Trial Outcomes & Findings for Study of Daptomycin in Subjects Undergoing Surgery for Osteomyelitis Associated With an Infected Prosthetic Caused by Staphylococci (NCT NCT00428844)
NCT ID: NCT00428844
Last Updated: 2018-01-31
Results Overview
Number of subjects with CPK \>500 U/L between Day 3 and 7 days following the last dose of study medication (Day 7P) as measured by the central laboratory.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
75 participants
Primary outcome timeframe
From the 3rd day of therapy to 1 week post last dose (approximately week 7)
Results posted on
2018-01-31
Participant Flow
Participant milestones
| Measure |
Daptomycin 6 mg/kg
Daptomycin (6 mg/kg every 24 hours \[q24h\]) as a 30 minute intravenous (IV) infusion for 6 weeks (± one week).
|
Daptomycin 8 mg/kg
Daptomycin (8 mg/kg q24h) as a 30 minute IV infusion for 6 weeks (± one week).
|
Comparator
Vancomycin was administered at 1 gram (gm)every 12 hours (q12h) as a 60-minute infusion and teicoplanin was administered 6 mg/kg q24h as a 30-minute infusion also for 6 weeks (±1 week). Semi-synthetic penicillin (nafcillin, oxacillin, or flucloxacillin) was administered according to standard of care for 6 weeks (±1 week).
|
|---|---|---|---|
|
Completed Study Drug Treatment
STARTED
|
25
|
24
|
26
|
|
Completed Study Drug Treatment
Received First Dose
|
25
|
24
|
25
|
|
Completed Study Drug Treatment
COMPLETED
|
23
|
18
|
19
|
|
Completed Study Drug Treatment
NOT COMPLETED
|
2
|
6
|
7
|
|
Completed Test of Cure (TOC) Visit
STARTED
|
23
|
18
|
19
|
|
Completed Test of Cure (TOC) Visit
COMPLETED
|
20
|
16
|
17
|
|
Completed Test of Cure (TOC) Visit
NOT COMPLETED
|
3
|
2
|
2
|
Reasons for withdrawal
| Measure |
Daptomycin 6 mg/kg
Daptomycin (6 mg/kg every 24 hours \[q24h\]) as a 30 minute intravenous (IV) infusion for 6 weeks (± one week).
|
Daptomycin 8 mg/kg
Daptomycin (8 mg/kg q24h) as a 30 minute IV infusion for 6 weeks (± one week).
|
Comparator
Vancomycin was administered at 1 gram (gm)every 12 hours (q12h) as a 60-minute infusion and teicoplanin was administered 6 mg/kg q24h as a 30-minute infusion also for 6 weeks (±1 week). Semi-synthetic penicillin (nafcillin, oxacillin, or flucloxacillin) was administered according to standard of care for 6 weeks (±1 week).
|
|---|---|---|---|
|
Completed Study Drug Treatment
Adverse Event
|
2
|
4
|
4
|
|
Completed Study Drug Treatment
Protocol Violation
|
0
|
1
|
1
|
|
Completed Study Drug Treatment
Withdrawal by Subject
|
0
|
1
|
1
|
|
Completed Study Drug Treatment
Randomized Not Treated
|
0
|
0
|
1
|
|
Completed Test of Cure (TOC) Visit
Adverse Event
|
0
|
1
|
1
|
|
Completed Test of Cure (TOC) Visit
Protocol Violation
|
0
|
0
|
1
|
|
Completed Test of Cure (TOC) Visit
Withdrawal by Subject
|
1
|
0
|
0
|
|
Completed Test of Cure (TOC) Visit
Lack of Efficacy
|
2
|
0
|
0
|
|
Completed Test of Cure (TOC) Visit
Microbiologic failure
|
0
|
1
|
0
|
Baseline Characteristics
Study of Daptomycin in Subjects Undergoing Surgery for Osteomyelitis Associated With an Infected Prosthetic Caused by Staphylococci
Baseline characteristics by cohort
| Measure |
Daptomycin 6 mg/kg
n=25 Participants
Daptomycin (6 mg/kg q24h) as a 30-minute IV infusion for 6 weeks (±1 week).
|
Daptomycin 8 mg/kg
n=24 Participants
Daptomycin (8 mg/kg q24h) as a 30-minute IV infusion for 6 weeks (±1 week).
|
Comparator
n=25 Participants
Vancomycin was administered at 1 gm q12h as a 60-minute infusion and teicoplanin was administered 6 mg/kg q24h as a 30-minute infusion also for 6 weeks (±1 week). Semi-synthetic penicillin (nafcillin, oxacillin, or flucloxacillin) was administered according to standard of care for 6 weeks (±1 week).
|
Total
n=74 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
39 Participants
n=4 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
39 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
15 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
35 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
35 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: From the 3rd day of therapy to 1 week post last dose (approximately week 7)Population: Safety Population
Number of subjects with CPK \>500 U/L between Day 3 and 7 days following the last dose of study medication (Day 7P) as measured by the central laboratory.
Outcome measures
| Measure |
Daptomycin 6 mg/kg
n=25 Participants
Daptomycin (6 mg/kg q24h) as a 30-minute IV infusion for 6 weeks (±1 week).
|
Daptomycin 8 mg/kg
n=24 Participants
Daptomycin (8 mg/kg q24h) as a 30-minute IV infusion for 6 weeks (±1 week).
|
Comparator
n=25 Participants
Vancomycin was administered at 1 gm q12h as a 60-minute infusion and teicoplanin was administered 6 mg/kg q24h as a 30-minute infusion also for 6 weeks (±1 week). Semi-synthetic penicillin (nafcillin, oxacillin, or flucloxacillin) was administered according to standard of care for 6 weeks (±1 week).
|
|---|---|---|---|
|
Any Creatine Phosphokinase (CPK) Elevation > 500 Units Per Liter (U/L)
|
4 Participants
|
5 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: From the 1st day of therapy to maximum of 23 weeks post last dose (up to maximum of week 30)Population: Safety Population
Summary of Notable Laboratory Abnormalities - description of the proportion of subjects within each treatment group that had clinical laboratory values outside the reference range.
Outcome measures
| Measure |
Daptomycin 6 mg/kg
n=25 Participants
Daptomycin (6 mg/kg q24h) as a 30-minute IV infusion for 6 weeks (±1 week).
|
Daptomycin 8 mg/kg
n=24 Participants
Daptomycin (8 mg/kg q24h) as a 30-minute IV infusion for 6 weeks (±1 week).
|
Comparator
n=25 Participants
Vancomycin was administered at 1 gm q12h as a 60-minute infusion and teicoplanin was administered 6 mg/kg q24h as a 30-minute infusion also for 6 weeks (±1 week). Semi-synthetic penicillin (nafcillin, oxacillin, or flucloxacillin) was administered according to standard of care for 6 weeks (±1 week).
|
|---|---|---|---|
|
Safety - Notable Laboratory Abnormalities
Alkaline Phosphatase (>1350 U/L)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Safety - Notable Laboratory Abnormalities
Hematocrit (<30%, >60%)
|
12 Participants
|
10 Participants
|
15 Participants
|
|
Safety - Notable Laboratory Abnormalities
Hemoglobin (<9,>19 g/dL)
|
10 Participants
|
10 Participants
|
12 Participants
|
|
Safety - Notable Laboratory Abnormalities
Red Blood Cell (Female <2.5,>6.0; Male <3.0, >6.5)
|
2 Participants
|
4 Participants
|
3 Participants
|
|
Safety - Notable Laboratory Abnormalities
White Blood Cell (<2, >20 x 10^9/L)
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Safety - Notable Laboratory Abnormalities
Platelets (<40, >450 x 10^9/L)
|
13 Participants
|
13 Participants
|
10 Participants
|
|
Safety - Notable Laboratory Abnormalities
Albumin (<3, >6 g/dL)
|
7 Participants
|
4 Participants
|
4 Participants
|
|
Safety - Notable Laboratory Abnormalities
Alanine aminotransferase (>235 U/L)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Safety - Notable Laboratory Abnormalities
Aspartate aminotransferase (>185 U/L)
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Safety - Notable Laboratory Abnormalities
Total bilirubin (>2.2 mg/dL)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Safety - Notable Laboratory Abnormalities
Blood Urea Nitrogen (>50 mg/dL)
|
2 Participants
|
0 Participants
|
1 Participants
|
|
Safety - Notable Laboratory Abnormalities
Creatinine (Female >2.0; Male>2.8 mg/dL)
|
1 Participants
|
0 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Approximately 6 weeks post last dose (approximately week 12)Population: Modified Intent-to-Treat Population. Six treated patients in the ITT population were not included in the mITT population, as they did not have confirmed baseline staphylococcal infection.
