Table 3.

Major Findings and Indications from Randomized Controlled Trials and Other Studies Reviewed

Studies	Type of Study	Number of Patients Included	Indications	Comparative Drugs	Adverse Effects (AE)
Boucher et al12 DISCOVER 1 DISCOVER 2	Randomised, double-blind, international, and multicentre clinical trials phase 3	Dalbavancin (D): 659 Vancomycin-Linezolid (V-L): 653 (both trial)	Treatment of acute bacterial skin and skin-structure infection*	Dalbavancin: 1 g intravenously (IV) on day (d) 1, 500 mg IV on d 8 Vancomycin-Linezolid: vancomycin 1 g (or 15 mg per kilogram) IV every 12 hours for at least 3 days. Option to switch to oral linezolid 600 mg every 12 hours, to complete 10 to 14 days of therapy	Total events (P=0.05) Dalbavancin: 32.8% Vancomycine-Linezolid: 37.9% Most common AE: Nausea: D) 2.5% V-L) 2.9% P= 0.62 Diarrhea: D) 0.8% V-L) 2.5% P=0.02 Pruritus: D) 0.6% V-L) 2.3% P=0.,01
VER001-828	Randomised, double-blind trial phase 3	Dalbavancin: 347 Cefazolin (C): 186	Uncomplicated skin and skin structure infection	Dalbavancin: 1 g IV D 1 ± 500mg IV D 8 Cefazolin: 500mg IV every 8h/cephalexin 500mg PO QID x 7 or 14 days	Available only aggregate safety analyses of all seven phase 2 and 3 studies26**
VER001-1628	Randomised, double-blind trial phase 3	Dalbavancin: 107 Vancomycin: 49	Complicated skin and skin structure infection	Dalbavancin: 1 g IV D 1 ± 500mg IV D 8 Vancomycin 1000mg IV q12h/switch based upon in vitro data x 7 or 14 days	Available only aggregate safety analyses of all seven phase 2 and 3 studies26**
VER001-927	Randomised, double-blind trial phase 3	Dalbavancin: 571 Linezolid (L): 283	Complicated skin and skin structure infection	Dalbavancin: 1 g IV d 1 + 500 mg IV d 8 Linezolid: 600 mg intravenously or intravenously/orally every 12 h for 14 days	Total events D) 25.4% L) 32.2% Most common AEs: Nausea: D) 3.2% L) 5.3% Diarrhea: D) 2.5% L) 5.7% Elevated blood LDH: D) 1.9% L) 1.8% Headache: D) 1.9% L) 1.8% Elevated GGT: D) 1.9% L) 1.4% Vomiting: D) 1.9% L) 1.1% Rash: D) 1.8% L) 1.8%
VER001-4	Randomized, open-label phase 2	Dalbavancin: 40 D1: 7 D2: 33 Vancomycin: 34	Catheter-related bloodstream Infections	Dalbavancin: D1) 650mg, then 65mg daily for 7–14 days D2) 1000mg Day 1 ±500mg Day 8 Vancomycin: 1000mg IV q12h for 7–14 days	Available only aggregate safety analyses of all seven phase 2 and 3 studies26**
VER001-5	Randomized (1:1:1), open-label	Dalbavancin: 41 D1:21 D2: 20 Standard of care: 21	Skin and Skin Structure Infection (SSSI) (mixed: uncomplicated and complicated)	Dalbavancin: D1) 1100mg x 1 D2) 1000mg Day1 ±500mg Day 8 Standard of care	Available only aggregate safety analyses of all seven phase 2 and 3 studies26**
Bouza et al15	Retrospective study (real-life)	Dalbavancin: 69	PJI: 29% ABSSSI:21.7% osteomyelitis: 17.4% catheter related Bacteraemia: 11.6%	Dalbavancin: 1500 mg IV, or 1000 mg + 500 mg IV	Rash 2 (2.9%) Tachycardia 2 (2.9%) Impaired renal function 2 (2.9%) Nausea 1 (1.4%) Rectal bleeding 1 (1.4%) Candidiasis 1 (1.4%)
Arrieta-Loitegui et al33	Retrospective study	Dalbavancin: 102	Skin and soft tissue Infections: 30.4% Catheter-related Bacteraemia: 15.7% Endocarditis: 13.7% Bacteraemia with Suspected endocarditis: 10.8% PJI: 10.8% Osteomyelitis:10.8% Bacteraemia: 4.9% Septic arthritis:1.9% Febrile syndrome: 1%	Dalbavancin: 1500 mg IV from 1 to 6 times every 7/15 days Dalbavancin: 500 mg IV from 1 to 5 times every 7 days	Total AEs: 4 (3.99%) Rash: 1 Nausea and vomiting: 1 Infusion reaction: 1 Hypersensitivity: 1
Wunsch et al49	Multicentre, retrospective study	Dalbavancin: 101	PJI: 31% osteomyelitis: 29% endocarditis: 25% ABSSSI: 12%	Dalbavancin regimen: - 1500 mg IV once: 23.8% - 1500 mg day (d)1 + d8: 13.9% - 1500 mg d1 + d8 and in week 8: 3% - 1000 mg d1 followed by 500 mg weekly: 42.6% - 1000 mg every 14 d: 3% - other regimens: 13.9%	Total AEs: 3 dyspnea and arterial hypertension: 1 severe fatigue: 1 (after 11w treatment) vertigo: 1 (long term therapy)
Durante-Mangoni et al5	Retrospective study	Dalbavancin: 30	ABSSSI: 8 osteomyelitis: 4 PJI: 12 catheter-related bloodstream infections: 4 infectious endocarditis: 2	Dalbavancin 1 g IV d1 + 500 mg Day 8	Total AEs: 3 cases (all moderate) evanescent rash (infusion), dizziness: 1 malaise, pruritus and chills: 1 dyspnea and hypotension: 1

Notes: *Skin-structure infection required the presence of cellulitis, a major abscess, or a wound infection, each associated with at least 75 cm2 of erythema. **Phase 2 studies: VER001-4, VER001-5; Phase 3 studies: VER001-8, VER001-9, VER001-16, DISCOVER 1, DISCOVER 2.

Abbreviations: ABSSSI, acute bacterial skin and skin-structure infection; PJI, prosthetic joint infection; LDH, lactate dehydrogenase level; GGT, g-glutamyltransferase.