Trial Outcomes & Findings for Randomized Control Trial of Fluid Therapy for Pediatric Diabetic Ketoacidosis (NCT NCT01365793)
NCT ID: NCT01365793
Last Updated: 2018-06-25
Results Overview
The primary outcome is the binary indicator that a patient's GCS score drops below 14 (i.e. abnormal score) within the first 24 hours of treatment of DKA. There will be two treatment factors: sodium concentration of re-hydration fluids and rate of rehydration. These effects will be tested separately, using the Mantel-Haenszel chi-square test, stratified by hospital, and by the other main factor.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1389 participants
Primary outcome timeframe
24 hours
Results posted on
2018-06-25
Participant Flow
Participant milestones
| Measure |
Rapid Rehydration Using 0.45% Saline Replacement Fluid
This arm involved more rapid intravenous fluid treatment which included a second 10cc/Kg bolus of 0.9% saline and assumed a 10% fluid deficit. Intravenous fluids were infused to replace half of the estimated fluid deficit over 12 hours and the remaining half over the following 24 hours, in addition to maintenance fluids. 0.45% saline was used as the replacement fluid for this arm.
|
Rapid Rehydration Using 0.9% Saline Replacement Fluid
This arm involved more rapid intravenous fluid treatment which included a second 10cc/Kg bolus of 0.9% saline and assumed a 10% fluid deficit. Intravenous fluids were infused to replace half of the estimated fluid deficit over 12 hours and the remaining half over the following 24 hours, in addition to maintenance fluids. 0.9% saline was used as the replacement fluid for this arm.
|
Slower Rehydration Using 0.45% Saline Replacement Fluid
This arm involved slower rehydration (assumed 5% fluid deficit and no additional fluid bolus). Intravenous fluids were infused to replace the estimated deficit over 48 hours, in addition to maintenance fluids. 0.45% saline was used as the replacement fluid for this arm.
|
Slower Rehydration Using 0.9% Saline Replacement Fluid
This arm involved slower rehydration (assumed 5% fluid deficit and no additional fluid bolus). Intravenous fluids were infused to replace the estimated deficit over 48 hours, in addition to maintenance fluids. 0.9% saline was used as the replacement fluid for this arm.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
344
|
351
|
345
|
349
|
|
Overall Study
COMPLETED
|
342
|
344
|
338
|
347
|
|
Overall Study
NOT COMPLETED
|
2
|
7
|
7
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Randomized Control Trial of Fluid Therapy for Pediatric Diabetic Ketoacidosis
Baseline characteristics by cohort
| Measure |
Rapid Rehydration Using 0.45% Saline Replacement Fluid
n=344 Participants
This arm involved more rapid intravenous fluid treatment which included a second 10cc/Kg bolus of 0.9% saline and assumed a 10% fluid deficit. Intravenous fluids were infused to replace half of the estimated fluid deficit over 12 hours and the remaining half over the following 24 hours, in addition to maintenance fluids. 0.45% saline was used as the replacement fluid for this arm.
|
Rapid Rehydration Using 0.9% Saline Replacement Fluid
n=351 Participants
This arm involved more rapid intravenous fluid treatment which included a second 10cc/Kg bolus of 0.9% saline and assumed a 10% fluid deficit. Intravenous fluids were infused to replace half of the estimated fluid deficit over 12 hours and the remaining half over the following 24 hours, in addition to maintenance fluids. 0.9% saline was used as the replacement fluid for this arm.
|
Slower Rehydration Using 0.45% Saline Replacement Fluid
n=345 Participants
This arm involved slower rehydration (assumed 5% fluid deficit and no additional fluid bolus). Intravenous fluids were infused to replace the estimated deficit over 48 hours, in addition to maintenance fluids. 0.45% saline was used as the replacement fluid for this arm.
|
Slower Rehydration Using 0.9% Saline Replacement Fluid
n=349 Participants
This arm involved slower rehydration (assumed 5% fluid deficit and no additional fluid bolus). Intravenous fluids were infused to replace the estimated deficit over 48 hours, in addition to maintenance fluids. 0.9% saline was used as the replacement fluid for this arm.
|
Total
n=1389 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Customized
0 to less than 6 years old
|
43 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
35 Participants
n=4 Participants
|
162 Participants
n=21 Participants
|
|
Age, Customized
6 to less than 18 years old
|
301 Participants
n=5 Participants
|
309 Participants
n=7 Participants
|
303 Participants
n=5 Participants
|
314 Participants
n=4 Participants
|
1227 Participants
n=21 Participants
|
|
Sex: Female, Male
Female
|
179 Participants
n=5 Participants
|
187 Participants
n=7 Participants
|
187 Participants
n=5 Participants
|
186 Participants
n=4 Participants
|
739 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
165 Participants
n=5 Participants
|
164 Participants
n=7 Participants
|
158 Participants
n=5 Participants
|
163 Participants
n=4 Participants
|
650 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
235 Participants
n=5 Participants
|
232 Participants
n=7 Participants
|
247 Participants
n=5 Participants
|
243 Participants
n=4 Participants
|
957 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Race · Black or African American
|
73 Participants
n=5 Participants
|
82 Participants
n=7 Participants
|
68 Participants
n=5 Participants
|
63 Participants
n=4 Participants
|
286 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Race · Other
|
19 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
23 Participants
n=4 Participants
|
72 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Race · Unknown
|
17 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
74 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Hispanic or Latino
|
48 Participants
n=5 Participants
|
62 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
69 Participants
n=4 Participants
|
228 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Not Hispanic or Latino, Other, or Unknown
|
296 Participants
n=5 Participants
|
289 Participants
n=7 Participants
|
296 Participants
n=5 Participants
|
280 Participants
n=4 Participants
|
1161 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 24 hoursPopulation: Patients with a GCS of 14 or 15 at randomization
The primary outcome is the binary indicator that a patient's GCS score drops below 14 (i.e. abnormal score) within the first 24 hours of treatment of DKA. There will be two treatment factors: sodium concentration of re-hydration fluids and rate of rehydration. These effects will be tested separately, using the Mantel-Haenszel chi-square test, stratified by hospital, and by the other main factor.
Outcome measures
| Measure |
Rapid Rehydration Using 0.45% Saline Replacement Fluid
n=337 Participants
This arm involved more rapid intravenous fluid treatment which included a second 10cc/Kg bolus of 0.9% saline and assumed a 10% fluid deficit. Intravenous fluids were infused to replace half of the estimated fluid deficit over 12 hours and the remaining half over the following 24 hours, in addition to maintenance fluids. 0.45% saline was used as the replacement fluid for this arm.
|
Rapid Rehydration Using 0.9% Saline Replacement Fluid
n=345 Participants
This arm involved more rapid intravenous fluid treatment which included a second 10cc/Kg bolus of 0.9% saline and assumed a 10% fluid deficit. Intravenous fluids were infused to replace half of the estimated fluid deficit over 12 hours and the remaining half over the following 24 hours, in addition to maintenance fluids. 0.9% saline was used as the replacement fluid for this arm.
|
Slower Rehydration Using 0.45% Saline Replacement Fluid
n=338 Participants
This arm involved slower rehydration (assumed 5% fluid deficit and no additional fluid bolus). Intravenous fluids were infused to replace the estimated deficit over 48 hours, in addition to maintenance fluids. 0.45% saline was used as the replacement fluid for this arm.
|
Slower Rehydration Using 0.9% Saline Replacement Fluid
n=341 Participants
This arm involved slower rehydration (assumed 5% fluid deficit and no additional fluid bolus). Intravenous fluids were infused to replace the estimated deficit over 48 hours, in addition to maintenance fluids. 0.9% saline was used as the replacement fluid for this arm.
|
|---|---|---|---|---|
|
the Number of Participants With Glasgow Coma Score (GCS) < 14 Within the First 24 Hours of Treatment for Diabetic Ketoacidosis (DKA)
|
10 Participants
|
11 Participants
|
11 Participants
|
16 Participants
|
SECONDARY outcome
Timeframe: 24 hoursPopulation: All randomized patients.
