Trial Outcomes & Findings for Treatment Algorithm to Reduce the Use of Vancomycin in Adults With Blood Stream Infection (NCT NCT01191840)
NCT ID: NCT01191840
Last Updated: 2018-01-05
Results Overview
To compare the cure rate at Test of Cure evaluation, between the proposed treatment algorithm and the standard of care therapy.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
509 participants
Primary outcome timeframe
Test of cure 2 (up to approximately 42 days)
Results posted on
2018-01-05
Participant Flow
Participant milestones
| Measure |
Standard of Care
Drugs used to treat the bacteremia and the duration of treatment will be determined by the patient's primary medical provider.
|
Algorithm-determined Therapy
Patients will be treated with Vancomycin or protocol-approved alternate antibiotic for 14 (-/+2) days for uncomplicated S. aureus, or 28-42 (-/+2) days if complicated S. aureus develops within the treatment period after randomization. Simple CoNS will be treated for 0 - 3 (+1) days, uncomplicated CoNS will be treated for 5 (-/+1) days, or 7-28 (-/+2) days if complicated CoNS develops within the treatment period after randomization.
|
|---|---|---|
|
Overall Study
STARTED
|
254
|
255
|
|
Overall Study
COMPLETED
|
240
|
240
|
|
Overall Study
NOT COMPLETED
|
14
|
15
|
Reasons for withdrawal
| Measure |
Standard of Care
Drugs used to treat the bacteremia and the duration of treatment will be determined by the patient's primary medical provider.
|
Algorithm-determined Therapy
Patients will be treated with Vancomycin or protocol-approved alternate antibiotic for 14 (-/+2) days for uncomplicated S. aureus, or 28-42 (-/+2) days if complicated S. aureus develops within the treatment period after randomization. Simple CoNS will be treated for 0 - 3 (+1) days, uncomplicated CoNS will be treated for 5 (-/+1) days, or 7-28 (-/+2) days if complicated CoNS develops within the treatment period after randomization.
|
|---|---|---|
|
Overall Study
withdrew consent
|
2
|
1
|
|
Overall Study
Subject discontinued treatment
|
1
|
2
|
|
Overall Study
Lost to Follow-up
|
4
|
6
|
|
Overall Study
Non Staph Infection
|
4
|
3
|
|
Overall Study
ineligible at enrollment
|
1
|
0
|
|
Overall Study
IRB approval lapse
|
0
|
2
|
|
Overall Study
lab error speciation - non Staph infecti
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
Baseline Characteristics
Treatment Algorithm to Reduce the Use of Vancomycin in Adults With Blood Stream Infection
Baseline characteristics by cohort
| Measure |
Standard of Care
n=254 Participants
Drugs used to treat the bacteremia and the duration of treatment will be determined by the patient's primary medical provider.
|
Algorithm-determined Therapy
n=255 Participants
Patients will be treated with Vancomycin or protocol-approved alternate antibiotic for 14 (-/+2) days for uncomplicated S. aureus, or 28-42 (-/+2) days if complicated S. aureus develops within the treatment period after randomization. Simple CoNS will be treated for 0 - 3 (+1) days, uncomplicated CoNS will be treated for 5 (-/+1) days, or 7-28 (-/+2) days if complicated CoNS develops within the treatment period after randomization.
|
Total
n=509 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
57.4 years
STANDARD_DEVIATION 17.1 • n=99 Participants
|
55.8 years
STANDARD_DEVIATION 16.5 • n=107 Participants
|
56.6 years
STANDARD_DEVIATION 16.8 • n=206 Participants
|
|
Sex: Female, Male
Female
|
117 Participants
n=99 Participants
|
109 Participants
n=107 Participants
|
226 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
137 Participants
n=99 Participants
|
146 Participants
n=107 Participants
|
283 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
23 Participants
n=99 Participants
|
21 Participants
n=107 Participants
|
44 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
231 Participants
n=99 Participants
|
234 Participants
n=107 Participants
|
465 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race · American Indian or Alaska Native
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race · Asian
|
4 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race · Native Hawaiian or Other Pacific Islander
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race · Black or African American
|
60 Participants
n=99 Participants
|
63 Participants
n=107 Participants
|
123 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
174 Participants
n=99 Participants
|
175 Participants
n=107 Participants
|
349 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race · More than one race
|
2 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race · Other
|
12 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
22 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Test of cure 2 (up to approximately 42 days)Population: Intent-to-treat population
To compare the cure rate at Test of Cure evaluation, between the proposed treatment algorithm and the standard of care therapy.
