Trial Outcomes & Findings for Comparison of Telavancin and Vancomycin for Complicated Skin and Skin Structure Infections With a Focus on Methicillin-resistant Staphylococcus Aureus (NCT NCT00091819)
NCT ID: NCT00091819
Last Updated: 2019-01-16
Results Overview
The Clinical Response for each patient was determined by the investigator by assessing a patient's clinical signs and symptoms at the specified evaluation compared with the Baseline evaluation. Cure: resolution of signs and symptoms associated with the skin infection present at study admission such that no further antibiotic therapy was necessary; Not Cured: inadequate response to study therapy; Indeterminate: unable to determine outcome.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
862 participants
Primary outcome timeframe
7-14 days following end of antibiotic treatment
Results posted on
2019-01-16
Participant Flow
Enrollment Period: 19 January 2005 to 12 June 2006
Participant milestones
| Measure |
Telavancin
Patients with complicated Gram-positive skin and skin structure infections (primarily due to MRSA) were randomized to receive telavancin 10 mg/kg IV once daily. The maximum allowable treatment period was 14 days.
|
Vancomycin
Patients with complicated Gram-positive skin and skin structure infections (primarily due to MRSA) were randomized to receive vancomycin 1 Gram every 12 hours. The maximum allowable treatment period was 14 days.
|
|---|---|---|
|
Overall Study
STARTED
|
429
|
433
|
|
Overall Study
COMPLETED
|
387
|
387
|
|
Overall Study
NOT COMPLETED
|
42
|
46
|
Reasons for withdrawal
| Measure |
Telavancin
Patients with complicated Gram-positive skin and skin structure infections (primarily due to MRSA) were randomized to receive telavancin 10 mg/kg IV once daily. The maximum allowable treatment period was 14 days.
|
Vancomycin
Patients with complicated Gram-positive skin and skin structure infections (primarily due to MRSA) were randomized to receive vancomycin 1 Gram every 12 hours. The maximum allowable treatment period was 14 days.
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
1
|
|
Overall Study
Death
|
4
|
5
|
|
Overall Study
Lost to Follow-up
|
26
|
23
|
|
Overall Study
Withdrawal by Subject
|
5
|
8
|
|
Overall Study
Protocol Violation
|
1
|
2
|
|
Overall Study
Other
|
2
|
3
|
|
Overall Study
Never received study treatment
|
3
|
4
|
Baseline Characteristics
Comparison of Telavancin and Vancomycin for Complicated Skin and Skin Structure Infections With a Focus on Methicillin-resistant Staphylococcus Aureus
Baseline characteristics by cohort
| Measure |
Telavancin
n=426 Participants
Patients with complicated Gram-positive skin and skin structure infections (primarily due to MRSA) were randomized to receive telavancin 10 mg/kg IV once daily. The maximum allowable treatment period was 14 days.
|
Vancomycin
n=429 Participants
Patients with complicated Gram-positive skin and skin structure infections (primarily due to MRSA) were randomized to receive vancomycin 1 Gram every 12 hours. The maximum allowable treatment period was 14 days.