Deterioration in neurological status requiring interventions such as hyperosmolar therapy or endotracheal intubation, or resulting in death. This outcome was determined by an adjudication committee.
Outcome measures
| Measure |
Rapid Rehydration Using 0.45% Saline Replacement Fluid
n=344 Participants
This arm involved more rapid intravenous fluid treatment which included a second 10cc/Kg bolus of 0.9% saline and assumed a 10% fluid deficit. Intravenous fluids were infused to replace half of the estimated fluid deficit over 12 hours and the remaining half over the following 24 hours, in addition to maintenance fluids. 0.45% saline was used as the replacement fluid for this arm.
|
Rapid Rehydration Using 0.9% Saline Replacement Fluid
n=351 Participants
This arm involved more rapid intravenous fluid treatment which included a second 10cc/Kg bolus of 0.9% saline and assumed a 10% fluid deficit. Intravenous fluids were infused to replace half of the estimated fluid deficit over 12 hours and the remaining half over the following 24 hours, in addition to maintenance fluids. 0.9% saline was used as the replacement fluid for this arm.
|
Slower Rehydration Using 0.45% Saline Replacement Fluid
n=345 Participants
This arm involved slower rehydration (assumed 5% fluid deficit and no additional fluid bolus). Intravenous fluids were infused to replace the estimated deficit over 48 hours, in addition to maintenance fluids. 0.45% saline was used as the replacement fluid for this arm.
|
Slower Rehydration Using 0.9% Saline Replacement Fluid
n=349 Participants
This arm involved slower rehydration (assumed 5% fluid deficit and no additional fluid bolus). Intravenous fluids were infused to replace the estimated deficit over 48 hours, in addition to maintenance fluids. 0.9% saline was used as the replacement fluid for this arm.
|
|---|---|---|---|---|
|
Frequency of Clinically Apparent Brain Injury
|
2 Participants
|
2 Participants
|
5 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: 24 hoursPopulation: All randomized patients with digit span measured during DKA
The Digit Span subtest is adapted from the Wechsler Intelligence Scale for Children, 4th version (WISC-IV) and it assesses working memory. It consists of a Digit Span Forward task in which individuals are asked to repeat numbers in the same sequence as they were presented verbally and a Digit Span Backward task in which participants repeat the numbers in the reversed order to which they were heard. Each task yields a score ranging from 0 to 16. Higher scores represent better outcomes for this test. The trajectory of digit span scores during the course of the hospitalization was used to assess improvements in mental status and whether these varied systematically as a function of treatment protocol. Digit span measurements were collected every four hours during waking hours (7AM to 10PM). The measure analyzed is the average linear change in scores between enrollment and either 24-hours or DKA resolution, whichever occurred first.
Outcome measures
| Measure |
Rapid Rehydration Using 0.45% Saline Replacement Fluid
n=344 Participants
This arm involved more rapid intravenous fluid treatment which included a second 10cc/Kg bolus of 0.9% saline and assumed a 10% fluid deficit. Intravenous fluids were infused to replace half of the estimated fluid deficit over 12 hours and the remaining half over the following 24 hours, in addition to maintenance fluids. 0.45% saline was used as the replacement fluid for this arm.
|
Rapid Rehydration Using 0.9% Saline Replacement Fluid
n=351 Participants
This arm involved more rapid intravenous fluid treatment which included a second 10cc/Kg bolus of 0.9% saline and assumed a 10% fluid deficit. Intravenous fluids were infused to replace half of the estimated fluid deficit over 12 hours and the remaining half over the following 24 hours, in addition to maintenance fluids. 0.9% saline was used as the replacement fluid for this arm.
|
Slower Rehydration Using 0.45% Saline Replacement Fluid
n=345 Participants
This arm involved slower rehydration (assumed 5% fluid deficit and no additional fluid bolus). Intravenous fluids were infused to replace the estimated deficit over 48 hours, in addition to maintenance fluids. 0.45% saline was used as the replacement fluid for this arm.
|
Slower Rehydration Using 0.9% Saline Replacement Fluid
n=349 Participants
This arm involved slower rehydration (assumed 5% fluid deficit and no additional fluid bolus). Intravenous fluids were infused to replace the estimated deficit over 48 hours, in addition to maintenance fluids. 0.9% saline was used as the replacement fluid for this arm.
|
|---|---|---|---|---|
|
Hourly Improvement in Forward and Backward Digit Span Scores During DKA Treatment (Mean Difference Per Hour)
Digit span recall test Forward slope
|
0.065 Digit Span Change per Hour
Standard Error 0.010
|
0.058 Digit Span Change per Hour
Standard Error 0.010
|
0.046 Digit Span Change per Hour
Standard Error 0.010
|
0.039 Digit Span Change per Hour
Standard Error 0.010
|
|
Hourly Improvement in Forward and Backward Digit Span Scores During DKA Treatment (Mean Difference Per Hour)
Digit span recall test Backward slope
|
0.052 Digit Span Change per Hour
Standard Error 0.009
|
0.053 Digit Span Change per Hour
Standard Error 0.009
|
0.042 Digit Span Change per Hour
Standard Error 0.009
|
0.043 Digit Span Change per Hour
Standard Error 0.009
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: All randomized subjects aged 6 years old and older with 3-month follow-up and successful completion of memory score tests, and d-prime (a measure of chance agreement) \>0.50
Contextual memory was assessed via color and spatial-position tasks. Color-Task: black-ink items on a white square background were shown on a computer screen with a colored border. Subjects were asked to remember the item and the item's border color. Items were shown for 1 second, followed by a 1-second interval in which a fixation point was shown. Then, subjects were given a self-paced recognition test including studied drawings and new drawings shown in random order with no color border. Subjects determined if they had seen the drawing before. For recognized drawings, subjects reported the previously shown border color. Spatial-Position task: identical to the color task except that the items instead varied in their spatial position on the computer screen. The item-context association rate is the rate of correct item-color and item-spatial position recalled over the total of previously viewed items correctly recognized. Score range: 0-1 with higher scores indicating a better outcome.
