Trial Outcomes & Findings for Efficacy and Safety of Dalbavancin for the Treatment of Acute Bacterial Skin and Skin Structure Infections (NCT NCT01339091)

NCT ID: NCT01339091

Last Updated: 2014-01-31

Results Overview

Clinical response at 48-72 hours post study drug initiation, based on measurements of acute bacterial skin and skin structure infections (ABSSSI) lesion size and temperature

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 573 participants
• Primary outcome timeframe: 48-72 hours after the initiation of study therapy
• Results posted on: 2014-01-31

Participant Flow

Participant milestones

Measure	Dalbavancin Dalbavancin : IV Dalbavancin 1000 mg on Day 1 and 500 mg on Day 8	Vancomycin +/- Oral Linezolid Vancomycin : IV Vancomycin (dosed per standard of care) with optional switch to oral linezolid (600 mg Q12 hours). Total duration of therapy is 10-14 days.
Overall Study STARTED	288	285
Overall Study Safety Population	284	284
Overall Study COMPLETED	261	257
Overall Study NOT COMPLETED	27	28

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Efficacy and Safety of Dalbavancin for the Treatment of Acute Bacterial Skin and Skin Structure Infections

Baseline characteristics by cohort

Measure	Dalbavancin n=288 Participants Dalbavancin : IV Dalbavancin 1000 mg on Day 1 and 500 mg on Day 8	Vancomycin +/- Oral Linezolid n=285 Participants Vancomycin : IV Vancomycin (dosed per standard of care) with optional switch to oral linezolid (600 mg Q12 hours). Total duration of therapy is 10-14 days.	Total n=573 Participants Total of all reporting groups
Age, Continuous	48.8 years STANDARD_DEVIATION 15.3 • n=5 Participants	48.9 years STANDARD_DEVIATION 15.08 • n=7 Participants	48.9 years STANDARD_DEVIATION 15.18 • n=5 Participants
Sex: Female, Male Female	118 Participants n=5 Participants	112 Participants n=7 Participants	230 Participants n=5 Participants
Sex: Female, Male Male	170 Participants n=5 Participants	173 Participants n=7 Participants	343 Participants n=5 Participants

PRIMARY outcome

Timeframe: 48-72 hours after the initiation of study therapy

Population: The ITT population consisted of all randomly assigned patients regardless of whether or not they received study drug.

Clinical response at 48-72 hours post study drug initiation, based on measurements of acute bacterial skin and skin structure infections (ABSSSI) lesion size and temperature

Outcome measures

Measure	Dalbavancin n=288 Participants Dalbavancin : IV Dalbavancin 1000 mg on Day 1 and 500 mg on Day 8	Vancomycin +/- Oral Linezolid n=285 Participants Vancomycin : IV Vancomycin (dosed per standard of care) with optional switch to oral linezolid (600 mg Q12 hours). Total duration of therapy is 10-14 days.
Early Clinical Efficacy Clinical Responder	240 participants	233 participants
Early Clinical Efficacy Clinical Non-Responder	48 participants	52 participants

SECONDARY outcome

Timeframe: 48-72 hours after the initiation of study therapy

Population: The ITT population consisted of all randomly assigned patients regardless of whether or not they received study drug.

Clinical response at 48-72 hours post study drug initiation, based on measurements of acute bacterial skin and skin structure infections (ABSSSI) lesion size

Outcome measures

Measure	Dalbavancin n=288 Participants Dalbavancin : IV Dalbavancin 1000 mg on Day 1 and 500 mg on Day 8	Vancomycin +/- Oral Linezolid n=285 Participants Vancomycin : IV Vancomycin (dosed per standard of care) with optional switch to oral linezolid (600 mg Q12 hours). Total duration of therapy is 10-14 days.
>= 20% Reduction in Lesion Area Clinical Responder	259 participants	259 participants
>= 20% Reduction in Lesion Area Clinical Non-Responder	29 participants	26 participants

SECONDARY outcome

Timeframe: End of Treatment Visit (Day 14-15)

Population: Clinical Evaluable Population based on certain inclusion/exclusion criteria, length of study therapy, concomitant antibacterials, concomitant surgical procedure and non-missing data.

