continuous h. Analysis was done treating the death as a new onset organ failure (counted in both the numerator and denominator).

  2. Number of Participants With New Onset Organ Failure of Respiratory Failure, Cardiovascular Failure, Renal Failure and Coagulopathy, Regardless of Cause, Occurring During the 28 Days Post Enrollment in an Organ Not in Failure at Enrollment [Baseline (Day 1, pre-infusion) up to Day 28 Follow up]

    Respiratory failure: defined by requiring mechanical ventilation not less than 24 hours due to surgery. Renal failure: defined by requiring the initiation of hemodialysis or hemofiltration. Coagulopathy: defined by disseminated intravascular coagulation (DIC) requiring transfusion with platelets or fresh frozen plasma or anticoagulant therapy. Cardiovascular failure: defined by sustained hypotension requiring vasopressor support of dopamine >5 microgram per kilogram per minute (µg/kg/min), epinephrine, norepinephrine, phenylephrine or vasopressin at any dose if used to increase blood pressure for >=6 continuous h. For each organ failure type and the number of new onset organ failures per participants for each organ failure type, the denominator only included participants who did not have that type of organ failure at Baseline. At Baseline a participant could enter the study with a type of organ failure, that type of failure was not reported as a new onset organ failure.

  3. Assessment of Safety/Tolerability by Determining the Number of Participants With Any Adverse Events (AE), Serious Adverse Events (SAE) and Fatal SAE [Day 1 (pre-infusion) up to Day 28 Follow-up]

    An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect, may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in this definition or common toxicity criteria (CTC) grade 4 laboratory abnormalities of national cancer institute not associated with the underlying sepsis unless more severe than expected for the participants condition.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion criteria:

  • Receiving parenteral antibiotic therapy for a suspected or confirmed Gram-negative infection.

  • Have at least one new hypoperfusion abnormality or at least one new onset organ failure resulting from the current septic episode.

  • Must be available and able to receive the first dose of study medication no more than 12 hours after the confirmation of a new hypoperfusion abnormality or new onset organ failure and within 36 hours after the initiation of new parenteral antibacterial therapy for the suspected or confirmed Gram-negative infection believed to be responsible for this episode of sepsis.

Exclusion criteria:

  • Subject is unlikely to remain in hospital for a minimum of three days (72 hours) following enrollment.

  • Subject has neutropenia (e.g., subject recently receiving cytotoxic chemotherapy with absolute neutrophil count <500/mcL or expected to decline to <500/mcL in the next 3 days).

  • Subject has known active hemolytic disease, immune hemolytic anemias, hemoglobinopathies (sickle cell anemia and thalassemia major).

  • Subject has a known bone marrow disorder of inadequate red cell production (eg, aplastic anemia, myelodysplasia).

  • Subject is at increased risk of complications from GR270773-related hemolysis due to the inability to increase cardiac function sufficiently to meet the demands for oxygen delivery.

  • Subject has a baseline hemoglobin (measured after adequate volume resuscitation) <9.0 g/dL (5.59 mmol/L).

  • Subject is currently being treated with XIGRIS (Drotrecogin alfa (activated)) or its use is considered imminent (ie., a decision to treat with XIGRIS has been made).

  • Subject has a history of allergic reaction to eggs (or egg products), soybeans, INTRALIPID, or any component of GR270773.

  • Subject has been designated as 'not full support do not resuscitate' (DNR), or other equivalent status which prohibits the use of life supporting interventions (e.g., mechanical ventilation, dialysis/hemofiltration, or others) thereby limiting the treatment options available.

Note: Subjects with advanced directives prohibiting only chest compression (CPR) are eligible for the study.

  • Subject has preexisting severe liver disease such as cirrhosis, primary biliary cirrhosis or known preexisting Child-Pugh class B or C liver dysfunction.

  • Subject is moribund (a state in which death is perceived to be imminent) or has a life expectancy of less than 3 months due to an underlying disease.

  • Subject is currently receiving one of the following prohibited concomitant medications; parenteral nutrition supplements containing lipid emulsions (e.g., INTRALIPID), amphotericin, liposomal amphotericin, or amphotericin B lipid complex.