Outcome measures
| Measure |
Rapid Rehydration Using 0.45% Saline Replacement Fluid
n=175 Participants
This arm involved more rapid intravenous fluid treatment which included a second 10cc/Kg bolus of 0.9% saline and assumed a 10% fluid deficit. Intravenous fluids were infused to replace half of the estimated fluid deficit over 12 hours and the remaining half over the following 24 hours, in addition to maintenance fluids. 0.45% saline was used as the replacement fluid for this arm.
|
Rapid Rehydration Using 0.9% Saline Replacement Fluid
n=184 Participants
This arm involved more rapid intravenous fluid treatment which included a second 10cc/Kg bolus of 0.9% saline and assumed a 10% fluid deficit. Intravenous fluids were infused to replace half of the estimated fluid deficit over 12 hours and the remaining half over the following 24 hours, in addition to maintenance fluids. 0.9% saline was used as the replacement fluid for this arm.
|
Slower Rehydration Using 0.45% Saline Replacement Fluid
n=178 Participants
This arm involved slower rehydration (assumed 5% fluid deficit and no additional fluid bolus). Intravenous fluids were infused to replace the estimated deficit over 48 hours, in addition to maintenance fluids. 0.45% saline was used as the replacement fluid for this arm.
|
Slower Rehydration Using 0.9% Saline Replacement Fluid
n=176 Participants
This arm involved slower rehydration (assumed 5% fluid deficit and no additional fluid bolus). Intravenous fluids were infused to replace the estimated deficit over 48 hours, in addition to maintenance fluids. 0.9% saline was used as the replacement fluid for this arm.
|
|---|---|---|---|---|
|
Mean Scores on Tests of Memory Capacity 3 Months After Recovery From DKA.
|
0.60 Item-context association rate
Standard Deviation 0.14
|
0.60 Item-context association rate
Standard Deviation 0.14
|
0.61 Item-context association rate
Standard Deviation 0.14
|
0.60 Item-context association rate
Standard Deviation 0.14
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: All randomized subjects aged 3 years and older with 3-month follow-up and successful completion of IQ testing.
IQ was assessed with the WASI (6-18 year olds) or WPPSI-III (3-5 year olds) at the 3 month follow-up visit. The Wechsler Abbreviated Scale of Intelligence (WASI) is a measure of IQ designed for individuals aged 6 to 89. The WASI includes four subtests; the Block Design and Matrix Reasoning tests measure Performance IQ, and the Vocabulary and Similarities tests measure Verbal IQ. Full scale IQ was computed from these scores and used for analyses. Scores typically vary from 75 to 135 with higher scores representing a better outcome.
Outcome measures
| Measure |
Rapid Rehydration Using 0.45% Saline Replacement Fluid
n=187 Participants
This arm involved more rapid intravenous fluid treatment which included a second 10cc/Kg bolus of 0.9% saline and assumed a 10% fluid deficit. Intravenous fluids were infused to replace half of the estimated fluid deficit over 12 hours and the remaining half over the following 24 hours, in addition to maintenance fluids. 0.45% saline was used as the replacement fluid for this arm.
|
Rapid Rehydration Using 0.9% Saline Replacement Fluid
n=201 Participants
This arm involved more rapid intravenous fluid treatment which included a second 10cc/Kg bolus of 0.9% saline and assumed a 10% fluid deficit. Intravenous fluids were infused to replace half of the estimated fluid deficit over 12 hours and the remaining half over the following 24 hours, in addition to maintenance fluids. 0.9% saline was used as the replacement fluid for this arm.
|
Slower Rehydration Using 0.45% Saline Replacement Fluid
n=191 Participants
This arm involved slower rehydration (assumed 5% fluid deficit and no additional fluid bolus). Intravenous fluids were infused to replace the estimated deficit over 48 hours, in addition to maintenance fluids. 0.45% saline was used as the replacement fluid for this arm.
|
Slower Rehydration Using 0.9% Saline Replacement Fluid
n=189 Participants
This arm involved slower rehydration (assumed 5% fluid deficit and no additional fluid bolus). Intravenous fluids were infused to replace the estimated deficit over 48 hours, in addition to maintenance fluids. 0.9% saline was used as the replacement fluid for this arm.
|
|---|---|---|---|---|
|
Intelligence Quotient (IQ) Testing
|
102 IQ points
Standard Deviation 12
|
102 IQ points
Standard Deviation 13
|
102 IQ points
Standard Deviation 13
|
103 IQ points
Standard Deviation 13
|
Adverse Events
Rapid Rehydration Using 0.45% Saline Replacement Fluid
Serious events: 5 serious events
Other events: 112 other events
Deaths: 1 deaths
Rapid Rehydration Using 0.9% Saline Replacement Fluid
Serious events: 4 serious events
Other events: 124 other events
Deaths: 0 deaths
Slower Rehydration Using 0.45% Saline Replacement Fluid
Serious events: 11 serious events
Other events: 117 other events
Deaths: 0 deaths
Slower Rehydration Using 0.9% Saline Replacement Fluid
Serious events: 10 serious events
Other events: 129 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Rapid Rehydration Using 0.45% Saline Replacement Fluid
n=342 participants at risk
This arm involved more rapid intravenous fluid treatment which included a second 10cc/Kg bolus of 0.9% saline and assumed a 10% fluid deficit. Intravenous fluids were infused to replace half of the estimated fluid deficit over 12 hours and the remaining half over the following 24 hours, in addition to maintenance fluids. 0.45% saline was used as the replacement fluid for this arm.
|
Rapid Rehydration Using 0.9% Saline Replacement Fluid
n=344 participants at risk
This arm involved more rapid intravenous fluid treatment which included a second 10cc/Kg bolus of 0.9% saline and assumed a 10% fluid deficit. Intravenous fluids were infused to replace half of the estimated fluid deficit over 12 hours and the remaining half over the following 24 hours, in addition to maintenance fluids. 0.9% saline was used as the replacement fluid for this arm.
|
Slower Rehydration Using 0.45% Saline Replacement Fluid
n=338 participants at risk
This arm involved slower rehydration (assumed 5% fluid deficit and no additional fluid bolus). Intravenous fluids were infused to replace the estimated deficit over 48 hours, in addition to maintenance fluids. 0.45% saline was used as the replacement fluid for this arm.
|
Slower Rehydration Using 0.9% Saline Replacement Fluid
n=347 participants at risk
This arm involved slower rehydration (assumed 5% fluid deficit and no additional fluid bolus). Intravenous fluids were infused to replace the estimated deficit over 48 hours, in addition to maintenance fluids. 0.9% saline was used as the replacement fluid for this arm.