The sponsor determined overall clinical outcome based on blinded review of clinical, microbiological, and radiological response of the subject including, but not limited to, clinical signs and symptoms of PJI, microbiological assessments, radiographic findings, and surgical procedures performed. Subjects were a success if both clinical and microbiological responses were success. A subject who failed to respond clinically or microbiologically was a failure. If microbiological response was non-evaluable and/or clinical evaluation at TOC was not performed, the subject was non-evaluable.
Outcome measures
| Measure |
Daptomycin 6 mg/kg
n=24 Participants
Daptomycin (6 mg/kg q24h) as a 30-minute IV infusion for 6 weeks (±1 week).
|
Daptomycin 8 mg/kg
n=23 Participants
Daptomycin (8 mg/kg q24h) as a 30-minute IV infusion for 6 weeks (±1 week).
|
Comparator
n=21 Participants
Vancomycin was administered at 1 gm q12h as a 60-minute infusion and teicoplanin was administered 6 mg/kg q24h as a 30-minute infusion also for 6 weeks (±1 week). Semi-synthetic penicillin (nafcillin, oxacillin, or flucloxacillin) was administered according to standard of care for 6 weeks (±1 week).
|
|---|---|---|---|
|
Overall Clinical Outcome
Success
|
13 Participants
|
13 Participants
|
8 Participants
|
|
Overall Clinical Outcome
Failure
|
10 Participants
|
8 Participants
|
11 Participants
|
|
Overall Clinical Outcome
Nonevaluable
|
1 Participants
|
2 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Approximately 6 weeks post last dose (approximately week 12)Population: Modified Intent to Treat Population. Six treated patients in the ITT population were not included in the mITT population, as they did not have confirmed baseline staphylococcal infection.
Sponsor's assessment of subject-level microbiological response at the test-of-cure visit for the modified Intent-to-Treat (mITT) population.
Outcome measures
| Measure |
Daptomycin 6 mg/kg
n=24 Participants
Daptomycin (6 mg/kg q24h) as a 30-minute IV infusion for 6 weeks (±1 week).
|
Daptomycin 8 mg/kg
n=23 Participants
Daptomycin (8 mg/kg q24h) as a 30-minute IV infusion for 6 weeks (±1 week).
|
Comparator
n=21 Participants
Vancomycin was administered at 1 gm q12h as a 60-minute infusion and teicoplanin was administered 6 mg/kg q24h as a 30-minute infusion also for 6 weeks (±1 week). Semi-synthetic penicillin (nafcillin, oxacillin, or flucloxacillin) was administered according to standard of care for 6 weeks (±1 week).
|
|---|---|---|---|
|
Microbiological Response
Success
|
12 Participants
|
12 Participants
|
8 Participants
|
|
Microbiological Response
Failure
|
8 Participants
|
3 Participants
|
6 Participants
|
|
Microbiological Response
Non-evaluable
|
4 Participants
|
8 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: Day 4 (steady state)Population: Pharmacokinetic evaluable population. Pharmacokinetics not analyzed for the comparator group.
The pharmacokinetic (PK) parameters of daptomycin at steady state for the 6 mg/kg and 8 mg/kg dose groups. On treatment day 4, PK samples for daptomycin levels were to be obtained prior to start of daptomycin infusion (0 hr) and at 0.5 hr (end of infusion), 1-1.5 hr, 3-5 hr, 8-12 hr, and 24 hr after the start of daptomycin infusion.
Outcome measures
| Measure |
Daptomycin 6 mg/kg
n=22 Participants
Daptomycin (6 mg/kg q24h) as a 30-minute IV infusion for 6 weeks (±1 week).
|
Daptomycin 8 mg/kg
n=20 Participants
Daptomycin (8 mg/kg q24h) as a 30-minute IV infusion for 6 weeks (±1 week).
|
Comparator
Vancomycin was administered at 1 gm q12h as a 60-minute infusion and teicoplanin was administered 6 mg/kg q24h as a 30-minute infusion also for 6 weeks (±1 week). Semi-synthetic penicillin (nafcillin, oxacillin, or flucloxacillin) was administered according to standard of care for 6 weeks (±1 week).
|
|---|---|---|---|
|
Pharmacokinetic Parameter: Maximum Plasma Concentration (Cmax)
|
59.1 µg/mL
Interval 22.5 to 156.0
|
92.3 µg/mL
Interval 56.1 to 172.0
|
—
|
SECONDARY outcome
Timeframe: Day 4 (steady state)Population: Pharmacokinetic evaluable population. Pharmacokinetics not analyzed for the comparator group.
The pharmacokinetic (PK) parameters of daptomycin at steady state for the 6 mg/kg and 8 mg/kg dose groups. On treatment day 4, PK samples for daptomycin levels were to be obtained prior to start of daptomycin infusion (0 hr) and at 0.5 hr (end of infusion), 1-1.5 hr, 3-5 hr, 8-12 hr, and 24 hr after the start of daptomycin infusion.
Outcome measures
| Measure |
Daptomycin 6 mg/kg
n=22 Participants
Daptomycin (6 mg/kg q24h) as a 30-minute IV infusion for 6 weeks (±1 week).
|
Daptomycin 8 mg/kg
n=20 Participants
Daptomycin (8 mg/kg q24h) as a 30-minute IV infusion for 6 weeks (±1 week).
|
Comparator
Vancomycin was administered at 1 gm q12h as a 60-minute infusion and teicoplanin was administered 6 mg/kg q24h as a 30-minute infusion also for 6 weeks (±1 week). Semi-synthetic penicillin (nafcillin, oxacillin, or flucloxacillin) was administered according to standard of care for 6 weeks (±1 week).
|
|---|---|---|---|
|
Pharmacokinetic Parameter: Area Under the Concentration-time Curve During a Dosing Interval at Steady State (AUCss)
|
499 µg•hr/mL
Interval 166.0 to 1205.0
|
821 µg•hr/mL
Interval 292.0 to 1606.0
|
—
|
Adverse Events
Daptomycin 6 mg/kg
Serious events: 8 serious events
Other events: 23 other events
Deaths: 0 deaths
Daptomycin 8 mg/kg
Serious events: 4 serious events
Other events: 18 other events
Deaths: 0 deaths
Comparator
Serious events: 8 serious events
Other events: 22 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Daptomycin 6 mg/kg
n=25 participants at risk
Daptomycin (6 mg/kg q24h) as a 30-minute IV infusion for 6 weeks (±1 week).
|
Daptomycin 8 mg/kg
n=24 participants at risk
Daptomycin (8 mg/kg q24h) as a 30-minute IV infusion for 6 weeks (±1 week).
|
Comparator
n=25 participants at risk
Vancomycin was administered at 1 gm q12h as a 60-minute infusion and teicoplanin was administered 6 mg/kg q24h as a 30-minute infusion also for 6 weeks (±1 week). Semi-synthetic penicillin (nafcillin, oxacillin, or flucloxacillin) was administered according to standard of care for 6 weeks (±1 week).
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/25 • From the 1st day of therapy to maximum of 23 weeks post last dose (up to maximum of week 30)
Subjects who prematurely discontinue study drug will undergo follow-up safety evaluations within 30 days (±5 days) of administration of the last dose of study drug.
|
0.00%
0/24 • From the 1st day of therapy to maximum of 23 weeks post last dose (up to maximum of week 30)
Subjects who prematurely discontinue study drug will undergo follow-up safety evaluations within 30 days (±5 days) of administration of the last dose of study drug.
|
4.0%
1/25 • Number of events 1 • From the 1st day of therapy to maximum of 23 weeks post last dose (up to maximum of week 30)
Subjects who prematurely discontinue study drug will undergo follow-up safety evaluations within 30 days (±5 days) of administration of the last dose of study drug.