Contacts and Locations

Locations

Site City State Country Postal Code
1 GSK Investigational Site Birmingham Alabama United States 35294
2 GSK Investigational Site Phoenix Arizona United States 85006
3 GSK Investigational Site Tucson Arizona United States 85711
4 GSK Investigational Site Tucson Arizona United States 85724
5 GSK Investigational Site Bentonville Arkansas United States 71712
6 GSK Investigational Site Little Rock Arkansas United States 72205
7 GSK Investigational Site Fresno California United States 93720
8 GSK Investigational Site Fullerton California United States 92835
9 GSK Investigational Site Loma Linda California United States 92534
10 GSK Investigational Site Los Angeles California United States 90089
11 GSK Investigational Site Orange California United States 92868
12 GSK Investigational Site Sacramento California United States 95816
13 GSK Investigational Site Sacramento California United States 95819
14 GSK Investigational Site San Jose California United States 95119
15 GSK Investigational Site Stanford California United States 94305
16 GSK Investigational Site Torrance California United States 90509
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18 GSK Investigational Site Colorado Springs Colorado United States 80919
19 GSK Investigational Site Denver Colorado United States 80204
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230 GSK Investigational Site Heidelberg Baden-Wuerttemberg Germany 69126
231 GSK Investigational Site Mannheim Baden-Wuerttemberg Germany 68167
232 GSK Investigational Site Augsburg Bayern Germany 86156
233 GSK Investigational Site Erlangen Bayern Germany 91054
234 GSK Investigational Site Muenchen Bayern Germany 80804
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239 GSK Investigational Site Marburg Hessen Germany 35043
240 GSK Investigational Site Greifswald Mecklenburg-Vorpommern Germany 17487
241 GSK Investigational Site Neubrandenburg Mecklenburg-Vorpommern Germany 17036
242 GSK Investigational Site Rostock Mecklenburg-Vorpommern Germany 18057
243 GSK Investigational Site Schwerin Mecklenburg-Vorpommern Germany 19055
244 GSK Investigational Site Wismar Mecklenburg-Vorpommern Germany 23966
245 GSK Investigational Site Goettingen Niedersachsen Germany 37075
246 GSK Investigational Site Hannover Niedersachsen Germany 30625
247 GSK Investigational Site Hannover Niedersachsen Germany 30659
248 GSK Investigational Site Bielefeld Nordrhein-Westfalen Germany 33617
249 GSK Investigational Site Bonn Nordrhein-Westfalen Germany 53111
250 GSK Investigational Site Bonn Nordrhein-Westfalen Germany 53127
251 GSK Investigational Site Koeln Nordrhein-Westfalen Germany 51109
252 GSK Investigational Site Wuppertal Nordrhein-Westfalen Germany 42283
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255 GSK Investigational Site Homburg Saarland Germany 66421
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257 GSK Investigational Site Dresden Sachsen Germany 01307
258 GSK Investigational Site Leipzig Sachsen Germany 04103
259 GSK Investigational Site Kiel Schleswig-Holstein Germany 24105
260 GSK Investigational Site Luebeck Schleswig-Holstein Germany 23538
261 GSK Investigational Site Bad Berka Thueringen Germany 99437
262 GSK Investigational Site Erfurt Thueringen Germany 99089
263 GSK Investigational Site Jena Thueringen Germany 07747
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265 GSK Investigational Site Berlin Germany 10249
266 GSK Investigational Site Berlin Germany 10967
267 GSK Investigational Site Berlin Germany 12351
268 GSK Investigational Site Berlin Germany 12683
269 GSK Investigational Site Berlin Germany 13353
270 GSK Investigational Site Berlin Germany 13585
271 GSK Investigational Site Berlin Germany 14050
272 GSK Investigational Site Bremen Germany 28325
273 GSK Investigational Site Hamburg Germany 21075
274 GSK Investigational Site Athens Greece 10676
275 GSK Investigational Site Athens Greece 11526
276 GSK Investigational Site Athens Greece 11527
277 GSK Investigational Site Haidari Greece 124 61
278 GSK Investigational Site Kifisia Greece 14561
279 GSK Investigational Site Rio, Patras Greece 265 00
280 GSK Investigational Site Thessaloniki Greece 54636
281 GSK Investigational Site Thessaloniki Greece 564 29
282 GSK Investigational Site Thessaloniki Greece 570 10
283 GSK Investigational Site Kowloon Hong Kong
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296 GSK Investigational Site Haifa Israel 31048
297 GSK Investigational Site Kfar Saba Israel 44281
298 GSK Investigational Site Zrifin Israel 70300
299 GSK Investigational Site Seoul Korea, Republic of 135-710
300 GSK Investigational Site Seoul Korea, Republic of 138-736
301 GSK Investigational Site Seoul Korea, Republic of 152-703
302 GSK Investigational Site Riga Latvia LV 1001
303 GSK Investigational Site Riga Latvia LV 1002
304 GSK Investigational Site Riga Latvia LV1079
305 GSK Investigational Site Kuala Lumpur Malaysia 59100
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307 GSK Investigational Site Amsterdam Netherlands 1081 HV
308 GSK Investigational Site Apeldoorn Netherlands 7334 DZ
309 GSK Investigational Site Den Bosch Netherlands 5211 RW
310 GSK Investigational Site EDE Netherlands 6716 RP
311 GSK Investigational Site Leeuwarden Netherlands 8934 AD
312 GSK Investigational Site Rotterdam Netherlands 3015 GD
313 GSK Investigational Site Utrecht Netherlands 3584 CX
314 GSK Investigational Site Auckland New Zealand 1001
315 GSK Investigational Site Auckland New Zealand 1701
316 GSK Investigational Site Christchurch New Zealand 8001
317 GSK Investigational Site Tauranga New Zealand 3001
318 GSK Investigational Site Almada Portugal 2800-950
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329 GSK Investigational Site Iasi Romania
330 GSK Investigational Site Barnaul Russian Federation 656 045
331 GSK Investigational Site Ekaterinburg Russian Federation 620109
332 GSK Investigational Site Krasnodar Russian Federation 350042
333 GSK Investigational Site Moscow Russian Federation 105203
334 GSK Investigational Site Moscow Russian Federation 111538
335 GSK Investigational Site Moscow Russian Federation 115446
336 GSK Investigational Site Moscow Russian Federation 117049
337 GSK Investigational Site Moscow Russian Federation 121552
338 GSK Investigational Site Moscow Russian Federation 125101
339 GSK Investigational Site Perm Russian Federation 614107
340 GSK Investigational Site Perm Russian Federation 614990
341 GSK Investigational Site Smolensk Russian Federation 214018
342 GSK Investigational Site St. Petersburgh Russian Federation 192242
343 GSK Investigational Site Tomsk Russian Federation 634 050
344 GSK Investigational Site Celje Slovenia 3000
345 GSK Investigational Site Ljubljana Slovenia 1000
346 GSK Investigational Site Maribor Slovenia 2000
347 GSK Investigational Site Novo Mesto Slovenia 8000
348 GSK Investigational Site Slovenj Gradec Slovenia 2380
349 GSK Investigational Site Šempeter pri Novi Gorici Slovenia
350 GSK Investigational Site Johannesburg Gauteng South Africa 2193
351 GSK Investigational Site Auckland Park, Johannesburg South Africa 2006
352 GSK Investigational Site Bloemfontein South Africa 9300
353 GSK Investigational Site Cape Town South Africa 7925
354 GSK Investigational Site George South Africa 6529
355 GSK Investigational Site PO Medunsa South Africa 0204
356 GSK Investigational Site Badalona Spain 08916
357 GSK Investigational Site Barcelona Spain 08035
358 GSK Investigational Site Getafe Spain 28905
359 GSK Investigational Site La Coruña Spain 15006
360 GSK Investigational Site Madrid Spain 28041
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362 GSK Investigational Site Palma de Mallorca Spain 07014
363 GSK Investigational Site Sevilla Spain 41013
364 GSK Investigational Site Sevilla Spain 41014
365 GSK Investigational Site Tarrasa Spain
366 GSK Investigational Site Terrassa Spain 08227
367 GSK Investigational Site Valencia Spain 46009
368 GSK Investigational Site Göteborg Sweden SE-416 85
369 GSK Investigational Site Lund Sweden SE-221 85
370 GSK Investigational Site Stockholm Sweden SE-141 86
371 GSK Investigational Site Kaohsiung Taiwan 813
372 GSK Investigational Site Taichung Taiwan 404
373 GSK Investigational Site Taipei Taiwan 100
374 GSK Investigational Site Tau-Yuan County Taiwan
375 GSK Investigational Site Bangkok Thailand 10330
376 GSK Investigational Site Bangkok Thailand 10700
377 GSK Investigational Site Chiangmai Thailand 50200
378 GSK Investigational Site Aberdeen Aberdeenshire United Kingdom AB25 2ZD
379 GSK Investigational Site Reading Berkshire United Kingdom RG1 7AN
380 GSK Investigational Site Glasgow Lanarkshire United Kingdom G11 6NT
381 GSK Investigational Site Glasgow Lanarkshire United Kingdom G42 9TY
382 GSK Investigational Site Glasgow Lanarkshire United Kingdom G51 4TF
383 GSK Investigational Site Wigan Lancashire United Kingdom WN6 9EP
384 GSK Investigational Site Liverpool Merseyside United Kingdom L7 8XP
385 GSK Investigational Site Oxford Oxfordshire United Kingdom OX3 9DU
386 GSK Investigational Site Bath Somerset United Kingdom BA1 3NG
387 GSK Investigational Site Livingston West Lothian United Kingdom EH54 6PP
388 GSK Investigational Site Leeds United Kingdom LS1 3EX
389 GSK Investigational Site Leeds United Kingdom LS9 7TF
390 GSK Investigational Site Sheffield United Kingdom S10 2JF