|
|---|---|---|---|---|
|
Cardiac disorders
Cardiac Arrest
|
0.29%
1/342 • Number of events 1
|
0.00%
0/344
|
0.00%
0/338
|
0.00%
0/347
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/342
|
0.00%
0/344
|
0.30%
1/338 • Number of events 1
|
0.00%
0/347
|
|
Hepatobiliary disorders
Hepatomegaly
|
0.00%
0/342
|
0.00%
0/344
|
0.30%
1/338 • Number of events 1
|
0.00%
0/347
|
|
Infections and infestations
Infection
|
0.00%
0/342
|
0.00%
0/344
|
0.00%
0/338
|
0.29%
1/347 • Number of events 1
|
|
Metabolism and nutrition disorders
Acidosis
|
0.00%
0/342
|
0.29%
1/344 • Number of events 1
|
0.00%
0/338
|
0.29%
1/347 • Number of events 1
|
|
Nervous system disorders
Brain oedema
|
0.58%
2/342 • Number of events 2
|
0.58%
2/344 • Number of events 2
|
2.4%
8/338 • Number of events 8
|
2.0%
7/347 • Number of events 7
|
|
Renal and urinary disorders
Renal injury
|
0.29%
1/342 • Number of events 1
|
0.00%
0/344
|
0.00%
0/338
|
0.00%
0/347
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.29%
1/342 • Number of events 1
|
0.00%
0/344
|
0.00%
0/338
|
0.00%
0/347
|
|
Vascular disorders
Hypovolemic shock
|
0.00%
0/342
|
0.00%
0/344
|
0.30%
1/338 • Number of events 1
|
0.00%
0/347
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/342
|
0.29%
1/344 • Number of events 1
|
0.00%
0/338
|
0.00%
0/347
|
|
Metabolism and nutrition disorders
Acidosis hyperchloraemic
|
0.00%
0/342
|
0.00%
0/344
|
0.00%
0/338
|
0.29%
1/347 • Number of events 1
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.00%
0/342
|
0.00%
0/344
|
0.00%
0/338
|
0.29%
1/347 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.29%
1/342 • Number of events 2
|
0.00%
0/344
|
0.00%
0/338
|
0.00%
0/347
|
|
Nervous system disorders
Cerebral infarction
|
0.29%
1/342 • Number of events 1
|
0.00%
0/344
|
0.00%
0/338
|
0.00%
0/347
|
|
Nervous system disorders
Somnolence
|
0.29%
1/342 • Number of events 1
|
0.00%
0/344
|
0.00%
0/338
|
0.00%
0/347
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.29%
1/342 • Number of events 1
|
0.00%
0/344
|
0.00%
0/338
|
0.00%
0/347
|
Other adverse events
| Measure |
Rapid Rehydration Using 0.45% Saline Replacement Fluid
n=342 participants at risk
This arm involved more rapid intravenous fluid treatment which included a second 10cc/Kg bolus of 0.9% saline and assumed a 10% fluid deficit. Intravenous fluids were infused to replace half of the estimated fluid deficit over 12 hours and the remaining half over the following 24 hours, in addition to maintenance fluids. 0.45% saline was used as the replacement fluid for this arm.
|
Rapid Rehydration Using 0.9% Saline Replacement Fluid
n=344 participants at risk
This arm involved more rapid intravenous fluid treatment which included a second 10cc/Kg bolus of 0.9% saline and assumed a 10% fluid deficit. Intravenous fluids were infused to replace half of the estimated fluid deficit over 12 hours and the remaining half over the following 24 hours, in addition to maintenance fluids. 0.9% saline was used as the replacement fluid for this arm.
|
Slower Rehydration Using 0.45% Saline Replacement Fluid
n=338 participants at risk
This arm involved slower rehydration (assumed 5% fluid deficit and no additional fluid bolus). Intravenous fluids were infused to replace the estimated deficit over 48 hours, in addition to maintenance fluids. 0.45% saline was used as the replacement fluid for this arm.
|
Slower Rehydration Using 0.9% Saline Replacement Fluid
n=347 participants at risk
This arm involved slower rehydration (assumed 5% fluid deficit and no additional fluid bolus). Intravenous fluids were infused to replace the estimated deficit over 48 hours, in addition to maintenance fluids. 0.9% saline was used as the replacement fluid for this arm.
|
|---|---|---|---|---|
|
Investigations
Influenza A virus test positive
|
0.29%
1/342 • Number of events 1
|
0.00%
0/344
|
0.00%
0/338
|
0.00%
0/347
|
|
Investigations
Lipase increased
|
0.29%
1/342 • Number of events 1
|
0.29%
1/344 • Number of events 1
|
0.00%
0/338
|
0.00%
0/347
|
|
Investigations
Liver function test increased
|
0.00%
0/342
|
0.00%
0/344
|
0.30%
1/338 • Number of events 1
|
0.00%
0/347
|
|
Investigations
Streptococcus test positive
|
0.29%
1/342 • Number of events 1
|
0.29%
1/344 • Number of events 1
|
0.00%
0/338
|
0.00%
0/347
|
|
Investigations
Urinary casts
|
0.00%
0/342
|
0.29%
1/344 • Number of events 1
|
0.00%
0/338
|
0.29%
1/347 • Number of events 1
|
|
Investigations
Urine analysis abnormal
|
0.29%
1/342 • Number of events 1
|
0.00%
0/344
|
0.00%
0/338
|
0.00%
0/347
|
|
Investigations
Urine output decreased
|
0.00%
0/342
|
0.00%
0/344
|
0.00%
0/338
|
0.29%
1/347 • Number of events 1
|
|
Investigations
White blood cell count increased
|
0.00%
0/342
|
0.00%
0/344
|
0.00%
0/338
|
0.29%
1/347 • Number of events 1
|
|
Metabolism and nutrition disorders
Acidosis
|
0.58%
2/342 • Number of events 2
|
0.00%
0/344
|
0.89%
3/338 • Number of events 3
|
0.58%
2/347 • Number of events 2
|
|
Metabolism and nutrition disorders
Acidosis hyperchloraemic
|
0.88%
3/342 • Number of events 3
|
4.7%
16/344 • Number of events 16
|
1.2%
4/338 • Number of events 4
|
5.8%
20/347 • Number of events 20
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.88%
3/342 • Number of events 3
|
1.5%
5/344 • Number of events 5
|
0.59%
2/338 • Number of events 2
|
1.4%
5/347 • Number of events 5
|
|
Metabolism and nutrition disorders
Alkalosis
|
0.29%
1/342 • Number of events 1
|
0.00%
0/344
|
0.00%
0/338
|
0.00%
0/347
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/342
|
0.00%
0/344
|
0.00%
0/338
|
0.29%
1/347 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyperchloraemia
|
0.88%
3/342 • Number of events 3
|
0.58%
2/344 • Number of events 2
|
0.00%
0/338
|
0.58%
2/347 • Number of events 2
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/342
|
0.87%
3/344 • Number of events 3
|
0.00%
0/338
|
0.29%
1/347 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
2.3%