Outcome measures
| Measure |
Standard of Care
n=254 Participants
Drugs used to treat the bacteremia and the duration of treatment will be determined by the patient's primary medical provider.
|
Algorithm-determined Therapy
n=255 Participants
Patients will be treated with Vancomycin or protocol-approved alternate antibiotic for 14 (-/+2) days for uncomplicated S. aureus, or 28-42 (-/+2) days if complicated S. aureus develops within the treatment period after randomization. Simple CoNS will be treated for 0 - 3 (+1) days, uncomplicated CoNS will be treated for 5 (-/+1) days, or 7-28 (-/+2) days if complicated CoNS develops within the treatment period after randomization.
|
|---|---|---|
|
Cure Rate
|
207 Participants
|
209 Participants
|
PRIMARY outcome
Timeframe: Test of cure 2 (up to approximately 42 days)Population: Intent-to-treat population
Number of Participants that reported a Serious Adverse Event
Outcome measures
| Measure |
Standard of Care
n=254 Participants
Drugs used to treat the bacteremia and the duration of treatment will be determined by the patient's primary medical provider.
|
Algorithm-determined Therapy
n=255 Participants
Patients will be treated with Vancomycin or protocol-approved alternate antibiotic for 14 (-/+2) days for uncomplicated S. aureus, or 28-42 (-/+2) days if complicated S. aureus develops within the treatment period after randomization. Simple CoNS will be treated for 0 - 3 (+1) days, uncomplicated CoNS will be treated for 5 (-/+1) days, or 7-28 (-/+2) days if complicated CoNS develops within the treatment period after randomization.
|
|---|---|---|
|
Number of Participants With Serious Adverse Events
|
72 Participants
|
83 Participants
|
PRIMARY outcome
Timeframe: Test of cure 2 (up to approximately 42 days)Population: Intent-to-treat population
Number of Participants with an Adverse Event leading to study drug withdrawal
Outcome measures
| Measure |
Standard of Care
n=254 Participants
Drugs used to treat the bacteremia and the duration of treatment will be determined by the patient's primary medical provider.
|
Algorithm-determined Therapy
n=255 Participants
Patients will be treated with Vancomycin or protocol-approved alternate antibiotic for 14 (-/+2) days for uncomplicated S. aureus, or 28-42 (-/+2) days if complicated S. aureus develops within the treatment period after randomization. Simple CoNS will be treated for 0 - 3 (+1) days, uncomplicated CoNS will be treated for 5 (-/+1) days, or 7-28 (-/+2) days if complicated CoNS develops within the treatment period after randomization.
|
|---|---|---|
|
Number of Participants With Adverse Events Leading to Study Drug Withdrawal
|
1 Participants
|
4 Participants
|
PRIMARY outcome
Timeframe: Test of cure 2 (up to approximately 42 days)Population: Intent-to-treat population
Patient changes from vancomycin or a protocol-approved study antibiotic to another protocol-approved study antibiotic due to AE associated with study drug
Outcome measures
| Measure |
Standard of Care
n=254 Participants
Drugs used to treat the bacteremia and the duration of treatment will be determined by the patient's primary medical provider.
|
Algorithm-determined Therapy
n=255 Participants
Patients will be treated with Vancomycin or protocol-approved alternate antibiotic for 14 (-/+2) days for uncomplicated S. aureus, or 28-42 (-/+2) days if complicated S. aureus develops within the treatment period after randomization. Simple CoNS will be treated for 0 - 3 (+1) days, uncomplicated CoNS will be treated for 5 (-/+1) days, or 7-28 (-/+2) days if complicated CoNS develops within the treatment period after randomization.
|
|---|---|---|
|
Number of Participants That Changed From Vancomycin to Another Study Antibiotic Due to an Adverse Event
|
2 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: Test of cure 2 (up to approximately 42 days)Population: PP (per protocol) population and PPE Population: Patients from the PP population who did not have complicated staphylococcal infection.
This will be analyzed by evaluating the difference in antibiotic days by treatment group and calculating 95% confidence intervals around the difference in antibiotic days among study patients randomized to algorithm-based treatment vs. among study patients randomized to standard treatment.