Compare the clinical efficacy at end of treatment visit of dalbavancin to the comparator regimen based on lesion size, local signs, temperature and receipt of non-study antibiotics

Outcome measures

Measure	Dalbavancin n=246 Participants Dalbavancin : IV Dalbavancin 1000 mg on Day 1 and 500 mg on Day 8	Vancomycin +/- Oral Linezolid n=243 Participants Vancomycin : IV Vancomycin (dosed per standard of care) with optional switch to oral linezolid (600 mg Q12 hours). Total duration of therapy is 10-14 days.
Clinical Status Clinical Success	214 participants	222 participants
Clinical Status Clinical Failure	32 participants	21 participants

SECONDARY outcome

Timeframe: Follow-Up Visit (day 28)

Population: Clinical Evaluable Population based on certain inclusion/exclusion criteria, length of study therapy, concomitant antibacterials, concomitant surgical procedure and non-missing data.

Compare the clinical efficacy at the day 28 follow-up visit of dalbavancin to the comparator regimen based on lesion size, local signs, temperature and receipt of non-study antibiotics

Outcome measures

Measure	Dalbavancin n=226 Participants Dalbavancin : IV Dalbavancin 1000 mg on Day 1 and 500 mg on Day 8	Vancomycin +/- Oral Linezolid n=229 Participants Vancomycin : IV Vancomycin (dosed per standard of care) with optional switch to oral linezolid (600 mg Q12 hours). Total duration of therapy is 10-14 days.
Clinical Status Clinical Success	212 participants	220 participants
Clinical Status Clinical Failure	14 participants	9 participants