8/342 • Number of events 8
|
1.2%
4/344 • Number of events 4
|
1.2%
4/338 • Number of events 4
|
0.29%
1/347 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
0.00%
0/342
|
0.00%
0/344
|
0.30%
1/338 • Number of events 1
|
0.86%
3/347 • Number of events 3
|
|
Metabolism and nutrition disorders
Hyperphosphataemia
|
0.00%
0/342
|
0.29%
1/344 • Number of events 1
|
0.00%
0/338
|
0.00%
0/347
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
0.00%
0/342
|
0.29%
1/344 • Number of events 1
|
0.00%
0/338
|
0.00%
0/347
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/342
|
0.58%
2/344 • Number of events 2
|
0.00%
0/338
|
0.00%
0/347
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
2.9%
10/342 • Number of events 10
|
2.6%
9/344 • Number of events 10
|
3.6%
12/338 • Number of events 13
|
4.3%
15/347 • Number of events 17
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
2.3%
8/342 • Number of events 9
|
4.4%
15/344 • Number of events 15
|
2.4%
8/338 • Number of events 8
|
4.3%
15/347 • Number of events 16
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.88%
3/342 • Number of events 3
|
0.00%
0/344
|
0.00%
0/338
|
0.29%
1/347 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
1.2%
4/342 • Number of events 4
|
0.00%
0/344
|
1.5%
5/338 • Number of events 5
|
0.00%
0/347
|
|
Metabolism and nutrition disorders
Hypophagia
|
0.00%
0/342
|
0.00%
0/344
|
0.00%
0/338
|
0.29%
1/347 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/342
|
0.58%
2/344 • Number of events 2
|
0.00%
0/338
|
0.00%
0/347
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/342
|
0.58%
2/344 • Number of events 2
|
0.30%
1/338 • Number of events 1
|
0.29%
1/347 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.29%
1/342 • Number of events 1
|
0.29%
1/344 • Number of events 1
|
0.00%
0/338
|
0.00%
0/347
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.29%
1/342 • Number of events 1
|
0.00%
0/344
|
0.00%
0/338
|
0.00%
0/347
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/342
|
0.29%
1/344 • Number of events 1
|
0.00%
0/338
|
0.00%
0/347
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/342
|
0.00%
0/344
|
0.30%
1/338 • Number of events 1
|
0.00%
0/347
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.58%
2/342 • Number of events 2
|
0.87%
3/344 • Number of events 3
|
0.30%
1/338 • Number of events 1
|
1.4%
5/347 • Number of events 5
|
|
Musculoskeletal and connective tissue disorders
Trismus
|
0.00%
0/342
|
0.00%
0/344
|
0.30%
1/338 • Number of events 1
|
0.00%
0/347
|
|
Nervous system disorders
Brain oedema
|
0.00%
0/342
|
0.00%
0/344
|
0.00%
0/338
|
0.29%
1/347 • Number of events 1
|
|
Nervous system disorders
Dizziness
|
0.88%
3/342 • Number of events 3
|
0.29%
1/344 • Number of events 1
|
0.30%
1/338 • Number of events 1
|
0.29%
1/347 • Number of events 1
|
|
Nervous system disorders
Dysarthria
|
0.00%
0/342
|
0.00%
0/344
|
0.30%
1/338 • Number of events 1
|
0.00%
0/347
|
|
Nervous system disorders
Headache
|
8.5%
29/342 • Number of events 29
|
4.7%
16/344 • Number of events 16
|
6.8%
23/338 • Number of events 23
|
8.1%
28/347 • Number of events 31
|
|
Nervous system disorders
Seizure
|
0.29%
1/342 • Number of events 1
|
0.00%
0/344
|
0.00%
0/338
|
0.00%
0/347
|
|
Nervous system disorders
Syncope
|
0.00%
0/342
|
0.00%
0/344
|
0.00%
0/338
|
0.29%
1/347 • Number of events 1
|
|
Psychiatric disorders
Agitation
|
0.00%
0/342
|
0.00%
0/344
|
0.30%
1/338 • Number of events 1
|
0.29%
1/347 • Number of events 1
|
|
Psychiatric disorders
Anxiety
|
0.29%
1/342 • Number of events 1
|
0.00%
0/344
|
0.00%
0/338
|
0.00%
0/347
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/342
|
0.29%
1/344 • Number of events 1
|
0.00%
0/338
|
0.00%
0/347
|
|
Psychiatric disorders
Insomnia
|
0.29%
1/342 • Number of events 1
|
0.00%
0/344
|
0.00%
0/338
|
0.00%
0/347
|
|
Psychiatric disorders
Irritability
|
0.29%
1/342 • Number of events 1
|
0.29%
1/344 • Number of events 2
|
0.30%
1/338 • Number of events 1
|
0.29%
1/347 • Number of events 1
|
|
Psychiatric disorders
Mental status changes
|
1.5%
5/342 • Number of events 5
|
1.5%
5/344 • Number of events 5
|
1.2%
4/338 • Number of events 4
|
1.7%
6/347 • Number of events 6
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/342
|
0.00%
0/344
|
0.30%
1/338 • Number of events 1
|
0.29%
1/347 • Number of events 1
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/342
|
0.29%
1/344 • Number of events 1
|
0.00%
0/338
|
0.00%
0/347
|
|
Renal and urinary disorders
Incontinence
|
0.00%
0/342
|
0.00%
0/344
|
0.00%
0/338
|
0.29%
1/347 • Number of events 1
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/342
|
0.00%
0/344
|
0.00%
0/338
|
0.29%
1/347 • Number of events 1
|
|
Reproductive system and breast disorders
Vaginal discharge
|
0.00%
0/342
|
0.29%
1/344 • Number of events 1
|
0.00%
0/338
|
0.29%
1/347 • Number of events 1
|
|
Reproductive system and breast disorders
Vulvovaginal pruritis
|
0.29%
1/342 • Number of events 1
|
0.00%
0/344
|
0.00%
0/338
|
0.00%
0/347
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.88%
3/342 • Number of events 3
|
0.29%
1/344 • Number of events 1
|
0.59%
2/338 • Number of events 2
|
0.29%
1/347 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.29%
1/342 • Number of events 1
|
0.00%
0/344
|
0.00%
0/338
|
0.00%
0/347
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.29%
1/342 • Number of events 1
|
0.00%
0/344
|
0.30%
1/338 • Number of events 1
|
0.00%
0/347
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.29%
1/342 • Number of events 1
|
0.00%
0/344
|
0.00%
0/338
|
0.00%
0/347
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.29%
1/342 • Number of events 1
|
0.29%
1/344 • Number of events 1
|
0.59%
2/338 • Number of events 2
|
0.00%
0/347
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
2.6%
9/342 • Number of events 9
|
3.2%
11/344 • Number of events 11
|
3.0%
10/338 • Number of events 10
|
2.6%
9/347 • Number of events 9