Outcome measures
| Measure |
Standard of Care
n=203 Participants
Drugs used to treat the bacteremia and the duration of treatment will be determined by the patient's primary medical provider.
|
Algorithm-determined Therapy
n=207 Participants
Patients will be treated with Vancomycin or protocol-approved alternate antibiotic for 14 (-/+2) days for uncomplicated S. aureus, or 28-42 (-/+2) days if complicated S. aureus develops within the treatment period after randomization. Simple CoNS will be treated for 0 - 3 (+1) days, uncomplicated CoNS will be treated for 5 (-/+1) days, or 7-28 (-/+2) days if complicated CoNS develops within the treatment period after randomization.
|
|---|---|---|
|
Antibiotic Days by Treatment Group
PP Population
|
7.9 Days
Standard Deviation 8.8
|
7.5 Days
Standard Deviation 10.0
|
|
Antibiotic Days by Treatment Group
PPE Population
|
6.2 Days
Standard Deviation 6.6
|
4.4 Days
Standard Deviation 5.5
|
Adverse Events
Standard of Care
Serious events: 72 serious events
Other events: 6 other events
Deaths: 14 deaths
Algorithm-determined Therapy
Serious events: 83 serious events
Other events: 7 other events
Deaths: 16 deaths
Serious adverse events
| Measure |
Standard of Care
n=254 participants at risk
Drugs used to treat the bacteremia and the duration of treatment will be determined by the patient's primary medical provider.
|
Algorithm-determined Therapy
n=255 participants at risk
Patients will be treated with Vancomycin or protocol-approved alternate antibiotic for 14 (-/+2) days for uncomplicated S. aureus, or 28-42 (-/+2) days if complicated S. aureus develops within the treatment period after randomization. Simple CoNS will be treated for 0 - 3 (+1) days, uncomplicated CoNS will be treated for 5 (-/+1) days, or 7-28 (-/+2) days if complicated CoNS develops within the treatment period after randomization.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
1.2%
3/254 • Number of events 3 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
0.00%
0/255 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
1.2%
3/254 • Number of events 4 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
2.0%
5/255 • Number of events 7 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
|
Blood and lymphatic system disorders
Haemolytic anaemia
|
0.00%
0/254 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
0.39%
1/255 • Number of events 1 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
|
Blood and lymphatic system disorders
Histiocytosis haematophagic
|
0.39%
1/254 • Number of events 1 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
0.00%
0/255 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
|
Blood and lymphatic system disorders
Leukaemoid reaction
|
0.00%
0/254 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
0.39%
1/255 • Number of events 1 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
|
Blood and lymphatic system disorders
Sickle cell anaemia with crisis
|
0.00%
0/254 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
0.78%
2/255 • Number of events 2 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
|
Cardiac disorders
Acute myocardial infarction
|
0.39%
1/254 • Number of events 1 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
0.00%
0/255 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
|
Cardiac disorders
Angina pectoris
|
0.39%
1/254 • Number of events 1 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
0.00%
0/255 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/254 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
0.39%
1/255 • Number of events 1 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
|
Cardiac disorders
Cardiac failure congestive
|
0.79%
2/254 • Number of events 2 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
0.78%
2/255 • Number of events 2 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/254 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
0.39%
1/255 • Number of events 1 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
|
Cardiac disorders
Pericarditis
|
0.00%
0/254 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
0.78%
2/255 • Number of events 2 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
|
Cardiac disorders
Pulseless electrical activity
|
0.39%
1/254 • Number of events 1 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
0.00%
0/255 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
|
Cardiac disorders
Right ventricular failure
|
0.00%
0/254 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
0.39%
1/255 • Number of events 1 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/254 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
0.39%
1/255 • Number of events 1 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
|
Endocrine disorders
Glucocorticoid deficiency
|
0.00%
0/254 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
0.39%
1/255 • Number of events 1 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
|
Gastrointestinal disorders
Abdominal pain
|
0.39%
1/254 • Number of events 1 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
0.00%
0/255 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/254 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
0.39%
1/255 • Number of events 1 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
|
Gastrointestinal disorders
Diarrhoea
|
0.79%
2/254 • Number of events 2 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
0.39%
1/255 • Number of events 2 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/254 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
0.39%
1/255 • Number of events 1 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/254 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
0.39%
1/255 • Number of events 1 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.39%
1/254 • Number of events 1 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
0.00%
0/255 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.39%
1/254 • Number of events 1 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
0.00%
0/255 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/254 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
0.39%
1/255 • Number of events 1 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
|
Gastrointestinal disorders
Internal hernia
|
0.39%
1/254 • Number of events 1 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
0.00%
0/255 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
|
Gastrointestinal disorders
Irritable bowel syndrome
|
0.00%
0/254 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
0.39%
1/255 • Number of events 1 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
|
Gastrointestinal disorders
Large intestine perforation
|
