Trial Outcomes & Findings for A Safety and Tolerability Study of Doripenem Compared With Cefepime in Children Hospitalized With Complicated Urinary Tract Infections (NCT NCT01110408)
NCT ID: NCT01110408
Last Updated: 2014-07-15
Results Overview
The participants were classified as cure if they had resolution or clinical improvement in signs and symptoms of complicated urinary tract infection; had no fever; no additional antimicrobial therapy was required for the treatment of the infection; and a clinical response assessment of improvement at End of IV visit.
TERMINATED
PHASE3
41 participants
TOC (7 to 14 days after the last dose of study medication therapy)
2014-07-15
Participant Flow
Participant milestones
| Measure |
Doripenem
Doripenem 20 mg/kg per dose (up to 500 mg/dose) was administered every 8 hours as 60-minutes IV (at least 3 days of IV doripenem only or IV doripenem followed by oral amoxicillin/clavulanate potassium or ciprofloxacin). Total duration of treatment 10 to 14 days.
|
Cefepime
Cefepime 50 mg/kg per dose (up to 2 g/dose) was administered every 8 hours as 30-minutes IV (at least 3 days of IV cefepime only or IV cefepime followed by oral amoxicillin/clavulanate potassium or ciprofloxacin). Total duration of treatment 10 to 14 days.
|
|---|---|---|
|
Overall Study
STARTED
|
31
|
10
|
|
Overall Study
COMPLETED
|
30
|
10
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Doripenem
Doripenem 20 mg/kg per dose (up to 500 mg/dose) was administered every 8 hours as 60-minutes IV (at least 3 days of IV doripenem only or IV doripenem followed by oral amoxicillin/clavulanate potassium or ciprofloxacin). Total duration of treatment 10 to 14 days.
|
Cefepime
Cefepime 50 mg/kg per dose (up to 2 g/dose) was administered every 8 hours as 30-minutes IV (at least 3 days of IV cefepime only or IV cefepime followed by oral amoxicillin/clavulanate potassium or ciprofloxacin). Total duration of treatment 10 to 14 days.
|
|---|---|---|
|
Overall Study
Protocol Violation
|
1
|
0
|
Baseline Characteristics
A Safety and Tolerability Study of Doripenem Compared With Cefepime in Children Hospitalized With Complicated Urinary Tract Infections
Baseline characteristics by cohort
| Measure |
Doripenem
n=31 Participants
Doripenem 20 mg/kg per dose (up to 500 mg/dose) was administered every 8 hours as 60-minutes IV (at least 3 days of IV doripenem only or IV doripenem followed by oral amoxicillin/clavulanate potassium or ciprofloxacin). Total duration of treatment 10 to 14 days.
|
Cefepime
n=10 Participants
Cefepime 50 mg/kg per dose (up to 2 g/dose) was administered every 8 hours as 30-minutes IV (at least 3 days of IV cefepime only or IV cefepime followed by oral amoxicillin/clavulanate potassium or ciprofloxacin). Total duration of treatment 10 to 14 days.
|
Total
n=41 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
31 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
4.7 years
STANDARD_DEVIATION 5.15 • n=5 Participants
|
4.3 years
STANDARD_DEVIATION 4.16 • n=7 Participants
|
4.6 years
STANDARD_DEVIATION 4.88 • n=5 Participants
|
|
Age, Customized
3 months to <2 years
|
12 participants
n=5 Participants
|
4 participants
n=7 Participants
|
16 participants
n=5 Participants
|
|
Age, Customized
2 to <6 years
|
8 participants
n=5 Participants
|
2 participants
n=7 Participants
|
10 participants
n=5 Participants
|
|
Age, Customized
6 to <12 years
|
7 participants
n=5 Participants
|
3 participants
n=7 Participants
|
10 participants
n=5 Participants
|
|
Age, Customized
12 to <18 years
|
4 participants
n=5 Participants
|
1 participants
n=7 Participants
|
5 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
26 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: TOC (7 to 14 days after the last dose of study medication therapy)Population: Clinical Intent-to-Treat (CITT): All randomized participants who met the minimal disease definition of complicated urinary tract infection regardless if a baseline pathogen was isolated from the pretreatment urine culture.