Sponsors and Collaborators

  • GlaxoSmithKline

Investigators

  • Study Director: GSK Clinical Trials, GlaxoSmithKline

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00089986
Other Study ID Numbers:
  • EMD20001
First Posted:
Aug 23, 2004
Last Update Posted:
Aug 21, 2017
Last Verified:
Jul 1, 2017
Keywords provided by GlaxoSmithKline
severe sepsis
septic shock
Gram-negative infection
phospholipid emulsion
Additional relevant MeSH terms:
Sepsis
Toxemia

Study Results

Participant Flow

Recruitment Details The study was planned on 1845 participants, hospitalized with suspected or confirmed gram-negative severe sepsis, male or female >=18 years of age at 235 centers across 31 countries from 02 September 2004 to 25 June 2007.
Pre-assignment Detail A total of 1415 participant numbers were assigned during randomization process, five were duplicate randomization numbers and for other two, the participants did not provide informed consent, precluding them from enrollment. Out of 1408 participants, 29 did not receive study medication, remaining 1379 included in Intent-to-Treat (ITT) Population.
Arm/Group Title Placebo Low GR270773 High GR270773
Arm/Group Description Eligible participants were administered matching placebo to low-dose GR270773 or high-dose GR270773, intravenously (IV) as a loading dose infused over 2 hours (h) followed by a maintenance dose administered as a continuous infusion for 70 h, for a total treatment period of 72 h. The low placebo rate consisted of a loading dose of 0.75 milliliters per kilogram per hour (mL/kg/h) for 2 h and a maintenance dose of 0.1 mL/kg/h for 70 h. The high placebo rate consisted of a loading dose of 1.5 mL/kg/h for 2 h and a maintenance dose of 0.15 mL/kg/h for 70 h. Eligible participants were administered low-dose GR270773 IV as a loading dose infused over 2 h followed by a maintenance dose administered as a continuous infusion for 70 h, for a total treatment period of 72 h. The study medication was administered as a sterile 100 milligrams per milliliter (mg/mL) lipid emulsion for IV administration. The low dose emulsion consisted of a loading dose of 75 milligram (mg)/kg/h which was equivalent to 0.75 mL/kg/h for 2 h and a maintenance dose of 10 mg/kg/h which was equivalent to 0.1 mL/kg/h for 70 h. The total dose was 850 mg/kg. Eligible participants were administered high-dose GR270773 IV as a loading dose infused over 2 h followed by a maintenance dose administered as a continuous infusion for 70 h, for a total treatment period of 72 h. The study medication was administered as a sterile 100 mg/mL lipid emulsion for IV administration. The high dose emulsion consisted of a loading dose of 15 mg/kg/h which was equivalent to 1.5 mL/kg/h for 2 h and a maintenance dose of 15 mg/kg/h which was equivalent to 0.15 mL/kg/h for 70 h. The total dose was 1350 mg/kg.
Period Title: Overall Study
STARTED 599 598 182
COMPLETED 584 574 172
NOT COMPLETED 15 24 10

Baseline Characteristics

Arm/Group Title Placebo Low GR270773 High GR270773 Total
Arm/Group Description Eligible participants were administered matching placebo to low-dose GR270773 or high-dose GR270773, IV as a loading dose infused over 2 h followed by a maintenance dose administered as a continuous infusion for 70 h, for a total treatment period of 72 h. The low placebo rate consisted of a loading dose of 0.75 mL/kg/h for 2 h and a maintenance dose of 0.1 mL/kg/h for 70 h. The high placebo rate consisted of a loading dose of 1.5 mL/kg/h for 2 h and a maintenance dose of 0.15 mL/kg/h for 70 h. Eligible participants were administered low-dose GR270773 IV as a loading dose infused over 2 h followed by a maintenance dose administered as a continuous infusion for 70 h, for a total treatment period of 72 h. The study medication was administered as a sterile 100 mg/mL lipid emulsion for IV administration. The low dose emulsion consisted of a loading dose of 75 mg/kg/h which was equivalent to 0.75 mL/kg/h for 2 h and a maintenance dose of 10 mg/kg/h which was equivalent to 0.1 mL/kg/h for 70 h. The total dose was 850 mg/kg. Eligible participants were administered high-dose GR270773 IV as a loading dose infused over 2 h followed by a maintenance dose administered as a continuous infusion for 70 h, for a total treatment period of 72 h. The study medication was administered as a sterile 100 mg/mL lipid emulsion for IV administration. The high dose emulsion consisted of a loading dose of 15 mg/kg/h which was equivalent to 1.5 mL/kg/h for 2 h and a maintenance dose of 15 mg/kg/h which was equivalent to 0.15 mL/kg/h for 70 h. The total dose was 1350 mg/kg. Total of all reporting groups
Overall Participants 599 598 182 1379
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]
63.1
(16.41)
62.8
(16.27)
64.8
(15.47)
63.2
(16.23)
Sex: Female, Male (Count of Participants)
Female
254
42.4%
239
40%
80
44%
573
41.6%
Male
345
57.6%
359
60%
102
56%
806
58.4%
Race/Ethnicity, Customized (Number) [Number]
Arabic/North African
7
1.2%
6
1%
1
0.5%
14
1%
Black
16
2.7%
14
2.3%
2
1.1%
32
2.3%
East & South East Asian
51
8.5%
44
7.4%
14
7.7%
109
7.9%
Japanese
3
0.5%
3
0.5%
0
0%
6
0.4%
South Asian
29
4.8%
32
5.4%
2
1.1%
63
4.6%
White/Caucasian
484
80.8%
494
82.6%
161
88.5%
1139
82.6%
Pacific Islander
1
0.2%
0
0%
0
0%
1
0.1%
American Indian
4
0.7%
2
0.3%
0
0%
6
0.4%
Native Hawaiian
2
0.3%
0
0%
0
0%
2
0.1%
Missing
2
0.3%
3
0.5%
2
1.1%
7
0.5%

Outcome Measures

1. Primary Outcome
Title Percentage of Participants With 28-Day All Cause Mortality
Description Mortality was assessed by the number of participants who died between days 1 and 28. A summary of death details was given which included whether the participant died between days 1 and 28, whether the death was related sepsis, cause of death, the source of the information, and whether the cause of death was verified by a death record. Participants who had withdrawn from study and all study assessments and for whom survival at day 28 could not be confirmed was treated as deaths for the primary endpoint. The difference in all-cause 28-day mortality rates for each treatment group versus the placebo group in the ITT Population was calculated as placebo - treatment.
Time Frame Day 1 (post-infusion) up to Day 28 Follow-up