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal erythema
|
0.00%
0/342
|
0.00%
0/344
|
0.30%
1/338 • Number of events 1
|
0.29%
1/347 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.29%
1/342 • Number of events 1
|
0.00%
0/344
|
0.00%
0/338
|
0.00%
0/347
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.00%
0/342
|
0.00%
0/344
|
0.00%
0/338
|
0.29%
1/347 • Number of events 1
|
|
Blood and lymphatic system disorders
Coagulopathy
|
0.29%
1/342 • Number of events 1
|
0.00%
0/344
|
0.00%
0/338
|
0.00%
0/347
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/342
|
0.29%
1/344 • Number of events 1
|
0.00%
0/338
|
0.00%
0/347
|
|
Cardiac disorders
Bradycardia
|
0.29%
1/342 • Number of events 1
|
0.29%
1/344 • Number of events 1
|
0.59%
2/338 • Number of events 2
|
0.29%
1/347 • Number of events 1
|
|
Cardiac disorders
Nodal Rythm
|
0.00%
0/342
|
0.00%
0/344
|
0.30%
1/338 • Number of events 1
|
0.00%
0/347
|
|
Cardiac disorders
Tachycardia
|
0.88%
3/342 • Number of events 3
|
0.58%
2/344 • Number of events 2
|
0.89%
3/338 • Number of events 3
|
0.29%
1/347 • Number of events 1
|
|
Cardiac disorders
Ventricular Extrasystoles
|
0.00%
0/342
|
0.29%
1/344 • Number of events 1
|
0.00%
0/338
|
0.29%
1/347 • Number of events 1
|
|
Ear and labyrinth disorders
Ear pain
|
0.58%
2/342 • Number of events 2
|
0.29%
1/344 • Number of events 1
|
0.00%
0/338
|
0.00%
0/347
|
|
Ear and labyrinth disorders
Middle ear effusion
|
0.29%
1/342 • Number of events 1
|
0.00%
0/344
|
0.00%
0/338
|
0.00%
0/347
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/342
|
0.00%
0/344
|
0.00%
0/338
|
0.29%
1/347 • Number of events 1
|
|
Eye disorders
Eye irritation
|
0.00%
0/342
|
0.00%
0/344
|
0.00%
0/338
|
0.29%
1/347 • Number of events 1
|
|
Eye disorders
Eye pain
|
0.58%
2/342 • Number of events 2
|
0.00%
0/344
|
0.00%
0/338
|
0.00%
0/347
|
|
Eye disorders
Ocular hyperaemia
|
0.00%
0/342
|
0.00%
0/344
|
0.30%
1/338 • Number of events 1
|
0.00%
0/347
|
|
Eye disorders
Vision blurred
|
0.58%
2/342 • Number of events 3
|
0.00%
0/344
|
0.30%
1/338 • Number of events 1
|
0.29%
1/347 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/342
|
0.00%
0/344
|
0.30%
1/338 • Number of events 1
|
0.00%
0/347
|
|
Gastrointestinal disorders
Abdominal pain
|
0.58%
2/342 • Number of events 2
|
3.2%
11/344 • Number of events 11
|
2.1%
7/338 • Number of events 7
|
0.86%
3/347 • Number of events 3
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/342
|
0.00%
0/344
|
0.00%
0/338
|
0.29%
1/347 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/342
|
0.29%
1/344 • Number of events 1
|
0.00%
0/338
|
0.00%
0/347
|
|
Gastrointestinal disorders
Abdominal tenderness
|
0.00%
0/342
|
0.29%
1/344 • Number of events 1
|
0.00%
0/338
|
0.00%
0/347
|
|
Gastrointestinal disorders
Constipation
|
0.88%
3/342 • Number of events 3
|
1.2%
4/344 • Number of events 4
|
0.59%
2/338 • Number of events 2
|
3.2%
11/347 • Number of events 11
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/342
|
0.29%
1/344 • Number of events 1
|
0.30%
1/338 • Number of events 1
|
0.00%
0/347
|
|
Gastrointestinal disorders
Dyspepsia
|
0.88%
3/342 • Number of events 3
|
0.29%
1/344 • Number of events 1
|
0.30%
1/338 • Number of events 1
|
0.29%
1/347 • Number of events 1
|
|
Gastrointestinal disorders
Dysphagia
|
0.29%
1/342 • Number of events 1
|
0.00%
0/344
|
0.00%
0/338
|
0.00%
0/347
|
|
Gastrointestinal disorders
Gastrointestinal sounds abnormal
|
0.00%
0/342
|
0.00%
0/344
|
0.30%
1/338 • Number of events 1
|
0.00%
0/347
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.58%
2/342 • Number of events 2
|
0.29%
1/344 • Number of events 1
|
0.00%
0/338
|
0.00%
0/347
|
|
Gastrointestinal disorders
Gingival pain
|
0.29%
1/342 • Number of events 1
|
0.00%
0/344
|
0.00%
0/338
|
0.00%
0/347
|
|
Gastrointestinal disorders
Glossodynia
|
0.29%
1/342 • Number of events 1
|
0.00%
0/344
|
0.30%
1/338 • Number of events 1
|
0.29%
1/347 • Number of events 1
|
|
Gastrointestinal disorders
Haematemesis
|
0.29%
1/342 • Number of events 1
|
0.00%
0/344
|
0.30%
1/338 • Number of events 1
|
0.00%
0/347
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/342
|
0.00%
0/344
|
0.00%
0/338
|
0.29%
1/347 • Number of events 1
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.29%
1/342 • Number of events 1
|
0.00%
0/344
|
0.00%
0/338
|
0.00%
0/347
|
|
Gastrointestinal disorders
Nausea
|
1.5%
5/342 • Number of events 5
|
0.87%
3/344 • Number of events 3
|
0.59%
2/338 • Number of events 2
|
1.4%
5/347 • Number of events 5
|
|
Gastrointestinal disorders
Oesophageal discomfort
|
0.29%
1/342 • Number of events 1
|
0.00%
0/344
|
0.00%
0/338
|
0.00%
0/347
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/342
|
0.29%
1/344 • Number of events 1
|
0.00%
0/338
|
0.00%
0/347
|
|
Gastrointestinal disorders
Oral Pain
|
0.00%
0/342
|
0.00%
0/344
|
0.89%
3/338 • Number of events 3
|
0.00%
0/347
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/342
|
0.00%
0/344
|
0.30%
1/338 • Number of events 1
|
0.00%
0/347
|
|
Gastrointestinal disorders
Proctalgia
|
0.00%
0/342
|
0.29%
1/344 • Number of events 1
|
0.00%
0/338
|
0.00%
0/347
|
|
Gastrointestinal disorders
Stomatitis
|
0.29%
1/342 • Number of events 1
|
0.00%
0/344
|
0.00%
0/338
|
0.00%
0/347
|
|
Gastrointestinal disorders
Toothache
|
0.29%
1/342 • Number of events 1
|
0.29%
1/344 • Number of events 1
|
0.00%
0/338
|
0.00%
0/347
|
|
Gastrointestinal disorders
Vomiting
|
0.58%
2/342 • Number of events 2
|
1.2%
4/344 • Number of events 4
|
0.59%
2/338 • Number of events 2
|
1.2%
4/347 • Number of events 4
|
|
General disorders
Catheter site inflammation
|
0.58%
2/342 • Number of events 2
|
0.58%
2/344 • Number of events 2
|
0.00%
0/338
|
0.58%
2/347 • Number of events 2
|
|
General disorders
Catheter site pain
|
0.88%
3/342 • Number of events 3
|
0.00%
0/344
|
0.59%
2/338 • Number of events 2
|
0.86%
3/347 • Number of events 3
|
|
General disorders
Chest discomfort
|
0.00%
0/342
|
0.00%