The participants were classified as cure if they had resolution or clinical improvement in signs and symptoms of complicated urinary tract infection; had no fever; no additional antimicrobial therapy was required for the treatment of the infection; and a clinical response assessment of improvement at End of IV visit.
Outcome measures
| Measure |
Doripenem
n=30 Participants
Doripenem 20 mg/kg per dose (up to 500 mg/dose) was administered every 8 hours as 60-minutes IV (at least 3 days of IV doripenem only or IV doripenem followed by oral amoxicillin/clavulanate potassium or ciprofloxacin). Total duration of treatment 10 to 14 days.
|
Cefepime
n=10 Participants
Cefepime 50 mg/kg per dose (up to 2 g/dose) was administered every 8 hours as 30-minutes IV (at least 3 days of IV cefepime only or IV cefepime followed by oral amoxicillin/clavulanate potassium or ciprofloxacin). Total duration of treatment 10 to 14 days.
|
|---|---|---|
|
The Number of Participants With Clinical Cure Rate at Test Of Cure (TOC) Visit
|
20 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: EIV (within 24 hours after completion of the last dose of IV study medication therapy)Population: Clinical Intent-to-Treat (CITT): All randomized participants who met the minimal disease definition of complicated urinary tract infection regardless if a baseline pathogen was isolated from the pretreatment urine culture.
The participants were considered as clinical improved if they had clinical improvement in signs and symptoms from baseline; no fever for at least the 24 hours before discontinuing the IV study drug; and not received nonstudy antibiotics for the treatment of urinary tract infection after IV study drug therapy had begun.
Outcome measures
| Measure |
Doripenem
n=30 Participants
Doripenem 20 mg/kg per dose (up to 500 mg/dose) was administered every 8 hours as 60-minutes IV (at least 3 days of IV doripenem only or IV doripenem followed by oral amoxicillin/clavulanate potassium or ciprofloxacin). Total duration of treatment 10 to 14 days.
|
Cefepime
n=10 Participants
Cefepime 50 mg/kg per dose (up to 2 g/dose) was administered every 8 hours as 30-minutes IV (at least 3 days of IV cefepime only or IV cefepime followed by oral amoxicillin/clavulanate potassium or ciprofloxacin). Total duration of treatment 10 to 14 days.
|
|---|---|---|
|
The Number of Participants With Clinical Improvement Rate at End of IV (EIV) Visit
|
28 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: LFU (28 to 42 days after the last dose of study medication therapy)Population: Clinical Intent-to-Treat (CITT): All randomized participants who met the minimal disease definition of complicated urinary tract infection regardless if a baseline pathogen was isolated from the pretreatment urine culture.
The participants were classified as clinical cure if all pretreatment signs and symptoms of complicated urinary tract infection showed no evidence of recurrence after test of cure.
Outcome measures
| Measure |
Doripenem
n=30 Participants
Doripenem 20 mg/kg per dose (up to 500 mg/dose) was administered every 8 hours as 60-minutes IV (at least 3 days of IV doripenem only or IV doripenem followed by oral amoxicillin/clavulanate potassium or ciprofloxacin). Total duration of treatment 10 to 14 days.
|
Cefepime
n=10 Participants
Cefepime 50 mg/kg per dose (up to 2 g/dose) was administered every 8 hours as 30-minutes IV (at least 3 days of IV cefepime only or IV cefepime followed by oral amoxicillin/clavulanate potassium or ciprofloxacin). Total duration of treatment 10 to 14 days.
|
|---|---|---|
|
The Number of Participants With Clinical Cure Rate at Late Follow-Up (LFU) Visit
|
18 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: EIV (within 24 hours after completion of the last dose of IV study medication therapy), TOC (7 to 14 days after the last dose of study medication therapy), and LFU (28 to 42 days after the last dose of study medication therapy)Population: Microbiological intent-to-treat - Participants of all CITT with at least 1 baseline bacterial pathogen isolated from the pretreatment urine culture, susceptible to both doripenem and cefepime. 6 and 2 participants from doripenem and cefepime, respectively had no susceptible urine pathogens at baseline and were excluded from this set.