|
Total
n=855 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
337 Participants
n=99 Participants
|
357 Participants
n=107 Participants
|
694 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
89 Participants
n=99 Participants
|
72 Participants
n=107 Participants
|
161 Participants
n=206 Participants
|
|
Age, Continuous
|
49 years
STANDARD_DEVIATION 17.3 • n=99 Participants
|
48 years
STANDARD_DEVIATION 16.1 • n=107 Participants
|
48 years
STANDARD_DEVIATION 16.7 • n=206 Participants
|
|
Sex: Female, Male
Female
|
196 Participants
n=99 Participants
|
181 Participants
n=107 Participants
|
377 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
230 Participants
n=99 Participants
|
248 Participants
n=107 Participants
|
478 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
114 Participants
n=99 Participants
|
97 Participants
n=107 Participants
|
211 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
312 Participants
n=99 Participants
|
332 Participants
n=107 Participants
|
644 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
3 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
7 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
3 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
59 Participants
n=99 Participants
|
52 Participants
n=107 Participants
|
111 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
349 Participants
n=99 Participants
|
353 Participants
n=107 Participants
|
702 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
4 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
306 participants
n=99 Participants
|
316 participants
n=107 Participants
|
622 participants
n=206 Participants
|
|
Region of Enrollment
South Africa
|
11 participants
n=99 Participants
|
12 participants
n=107 Participants
|
23 participants
n=206 Participants
|
|
Region of Enrollment
Australia
|
18 participants
n=99 Participants
|
15 participants
n=107 Participants
|
33 participants
n=206 Participants
|
|
Region of Enrollment
Belgium
|
2 participants
n=99 Participants
|
0 participants
n=107 Participants
|
2 participants
n=206 Participants
|
|
Region of Enrollment
Croatia
|
49 participants
n=99 Participants
|
51 participants
n=107 Participants
|
100 participants
n=206 Participants
|
|
Region of Enrollment
Israel
|
15 participants
n=99 Participants
|
12 participants
n=107 Participants
|
27 participants
n=206 Participants
|
|
Region of Enrollment
Malaysia
|
5 participants
n=99 Participants
|
4 participants
n=107 Participants
|
9 participants
n=206 Participants
|
|
Region of Enrollment
Russian Federation
|
20 participants
n=99 Participants
|
19 participants
n=107 Participants
|
39 participants
n=206 Participants
|
|
Diabetes Status
Diabetic
|
94 Participants
n=99 Participants
|
98 Participants
n=107 Participants
|
192 Participants
n=206 Participants
|
|
Diabetes Status
Not diabetic
|
332 Participants
n=99 Participants
|
331 Participants
n=107 Participants
|
663 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 7-14 days following end of antibiotic treatmentPopulation: Data for the all-treated (AT) population are presented. the AT and clinically evaluable (CE) populations were considered co-primary.
The Clinical Response for each patient was determined by the investigator by assessing a patient's clinical signs and symptoms at the specified evaluation compared with the Baseline evaluation. Cure: resolution of signs and symptoms associated with the skin infection present at study admission such that no further antibiotic therapy was necessary; Not Cured: inadequate response to study therapy; Indeterminate: unable to determine outcome.
Outcome measures
| Measure |
Telavancin
n=426 Participants
Patients with complicated Gram-positive skin and skin structure infections (primarily due to MRSA) were randomized to receive telavancin 10 mg/kg IV once daily. The maximum allowable treatment period was 14 days.
|
Vancomycin
n=429 Participants
Patients with complicated Gram-positive skin and skin structure infections (primarily due to MRSA) were randomized to receive vancomycin 1 Gram every 12 hours. The maximum allowable treatment period was 14 days.
|
|---|---|---|
|
Clinical Response
Cure
|
323 participants
|
321 participants
|
|
Clinical Response
Not cured
|
52 participants
|
58 participants
|
|
Clinical Response
Indeterminate
|
23 participants
|
16 participants
|
|
Clinical Response
Missing
|
28 participants
|
34 participants
|
Adverse Events
Telavancin
Serious events: 31 serious events
Other events: 358 other events
Deaths: 0 deaths
Vancomycin
Serious events: 27 serious events
Other events: 335 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Telavancin
n=426 participants at risk
Patients with complicated Gram-positive skin and skin structure infections (primarily due to MRSA) were randomized to receive telavancin 10 mg/kg IV once daily. The maximum allowable treatment period was 14 days.
|
Vancomycin
n=429 participants at risk
Patients with complicated Gram-positive skin and skin structure infections (primarily due to MRSA) were randomized to receive vancomycin 1 Gram every 12 hours. The maximum allowable treatment period was 14 days.