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/25 • From the 1st day of therapy to maximum of 23 weeks post last dose (up to maximum of week 30)
Subjects who prematurely discontinue study drug will undergo follow-up safety evaluations within 30 days (±5 days) of administration of the last dose of study drug.
|
0.00%
0/24 • From the 1st day of therapy to maximum of 23 weeks post last dose (up to maximum of week 30)
Subjects who prematurely discontinue study drug will undergo follow-up safety evaluations within 30 days (±5 days) of administration of the last dose of study drug.
|
4.0%
1/25 • Number of events 3 • From the 1st day of therapy to maximum of 23 weeks post last dose (up to maximum of week 30)
Subjects who prematurely discontinue study drug will undergo follow-up safety evaluations within 30 days (±5 days) of administration of the last dose of study drug.
|
|
General disorders
Wound necrosis
|
0.00%
0/25 • From the 1st day of therapy to maximum of 23 weeks post last dose (up to maximum of week 30)
Subjects who prematurely discontinue study drug will undergo follow-up safety evaluations within 30 days (±5 days) of administration of the last dose of study drug.
|
0.00%
0/24 • From the 1st day of therapy to maximum of 23 weeks post last dose (up to maximum of week 30)
Subjects who prematurely discontinue study drug will undergo follow-up safety evaluations within 30 days (±5 days) of administration of the last dose of study drug.
|
4.0%
1/25 • Number of events 1 • From the 1st day of therapy to maximum of 23 weeks post last dose (up to maximum of week 30)
Subjects who prematurely discontinue study drug will undergo follow-up safety evaluations within 30 days (±5 days) of administration of the last dose of study drug.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
4.0%
1/25 • Number of events 1 • From the 1st day of therapy to maximum of 23 weeks post last dose (up to maximum of week 30)
Subjects who prematurely discontinue study drug will undergo follow-up safety evaluations within 30 days (±5 days) of administration of the last dose of study drug.
|
0.00%
0/24 • From the 1st day of therapy to maximum of 23 weeks post last dose (up to maximum of week 30)
Subjects who prematurely discontinue study drug will undergo follow-up safety evaluations within 30 days (±5 days) of administration of the last dose of study drug.
|
0.00%
0/25 • From the 1st day of therapy to maximum of 23 weeks post last dose (up to maximum of week 30)
Subjects who prematurely discontinue study drug will undergo follow-up safety evaluations within 30 days (±5 days) of administration of the last dose of study drug.
|
|
Immune system disorders
Anaphylactic reaction
|
0.00%
0/25 • From the 1st day of therapy to maximum of 23 weeks post last dose (up to maximum of week 30)
Subjects who prematurely discontinue study drug will undergo follow-up safety evaluations within 30 days (±5 days) of administration of the last dose of study drug.
|
4.2%
1/24 • Number of events 1 • From the 1st day of therapy to maximum of 23 weeks post last dose (up to maximum of week 30)
Subjects who prematurely discontinue study drug will undergo follow-up safety evaluations within 30 days (±5 days) of administration of the last dose of study drug.
|
0.00%
0/25 • From the 1st day of therapy to maximum of 23 weeks post last dose (up to maximum of week 30)
Subjects who prematurely discontinue study drug will undergo follow-up safety evaluations within 30 days (±5 days) of administration of the last dose of study drug.
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/25 • From the 1st day of therapy to maximum of 23 weeks post last dose (up to maximum of week 30)
Subjects who prematurely discontinue study drug will undergo follow-up safety evaluations within 30 days (±5 days) of administration of the last dose of study drug.
|
0.00%
0/24 • From the 1st day of therapy to maximum of 23 weeks post last dose (up to maximum of week 30)
Subjects who prematurely discontinue study drug will undergo follow-up safety evaluations within 30 days (±5 days) of administration of the last dose of study drug.
|
4.0%
1/25 • Number of events 1 • From the 1st day of therapy to maximum of 23 weeks post last dose (up to maximum of week 30)
Subjects who prematurely discontinue study drug will undergo follow-up safety evaluations within 30 days (±5 days) of administration of the last dose of study drug.
|
|
Infections and infestations
Device related infection
|
0.00%
0/25 • From the 1st day of therapy to maximum of 23 weeks post last dose (up to maximum of week 30)
Subjects who prematurely discontinue study drug will undergo follow-up safety evaluations within 30 days (±5 days) of administration of the last dose of study drug.
|
4.2%
1/24 • Number of events 1 • From the 1st day of therapy to maximum of 23 weeks post last dose (up to maximum of week 30)
Subjects who prematurely discontinue study drug will undergo follow-up safety evaluations within 30 days (±5 days) of administration of the last dose of study drug.
|
0.00%
0/25 • From the 1st day of therapy to maximum of 23 weeks post last dose (up to maximum of week 30)
Subjects who prematurely discontinue study drug will undergo follow-up safety evaluations within 30 days (±5 days) of administration of the last dose of study drug.
|
|
Infections and infestations
Sepsis
|
0.00%
0/25 • From the 1st day of therapy to maximum of 23 weeks post last dose (up to maximum of week 30)
Subjects who prematurely discontinue study drug will undergo follow-up safety evaluations within 30 days (±5 days) of administration of the last dose of study drug.
|
0.00%
0/24 • From the 1st day of therapy to maximum of 23 weeks post last dose (up to maximum of week 30)
Subjects who prematurely discontinue study drug will undergo follow-up safety evaluations within 30 days (±5 days) of administration of the last dose of study drug.
|
4.0%
1/25 • Number of events 1 • From the 1st day of therapy to maximum of 23 weeks post last dose (up to maximum of week 30)
Subjects who prematurely discontinue study drug will undergo follow-up safety evaluations within 30 days (±5 days) of administration of the last dose of study drug.
|
|
Infections and infestations
Urinary tract infection
|
4.0%
1/25 • Number of events 1 • From the 1st day of therapy to maximum of 23 weeks post last dose (up to maximum of week 30)
Subjects who prematurely discontinue study drug will undergo follow-up safety evaluations within 30 days (±5 days) of administration of the last dose of study drug.
|
0.00%
0/24 • From the 1st day of therapy to maximum of 23 weeks post last dose (up to maximum of week 30)
Subjects who prematurely discontinue study drug will undergo follow-up safety evaluations within 30 days (±5 days) of administration of the last dose of study drug.
|
8.0%
2/25 • Number of events 2 • From the 1st day of therapy to maximum of 23 weeks post last dose (up to maximum of week 30)
Subjects who prematurely discontinue study drug will undergo follow-up safety evaluations within 30 days (±5 days) of administration of the last dose of study drug.
|
|
Infections and infestations
Viral infection
|
4.0%
1/25 • Number of events 1 • From the 1st day of therapy to maximum of 23 weeks post last dose (up to maximum of week 30)
Subjects who prematurely discontinue study drug will undergo follow-up safety evaluations within 30 days (±5 days) of administration of the last dose of study drug.
|
0.00%
0/24 • From the 1st day of therapy to maximum of 23 weeks post last dose (up to maximum of week 30)
Subjects who prematurely discontinue study drug will undergo follow-up safety evaluations within 30 days (±5 days) of administration of the last dose of study drug.
|
0.00%
0/25 • From the 1st day of therapy to maximum of 23 weeks post last dose (up to maximum of week 30)
Subjects who prematurely discontinue study drug will undergo follow-up safety evaluations within 30 days (±5 days) of administration of the last dose of study drug.
|
|
Injury, poisoning and procedural complications
Device dislocation
|
4.0%
1/25 • Number of events 1 • From the 1st day of therapy to maximum of 23 weeks post last dose (up to maximum of week 30)
Subjects who prematurely discontinue study drug will undergo follow-up safety evaluations within 30 days (±5 days) of administration of the last dose of study drug.
|
0.00%
0/24 • From the 1st day of therapy to maximum of 23 weeks post last dose (up to maximum of week 30)
Subjects who prematurely discontinue study drug will undergo follow-up safety evaluations within 30 days (±5 days) of administration of the last dose of study drug.
|
0.00%
0/25 • From the 1st day of therapy to maximum of 23 weeks post last dose (up to maximum of week 30)
Subjects who prematurely discontinue study drug will undergo follow-up safety evaluations within 30 days (±5 days) of administration of the last dose of study drug.
|
|
Injury, poisoning and procedural complications
Dislocation of joint prosthesis
|
8.0%
2/25 • Number of events 2 • From the 1st day of therapy to maximum of 23 weeks post last dose (up to maximum of week 30)
Subjects who prematurely discontinue study drug will undergo follow-up safety evaluations within 30 days (±5 days) of administration of the last dose of study drug.
|
0.00%
0/24 • From the 1st day of therapy to maximum of 23 weeks post last dose (up to maximum of week 30)
Subjects who prematurely discontinue study drug will undergo follow-up safety evaluations within 30 days (±5 days) of administration of the last dose of study drug.
|
0.00%
0/25 • From the 1st day of therapy to maximum of 23 weeks post last dose (up to maximum of week 30)
Subjects who prematurely discontinue study drug will undergo follow-up safety evaluations within 30 days (±5 days) of administration of the last dose of study drug.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
4.0%
1/25 • Number of events 1 • From the 1st day of therapy to maximum of 23 weeks post last dose (up to maximum of week 30)
Subjects who prematurely discontinue study drug will undergo follow-up safety evaluations within 30 days (±5 days) of administration of the last dose of study drug.
|
0.00%
0/24 • From the 1st day of therapy to maximum of 23 weeks post last dose (up to maximum of week 30)
Subjects who prematurely discontinue study drug will undergo follow-up safety evaluations within 30 days (±5 days) of administration of the last dose of study drug.
|
0.00%
0/25 • From the 1st day of therapy to maximum of 23 weeks post last dose (up to maximum of week 30)
Subjects who prematurely discontinue study drug will undergo follow-up safety evaluations within 30 days (±5 days) of administration of the last dose of study drug.