Favorable per-participant microbiological response rate was evaluated at the at End of IV (EIV) visit, Test Of Cure (TOC) visit, and Late Follow-Up (LFU) visit. The favorable per-participant microbiological response was considered when all baseline pathogens were eradicated (absence) or presumed eradicated (absence of material to culture in a participant who has a positive clinical response to treatment).
Outcome measures
| Measure |
Doripenem
n=24 Participants
Doripenem 20 mg/kg per dose (up to 500 mg/dose) was administered every 8 hours as 60-minutes IV (at least 3 days of IV doripenem only or IV doripenem followed by oral amoxicillin/clavulanate potassium or ciprofloxacin). Total duration of treatment 10 to 14 days.
|
Cefepime
n=8 Participants
Cefepime 50 mg/kg per dose (up to 2 g/dose) was administered every 8 hours as 30-minutes IV (at least 3 days of IV cefepime only or IV cefepime followed by oral amoxicillin/clavulanate potassium or ciprofloxacin). Total duration of treatment 10 to 14 days.
|
|---|---|---|
|
The Number of Participants With Favorable Per-participant Microbiological Response
EIV visit
|
24 Participants
|
8 Participants
|
|
The Number of Participants With Favorable Per-participant Microbiological Response
TOC visit
|
19 Participants
|
4 Participants
|
|
The Number of Participants With Favorable Per-participant Microbiological Response
LFU visit
|
16 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: EIV (within 24 hours after completion of the last dose of IV study medication therapy)Population: Microbiological intent-to-treat - Participants of all CITT with at least 1 baseline bacterial pathogen isolated from the pretreatment urine culture, susceptible to both doripenem and cefepime. 6 and 2 participants from doripenem and cefepime, respectively had no susceptible urine pathogens at baseline and were excluded from this set.
The favorable per-pathogen microbiological outcome was considered when all baseline pathogens were eradicated (absence) or presumed eradicated (absence of material to culture in a participant who has a positive clinical response to treatment).A total of 4 pathogens in the doripenem group and 2 pathogens in the cefepime group were isolated at baseline from urine culture and were susceptible to the study drug received (see listed in the table below; the numbers in parenthesis next to each pathogen represent the number of participants with the pathogen isolated at baseline in the doripenem and cefepime treatment groups, respectively).
Outcome measures
| Measure |
Doripenem
n=24 Participants
Doripenem 20 mg/kg per dose (up to 500 mg/dose) was administered every 8 hours as 60-minutes IV (at least 3 days of IV doripenem only or IV doripenem followed by oral amoxicillin/clavulanate potassium or ciprofloxacin). Total duration of treatment 10 to 14 days.
|
Cefepime
n=8 Participants
Cefepime 50 mg/kg per dose (up to 2 g/dose) was administered every 8 hours as 30-minutes IV (at least 3 days of IV cefepime only or IV cefepime followed by oral amoxicillin/clavulanate potassium or ciprofloxacin). Total duration of treatment 10 to 14 days.
|
|---|---|---|
|
Number of Participants With Favorable Per-pathogen Microbiological Outcome Rate at End of IV (EIV) Visit
Staphylococcus aureus (3, 0)
|
3 Participants
|
NA Participants
There were no participants with Stapylococcus aureus isolated at baseline.
|
|
Number of Participants With Favorable Per-pathogen Microbiological Outcome Rate at End of IV (EIV) Visit
Escherichia coli (22, 7)
|
22 Participants
|
7 Participants
|
|
Number of Participants With Favorable Per-pathogen Microbiological Outcome Rate at End of IV (EIV) Visit
Klebsiella oxytoca (1, 0)
|
1 Participants
|
NA Participants
There were no participants with Klebsiella oxytoca isolated at baseline.