0.39%
1/254 • Number of events 1 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
0.00%
0/255 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
|
Gastrointestinal disorders
Melaena
|
0.00%
0/254 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
0.39%
1/255 • Number of events 1 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/254 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
0.39%
1/255 • Number of events 2 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
|
Gastrointestinal disorders
Stomatitis
|
0.39%
1/254 • Number of events 1 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
0.00%
0/255 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.39%
1/254 • Number of events 1 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
0.00%
0/255 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
|
Gastrointestinal disorders
Vomiting
|
0.79%
2/254 • Number of events 3 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
0.00%
0/255 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
|
General disorders
Chest pain
|
0.39%
1/254 • Number of events 1 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
0.00%
0/255 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
|
General disorders
Death
|
1.2%
3/254 • Number of events 3 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
0.78%
2/255 • Number of events 2 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
|
General disorders
Fatigue
|
0.00%
0/254 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
0.39%
1/255 • Number of events 1 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/254 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
0.39%
1/255 • Number of events 1 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
|
General disorders
Pain
|
0.39%
1/254 • Number of events 1 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
0.00%
0/255 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
|
General disorders
Pyrexia
|
0.39%
1/254 • Number of events 1 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
1.2%
3/255 • Number of events 3 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
|
General disorders
Systemic inflammatory response syndrome
|
0.00%
0/254 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
0.39%
1/255 • Number of events 1 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
|
Hepatobiliary disorders
Biliary colic
|
0.39%
1/254 • Number of events 1 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
0.00%
0/255 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/254 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
0.39%
1/255 • Number of events 1 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
|
Hepatobiliary disorders
Chronic hepatic failure
|
0.39%
1/254 • Number of events 1 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
0.39%
1/255 • Number of events 1 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
|
Hepatobiliary disorders
Cirrhosis alcoholic
|
0.39%
1/254 • Number of events 1 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
0.00%
0/255 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
|
Hepatobiliary disorders
Portal vein thrombosis
|
0.00%
0/254 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
0.39%
1/255 • Number of events 1 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/254 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
0.39%
1/255 • Number of events 1 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
|
Immune system disorders
Graft versus host disease
|
0.39%
1/254 • Number of events 1 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
0.00%
0/255 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
|
Immune system disorders
Graft versus host disease in gastrointestinal tract
|
0.39%
1/254 • Number of events 2 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
0.00%
0/255 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
|
Infections and infestations
Abdominal abscess
|
0.00%
0/254 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
0.39%
1/255 • Number of events 1 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
|
Infections and infestations
Abdominal wall abscess
|
0.39%
1/254 • Number of events 1 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
0.00%
0/255 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
|
Infections and infestations
Abscess limb
|
0.00%
0/254 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
0.39%
1/255 • Number of events 1 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
|
Infections and infestations
Acinetobacter bacteraemia
|
0.39%
1/254 • Number of events 1 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
0.00%
0/255 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
|
Infections and infestations
Adenovirus infection
|
0.39%
1/254 • Number of events 1 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
0.00%
0/255 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
|
Infections and infestations
Arthritis bacterial
|
0.39%
1/254 • Number of events 1 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
0.00%
0/255 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
|
Infections and infestations
Bacteraemia
|
0.39%
1/254 • Number of events 1 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
0.39%
1/255 • Number of events 1 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
|
Infections and infestations
Cellulitis
|
0.39%
1/254 • Number of events 1 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
0.00%
0/255 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
|
Infections and infestations
Clostridium difficile colitis
|
0.00%
0/254 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
0.39%
1/255 • Number of events 1 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
|
Infections and infestations
Cytomegalovirus infection
|
0.00%
0/254 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
0.78%
2/255 • Number of events 2 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
|
Infections and infestations
Device related infection
|
0.79%
2/254 • Number of events 2 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
0.00%
0/255 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
|
Infections and infestations
Endocarditis
|
0.39%
1/254 • Number of events 1 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
0.00%
0/255 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
|
Infections and infestations
Fungaemia
|
0.39%
1/254 • Number of events 1 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
0.00%
0/255 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/254 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
0.39%
1/255 • Number of events 1 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
|