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
4.0%
1/25 • Number of events 1 • From the 1st day of therapy to maximum of 23 weeks post last dose (up to maximum of week 30)
Subjects who prematurely discontinue study drug will undergo follow-up safety evaluations within 30 days (±5 days) of administration of the last dose of study drug.
|
0.00%
0/24 • From the 1st day of therapy to maximum of 23 weeks post last dose (up to maximum of week 30)
Subjects who prematurely discontinue study drug will undergo follow-up safety evaluations within 30 days (±5 days) of administration of the last dose of study drug.
|
0.00%
0/25 • From the 1st day of therapy to maximum of 23 weeks post last dose (up to maximum of week 30)
Subjects who prematurely discontinue study drug will undergo follow-up safety evaluations within 30 days (±5 days) of administration of the last dose of study drug.
|
|
Injury, poisoning and procedural complications
Subcutaneous haematoma
|
4.0%
1/25 • Number of events 1 • From the 1st day of therapy to maximum of 23 weeks post last dose (up to maximum of week 30)
Subjects who prematurely discontinue study drug will undergo follow-up safety evaluations within 30 days (±5 days) of administration of the last dose of study drug.
|
0.00%
0/24 • From the 1st day of therapy to maximum of 23 weeks post last dose (up to maximum of week 30)
Subjects who prematurely discontinue study drug will undergo follow-up safety evaluations within 30 days (±5 days) of administration of the last dose of study drug.
|
0.00%
0/25 • From the 1st day of therapy to maximum of 23 weeks post last dose (up to maximum of week 30)
Subjects who prematurely discontinue study drug will undergo follow-up safety evaluations within 30 days (±5 days) of administration of the last dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthropathy
|
0.00%
0/25 • From the 1st day of therapy to maximum of 23 weeks post last dose (up to maximum of week 30)
Subjects who prematurely discontinue study drug will undergo follow-up safety evaluations within 30 days (±5 days) of administration of the last dose of study drug.
|
0.00%
0/24 • From the 1st day of therapy to maximum of 23 weeks post last dose (up to maximum of week 30)
Subjects who prematurely discontinue study drug will undergo follow-up safety evaluations within 30 days (±5 days) of administration of the last dose of study drug.
|
4.0%
1/25 • Number of events 1 • From the 1st day of therapy to maximum of 23 weeks post last dose (up to maximum of week 30)
Subjects who prematurely discontinue study drug will undergo follow-up safety evaluations within 30 days (±5 days) of administration of the last dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
4.0%
1/25 • Number of events 1 • From the 1st day of therapy to maximum of 23 weeks post last dose (up to maximum of week 30)
Subjects who prematurely discontinue study drug will undergo follow-up safety evaluations within 30 days (±5 days) of administration of the last dose of study drug.
|
4.2%
1/24 • Number of events 1 • From the 1st day of therapy to maximum of 23 weeks post last dose (up to maximum of week 30)
Subjects who prematurely discontinue study drug will undergo follow-up safety evaluations within 30 days (±5 days) of administration of the last dose of study drug.
|
0.00%
0/25 • From the 1st day of therapy to maximum of 23 weeks post last dose (up to maximum of week 30)
Subjects who prematurely discontinue study drug will undergo follow-up safety evaluations within 30 days (±5 days) of administration of the last dose of study drug.
|
|
Renal and urinary disorders
Renal failure
|
4.0%
1/25 • Number of events 1 • From the 1st day of therapy to maximum of 23 weeks post last dose (up to maximum of week 30)
Subjects who prematurely discontinue study drug will undergo follow-up safety evaluations within 30 days (±5 days) of administration of the last dose of study drug.
|
0.00%
0/24 • From the 1st day of therapy to maximum of 23 weeks post last dose (up to maximum of week 30)
Subjects who prematurely discontinue study drug will undergo follow-up safety evaluations within 30 days (±5 days) of administration of the last dose of study drug.
|
4.0%
1/25 • Number of events 1 • From the 1st day of therapy to maximum of 23 weeks post last dose (up to maximum of week 30)
Subjects who prematurely discontinue study drug will undergo follow-up safety evaluations within 30 days (±5 days) of administration of the last dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/25 • From the 1st day of therapy to maximum of 23 weeks post last dose (up to maximum of week 30)
Subjects who prematurely discontinue study drug will undergo follow-up safety evaluations within 30 days (±5 days) of administration of the last dose of study drug.
|
0.00%
0/24 • From the 1st day of therapy to maximum of 23 weeks post last dose (up to maximum of week 30)
Subjects who prematurely discontinue study drug will undergo follow-up safety evaluations within 30 days (±5 days) of administration of the last dose of study drug.
|
4.0%
1/25 • Number of events 1 • From the 1st day of therapy to maximum of 23 weeks post last dose (up to maximum of week 30)
Subjects who prematurely discontinue study drug will undergo follow-up safety evaluations within 30 days (±5 days) of administration of the last dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/25 • From the 1st day of therapy to maximum of 23 weeks post last dose (up to maximum of week 30)
Subjects who prematurely discontinue study drug will undergo follow-up safety evaluations within 30 days (±5 days) of administration of the last dose of study drug.
|
0.00%
0/24 • From the 1st day of therapy to maximum of 23 weeks post last dose (up to maximum of week 30)
Subjects who prematurely discontinue study drug will undergo follow-up safety evaluations within 30 days (±5 days) of administration of the last dose of study drug.
|
4.0%
1/25 • Number of events 1 • From the 1st day of therapy to maximum of 23 weeks post last dose (up to maximum of week 30)
Subjects who prematurely discontinue study drug will undergo follow-up safety evaluations within 30 days (±5 days) of administration of the last dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
4.0%
1/25 • Number of events 1 • From the 1st day of therapy to maximum of 23 weeks post last dose (up to maximum of week 30)
Subjects who prematurely discontinue study drug will undergo follow-up safety evaluations within 30 days (±5 days) of administration of the last dose of study drug.
|
0.00%
0/24 • From the 1st day of therapy to maximum of 23 weeks post last dose (up to maximum of week 30)
Subjects who prematurely discontinue study drug will undergo follow-up safety evaluations within 30 days (±5 days) of administration of the last dose of study drug.
|
0.00%
0/25 • From the 1st day of therapy to maximum of 23 weeks post last dose (up to maximum of week 30)
Subjects who prematurely discontinue study drug will undergo follow-up safety evaluations within 30 days (±5 days) of administration of the last dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash
|
4.0%
1/25 • Number of events 1 • From the 1st day of therapy to maximum of 23 weeks post last dose (up to maximum of week 30)
Subjects who prematurely discontinue study drug will undergo follow-up safety evaluations within 30 days (±5 days) of administration of the last dose of study drug.
|
0.00%
0/24 • From the 1st day of therapy to maximum of 23 weeks post last dose (up to maximum of week 30)
Subjects who prematurely discontinue study drug will undergo follow-up safety evaluations within 30 days (±5 days) of administration of the last dose of study drug.
|
0.00%
0/25 • From the 1st day of therapy to maximum of 23 weeks post last dose (up to maximum of week 30)
Subjects who prematurely discontinue study drug will undergo follow-up safety evaluations within 30 days (±5 days) of administration of the last dose of study drug.
|
|
Vascular disorders
Deep vein thrombosis
|
4.0%
1/25 • Number of events 1 • From the 1st day of therapy to maximum of 23 weeks post last dose (up to maximum of week 30)
Subjects who prematurely discontinue study drug will undergo follow-up safety evaluations within 30 days (±5 days) of administration of the last dose of study drug.
|
4.2%
1/24 • Number of events 1 • From the 1st day of therapy to maximum of 23 weeks post last dose (up to maximum of week 30)
Subjects who prematurely discontinue study drug will undergo follow-up safety evaluations within 30 days (±5 days) of administration of the last dose of study drug.
|
4.0%
1/25 • Number of events 1 • From the 1st day of therapy to maximum of 23 weeks post last dose (up to maximum of week 30)
Subjects who prematurely discontinue study drug will undergo follow-up safety evaluations within 30 days (±5 days) of administration of the last dose of study drug.
|
|
Vascular disorders
Haematoma
|
0.00%
0/25 • From the 1st day of therapy to maximum of 23 weeks post last dose (up to maximum of week 30)
Subjects who prematurely discontinue study drug will undergo follow-up safety evaluations within 30 days (±5 days) of administration of the last dose of study drug.