Adverse Events

Dalbavancin

Serious events: 5 serious events

Other events: 36 other events

Deaths: 0 deaths

Vancomycin +/- Oral Linezolid

Serious events: 12 serious events

Other events: 54 other events

Deaths: 0 deaths

Serious adverse events

Measure	Dalbavancin n=284 participants at risk Dalbavancin : IV Dalbavancin 1000 mg on Day 1 and 500 mg on Day 8	Vancomycin +/- Oral Linezolid n=284 participants at risk Vancomycin : IV Vancomycin (dosed per standard of care) with optional switch to oral linezolid (600 mg Q12 hours). Total duration of therapy is 10-14 days.
Infections and infestations Arthritis bacterial	0.35% 1/284 • Begins from the time that the patient provides informed consent through the last follow up visit, Day 70. Any SAE occurring any time after the reporting period must be promptly reported if a causal relationship to investigational product is suspected. Adverse events were analyzed in the safety population which is defined as all patients in the ITT population who received at least 1 dose of dalbavancin or vancomycin (active) study drug.	0.00% 0/284 • Begins from the time that the patient provides informed consent through the last follow up visit, Day 70. Any SAE occurring any time after the reporting period must be promptly reported if a causal relationship to investigational product is suspected. Adverse events were analyzed in the safety population which is defined as all patients in the ITT population who received at least 1 dose of dalbavancin or vancomycin (active) study drug.
Infections and infestations Bacteraemia	0.35% 1/284 • Begins from the time that the patient provides informed consent through the last follow up visit, Day 70. Any SAE occurring any time after the reporting period must be promptly reported if a causal relationship to investigational product is suspected. Adverse events were analyzed in the safety population which is defined as all patients in the ITT population who received at least 1 dose of dalbavancin or vancomycin (active) study drug.	0.00% 0/284 • Begins from the time that the patient provides informed consent through the last follow up visit, Day 70. Any SAE occurring any time after the reporting period must be promptly reported if a causal relationship to investigational product is suspected. Adverse events were analyzed in the safety population which is defined as all patients in the ITT population who received at least 1 dose of dalbavancin or vancomycin (active) study drug.
Infections and infestations Embolic pneumonia	0.35% 1/284 • Begins from the time that the patient provides informed consent through the last follow up visit, Day 70. Any SAE occurring any time after the reporting period must be promptly reported if a causal relationship to investigational product is suspected. Adverse events were analyzed in the safety population which is defined as all patients in the ITT population who received at least 1 dose of dalbavancin or vancomycin (active) study drug.	0.00% 0/284 • Begins from the time that the patient provides informed consent through the last follow up visit, Day 70. Any SAE occurring any time after the reporting period must be promptly reported if a causal relationship to investigational product is suspected. Adverse events were analyzed in the safety population which is defined as all patients in the ITT population who received at least 1 dose of dalbavancin or vancomycin (active) study drug.
Infections and infestations Abscess limb	0.00% 0/284 • Begins from the time that the patient provides informed consent through the last follow up visit, Day 70. Any SAE occurring any time after the reporting period must be promptly reported if a causal relationship to investigational product is suspected. Adverse events were analyzed in the safety population which is defined as all patients in the ITT population who received at least 1 dose of dalbavancin or vancomycin (active) study drug.	0.35% 1/284 • Begins from the time that the patient provides informed consent through the last follow up visit, Day 70. Any SAE occurring any time after the reporting period must be promptly reported if a causal relationship to investigational product is suspected. Adverse events were analyzed in the safety population which is defined as all patients in the ITT population who received at least 1 dose of dalbavancin or vancomycin (active) study drug.
Infections and infestations Cellulitis	0.00% 0/284 • Begins from the time that the patient provides informed consent through the last follow up visit, Day 70. Any SAE occurring any time after the reporting period must be promptly reported if a causal relationship to investigational product is suspected. Adverse events were analyzed in the safety population which is defined as all patients in the ITT population who received at least 1 dose of dalbavancin or vancomycin (active) study drug.	0.35% 1/284 • Begins from the time that the patient provides informed consent through the last follow up visit, Day 70. Any SAE occurring any time after the reporting period must be promptly reported if a causal relationship to investigational product is suspected. Adverse events were analyzed in the safety population which is defined as all patients in the ITT population who received at least 1 dose of dalbavancin or vancomycin (active) study drug.
Infections and infestations Diabetic foot infection	0.00% 0/284 • Begins from the time that the patient provides informed consent through the last follow up visit, Day 70. Any SAE occurring any time after the reporting period must be promptly reported if a causal relationship to investigational product is suspected. Adverse events were analyzed in the safety population which is defined as all patients in the ITT population who received at least 1 dose of dalbavancin or vancomycin (active) study drug.	0.35% 1/284 • Begins from the time that the patient provides informed consent through the last follow up visit, Day 70. Any SAE occurring any time after the reporting period must be promptly reported if a causal relationship to investigational product is suspected. Adverse events were analyzed in the safety population which is defined as all patients in the ITT population who received at least 1 dose of dalbavancin or vancomycin (active) study drug.