Infections and infestations
Gastroenteritis rotavirus
|
0.39%
1/254 • Number of events 1 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
0.00%
0/255 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
|
Infections and infestations
Hepatic infection
|
0.39%
1/254 • Number of events 1 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
0.00%
0/255 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
|
Infections and infestations
Influenza
|
0.39%
1/254 • Number of events 1 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
0.00%
0/255 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
|
Infections and infestations
Klebsiella bacteraemia
|
0.39%
1/254 • Number of events 1 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
0.39%
1/255 • Number of events 1 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
|
Infections and infestations
Meningitis cryptococcal
|
0.00%
0/254 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
0.39%
1/255 • Number of events 1 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/254 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
0.39%
1/255 • Number of events 1 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
|
Infections and infestations
Osteomyelitis
|
0.39%
1/254 • Number of events 1 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
0.78%
2/255 • Number of events 2 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
|
Infections and infestations
Pneumonia
|
2.4%
6/254 • Number of events 6 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
1.6%
4/255 • Number of events 4 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
|
Infections and infestations
Pneumonia fungal
|
0.00%
0/254 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
0.39%
1/255 • Number of events 1 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
|
Infections and infestations
Pneumonia respiratory syncytial viral
|
0.39%
1/254 • Number of events 1 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
0.00%
0/255 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
|
Infections and infestations
Pneumonia viral
|
0.39%
1/254 • Number of events 1 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
0.00%
0/255 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
|
Infections and infestations
Respiratory syncytial virus infection
|
0.79%
2/254 • Number of events 2 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
0.00%
0/255 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
|
Infections and infestations
Respiratory tract infection viral
|
0.39%
1/254 • Number of events 1 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
0.00%
0/255 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
|
Infections and infestations
Scrotal abscess
|
0.00%
0/254 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
0.39%
1/255 • Number of events 1 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
|
Infections and infestations
Sepsis
|
0.39%
1/254 • Number of events 1 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
1.6%
4/255 • Number of events 4 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
|
Infections and infestations
Septic shock
|
0.00%
0/254 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
0.39%
1/255 • Number of events 1 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
|
Infections and infestations
Sinusitis
|
0.39%
1/254 • Number of events 1 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
0.00%
0/255 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
|
Infections and infestations
Staphylococcal bacteraemia
|
0.00%
0/254 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
0.39%
1/255 • Number of events 1 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
|
Infections and infestations
Staphylococcal infection
|
0.39%
1/254 • Number of events 1 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
0.00%
0/255 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
|
Infections and infestations
Tooth abscess
|
0.39%
1/254 • Number of events 1 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
0.00%
0/255 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
|
Infections and infestations
Upper respiratory tract infection
|
1.2%
3/254 • Number of events 3 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
0.00%
0/255 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
|
Infections and infestations
Urinary tract infection
|
1.6%
4/254 • Number of events 4 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
2.7%
7/255 • Number of events 7 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
|
Infections and infestations
Urinary tract infection bacterial
|
0.39%
1/254 • Number of events 1 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
0.00%
0/255 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
|
Injury, poisoning and procedural complications
Anastomotic ulcer
|
0.00%
0/254 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
0.39%
1/255 • Number of events 1 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.39%
1/254 • Number of events 1 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
0.00%
0/255 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/254 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
0.39%
1/255 • Number of events 1 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/254 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
0.78%
2/255 • Number of events 2 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
|
Injury, poisoning and procedural complications
Head injury
|
0.00%
0/254 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
0.39%
1/255 • Number of events 1 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
|
Injury, poisoning and procedural complications
Overdose
|
0.39%
1/254 • Number of events 1 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
0.00%
0/255 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.39%
1/254 • Number of events 1 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
0.39%
1/255 • Number of events 1 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
|
Injury, poisoning and procedural complications
Subarachnoid haemorrhage
|
0.00%
0/254 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
0.39%
1/255 • Number of events 1 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
|
Injury, poisoning and procedural complications
Subdural haemorrhage
|
0.00%
0/254 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
0.39%
1/255 • Number of events 1 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
|
Injury, poisoning and procedural complications
Toxicity to various agents
|
0.39%
1/254 • Number of events 1 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
0.00%
0/255 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
|