|
|---|---|---|
|
Renal and urinary disorders
Renal Failure Acute
|
0.23%
1/426
|
0.00%
0/429
|
|
Cardiac disorders
Myocardial Infarction
|
0.47%
2/426
|
0.00%
0/429
|
|
Investigations
Blood creatinine increased
|
0.00%
0/426
|
0.47%
2/429
|
|
Immune system disorders
Drug Hypersensitivity
|
0.23%
1/426
|
0.23%
1/429
|
|
Vascular disorders
Hypotension
|
0.23%
1/426
|
0.23%
1/429
|
|
Psychiatric disorders
Mental Status Changes
|
0.23%
1/426
|
0.00%
0/429
|
|
Renal and urinary disorders
Renal Insufficiency
|
0.23%
1/426
|
0.00%
0/429
|
|
Vascular disorders
Deep Vein Thrombosis
|
0.47%
2/426
|
0.00%
0/429
|
|
Infections and infestations
Osteomyelitis
|
0.23%
1/426
|
0.00%
0/429
|
|
Vascular disorders
Peripheral Occlusive Disease
|
0.23%
1/426
|
0.00%
0/429
|
|
Infections and infestations
Pneumonia
|
0.00%
0/426
|
0.23%
1/429
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
0.47%
2/426
|
0.47%
2/429
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.23%
1/426
|
0.00%
0/429
|
|
Renal and urinary disorders
Renal Impairment
|
0.47%
2/426
|
0.00%
0/429
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Distress
|
0.47%
2/426
|
0.47%
2/429
|
|
Cardiac disorders
Angina Pectoris
|
0.23%
1/426
|
0.00%
0/429
|
|
Injury, poisoning and procedural complications
Ankle Fracture
|
0.23%
1/426
|
0.00%
0/429
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/426
|
0.47%
2/429
|
|
Cardiac disorders
Bradycardia
|
0.23%
1/426
|
0.23%
1/429
|
|
Renal and urinary disorders
Calculus Bladder
|
0.23%
1/426
|
0.00%
0/429
|
|
Cardiac disorders
Cardio-Respiratory Arrest
|
0.00%
0/426
|
0.23%
1/429
|
|
Nervous system disorders
Cerebrovascular Accident
|
0.23%
1/426
|
0.00%
0/429
|
|
General disorders
Chest Discomfort
|
0.23%
1/426
|
0.00%
0/429
|
|
Respiratory, thoracic and mediastinal disorders
Chronic Obstructive Airways Disease Exacerbated
|
0.23%
1/426
|
0.00%
0/429
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/426
|
0.23%
1/429
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/426
|
0.23%
1/429
|
|
General disorders
Injection Site Cellulitis
|
0.23%
1/426
|
0.00%
0/429
|
|
Investigations
International Normalised Ratio Increased
|
0.23%
1/426
|
0.00%
0/429
|
|
Cardiac disorders
Myocardial Ischaemia
|
0.23%
1/426
|
0.00%
0/429
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian Cancer
|
0.23%
1/426
|
0.00%
0/429
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Congestion
|
0.23%
1/426
|
0.00%
0/429
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
0.23%
1/426
|
0.70%
3/429
|
|
Psychiatric disorders
Schizophrenia, Paranoid Type
|
0.23%
1/426
|
0.00%
0/429
|
|
General disorders
Systemic Inflammatory Response Syndrome
|
0.23%
1/426
|
0.00%
0/429
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/426
|
0.23%
1/429
|
|
Renal and urinary disorders
Urinary Tract Infection
|
0.00%
0/426
|
0.23%
1/429
|
|
Vascular disorders
Varicose Vein Ruptured
|
0.23%
1/426
|
0.00%
0/429
|
|
Cardiac disorders
Ventricular Arrhythmia
|
0.23%
1/426
|
0.00%
0/429
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/426
|
0.47%
2/429
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/426
|
0.23%
1/429
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis
|
0.00%
0/426
|
0.23%
1/429
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/426
|
0.23%
1/429
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/426
|
0.23%
1/429
|
|
Infections and infestations
Cellulitis
|
0.00%
0/426
|
0.23%
1/429
|
|
Nervous system disorders
Coma Hepatic
|
0.00%
0/426
|
0.23%
1/429
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/426
|
0.23%
1/429
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/426
|
0.23%
1/429
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/426
|
0.23%
1/429
|
|
General disorders
Non-Cardiac Chest Pain
|
0.00%
0/426
|
0.23%
1/429
|
|
Reproductive system and breast disorders
Ovarian Cyst
|
0.00%
0/426
|
0.23%
1/429
|
|
Infections and infestations
Pelvic Infection
|
0.00%
0/426
|
0.23%
1/429
|
|
Injury, poisoning and procedural complications
Post-Procedural Haemorrhage
|
0.00%
0/426
|
0.23%
1/429
|
|
Injury, poisoning and procedural complications
Procedural Hypotension
|
0.00%
0/426
|
0.23%
1/429
|
|
General disorders
Pyrexia
|
0.00%
0/426
|
0.23%
1/429
|
|
Renal and urinary disorders
Renal Vessel Disorder
|
0.00%
0/426
|
0.23%
1/429
|
|
Gastrointestinal disorders
Upper Gastrointestinal Haemorrhage
|
0.00%
0/426
|
0.23%
1/429
|
|
Blood and lymphatic system disorders
White Blood Cell Count Increased
|
0.00%
0/426
|
0.23%
1/429
|
Other adverse events
| Measure |
Telavancin
n=426 participants at risk
Patients with complicated Gram-positive skin and skin structure infections (primarily due to MRSA) were randomized to receive telavancin 10 mg/kg IV once daily. The maximum allowable treatment period was 14 days.