Infections and infestations Rectal abscess	0.00% 0/284 • Begins from the time that the patient provides informed consent through the last follow up visit, Day 70. Any SAE occurring any time after the reporting period must be promptly reported if a causal relationship to investigational product is suspected. Adverse events were analyzed in the safety population which is defined as all patients in the ITT population who received at least 1 dose of dalbavancin or vancomycin (active) study drug.	0.35% 1/284 • Begins from the time that the patient provides informed consent through the last follow up visit, Day 70. Any SAE occurring any time after the reporting period must be promptly reported if a causal relationship to investigational product is suspected. Adverse events were analyzed in the safety population which is defined as all patients in the ITT population who received at least 1 dose of dalbavancin or vancomycin (active) study drug.
Cardiac disorders Atrial fibrillation	0.35% 1/284 • Begins from the time that the patient provides informed consent through the last follow up visit, Day 70. Any SAE occurring any time after the reporting period must be promptly reported if a causal relationship to investigational product is suspected. Adverse events were analyzed in the safety population which is defined as all patients in the ITT population who received at least 1 dose of dalbavancin or vancomycin (active) study drug.	0.00% 0/284 • Begins from the time that the patient provides informed consent through the last follow up visit, Day 70. Any SAE occurring any time after the reporting period must be promptly reported if a causal relationship to investigational product is suspected. Adverse events were analyzed in the safety population which is defined as all patients in the ITT population who received at least 1 dose of dalbavancin or vancomycin (active) study drug.
Cardiac disorders Cardiac failure	0.00% 0/284 • Begins from the time that the patient provides informed consent through the last follow up visit, Day 70. Any SAE occurring any time after the reporting period must be promptly reported if a causal relationship to investigational product is suspected. Adverse events were analyzed in the safety population which is defined as all patients in the ITT population who received at least 1 dose of dalbavancin or vancomycin (active) study drug.	0.35% 1/284 • Begins from the time that the patient provides informed consent through the last follow up visit, Day 70. Any SAE occurring any time after the reporting period must be promptly reported if a causal relationship to investigational product is suspected. Adverse events were analyzed in the safety population which is defined as all patients in the ITT population who received at least 1 dose of dalbavancin or vancomycin (active) study drug.
Cardiac disorders Cardiac failure acute	0.00% 0/284 • Begins from the time that the patient provides informed consent through the last follow up visit, Day 70. Any SAE occurring any time after the reporting period must be promptly reported if a causal relationship to investigational product is suspected. Adverse events were analyzed in the safety population which is defined as all patients in the ITT population who received at least 1 dose of dalbavancin or vancomycin (active) study drug.	0.35% 1/284 • Begins from the time that the patient provides informed consent through the last follow up visit, Day 70. Any SAE occurring any time after the reporting period must be promptly reported if a causal relationship to investigational product is suspected. Adverse events were analyzed in the safety population which is defined as all patients in the ITT population who received at least 1 dose of dalbavancin or vancomycin (active) study drug.
Cardiac disorders Cardiac failure congestive	0.00% 0/284 • Begins from the time that the patient provides informed consent through the last follow up visit, Day 70. Any SAE occurring any time after the reporting period must be promptly reported if a causal relationship to investigational product is suspected. Adverse events were analyzed in the safety population which is defined as all patients in the ITT population who received at least 1 dose of dalbavancin or vancomycin (active) study drug.	0.35% 1/284 • Begins from the time that the patient provides informed consent through the last follow up visit, Day 70. Any SAE occurring any time after the reporting period must be promptly reported if a causal relationship to investigational product is suspected. Adverse events were analyzed in the safety population which is defined as all patients in the ITT population who received at least 1 dose of dalbavancin or vancomycin (active) study drug.
Cardiac disorders Cardiopulmonary failure	0.00% 0/284 • Begins from the time that the patient provides informed consent through the last follow up visit, Day 70. Any SAE occurring any time after the reporting period must be promptly reported if a causal relationship to investigational product is suspected. Adverse events were analyzed in the safety population which is defined as all patients in the ITT population who received at least 1 dose of dalbavancin or vancomycin (active) study drug.	0.35% 1/284 • Begins from the time that the patient provides informed consent through the last follow up visit, Day 70. Any SAE occurring any time after the reporting period must be promptly reported if a causal relationship to investigational product is suspected. Adverse events were analyzed in the safety population which is defined as all patients in the ITT population who received at least 1 dose of dalbavancin or vancomycin (active) study drug.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.35% 1/284 • Begins from the time that the patient provides informed consent through the last follow up visit, Day 70. Any SAE occurring any time after the reporting period must be promptly reported if a causal relationship to investigational product is suspected. Adverse events were analyzed in the safety population which is defined as all patients in the ITT population who received at least 1 dose of dalbavancin or vancomycin (active) study drug.	0.35% 1/284 • Begins from the time that the patient provides informed consent through the last follow up visit, Day 70. Any SAE occurring any time after the reporting period must be promptly reported if a causal relationship to investigational product is suspected. Adverse events were analyzed in the safety population which is defined as all patients in the ITT population who received at least 1 dose of dalbavancin or vancomycin (active) study drug.