|
|
Number of Participants With Favorable Per-pathogen Microbiological Outcome Rate at End of IV (EIV) Visit
Klebsiella pneumoniae (1, 1)
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: TOC (7 to 14 days after the last dose of study medication therapy)Population: Microbiological intent-to-treat - Participants of all CITT with at least 1 baseline bacterial pathogen isolated from the pretreatment urine culture, susceptible to both doripenem and cefepime. 6 and 2 participants from doripenem and cefepime, respectively had no susceptible urine pathogens at baseline and were excluded from this set.
The favorable per-pathogen microbiological outcome was considered when all baseline pathogens were eradicated (absence) or presumed eradicated (absence of material to culture in a participant who has a positive clinical response to treatment). A total of 4 pathogens in the doripenem group and 2 pathogens in the cefepime group were isolated at baseline from urine culture and were susceptible to the study drug received (see listed in the table below; the numbers in parenthesis next to each pathogen represent the number of participants with the pathogen isolated at baseline in the doripenem and cefepime treatment groups, respectively).
Outcome measures
| Measure |
Doripenem
n=24 Participants
Doripenem 20 mg/kg per dose (up to 500 mg/dose) was administered every 8 hours as 60-minutes IV (at least 3 days of IV doripenem only or IV doripenem followed by oral amoxicillin/clavulanate potassium or ciprofloxacin). Total duration of treatment 10 to 14 days.
|
Cefepime
n=8 Participants
Cefepime 50 mg/kg per dose (up to 2 g/dose) was administered every 8 hours as 30-minutes IV (at least 3 days of IV cefepime only or IV cefepime followed by oral amoxicillin/clavulanate potassium or ciprofloxacin). Total duration of treatment 10 to 14 days.
|
|---|---|---|
|
Number of Participants With Favorable Per-pathogen Microbiological Outcome Rate at Test Of Cure (TOC) Visit
Staphylococcus aureus (3, 0)
|
3 Participants
|
NA Participants
There were no participants with Stapylococcus aureus isolated at baseline.
|
|
Number of Participants With Favorable Per-pathogen Microbiological Outcome Rate at Test Of Cure (TOC) Visit
Escherichia coli (22, 7)
|
17 Participants
|
4 Participants
|
|
Number of Participants With Favorable Per-pathogen Microbiological Outcome Rate at Test Of Cure (TOC) Visit
Klebsiella oxytoca (1, 0)
|
1 Participants
|
NA Participants
There were no participants with Klebsiella oxytoca isolated at baseline
|
|
Number of Participants With Favorable Per-pathogen Microbiological Outcome Rate at Test Of Cure (TOC) Visit
Klebsiella pneumoniae (1, 1)
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: LFU (28 to 42 days after the last dose of study medication therapy)Population: Microbiological intent-to-treat - Participants of all CITT with at least 1 baseline bacterial pathogen isolated from the pretreatment urine culture, susceptible to both doripenem and cefepime. 6 and 2 participants from doripenem and cefepime, respectively had no susceptible urine pathogens at baseline and were excluded from this set.
The sustained favorable per-pathogen microbiological outcome was considered when all baseline pathogens were eradicated (absence) or presumed eradicated (absence of material to culture in a participant who has a positive clinical response to treatment). A total of 4 pathogens in the doripenem group and 2 pathogens in the cefepime group were isolated at baseline from urine culture and were susceptible to the study drug received (see listed in the table below; the numbers in parenthesis next to each pathogen represent the number of participants with the pathogen isolated at baseline in the doripenem and cefepime treatment groups, respectively).