|
0.00%
0/24 • From the 1st day of therapy to maximum of 23 weeks post last dose (up to maximum of week 30)
Subjects who prematurely discontinue study drug will undergo follow-up safety evaluations within 30 days (±5 days) of administration of the last dose of study drug.
|
4.0%
1/25 • Number of events 1 • From the 1st day of therapy to maximum of 23 weeks post last dose (up to maximum of week 30)
Subjects who prematurely discontinue study drug will undergo follow-up safety evaluations within 30 days (±5 days) of administration of the last dose of study drug.
|
Other adverse events
| Measure |
Daptomycin 6 mg/kg
n=25 participants at risk
Daptomycin (6 mg/kg q24h) as a 30-minute IV infusion for 6 weeks (±1 week).
|
Daptomycin 8 mg/kg
n=24 participants at risk
Daptomycin (8 mg/kg q24h) as a 30-minute IV infusion for 6 weeks (±1 week).
|
Comparator
n=25 participants at risk
Vancomycin was administered at 1 gm q12h as a 60-minute infusion and teicoplanin was administered 6 mg/kg q24h as a 30-minute infusion also for 6 weeks (±1 week). Semi-synthetic penicillin (nafcillin, oxacillin, or flucloxacillin) was administered according to standard of care for 6 weeks (±1 week).
|
|---|---|---|---|
|
Eye disorders
Vision blurred
|
0.00%
0/25 • From the 1st day of therapy to maximum of 23 weeks post last dose (up to maximum of week 30)
Subjects who prematurely discontinue study drug will undergo follow-up safety evaluations within 30 days (±5 days) of administration of the last dose of study drug.
|
0.00%
0/24 • From the 1st day of therapy to maximum of 23 weeks post last dose (up to maximum of week 30)
Subjects who prematurely discontinue study drug will undergo follow-up safety evaluations within 30 days (±5 days) of administration of the last dose of study drug.
|
8.0%
2/25 • Number of events 2 • From the 1st day of therapy to maximum of 23 weeks post last dose (up to maximum of week 30)
Subjects who prematurely discontinue study drug will undergo follow-up safety evaluations within 30 days (±5 days) of administration of the last dose of study drug.
|
|
Gastrointestinal disorders
Constipation
|
16.0%
4/25 • Number of events 5 • From the 1st day of therapy to maximum of 23 weeks post last dose (up to maximum of week 30)
Subjects who prematurely discontinue study drug will undergo follow-up safety evaluations within 30 days (±5 days) of administration of the last dose of study drug.
|
8.3%
2/24 • Number of events 2 • From the 1st day of therapy to maximum of 23 weeks post last dose (up to maximum of week 30)
Subjects who prematurely discontinue study drug will undergo follow-up safety evaluations within 30 days (±5 days) of administration of the last dose of study drug.
|
4.0%
1/25 • Number of events 1 • From the 1st day of therapy to maximum of 23 weeks post last dose (up to maximum of week 30)
Subjects who prematurely discontinue study drug will undergo follow-up safety evaluations within 30 days (±5 days) of administration of the last dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
8.0%
2/25 • Number of events 2 • From the 1st day of therapy to maximum of 23 weeks post last dose (up to maximum of week 30)
Subjects who prematurely discontinue study drug will undergo follow-up safety evaluations within 30 days (±5 days) of administration of the last dose of study drug.
|
8.3%
2/24 • Number of events 3 • From the 1st day of therapy to maximum of 23 weeks post last dose (up to maximum of week 30)
Subjects who prematurely discontinue study drug will undergo follow-up safety evaluations within 30 days (±5 days) of administration of the last dose of study drug.
|
8.0%
2/25 • Number of events 3 • From the 1st day of therapy to maximum of 23 weeks post last dose (up to maximum of week 30)
Subjects who prematurely discontinue study drug will undergo follow-up safety evaluations within 30 days (±5 days) of administration of the last dose of study drug.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/25 • From the 1st day of therapy to maximum of 23 weeks post last dose (up to maximum of week 30)
Subjects who prematurely discontinue study drug will undergo follow-up safety evaluations within 30 days (±5 days) of administration of the last dose of study drug.
|
0.00%
0/24 • From the 1st day of therapy to maximum of 23 weeks post last dose (up to maximum of week 30)
Subjects who prematurely discontinue study drug will undergo follow-up safety evaluations within 30 days (±5 days) of administration of the last dose of study drug.
|
8.0%
2/25 • Number of events 2 • From the 1st day of therapy to maximum of 23 weeks post last dose (up to maximum of week 30)
Subjects who prematurely discontinue study drug will undergo follow-up safety evaluations within 30 days (±5 days) of administration of the last dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
20.0%
5/25 • Number of events 5 • From the 1st day of therapy to maximum of 23 weeks post last dose (up to maximum of week 30)
Subjects who prematurely discontinue study drug will undergo follow-up safety evaluations within 30 days (±5 days) of administration of the last dose of study drug.
|
12.5%
3/24 • Number of events 3 • From the 1st day of therapy to maximum of 23 weeks post last dose (up to maximum of week 30)
Subjects who prematurely discontinue study drug will undergo follow-up safety evaluations within 30 days (±5 days) of administration of the last dose of study drug.
|
16.0%
4/25 • Number of events 7 • From the 1st day of therapy to maximum of 23 weeks post last dose (up to maximum of week 30)
Subjects who prematurely discontinue study drug will undergo follow-up safety evaluations within 30 days (±5 days) of administration of the last dose of study drug.
|
|
Gastrointestinal disorders
Stomach discomfort
|
0.00%
0/25 • From the 1st day of therapy to maximum of 23 weeks post last dose (up to maximum of week 30)
Subjects who prematurely discontinue study drug will undergo follow-up safety evaluations within 30 days (±5 days) of administration of the last dose of study drug.
|
0.00%
0/24 • From the 1st day of therapy to maximum of 23 weeks post last dose (up to maximum of week 30)
Subjects who prematurely discontinue study drug will undergo follow-up safety evaluations within 30 days (±5 days) of administration of the last dose of study drug.
|
8.0%
2/25 • Number of events 2 • From the 1st day of therapy to maximum of 23 weeks post last dose (up to maximum of week 30)
Subjects who prematurely discontinue study drug will undergo follow-up safety evaluations within 30 days (±5 days) of administration of the last dose of study drug.
|
|
Gastrointestinal disorders
Vomiting
|
4.0%
1/25 • Number of events 1 • From the 1st day of therapy to maximum of 23 weeks post last dose (up to maximum of week 30)
Subjects who prematurely discontinue study drug will undergo follow-up safety evaluations within 30 days (±5 days) of administration of the last dose of study drug.
|
4.2%
1/24 • Number of events 2 • From the 1st day of therapy to maximum of 23 weeks post last dose (up to maximum of week 30)
Subjects who prematurely discontinue study drug will undergo follow-up safety evaluations within 30 days (±5 days) of administration of the last dose of study drug.
|
8.0%
2/25 • Number of events 5 • From the 1st day of therapy to maximum of 23 weeks post last dose (up to maximum of week 30)
Subjects who prematurely discontinue study drug will undergo follow-up safety evaluations within 30 days (±5 days) of administration of the last dose of study drug.
|
|
General disorders
Asthenia
|
0.00%
0/25 • From the 1st day of therapy to maximum of 23 weeks post last dose (up to maximum of week 30)
Subjects who prematurely discontinue study drug will undergo follow-up safety evaluations within 30 days (±5 days) of administration of the last dose of study drug.
|
0.00%
0/24 • From the 1st day of therapy to maximum of 23 weeks post last dose (up to maximum of week 30)
Subjects who prematurely discontinue study drug will undergo follow-up safety evaluations within 30 days (±5 days) of administration of the last dose of study drug.
|
8.0%
2/25 • Number of events 2 • From the 1st day of therapy to maximum of 23 weeks post last dose (up to maximum of week 30)
Subjects who prematurely discontinue study drug will undergo follow-up safety evaluations within 30 days (±5 days) of administration of the last dose of study drug.
|
|
General disorders
Catheter related complication
|
4.0%
1/25 • Number of events 1 • From the 1st day of therapy to maximum of 23 weeks post last dose (up to maximum of week 30)
Subjects who prematurely discontinue study drug will undergo follow-up safety evaluations within 30 days (±5 days) of administration of the last dose of study drug.
|
8.3%
2/24 • Number of events 3 • From the 1st day of therapy to maximum of 23 weeks post last dose (up to maximum of week 30)
Subjects who prematurely discontinue study drug will undergo follow-up safety evaluations within 30 days (±5 days) of administration of the last dose of study drug.