0/344
|
0.30%
1/338 • Number of events 1
|
0.29%
1/347 • Number of events 1
|
|
General disorders
Chest pain
|
0.29%
1/342 • Number of events 1
|
0.58%
2/344 • Number of events 2
|
1.2%
4/338 • Number of events 4
|
0.58%
2/347 • Number of events 2
|
|
General disorders
Chills
|
0.29%
1/342 • Number of events 1
|
0.29%
1/344 • Number of events 1
|
0.30%
1/338 • Number of events 1
|
0.00%
0/347
|
|
General disorders
Complication associated with device
|
0.00%
0/342
|
0.29%
1/344 • Number of events 1
|
0.00%
0/338
|
0.29%
1/347 • Number of events 1
|
|
General disorders
Crying
|
0.29%
1/342 • Number of events 1
|
0.00%
0/344
|
0.00%
0/338
|
0.00%
0/347
|
|
General disorders
Facial pain
|
0.00%
0/342
|
0.00%
0/344
|
0.00%
0/338
|
0.29%
1/347 • Number of events 1
|
|
General disorders
Hypothermia
|
0.29%
1/342 • Number of events 1
|
0.00%
0/344
|
0.00%
0/338
|
0.00%
0/347
|
|
General disorders
Infusion site extravasation
|
0.00%
0/342
|
0.29%
1/344 • Number of events 1
|
0.30%
1/338 • Number of events 1
|
0.58%
2/347 • Number of events 2
|
|
General disorders
Infusion site pain
|
0.29%
1/342 • Number of events 1
|
0.29%
1/344 • Number of events 1
|
0.00%
0/338
|
0.29%
1/347 • Number of events 1
|
|
General disorders
Injection site pain
|
0.00%
0/342
|
0.00%
0/344
|
0.59%
2/338 • Number of events 2
|
0.00%
0/347
|
|
General disorders
Oedema peripheral
|
0.00%
0/342
|
0.00%
0/344
|
0.00%
0/338
|
0.29%
1/347 • Number of events 1
|
|
General disorders
Pain
|
0.29%
1/342 • Number of events 1
|
0.29%
1/344 • Number of events 1
|
0.59%
2/338 • Number of events 2
|
0.00%
0/347
|
|
General disorders
Peripheral swelling
|
0.00%
0/342
|
0.00%
0/344
|
0.00%
0/338
|
0.58%
2/347 • Number of events 2
|
|
General disorders
Pyrexia
|
2.3%
8/342 • Number of events 8
|
3.2%
11/344 • Number of events 11
|
2.4%
8/338 • Number of events 8
|
2.9%
10/347 • Number of events 10
|
|
Infections and infestations
Abscess
|
0.00%
0/342
|
0.00%
0/344
|
0.30%
1/338 • Number of events 1
|
0.00%
0/347
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/342
|
0.00%
0/344
|
0.00%
0/338
|
0.29%
1/347 • Number of events 1
|
|
Infections and infestations
Candida infection
|
0.29%
1/342 • Number of events 1
|
0.00%
0/344
|
0.30%
1/338 • Number of events 1
|
0.29%
1/347 • Number of events 1
|
|
Infections and infestations
Candiduria
|
0.29%
1/342 • Number of events 1
|
0.00%
0/344
|
0.00%
0/338
|
0.00%
0/347
|
|
Infections and infestations
Cellulitis
|
0.29%
1/342 • Number of events 1
|
0.00%
0/344
|
0.00%
0/338
|
0.29%
1/347 • Number of events 1
|
|
Infections and infestations
Clostridium difficile colitis
|
0.29%
1/342 • Number of events 1
|
0.00%
0/344
|
0.00%
0/338
|
0.00%
0/347
|
|
Infections and infestations
Fungal infection
|
0.00%
0/342
|
0.29%
1/344 • Number of events 1
|
0.30%
1/338 • Number of events 1
|
0.00%
0/347
|
|
Infections and infestations
Lice infestation
|
0.00%
0/342
|
0.00%
0/344
|
0.00%
0/338
|
0.29%
1/347 • Number of events 1
|
|
Infections and infestations
Metapneumovirus infection
|
0.29%
1/342 • Number of events 1
|
0.00%
0/344
|
0.00%
0/338
|
0.00%
0/347
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/342
|
0.58%
2/344 • Number of events 2
|
0.00%
0/338
|
0.58%
2/347 • Number of events 2
|
|
Infections and infestations
Otitits media
|
0.58%
2/342 • Number of events 2
|
0.00%
0/344
|
0.00%
0/338
|
0.29%
1/347 • Number of events 1
|
|
Infections and infestations
Periorbital cellulitis
|
0.00%
0/342
|
0.29%
1/344 • Number of events 1
|
0.00%
0/338
|
0.00%
0/347
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/342
|
0.58%
2/344 • Number of events 2
|
0.30%
1/338 • Number of events 1
|
0.29%
1/347 • Number of events 1
|
|
Infections and infestations
Pharyngitis streptococcal
|
0.00%
0/342
|
0.58%
2/344 • Number of events 2
|
0.00%
0/338
|
0.29%
1/347 • Number of events 1
|
|
Infections and infestations
Pneumonia
|
0.29%
1/342 • Number of events 1
|
0.00%
0/344
|
0.00%
0/338
|
0.00%
0/347
|
|
Infections and infestations
Pyuria
|
0.58%
2/342 • Number of events 2
|
0.00%
0/344
|
0.00%
0/338
|
0.00%
0/347
|
|
Infections and infestations
Sinusitis
|
0.29%
1/342 • Number of events 1
|
0.00%
0/344
|
0.00%
0/338
|
0.00%
0/347
|
|
Infections and infestations
Skin candida
|
0.29%
1/342 • Number of events 1
|
0.29%
1/344 • Number of events 1
|
0.00%
0/338
|
0.29%
1/347 • Number of events 1
|
|
Infections and infestations
Tooth infection
|
0.00%
0/342
|
0.29%
1/344 • Number of events 1
|
0.00%
0/338
|
0.00%
0/347
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/342
|
0.00%
0/344
|
0.00%
0/338
|
0.29%
1/347 • Number of events 1
|
|
Infections and infestations
Urethritis
|
0.00%
0/342
|
0.29%
1/344 • Number of events 1
|
0.00%
0/338
|
0.00%
0/347
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/342
|
0.00%
0/344
|
0.89%
3/338 • Number of events 3
|
0.86%
3/347 • Number of events 3
|
|
Infections and infestations
Vaginal infection
|
0.00%
0/342
|
0.58%
2/344 • Number of events 2
|
0.00%
0/338
|
0.00%
0/347
|
|
Infections and infestations
Vulvovaginal candidiasis
|
0.58%
2/342 • Number of events 2
|
0.00%
0/344
|
0.00%
0/338
|
0.00%
0/347
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
0.00%
0/342
|
0.29%
1/344 • Number of events 1
|
0.00%
0/338
|
0.29%
1/347 • Number of events 1
|
|
Infections and infestations
Vuvlovaginitis
|
0.00%
0/342
|
0.00%
0/344
|
0.00%
0/338
|
0.29%
1/347 • Number of events 1
|
|
Injury, poisoning and procedural complications
Heart injury
|
0.29%
1/342 • Number of events 1
|
0.00%
0/344
|
0.00%
0/338
|
0.00%
0/347
|
|
Injury, poisoning and procedural complications
Medication error
|
0.00%
0/342
|
0.29%
1/344 • Number of events 1
|
0.00%
0/338
|
0.00%
0/347
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.00%
0/342
|
0.00%
0/344
|
0.30%
1/338 • Number of events 1
|
0.00%
0/347
|
|
Investigations
Amylase increased
|
0.00%
0/342
|
0.29%
1/344 • Number of events 1
|
0.00%
0/338
|
0.00%
0/347
|
|
Investigations