Outcome measures
| Measure |
Doripenem
n=24 Participants
Doripenem 20 mg/kg per dose (up to 500 mg/dose) was administered every 8 hours as 60-minutes IV (at least 3 days of IV doripenem only or IV doripenem followed by oral amoxicillin/clavulanate potassium or ciprofloxacin). Total duration of treatment 10 to 14 days.
|
Cefepime
n=8 Participants
Cefepime 50 mg/kg per dose (up to 2 g/dose) was administered every 8 hours as 30-minutes IV (at least 3 days of IV cefepime only or IV cefepime followed by oral amoxicillin/clavulanate potassium or ciprofloxacin). Total duration of treatment 10 to 14 days.
|
|---|---|---|
|
Number of Participants With Sustained Favorable Per-pathogen Microbiological Outcome Rate at Late Follow-Up (LFU) Visit
Staphylococcus aureus (3, 0)
|
2 Participants
|
NA Participants
There were no participants with Stapylococcus aureus isolated at baseline.
|
|
Number of Participants With Sustained Favorable Per-pathogen Microbiological Outcome Rate at Late Follow-Up (LFU) Visit
Escherichia coli (22, 7)
|
14 Participants
|
4 Participants
|
|
Number of Participants With Sustained Favorable Per-pathogen Microbiological Outcome Rate at Late Follow-Up (LFU) Visit
Klebsiella oxytoca (1, 0)
|
1 Participants
|
NA Participants
There were no participants with Klebsiella oxytoca isolated at baseline.
|
|
Number of Participants With Sustained Favorable Per-pathogen Microbiological Outcome Rate at Late Follow-Up (LFU) Visit
Klebsiella pneumoniae (1, 1)
|
1 Participants
|
0 Participants
|
Adverse Events
Doripenem
Cefepime
Serious adverse events
| Measure |
Doripenem
n=30 participants at risk
Doripenem 20 mg/kg per dose (up to 500 mg/dose) was administered every 8 hours as 60-minutes IV (at least 3 days of IV doripenem only or IV doripenem followed by oral amoxicillin/clavulanate potassium or ciprofloxacin). Total duration of treatment 10 to 14 days.
|
Cefepime
n=10 participants at risk
Cefepime 50 mg/kg per dose (up to 2 g/dose) was administered every 8 hours as 30-minutes IV (at least 3 days of IV cefepime only or IV cefepime followed by oral amoxicillin/clavulanate potassium or ciprofloxacin). Total duration of treatment 10 to 14 days.
|
|---|---|---|
|
Renal and urinary disorders
Pyuria
|
3.3%
1/30 • Approximately 8 weeks
|
0.00%
0/10 • Approximately 8 weeks
|
|
Infections and infestations
Pseudomembranous Colitis
|
0.00%
0/30 • Approximately 8 weeks
|
10.0%
1/10 • Approximately 8 weeks
|
|
Infections and infestations
Pyelonephritis Acute
|
0.00%
0/30 • Approximately 8 weeks
|
10.0%
1/10 • Approximately 8 weeks
|
|
Infections and infestations
Urinary Tract Infection
|
0.00%
0/30 • Approximately 8 weeks
|
20.0%
2/10 • Approximately 8 weeks
|
Other adverse events
| Measure |
Doripenem
n=30 participants at risk
Doripenem 20 mg/kg per dose (up to 500 mg/dose) was administered every 8 hours as 60-minutes IV (at least 3 days of IV doripenem only or IV doripenem followed by oral amoxicillin/clavulanate potassium or ciprofloxacin). Total duration of treatment 10 to 14 days.
|
Cefepime
n=10 participants at risk
Cefepime 50 mg/kg per dose (up to 2 g/dose) was administered every 8 hours as 30-minutes IV (at least 3 days of IV cefepime only or IV cefepime followed by oral amoxicillin/clavulanate potassium or ciprofloxacin). Total duration of treatment 10 to 14 days.