Outcome Measure Data

Analysis Population Description
ITT Population was defined as all randomized participants from all three stages who receive any study drug.
Arm/Group Title Placebo Low GR270773 High GR270773
Arm/Group Description Eligible participants were administered matching placebo to low-dose GR270773 or high-dose GR270773, IV as a loading dose infused over 2 h followed by a maintenance dose administered as a continuous infusion for 70 h, for a total treatment period of 72 h. The low placebo rate consisted of a loading dose of 0.75 mL/kg/h for 2 h and a maintenance dose of 0.1 mL/kg/h for 70 h. The high placebo rate consisted of a loading dose of 1.5 mL/kg/h for 2 h and a maintenance dose of 0.15 mL/kg/h for 70 h. Eligible participants were administered low-dose GR270773 IV as a loading dose infused over 2 h followed by a maintenance dose administered as a continuous infusion for 70 h, for a total treatment period of 72 h. The study medication was administered as a sterile 100 mg/mL lipid emulsion for IV administration. The low dose emulsion consisted of a loading dose of 75 mg/kg/h which was equivalent to 0.75 mL/kg/h for 2 h and a maintenance dose of 10 mg/kg/h which was equivalent to 0.1 mL/kg/h for 70 h. The total dose was 850 mg/kg. Eligible participants were administered high-dose GR270773 IV as a loading dose infused over 2 h followed by a maintenance dose administered as a continuous infusion for 70 h, for a total treatment period of 72 h. The study medication was administered as a sterile 100 mg/mL lipid emulsion for IV administration. The high dose emulsion consisted of a loading dose of 15 mg/kg/h which was equivalent to 1.5 mL/kg/h for 2 h and a maintenance dose of 15 mg/kg/h which was equivalent to 0.15 mL/kg/h for 70 h. The total dose was 1350 mg/kg.
Measure Participants 599 598 182
Number [Percentage of participants]
26.9
4.5%
25.8
4.3%
31.3
17.2%
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Low GR270773
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesis p-Value 0.329
Comments
Method Chi-squared
Comments
Method of Estimation Estimation Parameter Rate difference
Estimated Value 1.1
Confidence Interval (1-Sided) 90%
-2.1 to
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, High GR270773
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesis p-Value 0.879
Comments
Method Chi-squared
Comments
Method of Estimation Estimation Parameter Rate Difference
Estimated Value -4.4
Confidence Interval (1-Sided) 90%
-9.4 to
Parameter Dispersion Type:
Value:
Estimation Comments
2. Secondary Outcome
Title Number of Participants With New Onset Organ Failure, Regardless of Cause, Occurring During the 28 Days Post Enrollment in an Organ Not in Failure at Enrolment
Description The new onset organ failure was defined as first time each of the following criteria were met after start of study medication up to Day 28. Respiratory failure: defined by requiring mechanical ventilation not less than 24 hours due to surgery. Renal failure: defined by requiring the initiation of hemodialysis or hemofiltration. Coagulopathy: defined by disseminated intravascular coagulation (DIC) requiring transfusion with platelets or fresh frozen plasma or anticoagulant therapy. Cardiovascular failure: defined by sustained hypotension requiring vasopressor support of dopamine >5 microgram per kilogram per minute (µg/kg/min), epinephrine, norepinephrine, phenylephrine or vasopressin at any dose if used to increase blood pressure for >=6 continuous h. Analysis was done treating the death as a new onset organ failure (counted in both the numerator and denominator).
Time Frame Baseline (Day 1, pre-infusion) up to Day 28 Follow-up

Outcome Measure Data

Analysis Population Description
ITT Population. Organ failure occurring during the 28 days post-enrollment that was not in failure at enrollment. Subjects who die prior to observing a new organ failure are counted as a failure.
Arm/Group Title Placebo Low GR270773 High GR270773
Arm/Group Description Eligible participants were administered matching placebo to low-dose GR270773 or high-dose GR270773, IV as a loading dose infused over 2 h followed by a maintenance dose administered as a continuous infusion for 70 h, for a total treatment period of 72 h. The low placebo rate consisted of a loading dose of 0.75 mL/kg/h for 2 h and a maintenance dose of 0.1 mL/kg/h for 70 h. The high placebo rate consisted of a loading dose of 1.5 mL/kg/h for 2 h and a maintenance dose of 0.15 mL/kg/h for 70 h. Eligible participants were administered low-dose GR270773 IV as a loading dose infused over 2 h followed by a maintenance dose administered as a continuous infusion for 70 h, for a total treatment period of 72 h. The study medication was administered as a sterile 100 mg/mL lipid emulsion for IV administration. The low dose emulsion consisted of a loading dose of 75 mg/kg/h which was equivalent to 0.75 mL/kg/h for 2 h and a maintenance dose of 10 mg/kg/h which was equivalent to 0.1 mL/kg/h for 70 h. The total dose was 850 mg/kg. Eligible participants were administered high-dose GR270773 IV as a loading dose infused over 2 h followed by a maintenance dose administered as a continuous infusion for 70 h, for a total treatment period of 72 h. The study medication was administered as a sterile 100 mg/mL lipid emulsion for IV administration. The high dose emulsion consisted of a loading dose of 15 mg/kg/h which was equivalent to 1.5 mL/kg/h for 2 h and a maintenance dose of 15 mg/kg/h which was equivalent to 0.15 mL/kg/h for 70 h. The total dose was 1350 mg/kg.
Measure Participants 599 598 182
Count of Participants [Participants]
122
20.4%
157
26.3%
57
31.3%
3. Secondary Outcome
Title Number of Participants With New Onset Organ Failure of Respiratory Failure, Cardiovascular Failure, Renal Failure and Coagulopathy, Regardless of Cause, Occurring During the 28 Days Post Enrollment in an Organ Not in Failure at Enrollment
Description Respiratory failure: defined by requiring mechanical ventilation not less than 24 hours due to surgery. Renal failure: defined by requiring the initiation of hemodialysis or hemofiltration. Coagulopathy: defined by disseminated intravascular coagulation (DIC) requiring transfusion with platelets or fresh frozen plasma or anticoagulant therapy. Cardiovascular failure: defined by sustained hypotension requiring vasopressor support of dopamine >5 microgram per kilogram per minute (µg/kg/min), epinephrine, norepinephrine, phenylephrine or vasopressin at any dose if used to increase blood pressure for >=6 continuous h. For each organ failure type and the number of new onset organ failures per participants for each organ failure type, the denominator only included participants who did not have that type of organ failure at Baseline. At Baseline a participant could enter the study with a type of organ failure, that type of failure was not reported as a new onset organ failure.
Time Frame Baseline (Day 1, pre-infusion) up to Day 28 Follow up