Gastrointestinal disorders Enterocutaneous fistula	0.00% 0/284 • Begins from the time that the patient provides informed consent through the last follow up visit, Day 70. Any SAE occurring any time after the reporting period must be promptly reported if a causal relationship to investigational product is suspected. Adverse events were analyzed in the safety population which is defined as all patients in the ITT population who received at least 1 dose of dalbavancin or vancomycin (active) study drug.	0.35% 1/284 • Begins from the time that the patient provides informed consent through the last follow up visit, Day 70. Any SAE occurring any time after the reporting period must be promptly reported if a causal relationship to investigational product is suspected. Adverse events were analyzed in the safety population which is defined as all patients in the ITT population who received at least 1 dose of dalbavancin or vancomycin (active) study drug.
Gastrointestinal disorders Small intestinal obstruction	0.00% 0/284 • Begins from the time that the patient provides informed consent through the last follow up visit, Day 70. Any SAE occurring any time after the reporting period must be promptly reported if a causal relationship to investigational product is suspected. Adverse events were analyzed in the safety population which is defined as all patients in the ITT population who received at least 1 dose of dalbavancin or vancomycin (active) study drug.	0.35% 1/284 • Begins from the time that the patient provides informed consent through the last follow up visit, Day 70. Any SAE occurring any time after the reporting period must be promptly reported if a causal relationship to investigational product is suspected. Adverse events were analyzed in the safety population which is defined as all patients in the ITT population who received at least 1 dose of dalbavancin or vancomycin (active) study drug.
Injury, poisoning and procedural complications Procedural complication	0.35% 1/284 • Begins from the time that the patient provides informed consent through the last follow up visit, Day 70. Any SAE occurring any time after the reporting period must be promptly reported if a causal relationship to investigational product is suspected. Adverse events were analyzed in the safety population which is defined as all patients in the ITT population who received at least 1 dose of dalbavancin or vancomycin (active) study drug.	0.00% 0/284 • Begins from the time that the patient provides informed consent through the last follow up visit, Day 70. Any SAE occurring any time after the reporting period must be promptly reported if a causal relationship to investigational product is suspected. Adverse events were analyzed in the safety population which is defined as all patients in the ITT population who received at least 1 dose of dalbavancin or vancomycin (active) study drug.
Metabolism and nutrition disorders Hypovolaemia	0.00% 0/284 • Begins from the time that the patient provides informed consent through the last follow up visit, Day 70. Any SAE occurring any time after the reporting period must be promptly reported if a causal relationship to investigational product is suspected. Adverse events were analyzed in the safety population which is defined as all patients in the ITT population who received at least 1 dose of dalbavancin or vancomycin (active) study drug.	0.35% 1/284 • Begins from the time that the patient provides informed consent through the last follow up visit, Day 70. Any SAE occurring any time after the reporting period must be promptly reported if a causal relationship to investigational product is suspected. Adverse events were analyzed in the safety population which is defined as all patients in the ITT population who received at least 1 dose of dalbavancin or vancomycin (active) study drug.
Musculoskeletal and connective tissue disorders Systemic lupus erythematosus	0.00% 0/284 • Begins from the time that the patient provides informed consent through the last follow up visit, Day 70. Any SAE occurring any time after the reporting period must be promptly reported if a causal relationship to investigational product is suspected. Adverse events were analyzed in the safety population which is defined as all patients in the ITT population who received at least 1 dose of dalbavancin or vancomycin (active) study drug.	0.35% 1/284 • Begins from the time that the patient provides informed consent through the last follow up visit, Day 70. Any SAE occurring any time after the reporting period must be promptly reported if a causal relationship to investigational product is suspected. Adverse events were analyzed in the safety population which is defined as all patients in the ITT population who received at least 1 dose of dalbavancin or vancomycin (active) study drug.
Renal and urinary disorders Nephropathy toxic	0.00% 0/284 • Begins from the time that the patient provides informed consent through the last follow up visit, Day 70. Any SAE occurring any time after the reporting period must be promptly reported if a causal relationship to investigational product is suspected. Adverse events were analyzed in the safety population which is defined as all patients in the ITT population who received at least 1 dose of dalbavancin or vancomycin (active) study drug.	0.35% 1/284 • Begins from the time that the patient provides informed consent through the last follow up visit, Day 70. Any SAE occurring any time after the reporting period must be promptly reported if a causal relationship to investigational product is suspected. Adverse events were analyzed in the safety population which is defined as all patients in the ITT population who received at least 1 dose of dalbavancin or vancomycin (active) study drug.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/284 • Begins from the time that the patient provides informed consent through the last follow up visit, Day 70. Any SAE occurring any time after the reporting period must be promptly reported if a causal relationship to investigational product is suspected. Adverse events were analyzed in the safety population which is defined as all patients in the ITT population who received at least 1 dose of dalbavancin or vancomycin (active) study drug.	0.35% 1/284 • Begins from the time that the patient provides informed consent through the last follow up visit, Day 70. Any SAE occurring any time after the reporting period must be promptly reported if a causal relationship to investigational product is suspected. Adverse events were analyzed in the safety population which is defined as all patients in the ITT population who received at least 1 dose of dalbavancin or vancomycin (active) study drug.