Blood bicarbonate decreased
|
0.29%
1/342 • Number of events 1
|
0.00%
0/344
|
0.30%
1/338 • Number of events 1
|
0.29%
1/347 • Number of events 1
|
|
Investigations
Blood chloride increased
|
0.00%
0/342
|
0.29%
1/344 • Number of events 1
|
0.00%
0/338
|
0.00%
0/347
|
|
Investigations
Blood creatinine phosphokinase decreased
|
0.00%
0/342
|
0.00%
0/344
|
0.00%
0/338
|
0.29%
1/347 • Number of events 1
|
|
Investigations
Blood glucose decreased
|
0.29%
1/342 • Number of events 1
|
0.87%
3/344 • Number of events 3
|
0.59%
2/338 • Number of events 2
|
1.2%
4/347 • Number of events 4
|
|
Investigations
Blood glucose increased
|
0.00%
0/342
|
0.29%
1/344 • Number of events 1
|
0.00%
0/338
|
0.00%
0/347
|
|
Investigations
Blood immunoglobulin A increased
|
0.00%
0/342
|
0.00%
0/344
|
0.00%
0/338
|
0.29%
1/347 • Number of events 1
|
|
Investigations
Blood ketone body increased
|
0.00%
0/342
|
0.00%
0/344
|
0.30%
1/338 • Number of events 1
|
0.00%
0/347
|
|
Investigations
Blood magnesium decreased
|
0.29%
1/342 • Number of events 1
|
0.29%
1/344 • Number of events 1
|
0.00%
0/338
|
0.29%
1/347 • Number of events 1
|
|
Investigations
Blood osmolarity decreased
|
0.00%
0/342
|
0.00%
0/344
|
0.30%
1/338 • Number of events 1
|
0.00%
0/347
|
|
Investigations
Blood phosphorus decreased
|
0.00%
0/342
|
0.29%
1/344 • Number of events 1
|
0.00%
0/338
|
0.86%
3/347 • Number of events 3
|
|
Investigations
Blood potassium decreased
|
0.00%
0/342
|
0.87%
3/344 • Number of events 3
|
0.30%
1/338 • Number of events 1
|
0.58%
2/347 • Number of events 2
|
|
Investigations
Blood potassium increased
|
0.00%
0/342
|
0.29%
1/344 • Number of events 1
|
0.00%
0/338
|
0.00%
0/347
|
|
Investigations
Blood pressure increased
|
0.00%
0/342
|
0.29%
1/344 • Number of events 1
|
0.00%
0/338
|
0.00%
0/347
|
|
Investigations
Blood sodium decreased
|
0.29%
1/342 • Number of events 1
|
0.00%
0/344
|
0.59%
2/338 • Number of events 2
|
0.00%
0/347
|
|
Investigations
Blood sodium increased
|
0.00%
0/342
|
0.29%
1/344 • Number of events 1
|
0.00%
0/338
|
0.00%
0/347
|
|
Investigations
Blood thyroid stimulating hormone increased
|
0.00%
0/342
|
0.29%
1/344 • Number of events 1
|
0.00%
0/338
|
0.00%
0/347
|
|
Investigations
Blood urea decreased
|
0.00%
0/342
|
0.29%
1/344 • Number of events 1
|
0.00%
0/338
|
0.00%
0/347
|
|
Investigations
Cardiac murmur
|
0.00%
0/342
|
0.00%
0/344
|
0.00%
0/338
|
0.29%
1/347 • Number of events 1
|
|
Investigations
Coma scale abnormal
|
0.00%
0/342
|
1.2%
4/344 • Number of events 4
|
0.30%
1/338 • Number of events 2
|
0.00%
0/347
|
|
Investigations
Crystal urine present
|
0.00%
0/342
|
0.00%
0/344
|
0.00%
0/338
|
0.29%
1/347 • Number of events 1
|
|
Investigations
Electrocardiogram QT prolonged
|
0.00%
0/342
|
0.00%
0/344
|
0.30%
1/338 • Number of events 1
|
0.00%
0/347
|
|
Investigations
Electrocardiogram T wave peaked
|
0.00%
0/342
|
0.00%
0/344
|
0.00%
0/338
|
0.29%
1/347 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.29%
1/342 • Number of events 1
|
0.00%
0/344
|
0.00%
0/338
|
0.00%
0/347
|
|
Respiratory, thoracic and mediastinal disorders
Stridor
|
0.00%
0/342
|
0.29%
1/344 • Number of events 1
|
0.00%
0/338
|
0.00%
0/347
|
|
Respiratory, thoracic and mediastinal disorders
Tachypnoea
|
0.00%
0/342
|
0.00%
0/344
|
0.30%
1/338 • Number of events 1
|
0.00%
0/347
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
0.00%
0/342
|
0.29%
1/344 • Number of events 1
|
0.00%
0/338
|
0.00%
0/347
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/342
|
0.00%
0/344
|
0.30%
1/338 • Number of events 1
|
0.29%
1/347 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
0.29%
1/342 • Number of events 1
|
0.00%
0/344
|
0.00%
0/338
|
0.00%
0/347
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.29%
1/342 • Number of events 1
|
0.00%
0/344
|
0.00%
0/338
|
0.00%
0/347
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
0.29%
1/342 • Number of events 1
|
0.29%
1/344 • Number of events 1
|
0.30%
1/338 • Number of events 1
|
0.58%
2/347 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.88%
3/342 • Number of events 3
|
0.29%
1/344 • Number of events 1
|
1.2%
4/338 • Number of events 4
|
0.86%
3/347 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
0.00%
0/342
|
0.00%
0/344
|
0.00%
0/338
|
0.29%
1/347 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.00%
0/342
|
0.00%
0/344
|
0.30%
1/338 • Number of events 1
|
0.00%
0/347
|
|
Skin and subcutaneous tissue disorders
Skin disorder
|
0.00%
0/342
|
0.00%
0/344
|
0.30%
1/338 • Number of events 1
|
0.00%
0/347
|
|
Skin and subcutaneous tissue disorders
Skin warm
|
0.29%
1/342 • Number of events 1
|
0.00%
0/344
|
0.00%
0/338
|
0.00%
0/347
|
|
Skin and subcutaneous tissue disorders
Swelling face
|
0.00%
0/342
|
0.00%
0/344
|
0.00%
0/338
|
0.29%
1/347 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/342
|
0.00%
0/344
|
0.30%
1/338 • Number of events 1
|
0.00%
0/347
|
|
Vascular disorders
Flushing
|
0.29%
1/342 • Number of events 1
|
0.00%
0/344
|
0.00%
0/338
|
0.00%
0/347
|
|
Vascular disorders
Hypertension
|
1.2%
4/342 • Number of events 4
|
0.00%
0/344
|
0.30%
1/338 • Number of events 1
|
0.29%
1/347 • Number of events 1
|
|
Vascular disorders
Hypotension
|
0.00%
0/342
|
0.58%
2/344 • Number of events 2
|
0.59%
2/338 • Number of events 2
|
0.00%
0/347
|
|
Vascular disorders
Orthostatic hypotension
|
0.29%
1/342 • Number of events 1
|
0.00%
0/344
|
0.00%
0/338
|
0.00%
0/347
|
|
Vascular disorders
Peripheral coldness
|
0.00%
0/342
|
0.00%
0/344
|
0.30%
1/338 • Number of events 1
|
0.00%
0/347
|
|
Vascular disorders
Phlebitis
|
0.00%
0/342
|
0.00%
0/344
|
0.00%
0/338
|
0.29%
1/347 • Number of events 1
|
|
Vascular disorders
Poor peripheral circulation
|
0.00%
0/342
|
0.00%
0/344
|
0.00%
0/338
|
0.58%
2/347 • Number of events 2
|
Additional Information
Nathan Kuppermann
University of California, Davis (UC Davis Health)
Phone: 916-734-1535
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place