Outcome Measure Data

Analysis Population Description
ITT Population. Organ failure occurring during the 28 days post-enrollment that was not in failure at enrollment. Participants who died prior to observing a new failure are excluded from analysis.
Arm/Group Title Placebo Low GR270773 High GR270773
Arm/Group Description Eligible participants were administered matching placebo to low-dose GR270773 or high-dose GR270773, IV as a loading dose infused over 2 h followed by a maintenance dose administered as a continuous infusion for 70 h, for a total treatment period of 72 h. The low placebo rate consisted of a loading dose of 0.75 mL/kg/h for 2 h and a maintenance dose of 0.1 mL/kg/h for 70 h. The high placebo rate consisted of a loading dose of 1.5 mL/kg/h for 2 h and a maintenance dose of 0.15 mL/kg/h for 70 h. Eligible participants were administered low-dose GR270773 IV as a loading dose infused over 2 h followed by a maintenance dose administered as a continuous infusion for 70 h, for a total treatment period of 72 h. The study medication was administered as a sterile 100 mg/mL lipid emulsion for IV administration. The low dose emulsion consisted of a loading dose of 75 mg/kg/h which was equivalent to 0.75 mL/kg/h for 2 h and a maintenance dose of 10 mg/kg/h which was equivalent to 0.1 mL/kg/h for 70 h. The total dose was 850 mg/kg. Eligible participants were administered high-dose GR270773 IV as a loading dose infused over 2 h followed by a maintenance dose administered as a continuous infusion for 70 h, for a total treatment period of 72 h. The study medication was administered as a sterile 100 mg/mL lipid emulsion for IV administration. The high dose emulsion consisted of a loading dose of 15 mg/kg/h which was equivalent to 1.5 mL/kg/h for 2 h and a maintenance dose of 15 mg/kg/h which was equivalent to 0.15 mL/kg/h for 70 h. The total dose was 1350 mg/kg.
Measure Participants 599 598 182
Respiratory failure, n= 297, 333, 99
50
8.3%
61
10.2%
23
12.6%
Cardiovascular failure, n= 150, 161, 43
33
5.5%
48
8%
15
8.2%
Renal failure, n= 460, 474, 138
40
6.7%
47
7.9%
22
12.1%
Coagulopathy, n= 344, 355, 107
36
6%
41
6.9%
16
8.8%
4. Secondary Outcome
Title Assessment of Safety/Tolerability by Determining the Number of Participants With Any Adverse Events (AE), Serious Adverse Events (SAE) and Fatal SAE
Description An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect, may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in this definition or common toxicity criteria (CTC) grade 4 laboratory abnormalities of national cancer institute not associated with the underlying sepsis unless more severe than expected for the participants condition.
Time Frame Day 1 (pre-infusion) up to Day 28 Follow-up

Outcome Measure Data

Analysis Population Description
ITT Population.
Arm/Group Title Placebo Low GR270773 High GR270773
Arm/Group Description Eligible participants were administered matching placebo to low-dose GR270773 or high-dose GR270773, IV as a loading dose infused over 2 h followed by a maintenance dose administered as a continuous infusion for 70 h, for a total treatment period of 72 h. The low placebo rate consisted of a loading dose of 0.75 mL/kg/h for 2 h and a maintenance dose of 0.1 mL/kg/h for 70 h. The high placebo rate consisted of a loading dose of 1.5 mL/kg/h for 2 h and a maintenance dose of 0.15 mL/kg/h for 70 h. Eligible participants were administered low-dose GR270773 IV as a loading dose infused over 2 h followed by a maintenance dose administered as a continuous infusion for 70 h, for a total treatment period of 72 h. The study medication was administered as a sterile 100 mg/mL lipid emulsion for IV administration. The low dose emulsion consisted of a loading dose of 75 mg/kg/h which was equivalent to 0.75 mL/kg/h for 2 h and a maintenance dose of 10 mg/kg/h which was equivalent to 0.1 mL/kg/h for 70 h. The total dose was 850 mg/kg. Eligible participants were administered high-dose GR270773 IV as a loading dose infused over 2 h followed by a maintenance dose administered as a continuous infusion for 70 h, for a total treatment period of 72 h. The study medication was administered as a sterile 100 mg/mL lipid emulsion for IV administration. The high dose emulsion consisted of a loading dose of 15 mg/kg/h which was equivalent to 1.5 mL/kg/h for 2 h and a maintenance dose of 15 mg/kg/h which was equivalent to 0.15 mL/kg/h for 70 h. The total dose was 1350 mg/kg.
Measure Participants 599 598 182
Any AE
423
70.6%
442
73.9%
144
79.1%
Any SAE
213
35.6%
235
39.3%
77
42.3%
Any fatal SAE
85
14.2%
70
11.7%
33
18.1%