Injury, poisoning and procedural complications
Unintentional medical device removal
|
0.39%
1/254 • Number of events 1 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
0.00%
0/255 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/254 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
0.39%
1/255 • Number of events 1 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
|
Investigations
Anticoagulation drug level below therapeutic
|
0.00%
0/254 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
0.39%
1/255 • Number of events 1 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/254 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
0.39%
1/255 • Number of events 1 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
|
Investigations
Blood creatinine increased
|
0.00%
0/254 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
0.39%
1/255 • Number of events 1 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/254 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
0.39%
1/255 • Number of events 1 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
|
Investigations
Transaminases increased
|
0.39%
1/254 • Number of events 1 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
0.00%
0/255 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/254 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
0.78%
2/255 • Number of events 2 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.00%
0/254 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
0.39%
1/255 • Number of events 1 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.00%
0/254 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
0.39%
1/255 • Number of events 1 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
|
Metabolism and nutrition disorders
Feeding intolerance
|
0.39%
1/254 • Number of events 1 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
0.00%
0/255 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.79%
2/254 • Number of events 2 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
0.00%
0/255 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/254 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
0.78%
2/255 • Number of events 2 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
0.39%
1/254 • Number of events 1 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
0.00%
0/255 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.39%
1/254 • Number of events 1 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
0.39%
1/255 • Number of events 1 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
|
Musculoskeletal and connective tissue disorders
Fasciitis
|
0.39%
1/254 • Number of events 1 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
0.00%
0/255 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/254 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
0.39%
1/255 • Number of events 1 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute lymphocytic leukaemia
|
0.00%
0/254 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
0.39%
1/255 • Number of events 1 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma pancreas
|
0.39%
1/254 • Number of events 1 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
0.00%
0/255 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Astrocytoma
|
0.00%
0/254 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
0.39%
1/255 • Number of events 1 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung cancer metastatic
|
0.00%
0/254 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
0.39%
1/255 • Number of events 1 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neuroendocrine carcinoma
|
0.39%
1/254 • Number of events 2 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
0.00%
0/255 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Sarcoma metastatic
|
0.39%
1/254 • Number of events 1 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
0.00%
0/255 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.39%
1/254 • Number of events 1 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
0.00%
0/255 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
|
Nervous system disorders
Embolic stroke
|
0.39%
1/254 • Number of events 1 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
0.00%
0/255 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
|
Nervous system disorders
Encephalopathy
|
0.39%
1/254 • Number of events 1 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
0.00%
0/255 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
|
Nervous system disorders
Hepatic encephalopathy
|
0.39%
1/254 • Number of events 1 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
0.00%
0/255 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
|
Nervous system disorders
Myoclonus
|
0.00%
0/254 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
0.39%
1/255 • Number of events 1 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
|
Nervous system disorders
Parkinson's disease
|
0.39%
1/254 • Number of events 1 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
0.00%
0/255 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
|
Nervous system disorders
Seizure
|
0.00%
0/254 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
0.78%
2/255 • Number of events 2 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
|
Nervous system disorders
Syncope
|
0.39%
1/254 • Number of events 1 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
0.39%
1/255 • Number of events 1 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
|
Product Issues
Device malfunction
|
0.39%
1/254 • Number of events 2 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
0.00%
0/255 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
|
Product Issues
Thrombosis in device
|
0.39%
1/254 • Number of events 1 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
0.00%
0/255 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
|
Psychiatric disorders
Delirium
|
0.00%
0/254 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
0.39%
1/255 • Number of events 1 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
|
Psychiatric disorders
Mental status changes
|
1.2%
3/254 • Number of events 3 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
1.2%
3/255 • Number of events 3 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
|
Renal and urinary disorders
Acute kidney injury
|
1.2%
3/254 • Number of events 3 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
3.5%
9/255 • Number of events 9 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/254 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
0.39%
1/255 • Number of events 1 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
|
Renal and urinary disorders
Renal failure
|
0.79%