Other adverse events

Measure	Dalbavancin n=284 participants at risk Dalbavancin : IV Dalbavancin 1000 mg on Day 1 and 500 mg on Day 8	Vancomycin +/- Oral Linezolid n=284 participants at risk Vancomycin : IV Vancomycin (dosed per standard of care) with optional switch to oral linezolid (600 mg Q12 hours). Total duration of therapy is 10-14 days.
Nervous system disorders Headache	4.9% 14/284 • Begins from the time that the patient provides informed consent through the last follow up visit, Day 70. Any SAE occurring any time after the reporting period must be promptly reported if a causal relationship to investigational product is suspected. Adverse events were analyzed in the safety population which is defined as all patients in the ITT population who received at least 1 dose of dalbavancin or vancomycin (active) study drug.	4.9% 14/284 • Begins from the time that the patient provides informed consent through the last follow up visit, Day 70. Any SAE occurring any time after the reporting period must be promptly reported if a causal relationship to investigational product is suspected. Adverse events were analyzed in the safety population which is defined as all patients in the ITT population who received at least 1 dose of dalbavancin or vancomycin (active) study drug.
Gastrointestinal disorders Nausea	4.2% 12/284 • Begins from the time that the patient provides informed consent through the last follow up visit, Day 70. Any SAE occurring any time after the reporting period must be promptly reported if a causal relationship to investigational product is suspected. Adverse events were analyzed in the safety population which is defined as all patients in the ITT population who received at least 1 dose of dalbavancin or vancomycin (active) study drug.	4.6% 13/284 • Begins from the time that the patient provides informed consent through the last follow up visit, Day 70. Any SAE occurring any time after the reporting period must be promptly reported if a causal relationship to investigational product is suspected. Adverse events were analyzed in the safety population which is defined as all patients in the ITT population who received at least 1 dose of dalbavancin or vancomycin (active) study drug.
Vascular disorders Hypertension	2.5% 7/284 • Begins from the time that the patient provides informed consent through the last follow up visit, Day 70. Any SAE occurring any time after the reporting period must be promptly reported if a causal relationship to investigational product is suspected. Adverse events were analyzed in the safety population which is defined as all patients in the ITT population who received at least 1 dose of dalbavancin or vancomycin (active) study drug.	2.5% 7/284 • Begins from the time that the patient provides informed consent through the last follow up visit, Day 70. Any SAE occurring any time after the reporting period must be promptly reported if a causal relationship to investigational product is suspected. Adverse events were analyzed in the safety population which is defined as all patients in the ITT population who received at least 1 dose of dalbavancin or vancomycin (active) study drug.
Skin and subcutaneous tissue disorders Rash	2.1% 6/284 • Begins from the time that the patient provides informed consent through the last follow up visit, Day 70. Any SAE occurring any time after the reporting period must be promptly reported if a causal relationship to investigational product is suspected. Adverse events were analyzed in the safety population which is defined as all patients in the ITT population who received at least 1 dose of dalbavancin or vancomycin (active) study drug.	2.1% 6/284 • Begins from the time that the patient provides informed consent through the last follow up visit, Day 70. Any SAE occurring any time after the reporting period must be promptly reported if a causal relationship to investigational product is suspected. Adverse events were analyzed in the safety population which is defined as all patients in the ITT population who received at least 1 dose of dalbavancin or vancomycin (active) study drug.
Gastrointestinal disorders Diarrhoea	1.4% 4/284 • Begins from the time that the patient provides informed consent through the last follow up visit, Day 70. Any SAE occurring any time after the reporting period must be promptly reported if a causal relationship to investigational product is suspected. Adverse events were analyzed in the safety population which is defined as all patients in the ITT population who received at least 1 dose of dalbavancin or vancomycin (active) study drug.	3.9% 11/284 • Begins from the time that the patient provides informed consent through the last follow up visit, Day 70. Any SAE occurring any time after the reporting period must be promptly reported if a causal relationship to investigational product is suspected. Adverse events were analyzed in the safety population which is defined as all patients in the ITT population who received at least 1 dose of dalbavancin or vancomycin (active) study drug.