Adverse Events

Time Frame AE and SAE were collected from Baseline (Day 1, pre-infusion) to Day 28 Follow-up
Adverse Event Reporting Description ITT Population was used which was defined as all randomized participants from all three stages who receive any study drug.
Arm/Group Title Placebo Low GR270773 High GR270773
Arm/Group Description Eligible participants were administered matching placebo to low-dose GR270773 or high-dose GR270773, IV as a loading dose infused over 2 h followed by a maintenance dose administered as a continuous infusion for 70 h, for a total treatment period of 72 h. The low placebo rate consisted of a loading dose of 0.75 mL/kg/h for 2 h and a maintenance dose of 0.1 mL/kg/h for 70 h. The high placebo rate consisted of a loading dose of 1.5 mL/kg/h for 2 h and a maintenance dose of 0.15 mL/kg/h for 70 h. Eligible participants were administered low-dose GR270773 IV as a loading dose infused over 2 h followed by a maintenance dose administered as a continuous infusion for 70 h, for a total treatment period of 72 h. The study medication was administered as a sterile 100 mg/mL lipid emulsion for IV administration. The low dose emulsion consisted of a loading dose of 75 mg/kg/h which was equivalent to 0.75 mL/kg/h for 2 h and a maintenance dose of 10 mg/kg/h which was equivalent to 0.1 mL/kg/h for 70 h. The total dose was 850 mg/kg. Eligible participants were administered high-dose GR270773 IV as a loading dose infused over 2 h followed by a maintenance dose administered as a continuous infusion for 70 h, for a total treatment period of 72 h. The study medication was administered as a sterile 100 mg/mL lipid emulsion for IV administration. The high dose emulsion consisted of a loading dose of 15 mg/kg/h which was equivalent to 1.5 mL/kg/h for 2 h and a maintenance dose of 15 mg/kg/h which was equivalent to 0.15 mL/kg/h for 70 h. The total dose was 1350 mg/kg.
All Cause Mortality
Placebo Low GR270773 High GR270773
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 85/599 (14.2%) 70/598 (11.7%) 33/182 (18.1%)
Serious Adverse Events
Placebo Low GR270773 High GR270773
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 213/599 (35.6%) 235/598 (39.3%) 77/182 (42.3%)
Blood and lymphatic system disorders
Anaemia 3/599 (0.5%) 8/598 (1.3%) 1/182 (0.5%)
Thrombocytopenia 6/599 (1%) 2/598 (0.3%) 0/182 (0%)
Coombs negative haemolytic anaemia 0/599 (0%) 1/598 (0.2%) 0/182 (0%)
Haemoglobinaemia 0/599 (0%) 1/598 (0.2%) 0/182 (0%)
Haemolysis 0/599 (0%) 1/598 (0.2%) 0/182 (0%)
Leukocytosis 0/599 (0%) 1/598 (0.2%) 0/182 (0%)
Leukopenia 0/599 (0%) 0/598 (0%) 1/182 (0.5%)
Lymphopenia 0/599 (0%) 1/598 (0.2%) 0/182 (0%)
Red blood cell abnormality 0/599 (0%) 1/598 (0.2%) 0/182 (0%)
Thrombocytopenic purpura 1/599 (0.2%) 0/598 (0%) 0/182 (0%)
Cardiac disorders
Cardiac arrest 46/599 (7.7%) 42/598 (7%) 17/182 (9.3%)
Atrial fibrillation 3/599 (0.5%) 6/598 (1%) 1/182 (0.5%)
Myocardial infarction 4/599 (0.7%) 1/598 (0.2%) 2/182 (1.1%)
Acute myocardial infarction 0/599 (0%) 3/598 (0.5%) 3/182 (1.6%)
Ventricular tachycardia 4/599 (0.7%) 0/598 (0%) 1/182 (0.5%)
Cardiac failure 2/599 (0.3%) 1/598 (0.2%) 1/182 (0.5%)
Bradycardia 0/599 (0%) 3/598 (0.5%) 0/182 (0%)
Ventricular fibrillation 1/599 (0.2%) 2/598 (0.3%) 0/182 (0%)
Cardiac failure acute 0/599 (0%) 2/598 (0.3%) 0/182 (0%)
Cardiac failure congestive 1/599 (0.2%) 1/598 (0.2%) 0/182 (0%)
Tachyarrhythmia 0/599 (0%) 2/598 (0.3%) 0/182 (0%)
Torsade de pointes 0/599 (0%) 1/598 (0.2%) 1/182 (0.5%)
Angina pectoris 0/599 (0%) 1/598 (0.2%) 0/182 (0%)
Arrhythmia 1/599 (0.2%) 0/598 (0%) 0/182 (0%)
Bradyarrhythmia 1/599 (0.2%) 0/598 (0%) 0/182 (0%)
Cardio-respiratory arrest 1/599 (0.2%) 0/598 (0%) 0/182 (0%)
Cardiogenic shock 0/599 (0%) 1/598 (0.2%) 0/182 (0%)
Electromechanical dissociation 0/599 (0%) 0/598 (0%) 1/182 (0.5%)
Left ventricular failure 0/599 (0%) 1/598 (0.2%) 0/182 (0%)
Nodal arrhythmia 0/599 (0%) 1/598 (0.2%) 0/182 (0%)
Supraventricular tachyarrhythmia 0/599 (0%) 1/598 (0.2%) 0/182 (0%)
Supraventricular tachycardia 1/599 (0.2%) 0/598 (0%) 0/182 (0%)
Ventricular tachyarrhythmia 0/599 (0%) 1/598 (0.2%) 0/182 (0%)
Gastrointestinal disorders
Gastrointestinal haemorrhage 3/599 (0.5%) 4/598 (0.7%) 0/182 (0%)
Pancreatitis 1/599 (0.2%) 3/598 (0.5%) 0/182 (0%)
Intestinal ischaemia 2/599 (0.3%) 1/598 (0.2%) 0/182 (0%)
Pancreatitis acute 2/599 (0.3%) 1/598 (0.2%) 0/182 (0%)
Rectal haemorrhage 2/599 (0.3%) 1/598 (0.2%) 0/182 (0%)
Upper gastrointestinal haemorrhage 2/599 (0.3%) 1/598 (0.2%) 0/182 (0%)
Ileus paralytic 1/599 (0.2%) 1/598 (0.2%) 0/182 (0%)
Intestinal obstruction 1/599 (0.2%) 1/598 (0.2%) 0/182 (0%)
Intra-abdominal haemorrhage 0/599 (0%) 1/598 (0.2%) 1/182 (0.5%)
Abdominal hernia 0/599 (0%) 1/598 (0.2%) 0/182 (0%)
Abdominal pain 1/599 (0.2%) 0/598 (0%) 0/182 (0%)
Acute abdomen 1/599 (0.2%) 0/598 (0%) 0/182 (0%)
Duodenal perforation 0/599 (0%) 1/598 (0.2%) 0/182 (0%)
Duodenal ulcer perforation 0/599 (0%) 0/598 (0%) 1/182 (0.5%)
Gastric ulcer haemorrhage 1/599 (0.2%) 0/598 (0%) 0/182 (0%)