2/254 • Number of events 2 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
0.39%
1/255 • Number of events 1 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/254 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
0.39%
1/255 • Number of events 1 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
|
Reproductive system and breast disorders
Breast pain
|
0.00%
0/254 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
0.39%
1/255 • Number of events 1 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
|
0.00%
0/254 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
0.39%
1/255 • Number of events 1 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.39%
1/254 • Number of events 1 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
0.00%
0/255 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
|
Respiratory, thoracic and mediastinal disorders
Chronic respiratory failure
|
0.39%
1/254 • Number of events 1 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
0.00%
0/255 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.39%
1/254 • Number of events 1 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
0.00%
0/255 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/254 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
0.39%
1/255 • Number of events 1 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
1.2%
3/254 • Number of events 3 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
0.39%
1/255 • Number of events 1 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.00%
0/254 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
0.39%
1/255 • Number of events 1 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
|
Respiratory, thoracic and mediastinal disorders
Pneumomediastinum
|
0.00%
0/254 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
0.39%
1/255 • Number of events 1 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.00%
0/254 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
0.78%
2/255 • Number of events 2 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
1.2%
3/254 • Number of events 3 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
0.00%
0/255 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary fibrosis
|
0.39%
1/254 • Number of events 1 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
0.00%
0/255 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory depression
|
0.39%
1/254 • Number of events 1 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
0.00%
0/255 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
2.0%
5/254 • Number of events 5 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
1.6%
4/255 • Number of events 5 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.39%
1/254 • Number of events 1 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
0.00%
0/255 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
|
Vascular disorders
Axillary vein thrombosis
|
0.39%
1/254 • Number of events 1 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
0.00%
0/255 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
|
Vascular disorders
Deep vein thrombosis
|
0.39%
1/254 • Number of events 1 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
0.39%
1/255 • Number of events 1 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
|
Vascular disorders
Haemorrhage
|
0.00%
0/254 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
0.39%
1/255 • Number of events 1 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
|
Vascular disorders
Hypertension
|
0.00%
0/254 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
0.39%
1/255 • Number of events 1 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
|
Vascular disorders
Hypotension
|
0.00%
0/254 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
0.39%
1/255 • Number of events 1 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
|
Vascular disorders
Thrombophlebitis superficial
|
0.00%
0/254 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
0.39%
1/255 • Number of events 1 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
Other adverse events
| Measure |
Standard of Care
n=254 participants at risk
Drugs used to treat the bacteremia and the duration of treatment will be determined by the patient's primary medical provider.
|
Algorithm-determined Therapy
n=255 participants at risk
Patients will be treated with Vancomycin or protocol-approved alternate antibiotic for 14 (-/+2) days for uncomplicated S. aureus, or 28-42 (-/+2) days if complicated S. aureus develops within the treatment period after randomization. Simple CoNS will be treated for 0 - 3 (+1) days, uncomplicated CoNS will be treated for 5 (-/+1) days, or 7-28 (-/+2) days if complicated CoNS develops within the treatment period after randomization.
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
0.39%
1/254 • Number of events 1 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
0.39%
1/255 • Number of events 1 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/254 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
0.39%
1/255 • Number of events 1 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
|
Infections and infestations
Urinary tract infection
|
0.39%
1/254 • Number of events 1 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
0.39%
1/255 • Number of events 1 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
|
Investigations
Blood creatinine increased
|
0.00%
0/254 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
1.2%
3/255 • Number of events 3 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.39%
1/254 • Number of events 1 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
0.00%
0/255 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
|
Renal and urinary disorders
Acute kidney injury
|
0.39%
1/254 • Number of events 1 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
0.39%
1/255 • Number of events 1 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.39%
1/254 • Number of events 1 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
0.00%
0/255 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
|
Skin and subcutaneous tissue disorders
Blister
|
0.00%
0/254 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
0.39%
1/255 • Number of events 1 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
0.39%
1/254 • Number of events 1 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
0.00%
0/255 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
|
Skin and subcutaneous tissue disorders
Pruritus allergic
|
0.39%
1/254 • Number of events 1 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
0.00%
0/255 • Baseline until the final TOC (test of cure, up to approximately 42 days).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place