|
|---|---|---|
|
Gastrointestinal disorders
Vomiting
|
10.0%
3/30 • Approximately 8 weeks
|
0.00%
0/10 • Approximately 8 weeks
|
|
Gastrointestinal disorders
Diarrhoea
|
6.7%
2/30 • Approximately 8 weeks
|
0.00%
0/10 • Approximately 8 weeks
|
|
General disorders
Pyrexia
|
10.0%
3/30 • Approximately 8 weeks
|
10.0%
1/10 • Approximately 8 weeks
|
|
General disorders
Infusion Site Pain
|
0.00%
0/30 • Approximately 8 weeks
|
10.0%
1/10 • Approximately 8 weeks
|
|
General disorders
Vessel Puncture Site Pain
|
0.00%
0/30 • Approximately 8 weeks
|
10.0%
1/10 • Approximately 8 weeks
|
|
Infections and infestations
Nasopharyngitis
|
10.0%
3/30 • Approximately 8 weeks
|
0.00%
0/10 • Approximately 8 weeks
|
|
Infections and infestations
Bacteriuria
|
0.00%
0/30 • Approximately 8 weeks
|
10.0%
1/10 • Approximately 8 weeks
|
|
Infections and infestations
Candidiasis
|
0.00%
0/30 • Approximately 8 weeks
|
10.0%
1/10 • Approximately 8 weeks
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/30 • Approximately 8 weeks
|
10.0%
1/10 • Approximately 8 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
6.7%
2/30 • Approximately 8 weeks
|
0.00%
0/10 • Approximately 8 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Productive Cough
|
0.00%
0/30 • Approximately 8 weeks
|
10.0%
1/10 • Approximately 8 weeks
|
|
Blood and lymphatic system disorders
Eosinophilia
|
3.3%
1/30 • Approximately 8 weeks
|
10.0%
1/10 • Approximately 8 weeks
|
|
Blood and lymphatic system disorders
Hypochromic Anaemia
|
0.00%
0/30 • Approximately 8 weeks
|
10.0%
1/10 • Approximately 8 weeks
|
|
Blood and lymphatic system disorders
Neutrophilia
|
0.00%
0/30 • Approximately 8 weeks
|
10.0%
1/10 • Approximately 8 weeks
|
|
Skin and subcutaneous tissue disorders
Papule
|
3.3%
1/30 • Approximately 8 weeks
|
10.0%
1/10 • Approximately 8 weeks
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/30 • Approximately 8 weeks
|
10.0%
1/10 • Approximately 8 weeks
|
|
Skin and subcutaneous tissue disorders
Skin Haemorrhage
|
0.00%
0/30 • Approximately 8 weeks
|
10.0%
1/10 • Approximately 8 weeks
|
|
Congenital, familial and genetic disorders
Congenital Thrombocyte Disorder
|
0.00%
0/30 • Approximately 8 weeks
|
10.0%
1/10 • Approximately 8 weeks
|
|
Injury, poisoning and procedural complications
Overdose
|
0.00%
0/30 • Approximately 8 weeks
|
10.0%
1/10 • Approximately 8 weeks
|
|
Investigations
Basophil Count Increased
|
0.00%
0/30 • Approximately 8 weeks
|
10.0%
1/10 • Approximately 8 weeks
|
|
Investigations
Urine Leukocyte Esterase
|
0.00%
0/30 • Approximately 8 weeks
|
10.0%
1/10 • Approximately 8 weeks
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/30 • Approximately 8 weeks
|
10.0%
1/10 • Approximately 8 weeks
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/30 • Approximately 8 weeks
|
10.0%
1/10 • Approximately 8 weeks
|
|
Renal and urinary disorders
Crystalluria
|
0.00%
0/30 • Approximately 8 weeks
|
10.0%
1/10 • Approximately 8 weeks
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/30 • Approximately 8 weeks
|
10.0%
1/10 • Approximately 8 weeks
|
|
Renal and urinary disorders
Leukocyturia
|
0.00%
0/30 • Approximately 8 weeks
|
10.0%
1/10 • Approximately 8 weeks
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/30 • Approximately 8 weeks
|
10.0%
1/10 • Approximately 8 weeks
|
|
Vascular disorders
Phlebitis
|
0.00%
0/30 • Approximately 8 weeks
|
10.0%
1/10 • Approximately 8 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60