Haematochezia 1/599 (0.2%) 0/598 (0%) 0/182 (0%)
Intestinal perforation 0/599 (0%) 1/598 (0.2%) 0/182 (0%)
Lower gastrointestinal haemorrhage 0/599 (0%) 0/598 (0%) 1/182 (0.5%)
Mesenteric artery thrombosis 0/599 (0%) 1/598 (0.2%) 0/182 (0%)
Oesophageal rupture 0/599 (0%) 0/598 (0%) 1/182 (0.5%)
Pancreatic duct obstruction 0/599 (0%) 1/598 (0.2%) 0/182 (0%)
Pancreatitis necrotising 1/599 (0.2%) 0/598 (0%) 0/182 (0%)
Peritoneal haemorrhage 0/599 (0%) 1/598 (0.2%) 0/182 (0%)
Peritoneal necrosis 1/599 (0.2%) 0/598 (0%) 0/182 (0%)
Peritonitis 0/599 (0%) 1/598 (0.2%) 0/182 (0%)
Retroperitoneal haematoma 1/599 (0.2%) 0/598 (0%) 0/182 (0%)
Retroperitoneal haemorrhage 1/599 (0.2%) 0/598 (0%) 0/182 (0%)
Small intestinal haemorrhage 1/599 (0.2%) 0/598 (0%) 0/182 (0%)
Large intestine perforation 1/599 (0.2%) 0/598 (0%) 0/182 (0%)
General disorders
Multi-organ failure 3/599 (0.5%) 1/598 (0.2%) 1/182 (0.5%)
Pyrexia 2/599 (0.3%) 1/598 (0.2%) 1/182 (0.5%)
Cardiac death 1/599 (0.2%) 0/598 (0%) 0/182 (0%)
General physical health deterioration 0/599 (0%) 0/598 (0%) 1/182 (0.5%)
Hyperpyrexia 0/599 (0%) 1/598 (0.2%) 0/182 (0%)
Multi-organ disorder 0/599 (0%) 1/598 (0.2%) 0/182 (0%)
Sudden cardiac death 0/599 (0%) 0/598 (0%) 1/182 (0.5%)
Hepatobiliary disorders
Hepatic failure 20/599 (3.3%) 25/598 (4.2%) 15/182 (8.2%)
Cholangitis 1/599 (0.2%) 2/598 (0.3%) 0/182 (0%)
Hyperbilirubinaemia 2/599 (0.3%) 1/598 (0.2%) 0/182 (0%)
Bile duct stone 0/599 (0%) 2/598 (0.3%) 0/182 (0%)
Cholestasis 1/599 (0.2%) 0/598 (0%) 0/182 (0%)
Cytolytic hepatitis 1/599 (0.2%) 0/598 (0%) 0/182 (0%)
Hepatic function abnormal 0/599 (0%) 1/598 (0.2%) 0/182 (0%)
Hydrocholecystis 0/599 (0%) 1/598 (0.2%) 0/182 (0%)
Ischaemic hepatitis 0/599 (0%) 1/598 (0.2%) 0/182 (0%)
Jaundice 0/599 (0%) 1/598 (0.2%) 0/182 (0%)
Liver disorder 0/599 (0%) 1/598 (0.2%) 0/182 (0%)
Cholecystitis 1/599 (0.2%) 1/598 (0.2%) 1/182 (0.5%)
Immune system disorders
Hypersensitivity 1/599 (0.2%) 0/598 (0%) 0/182 (0%)
Infections and infestations
Pneumonia 5/599 (0.8%) 2/598 (0.3%) 2/182 (1.1%)
Septic shock 6/599 (1%) 2/598 (0.3%) 0/182 (0%)
Sepsis 1/599 (0.2%) 2/598 (0.3%) 1/182 (0.5%)
Urinary tract infection 3/599 (0.5%) 0/598 (0%) 0/182 (0%)
Abdominal abscess 0/599 (0%) 2/598 (0.3%) 0/182 (0%)
Bacteraemia 1/599 (0.2%) 0/598 (0%) 1/182 (0.5%)
Pyelonephritis 1/599 (0.2%) 0/598 (0%) 1/182 (0.5%)
Wound infection 1/599 (0.2%) 1/598 (0.2%) 0/182 (0%)
Brain abscess 0/599 (0%) 1/598 (0.2%) 0/182 (0%)
Bronchitis 1/599 (0.2%) 0/598 (0%) 0/182 (0%)
Bronchopneumonia 1/599 (0.2%) 0/598 (0%) 0/182 (0%)
Citrobacter sepsis 0/599 (0%) 0/598 (0%) 1/182 (0.5%)
Colitis pseudomembranous 0/599 (0%) 1/598 (0.2%) 0/182 (0%)
Endocarditis bacterial 1/599 (0.2%) 0/598 (0%) 0/182 (0%)
Extradural abscess 1/599 (0.2%) 0/598 (0%) 0/182 (0%)
Fungaemia 0/599 (0%) 1/598 (0.2%) 0/182 (0%)
Infected skin ulcer 1/599 (0.2%) 0/598 (0%) 0/182 (0%)
Lobar pneumonia 1/599 (0.2%) 0/598 (0%) 0/182 (0%)
Localised infection 1/599 (0.2%) 0/598 (0%) 0/182 (0%)
Lower respiratory tract infection 0/599 (0%) 1/598 (0.2%) 0/182 (0%)
Necrotising fasciitis 0/599 (0%) 1/598 (0.2%) 0/182 (0%)
Perinephric abscess 0/599 (0%) 1/598 (0.2%) 0/182 (0%)
Postoperative wound infection 1/599 (0.2%) 0/598 (0%) 0/182 (0%)
Injury, poisoning and procedural complications
Heart injury 3/599 (0.5%) 1/598 (0.2%) 0/182 (0%)
Wound dehiscence 2/599 (0.3%) 2/598 (0.3%) 0/182 (0%)
Graft complication 1/599 (0.2%) 1/598 (0.2%) 0/182 (0%)
Wound evisceration 0/599 (0%) 2/598 (0.3%) 0/182 (0%)
Anastomotic leak 0/599 (0%) 1/598 (0.2%) 0/182 (0%)
Failure to anastomose 1/599 (0.2%) 0/598 (0%) 0/182 (0%)
Post procedural bile leak 0/599 (0%) 1/598 (0.2%) 0/182 (0%)
Post procedural haemorrhage 0/599 (0%) 0/598 (0%) 1/182 (0.5%)
Splenic rupture 1/599 (0.2%) 0/598 (0%) 0/182 (0%)
Tracheal haemorrhage 1/599 (0.2%) 0/598 (0%) 0/182 (0%)
Investigations
Lipase increased 7/599 (1.2%) 10/598 (1.7%) 1/182 (0.5%)
Gamma-glutamyltransferase increased 4/599 (0.7%) 3/598 (0.5%) 0/182 (0%)
Haemoglobin decreased 2/599 (0.3%) 2/598 (0.3%) 0/182 (0%)
Hepatic enzyme increased 3/599 (0.5%) 1/598 (0.2%) 0/182 (0%)
Aspartate aminotransferase increased 1/599 (0.2%) 2/598 (0.3%) 0/182 (0%)
Blood amylase increased 1/599 (0.2%) 1/598 (0.2%) 1/182 (0.5%)
Alanine aminotransferase increased 1/599 (0.2%) 1/598 (0.2%) 0/182 (0%)
Carbon dioxide decreased 2/599 (0.3%) 0/598 (0%) 0/182 (0%)
Blood bilirubin increased 0/599 (0%) 0/598 (0%) 1/182 (0.5%)
Blood creatinine increased 0/599 (0%) 1/598 (0.2%) 0/182 (0%)
Cardiac output decreased 1/599 (0.2%) 0/598 (0%) 0/182 (0%)
Haematocrit decreased 1/599 (0.2%) 0/598 (0%) 0/182 (0%)
Myelocyte present 0/599 (0%) 1/598 (0.2%) 0/182 (0%)
Pancreatic enzymes increased 0/599 (0%) 0/598 (0%) 1/182 (0.5%)
Platelet count decreased 1/599 (0.2%) 0/598 (0%) 0/182 (0%)
Transaminases increased 0/599 (0%) 1/598 (0.2%) 0/182 (0%)
Troponin increased 1/599 (0.2%) 0/598 (0%) 0/182 (0%)
Metabolism and nutrition disorders
Metabolic acidosis 49/599 (8.2%) 61/598 (10.2%) 23/182 (12.6%)