|
8.0%
2/25 • Number of events 9 • From the 1st day of therapy to maximum of 23 weeks post last dose (up to maximum of week 30)
Subjects who prematurely discontinue study drug will undergo follow-up safety evaluations within 30 days (±5 days) of administration of the last dose of study drug.
|
|
General disorders
Chest pain
|
8.0%
2/25 • Number of events 2 • From the 1st day of therapy to maximum of 23 weeks post last dose (up to maximum of week 30)
Subjects who prematurely discontinue study drug will undergo follow-up safety evaluations within 30 days (±5 days) of administration of the last dose of study drug.
|
0.00%
0/24 • From the 1st day of therapy to maximum of 23 weeks post last dose (up to maximum of week 30)
Subjects who prematurely discontinue study drug will undergo follow-up safety evaluations within 30 days (±5 days) of administration of the last dose of study drug.
|
0.00%
0/25 • From the 1st day of therapy to maximum of 23 weeks post last dose (up to maximum of week 30)
Subjects who prematurely discontinue study drug will undergo follow-up safety evaluations within 30 days (±5 days) of administration of the last dose of study drug.
|
|
General disorders
Fatigue
|
4.0%
1/25 • Number of events 1 • From the 1st day of therapy to maximum of 23 weeks post last dose (up to maximum of week 30)
Subjects who prematurely discontinue study drug will undergo follow-up safety evaluations within 30 days (±5 days) of administration of the last dose of study drug.
|
0.00%
0/24 • From the 1st day of therapy to maximum of 23 weeks post last dose (up to maximum of week 30)
Subjects who prematurely discontinue study drug will undergo follow-up safety evaluations within 30 days (±5 days) of administration of the last dose of study drug.
|
8.0%
2/25 • Number of events 3 • From the 1st day of therapy to maximum of 23 weeks post last dose (up to maximum of week 30)
Subjects who prematurely discontinue study drug will undergo follow-up safety evaluations within 30 days (±5 days) of administration of the last dose of study drug.
|
|
General disorders
Oedema peripheral
|
8.0%
2/25 • Number of events 5 • From the 1st day of therapy to maximum of 23 weeks post last dose (up to maximum of week 30)
Subjects who prematurely discontinue study drug will undergo follow-up safety evaluations within 30 days (±5 days) of administration of the last dose of study drug.
|
8.3%
2/24 • Number of events 4 • From the 1st day of therapy to maximum of 23 weeks post last dose (up to maximum of week 30)
Subjects who prematurely discontinue study drug will undergo follow-up safety evaluations within 30 days (±5 days) of administration of the last dose of study drug.
|
16.0%
4/25 • Number of events 7 • From the 1st day of therapy to maximum of 23 weeks post last dose (up to maximum of week 30)
Subjects who prematurely discontinue study drug will undergo follow-up safety evaluations within 30 days (±5 days) of administration of the last dose of study drug.
|
|
General disorders
Pyrexia
|
16.0%
4/25 • Number of events 5 • From the 1st day of therapy to maximum of 23 weeks post last dose (up to maximum of week 30)
Subjects who prematurely discontinue study drug will undergo follow-up safety evaluations within 30 days (±5 days) of administration of the last dose of study drug.
|
8.3%
2/24 • Number of events 2 • From the 1st day of therapy to maximum of 23 weeks post last dose (up to maximum of week 30)
Subjects who prematurely discontinue study drug will undergo follow-up safety evaluations within 30 days (±5 days) of administration of the last dose of study drug.
|
16.0%
4/25 • Number of events 7 • From the 1st day of therapy to maximum of 23 weeks post last dose (up to maximum of week 30)
Subjects who prematurely discontinue study drug will undergo follow-up safety evaluations within 30 days (±5 days) of administration of the last dose of study drug.
|
|
Infections and infestations
Arthritis infective
|
0.00%
0/25 • From the 1st day of therapy to maximum of 23 weeks post last dose (up to maximum of week 30)
Subjects who prematurely discontinue study drug will undergo follow-up safety evaluations within 30 days (±5 days) of administration of the last dose of study drug.
|
0.00%
0/24 • From the 1st day of therapy to maximum of 23 weeks post last dose (up to maximum of week 30)
Subjects who prematurely discontinue study drug will undergo follow-up safety evaluations within 30 days (±5 days) of administration of the last dose of study drug.
|
8.0%
2/25 • Number of events 2 • From the 1st day of therapy to maximum of 23 weeks post last dose (up to maximum of week 30)
Subjects who prematurely discontinue study drug will undergo follow-up safety evaluations within 30 days (±5 days) of administration of the last dose of study drug.
|
|
Infections and infestations
Bacteriuria
|
8.0%
2/25 • Number of events 2 • From the 1st day of therapy to maximum of 23 weeks post last dose (up to maximum of week 30)
Subjects who prematurely discontinue study drug will undergo follow-up safety evaluations within 30 days (±5 days) of administration of the last dose of study drug.
|
4.2%
1/24 • Number of events 1 • From the 1st day of therapy to maximum of 23 weeks post last dose (up to maximum of week 30)
Subjects who prematurely discontinue study drug will undergo follow-up safety evaluations within 30 days (±5 days) of administration of the last dose of study drug.
|
0.00%
0/25 • From the 1st day of therapy to maximum of 23 weeks post last dose (up to maximum of week 30)
Subjects who prematurely discontinue study drug will undergo follow-up safety evaluations within 30 days (±5 days) of administration of the last dose of study drug.
|
|
Infections and infestations
Urinary tract infection
|
12.0%
3/25 • Number of events 4 • From the 1st day of therapy to maximum of 23 weeks post last dose (up to maximum of week 30)
Subjects who prematurely discontinue study drug will undergo follow-up safety evaluations within 30 days (±5 days) of administration of the last dose of study drug.
|
4.2%
1/24 • Number of events 1 • From the 1st day of therapy to maximum of 23 weeks post last dose (up to maximum of week 30)
Subjects who prematurely discontinue study drug will undergo follow-up safety evaluations within 30 days (±5 days) of administration of the last dose of study drug.
|
8.0%
2/25 • Number of events 2 • From the 1st day of therapy to maximum of 23 weeks post last dose (up to maximum of week 30)
Subjects who prematurely discontinue study drug will undergo follow-up safety evaluations within 30 days (±5 days) of administration of the last dose of study drug.
|
|
Investigations
Blood alkaline phosphatase increased
|
8.0%
2/25 • Number of events 2 • From the 1st day of therapy to maximum of 23 weeks post last dose (up to maximum of week 30)
Subjects who prematurely discontinue study drug will undergo follow-up safety evaluations within 30 days (±5 days) of administration of the last dose of study drug.
|
4.2%
1/24 • Number of events 1 • From the 1st day of therapy to maximum of 23 weeks post last dose (up to maximum of week 30)
Subjects who prematurely discontinue study drug will undergo follow-up safety evaluations within 30 days (±5 days) of administration of the last dose of study drug.
|
8.0%
2/25 • Number of events 2 • From the 1st day of therapy to maximum of 23 weeks post last dose (up to maximum of week 30)
Subjects who prematurely discontinue study drug will undergo follow-up safety evaluations within 30 days (±5 days) of administration of the last dose of study drug.
|
|
Investigations
Blood creatine phosphokinase increased
|
12.0%
3/25 • Number of events 3 • From the 1st day of therapy to maximum of 23 weeks post last dose (up to maximum of week 30)
Subjects who prematurely discontinue study drug will undergo follow-up safety evaluations within 30 days (±5 days) of administration of the last dose of study drug.
|
8.3%
2/24 • Number of events 2 • From the 1st day of therapy to maximum of 23 weeks post last dose (up to maximum of week 30)
Subjects who prematurely discontinue study drug will undergo follow-up safety evaluations within 30 days (±5 days) of administration of the last dose of study drug.
|
4.0%
1/25 • Number of events 1 • From the 1st day of therapy to maximum of 23 weeks post last dose (up to maximum of week 30)
Subjects who prematurely discontinue study drug will undergo follow-up safety evaluations within 30 days (±5 days) of administration of the last dose of study drug.
|
|
Investigations
Blood pressure increased
|
0.00%
0/25 • From the 1st day of therapy to maximum of 23 weeks post last dose (up to maximum of week 30)
Subjects who prematurely discontinue study drug will undergo follow-up safety evaluations within 30 days (±5 days) of administration of the last dose of study drug.
|
8.3%
2/24 • Number of events 2 • From the 1st day of therapy to maximum of 23 weeks post last dose (up to maximum of week 30)
Subjects who prematurely discontinue study drug will undergo follow-up safety evaluations within 30 days (±5 days) of administration of the last dose of study drug.
|
4.0%
1/25 • Number of events 1 • From the 1st day of therapy to maximum of 23 weeks post last dose (up to maximum of week 30)
Subjects who prematurely discontinue study drug will undergo follow-up safety evaluations within 30 days (±5 days) of administration of the last dose of study drug.
|
|
Investigations
Haematocrit decreased
|
0.00%
0/25 • From the 1st day of therapy to maximum of 23 weeks post last dose (up to maximum of week 30)
Subjects who prematurely discontinue study drug will undergo follow-up safety evaluations within 30 days (±5 days) of administration of the last dose of study drug.
|
8.3%
2/24 • Number of events 2 • From the 1st day of therapy to maximum of 23 weeks post last dose (up to maximum of week 30)
Subjects who prematurely discontinue study drug will undergo follow-up safety evaluations within 30 days (±5 days) of administration of the last dose of study drug.
|
4.0%
1/25 • Number of events 1 • From the 1st day of therapy to maximum of 23 weeks post last dose (up to maximum of week 30)
Subjects who prematurely discontinue study drug will undergo follow-up safety evaluations within 30 days (±5 days) of administration of the last dose of study drug.