Gastrointestinal disorders Vomiting	1.1% 3/284 • Begins from the time that the patient provides informed consent through the last follow up visit, Day 70. Any SAE occurring any time after the reporting period must be promptly reported if a causal relationship to investigational product is suspected. Adverse events were analyzed in the safety population which is defined as all patients in the ITT population who received at least 1 dose of dalbavancin or vancomycin (active) study drug.	2.1% 6/284 • Begins from the time that the patient provides informed consent through the last follow up visit, Day 70. Any SAE occurring any time after the reporting period must be promptly reported if a causal relationship to investigational product is suspected. Adverse events were analyzed in the safety population which is defined as all patients in the ITT population who received at least 1 dose of dalbavancin or vancomycin (active) study drug.
General disorders Asthenia	0.35% 1/284 • Begins from the time that the patient provides informed consent through the last follow up visit, Day 70. Any SAE occurring any time after the reporting period must be promptly reported if a causal relationship to investigational product is suspected. Adverse events were analyzed in the safety population which is defined as all patients in the ITT population who received at least 1 dose of dalbavancin or vancomycin (active) study drug.	2.1% 6/284 • Begins from the time that the patient provides informed consent through the last follow up visit, Day 70. Any SAE occurring any time after the reporting period must be promptly reported if a causal relationship to investigational product is suspected. Adverse events were analyzed in the safety population which is defined as all patients in the ITT population who received at least 1 dose of dalbavancin or vancomycin (active) study drug.
Skin and subcutaneous tissue disorders Dermatitis contact	0.35% 1/284 • Begins from the time that the patient provides informed consent through the last follow up visit, Day 70. Any SAE occurring any time after the reporting period must be promptly reported if a causal relationship to investigational product is suspected. Adverse events were analyzed in the safety population which is defined as all patients in the ITT population who received at least 1 dose of dalbavancin or vancomycin (active) study drug.	2.1% 6/284 • Begins from the time that the patient provides informed consent through the last follow up visit, Day 70. Any SAE occurring any time after the reporting period must be promptly reported if a causal relationship to investigational product is suspected. Adverse events were analyzed in the safety population which is defined as all patients in the ITT population who received at least 1 dose of dalbavancin or vancomycin (active) study drug.
Skin and subcutaneous tissue disorders Pruritus	0.35% 1/284 • Begins from the time that the patient provides informed consent through the last follow up visit, Day 70. Any SAE occurring any time after the reporting period must be promptly reported if a causal relationship to investigational product is suspected. Adverse events were analyzed in the safety population which is defined as all patients in the ITT population who received at least 1 dose of dalbavancin or vancomycin (active) study drug.	3.9% 11/284 • Begins from the time that the patient provides informed consent through the last follow up visit, Day 70. Any SAE occurring any time after the reporting period must be promptly reported if a causal relationship to investigational product is suspected. Adverse events were analyzed in the safety population which is defined as all patients in the ITT population who received at least 1 dose of dalbavancin or vancomycin (active) study drug.

Additional Information

Michael Zelasky

Durata Therapeutics

Phone: 203-871-4616

Email: mzelasky@duratatherapeutics.com

Results disclosure agreements

• Principal investigator is a sponsor employee The PI will provide Durata an opportunity to review any proposed publication or other type of disclosure at least 30 days before they are submitted. If any patent action is required to protect intellectual property rights, the Investigator agrees to delay the disclosure for a period not to exceed an additional 60 days. If the study is part of a multi-center study, the Investigator agrees that the first publication is to be a joint publication covering all centers.
• Publication restrictions are in place

Restriction type: OTHER