Hypoglycaemia 4/599 (0.7%) 10/598 (1.7%) 2/182 (1.1%)
Hypokalaemia 7/599 (1.2%) 1/598 (0.2%) 0/182 (0%)
Hyperkalaemia 2/599 (0.3%) 3/598 (0.5%) 0/182 (0%)
Hyperamylasaemia 1/599 (0.2%) 3/598 (0.5%) 0/182 (0%)
Hyperglycaemia 1/599 (0.2%) 2/598 (0.3%) 0/182 (0%)
Hypernatraemia 2/599 (0.3%) 1/598 (0.2%) 0/182 (0%)
Dehydration 1/599 (0.2%) 0/598 (0%) 0/182 (0%)
Hyperuricaemia 0/599 (0%) 0/598 (0%) 1/182 (0.5%)
Hyponatraemia 0/599 (0%) 1/598 (0.2%) 0/182 (0%)
Shock hypoglycaemic 1/599 (0.2%) 0/598 (0%) 0/182 (0%)
Musculoskeletal and connective tissue disorders
Muscle necrosis 2/599 (0.3%) 0/598 (0%) 0/182 (0%)
Arthralgia 1/599 (0.2%) 0/598 (0%) 0/182 (0%)
Pain in extremity 1/599 (0.2%) 0/598 (0%) 0/182 (0%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic syndrome 1/599 (0.2%) 1/598 (0.2%) 1/182 (0.5%)
Bile duct cancer 0/599 (0%) 0/598 (0%) 1/182 (0.5%)
Metastases to central nervous system 0/599 (0%) 1/598 (0.2%) 0/182 (0%)
Metastases to liver 1/599 (0.2%) 0/598 (0%) 0/182 (0%)
Non-Hodgkin's lymphoma 1/599 (0.2%) 0/598 (0%) 0/182 (0%)
Salivary gland neoplasm 0/599 (0%) 1/598 (0.2%) 0/182 (0%)
Transitional cell carcinoma 1/599 (0.2%) 0/598 (0%) 0/182 (0%)
Nervous system disorders
Mental impairment 38/599 (6.3%) 38/598 (6.4%) 12/182 (6.6%)
Cerebrovascular accident 2/599 (0.3%) 2/598 (0.3%) 1/182 (0.5%)
Brain oedema 1/599 (0.2%) 2/598 (0.3%) 1/182 (0.5%)
Anoxic encephalopathy 1/599 (0.2%) 1/598 (0.2%) 0/182 (0%)
Cerebral infarction 1/599 (0.2%) 0/598 (0%) 0/182 (0%)
Cerebral ischaemia 0/599 (0%) 1/598 (0.2%) 0/182 (0%)
Coma 1/599 (0.2%) 0/598 (0%) 0/182 (0%)
Dizziness 0/599 (0%) 1/598 (0.2%) 0/182 (0%)
Dizziness postural 0/599 (0%) 1/598 (0.2%) 0/182 (0%)
Encephalitis 0/599 (0%) 1/598 (0.2%) 0/182 (0%)
Encephalopathy 0/599 (0%) 1/598 (0.2%) 0/182 (0%)
Guillain-Barre syndrome 0/599 (0%) 1/598 (0.2%) 0/182 (0%)
Hepatic encephalopathy 0/599 (0%) 0/598 (0%) 1/182 (0.5%)
Hypoxic encephalopathy 1/599 (0.2%) 0/598 (0%) 0/182 (0%)
Ischaemic stroke 0/599 (0%) 0/598 (0%) 1/182 (0.5%)
Transient ischaemic attack 0/599 (0%) 0/598 (0%) 1/182 (0.5%)
Psychiatric disorders
Mental status changes 1/599 (0.2%) 0/598 (0%) 0/182 (0%)
Renal and urinary disorders
Renal failure 1/599 (0.2%) 1/598 (0.2%) 0/182 (0%)
Renal failure acute 1/599 (0.2%) 1/598 (0.2%) 0/182 (0%)
Bladder distension 1/599 (0.2%) 0/598 (0%) 0/182 (0%)
Haematuria 0/599 (0%) 1/598 (0.2%) 0/182 (0%)
Hydronephrosis 1/599 (0.2%) 0/598 (0%) 0/182 (0%)
Respiratory, thoracic and mediastinal disorders
Respiratory failure 1/599 (0.2%) 9/598 (1.5%) 1/182 (0.5%)
Pulmonary embolism 3/599 (0.5%) 3/598 (0.5%) 0/182 (0%)
Respiratory distress 3/599 (0.5%) 1/598 (0.2%) 1/182 (0.5%)
Pneumothorax 1/599 (0.2%) 0/598 (0%) 2/182 (1.1%)
Respiratory arrest 0/599 (0%) 2/598 (0.3%) 1/182 (0.5%)
Acute pulmonary oedema 0/599 (0%) 1/598 (0.2%) 1/182 (0.5%)
Hypoxia 0/599 (0%) 1/598 (0.2%) 1/182 (0.5%)
Pulmonary oedema 1/599 (0.2%) 0/598 (0%) 1/182 (0.5%)
Acute respiratory failure 0/599 (0%) 1/598 (0.2%) 0/182 (0%)
Aspiration 1/599 (0.2%) 0/598 (0%) 0/182 (0%)
Asthma 1/599 (0.2%) 0/598 (0%) 0/182 (0%)
Atelectasis 0/599 (0%) 0/598 (0%) 1/182 (0.5%)
Chronic obstructive pulmonary disease 1/599 (0.2%) 0/598 (0%) 0/182 (0%)
Haemopneumothorax 0/599 (0%) 1/598 (0.2%) 0/182 (0%)
Hypercapnia 0/599 (0%) 1/598 (0.2%) 0/182 (0%)
Hypoventilation 0/599 (0%) 1/598 (0.2%) 0/182 (0%)
Pneumonia aspiration 0/599 (0%) 0/598 (0%) 1/182 (0.5%)
Tachypnoea 0/599 (0%) 1/598 (0.2%) 0/182 (0%)
Thoracic haemorrhage 0/599 (0%) 0/598 (0%) 1/182 (0.5%)
Skin and subcutaneous tissue disorders
Decubitus ulcer 1/599 (0.2%) 0/598 (0%) 0/182 (0%)
Vascular disorders
Haemorrhage 0/599 (0%) 2/598 (0.3%) 3/182 (1.6%)
Deep vein thrombosis 2/599 (0.3%) 2/598 (0.3%) 0/182 (0%)
Shock haemorrhagic 3/599 (0.5%) 0/598 (0%) 1/182 (0.5%)
Hypotension 0/599 (0%) 2/598 (0.3%) 0/182 (0%)
Hypovolaemic shock 0/599 (0%) 1/598 (0.2%) 1/182 (0.5%)
Aortic aneurysm rupture 0/599 (0%) 0/598 (0%) 1/182 (0.5%)
Extremity necrosis 1/599 (0.2%) 0/598 (0%) 0/182 (0%)
Jugular vein thrombosis 0/599 (0%) 1/598 (0.2%) 0/182 (0%)
Shock 0/599 (0%) 1/598 (0.2%) 0/182 (0%)
Other (Not Including Serious) Adverse Events
Placebo Low GR270773 High GR270773
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 160/599 (26.7%) 183/598 (30.6%) 60/182 (33%)
Blood and lymphatic system disorders
Anaemia 76/599 (12.7%) 87/598 (14.5%) 28/182 (15.4%)
Cardiac disorders
Atrial fibrillation 44/599 (7.3%) 41/598 (6.9%) 10/182 (5.5%)
Gastrointestinal disorders
Diarrhoea 33/599 (5.5%) 50/598 (8.4%) 28/182 (15.4%)
Nausea 25/599 (4.2%) 31/598 (5.2%) 15/182 (8.2%)
Metabolism and nutrition disorders
Hypokalaemia 51/599 (8.5%) 53/598 (8.9%) 16/182 (8.8%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.

Results Point of Contact

Name/Title GSK Response Center
Organization GlaxoSmithKline
Phone 866-435-7343
Email
Responsible Party:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00089986
Other Study ID Numbers:
  • EMD20001
First Posted:
Aug 23, 2004
Last Update Posted:
Aug 21, 2017
Last Verified:
Jul 1, 2017