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/25 • From the 1st day of therapy to maximum of 23 weeks post last dose (up to maximum of week 30)
Subjects who prematurely discontinue study drug will undergo follow-up safety evaluations within 30 days (±5 days) of administration of the last dose of study drug.
|
8.3%
2/24 • Number of events 2 • From the 1st day of therapy to maximum of 23 weeks post last dose (up to maximum of week 30)
Subjects who prematurely discontinue study drug will undergo follow-up safety evaluations within 30 days (±5 days) of administration of the last dose of study drug.
|
4.0%
1/25 • Number of events 1 • From the 1st day of therapy to maximum of 23 weeks post last dose (up to maximum of week 30)
Subjects who prematurely discontinue study drug will undergo follow-up safety evaluations within 30 days (±5 days) of administration of the last dose of study drug.
|
|
Investigations
Urine output decreased
|
0.00%
0/25 • From the 1st day of therapy to maximum of 23 weeks post last dose (up to maximum of week 30)
Subjects who prematurely discontinue study drug will undergo follow-up safety evaluations within 30 days (±5 days) of administration of the last dose of study drug.
|
8.3%
2/24 • Number of events 2 • From the 1st day of therapy to maximum of 23 weeks post last dose (up to maximum of week 30)
Subjects who prematurely discontinue study drug will undergo follow-up safety evaluations within 30 days (±5 days) of administration of the last dose of study drug.
|
0.00%
0/25 • From the 1st day of therapy to maximum of 23 weeks post last dose (up to maximum of week 30)
Subjects who prematurely discontinue study drug will undergo follow-up safety evaluations within 30 days (±5 days) of administration of the last dose of study drug.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
8.0%
2/25 • Number of events 2 • From the 1st day of therapy to maximum of 23 weeks post last dose (up to maximum of week 30)
Subjects who prematurely discontinue study drug will undergo follow-up safety evaluations within 30 days (±5 days) of administration of the last dose of study drug.
|
4.2%
1/24 • Number of events 2 • From the 1st day of therapy to maximum of 23 weeks post last dose (up to maximum of week 30)
Subjects who prematurely discontinue study drug will undergo follow-up safety evaluations within 30 days (±5 days) of administration of the last dose of study drug.
|
4.0%
1/25 • Number of events 1 • From the 1st day of therapy to maximum of 23 weeks post last dose (up to maximum of week 30)
Subjects who prematurely discontinue study drug will undergo follow-up safety evaluations within 30 days (±5 days) of administration of the last dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
4.0%
1/25 • Number of events 1 • From the 1st day of therapy to maximum of 23 weeks post last dose (up to maximum of week 30)
Subjects who prematurely discontinue study drug will undergo follow-up safety evaluations within 30 days (±5 days) of administration of the last dose of study drug.
|
0.00%
0/24 • From the 1st day of therapy to maximum of 23 weeks post last dose (up to maximum of week 30)
Subjects who prematurely discontinue study drug will undergo follow-up safety evaluations within 30 days (±5 days) of administration of the last dose of study drug.
|
8.0%
2/25 • Number of events 2 • From the 1st day of therapy to maximum of 23 weeks post last dose (up to maximum of week 30)
Subjects who prematurely discontinue study drug will undergo follow-up safety evaluations within 30 days (±5 days) of administration of the last dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/25 • From the 1st day of therapy to maximum of 23 weeks post last dose (up to maximum of week 30)
Subjects who prematurely discontinue study drug will undergo follow-up safety evaluations within 30 days (±5 days) of administration of the last dose of study drug.
|
4.2%
1/24 • Number of events 1 • From the 1st day of therapy to maximum of 23 weeks post last dose (up to maximum of week 30)
Subjects who prematurely discontinue study drug will undergo follow-up safety evaluations within 30 days (±5 days) of administration of the last dose of study drug.
|
8.0%
2/25 • Number of events 2 • From the 1st day of therapy to maximum of 23 weeks post last dose (up to maximum of week 30)
Subjects who prematurely discontinue study drug will undergo follow-up safety evaluations within 30 days (±5 days) of administration of the last dose of study drug.
|
|
Nervous system disorders
Dizziness
|
8.0%
2/25 • Number of events 2 • From the 1st day of therapy to maximum of 23 weeks post last dose (up to maximum of week 30)
Subjects who prematurely discontinue study drug will undergo follow-up safety evaluations within 30 days (±5 days) of administration of the last dose of study drug.
|
0.00%
0/24 • From the 1st day of therapy to maximum of 23 weeks post last dose (up to maximum of week 30)
Subjects who prematurely discontinue study drug will undergo follow-up safety evaluations within 30 days (±5 days) of administration of the last dose of study drug.
|
8.0%
2/25 • Number of events 3 • From the 1st day of therapy to maximum of 23 weeks post last dose (up to maximum of week 30)
Subjects who prematurely discontinue study drug will undergo follow-up safety evaluations within 30 days (±5 days) of administration of the last dose of study drug.
|
|
Nervous system disorders
Headache
|
12.0%
3/25 • Number of events 5 • From the 1st day of therapy to maximum of 23 weeks post last dose (up to maximum of week 30)
Subjects who prematurely discontinue study drug will undergo follow-up safety evaluations within 30 days (±5 days) of administration of the last dose of study drug.
|
0.00%
0/24 • From the 1st day of therapy to maximum of 23 weeks post last dose (up to maximum of week 30)
Subjects who prematurely discontinue study drug will undergo follow-up safety evaluations within 30 days (±5 days) of administration of the last dose of study drug.
|
8.0%
2/25 • Number of events 2 • From the 1st day of therapy to maximum of 23 weeks post last dose (up to maximum of week 30)
Subjects who prematurely discontinue study drug will undergo follow-up safety evaluations within 30 days (±5 days) of administration of the last dose of study drug.
|
|
Nervous system disorders
Tremor
|
8.0%
2/25 • Number of events 3 • From the 1st day of therapy to maximum of 23 weeks post last dose (up to maximum of week 30)
Subjects who prematurely discontinue study drug will undergo follow-up safety evaluations within 30 days (±5 days) of administration of the last dose of study drug.
|
0.00%
0/24 • From the 1st day of therapy to maximum of 23 weeks post last dose (up to maximum of week 30)
Subjects who prematurely discontinue study drug will undergo follow-up safety evaluations within 30 days (±5 days) of administration of the last dose of study drug.
|
0.00%
0/25 • From the 1st day of therapy to maximum of 23 weeks post last dose (up to maximum of week 30)
Subjects who prematurely discontinue study drug will undergo follow-up safety evaluations within 30 days (±5 days) of administration of the last dose of study drug.
|
|
Psychiatric disorders
Anxiety
|
8.0%
2/25 • Number of events 2 • From the 1st day of therapy to maximum of 23 weeks post last dose (up to maximum of week 30)
Subjects who prematurely discontinue study drug will undergo follow-up safety evaluations within 30 days (±5 days) of administration of the last dose of study drug.
|
4.2%
1/24 • Number of events 1 • From the 1st day of therapy to maximum of 23 weeks post last dose (up to maximum of week 30)
Subjects who prematurely discontinue study drug will undergo follow-up safety evaluations within 30 days (±5 days) of administration of the last dose of study drug.
|
4.0%
1/25 • Number of events 1 • From the 1st day of therapy to maximum of 23 weeks post last dose (up to maximum of week 30)
Subjects who prematurely discontinue study drug will undergo follow-up safety evaluations within 30 days (±5 days) of administration of the last dose of study drug.
|
|
Psychiatric disorders
Hallucination
|
0.00%
0/25 • From the 1st day of therapy to maximum of 23 weeks post last dose (up to maximum of week 30)
Subjects who prematurely discontinue study drug will undergo follow-up safety evaluations within 30 days (±5 days) of administration of the last dose of study drug.
|
0.00%
0/24 • From the 1st day of therapy to maximum of 23 weeks post last dose (up to maximum of week 30)
Subjects who prematurely discontinue study drug will undergo follow-up safety evaluations within 30 days (±5 days) of administration of the last dose of study drug.
|
8.0%
2/25 • Number of events 2 • From the 1st day of therapy to maximum of 23 weeks post last dose (up to maximum of week 30)
Subjects who prematurely discontinue study drug will undergo follow-up safety evaluations within 30 days (±5 days) of administration of the last dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
8.0%
2/25 • Number of events 2 • From the 1st day of therapy to maximum of 23 weeks post last dose (up to maximum of week 30)
Subjects who prematurely discontinue study drug will undergo follow-up safety evaluations within 30 days (±5 days) of administration of the last dose of study drug.
|
8.3%
2/24 • Number of events 2 • From the 1st day of therapy to maximum of 23 weeks post last dose (up to maximum of week 30)
Subjects who prematurely discontinue study drug will undergo follow-up safety evaluations within 30 days (±5 days) of administration of the last dose of study drug.
|
8.0%
2/25 • Number of events 2 • From the 1st day of therapy to maximum of 23 weeks post last dose (up to maximum of week 30)
Subjects who prematurely discontinue study drug will undergo follow-up safety evaluations within 30 days (±5 days) of administration of the last dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
4.0%
1/25 • Number of events 1 • From the 1st day of therapy to maximum of 23 weeks post last dose (up to maximum of week 30)
Subjects who prematurely discontinue study drug will undergo follow-up safety evaluations within 30 days (±5 days) of administration of the last dose of study drug.
|
0.00%
0/24 • From the 1st day of therapy to maximum of 23 weeks post last dose (up to maximum of week 30)
Subjects who prematurely discontinue study drug will undergo follow-up safety evaluations within 30 days (±5 days) of administration of the last dose of study drug.
|
12.0%
3/25 • Number of events 4 • From the 1st day of therapy to maximum of 23 weeks post last dose (up to maximum of week 30)
Subjects who prematurely discontinue study drug will undergo follow-up safety evaluations within 30 days (±5 days) of administration of the last dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
8.0%
2/25 • Number of events 2 • From the 1st day of therapy to maximum of 23 weeks post last dose (up to maximum of week 30)
Subjects who prematurely discontinue study drug will undergo follow-up safety evaluations within 30 days (±5 days) of administration of the last dose of study drug.
|
4.2%
1/24 • Number of events 1 • From the 1st day of therapy to maximum of 23 weeks post last dose (up to maximum of week 30)
Subjects who prematurely discontinue study drug will undergo follow-up safety evaluations within 30 days (±5 days) of administration of the last dose of study drug.
|
8.0%
2/25 • Number of events 3 • From the 1st day of therapy to maximum of 23 weeks post last dose (up to maximum of week 30)
Subjects who prematurely discontinue study drug will undergo follow-up safety evaluations within 30 days (±5 days) of administration of the last dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
4.0%
1/25 • Number of events 2 • From the 1st day of therapy to maximum of 23 weeks post last dose (up to maximum of week 30)
Subjects who prematurely discontinue study drug will undergo follow-up safety evaluations within 30 days (±5 days) of administration of the last dose of study drug.
|
12.5%
3/24 • Number of events 3 • From the 1st day of therapy to maximum of 23 weeks post last dose (up to maximum of week 30)
Subjects who prematurely discontinue study drug will undergo follow-up safety evaluations within 30 days (±5 days) of administration of the last dose of study drug.
|
8.0%
2/25 • Number of events 2 • From the 1st day of therapy to maximum of 23 weeks post last dose (up to maximum of week 30)
Subjects who prematurely discontinue study drug will undergo follow-up safety evaluations within 30 days (±5 days) of administration of the last dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/25 • From the 1st day of therapy to maximum of 23 weeks post last dose (up to maximum of week 30)
Subjects who prematurely discontinue study drug will undergo follow-up safety evaluations within 30 days (±5 days) of administration of the last dose of study drug.
|
12.5%
3/24 • Number of events 4 • From the 1st day of therapy to maximum of 23 weeks post last dose (up to maximum of week 30)
Subjects who prematurely discontinue study drug will undergo follow-up safety evaluations within 30 days (±5 days) of administration of the last dose of study drug.
|
8.0%
2/25 • Number of events 2 • From the 1st day of therapy to maximum of 23 weeks post last dose (up to maximum of week 30)
Subjects who prematurely discontinue study drug will undergo follow-up safety evaluations within 30 days (±5 days) of administration of the last dose of study drug.
|
|
Vascular disorders
Deep vein thrombosis
|
12.0%
3/25 • Number of events 3 • From the 1st day of therapy to maximum of 23 weeks post last dose (up to maximum of week 30)
Subjects who prematurely discontinue study drug will undergo follow-up safety evaluations within 30 days (±5 days) of administration of the last dose of study drug.
|
0.00%
0/24 • From the 1st day of therapy to maximum of 23 weeks post last dose (up to maximum of week 30)
Subjects who prematurely discontinue study drug will undergo follow-up safety evaluations within 30 days (±5 days) of administration of the last dose of study drug.
|
0.00%
0/25 • From the 1st day of therapy to maximum of 23 weeks post last dose (up to maximum of week 30)
Subjects who prematurely discontinue study drug will undergo follow-up safety evaluations within 30 days (±5 days) of administration of the last dose of study drug.
|
|
Vascular disorders
Hypertension
|
8.0%
2/25 • Number of events 2 • From the 1st day of therapy to maximum of 23 weeks post last dose (up to maximum of week 30)
Subjects who prematurely discontinue study drug will undergo follow-up safety evaluations within 30 days (±5 days) of administration of the last dose of study drug.
|
4.2%
1/24 • Number of events 2 • From the 1st day of therapy to maximum of 23 weeks post last dose (up to maximum of week 30)
Subjects who prematurely discontinue study drug will undergo follow-up safety evaluations within 30 days (±5 days) of administration of the last dose of study drug.
|
4.0%
1/25 • Number of events 1 • From the 1st day of therapy to maximum of 23 weeks post last dose (up to maximum of week 30)
Subjects who prematurely discontinue study drug will undergo follow-up safety evaluations within 30 days (±5 days) of administration of the last dose of study drug.
|
|
Vascular disorders
Hypertensive crisis
|
4.0%
1/25 • Number of events 1 • From the 1st day of therapy to maximum of 23 weeks post last dose (up to maximum of week 30)
Subjects who prematurely discontinue study drug will undergo follow-up safety evaluations within 30 days (±5 days) of administration of the last dose of study drug.
|
8.3%
2/24 • Number of events 2 • From the 1st day of therapy to maximum of 23 weeks post last dose (up to maximum of week 30)
Subjects who prematurely discontinue study drug will undergo follow-up safety evaluations within 30 days (±5 days) of administration of the last dose of study drug.
|
0.00%
0/25 • From the 1st day of therapy to maximum of 23 weeks post last dose (up to maximum of week 30)
Subjects who prematurely discontinue study drug will undergo follow-up safety evaluations within 30 days (±5 days) of administration of the last dose of study drug.
|
|
Vascular disorders
Hypotension
|
4.0%
1/25 • Number of events 1 • From the 1st day of therapy to maximum of 23 weeks post last dose (up to maximum of week 30)
Subjects who prematurely discontinue study drug will undergo follow-up safety evaluations within 30 days (±5 days) of administration of the last dose of study drug.
|
8.3%
2/24 • Number of events 2 • From the 1st day of therapy to maximum of 23 weeks post last dose (up to maximum of week 30)
Subjects who prematurely discontinue study drug will undergo follow-up safety evaluations within 30 days (±5 days) of administration of the last dose of study drug.
|
12.0%
3/25 • Number of events 3 • From the 1st day of therapy to maximum of 23 weeks post last dose (up to maximum of week 30)
Subjects who prematurely discontinue study drug will undergo follow-up safety evaluations within 30 days (±5 days) of administration of the last dose of study drug.
|
Additional Information
Ed Campanaro, VP Clinical Operations
Cubist Pharmaceuticals, Inc.
Phone: 781-860-8318
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The first publication is initiated by Cubist. If first publication not published within 1 year of study conclusion or termination, Investigator has right to publish and disclose the Data. Prior to any submission for publication, presentation, or communication of results or information arising from the Study, Investigator shall provide Cubist at least 90 days for review and comment upon the manuscript or other material for such publication or presentation.
- Publication restrictions are in place
Restriction type: OTHER