|
Vancomycin
n=429 participants at risk
Patients with complicated Gram-positive skin and skin structure infections (primarily due to MRSA) were randomized to receive vancomycin 1 Gram every 12 hours. The maximum allowable treatment period was 14 days.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
2.8%
12/426
|
1.9%
8/429
|
|
Cardiac disorders
Angina Pectoris
|
1.2%
5/426
|
0.23%
1/429
|
|
Cardiac disorders
Bradycardia
|
0.47%
2/426
|
1.2%
5/429
|
|
Cardiac disorders
Cardiac failure congestive
|
1.2%
5/426
|
0.47%
2/429
|
|
Cardiac disorders
Palpitations
|
1.4%
6/426
|
0.70%
3/429
|
|
Eye disorders
Vision blurred
|
1.2%
5/426
|
0.70%
3/429
|
|
Gastrointestinal disorders
Abdominal Distension
|
1.2%
5/426
|
0.93%
4/429
|
|
Gastrointestinal disorders
Abdominal pain
|
2.6%
11/426
|
4.0%
17/429
|
|
Gastrointestinal disorders
Abdominal pain upper
|
1.2%
5/426
|
1.9%
8/429
|
|
Gastrointestinal disorders
Constipation
|
14.3%
61/426
|
8.6%
37/429
|
|
Gastrointestinal disorders
Diarrhoea
|
7.3%
31/426
|
9.6%
41/429
|
|
Gastrointestinal disorders
Dry Mouth
|
2.6%
11/426
|
3.5%
15/429
|
|
Gastrointestinal disorders
Dyspepsia
|
3.3%
14/426
|
3.7%
16/429
|
|
Gastrointestinal disorders
Loose stools
|
1.2%
5/426
|
1.6%
7/429
|
|
Gastrointestinal disorders
Nausea
|
30.0%
128/426
|
22.1%
95/429
|
|
Gastrointestinal disorders
Vomiting
|
18.3%
78/426
|
11.7%
50/429
|
|
General disorders
Asthenia
|
1.9%
8/426
|
2.1%
9/429
|
|
General disorders
Fatigue
|
4.5%
19/426
|
4.9%
21/429
|
|
General disorders
Infusion site erythema
|
1.6%
7/426
|
2.1%
9/429
|
|
General disorders
Infusion site pain
|
4.9%
21/426
|
4.9%
21/429
|
|
General disorders
Infusion site phlebitis
|
1.4%
6/426
|
1.6%
7/429
|
|
General disorders
Infusion site pruritis
|
1.2%
5/426
|
2.1%
9/429
|
|
General disorders
Infusion site reaction
|
1.6%
7/426
|
1.6%
7/429
|
|
General disorders
Lethargy
|
1.4%
6/426
|
0.23%
1/429
|
|
General disorders
Non-Cardiac Chest Pain
|
2.8%
12/426
|
1.6%
7/429
|
|
General disorders
Oedema Peripheral
|
1.9%
8/426
|
2.6%
11/429
|
|
General disorders
Pain
|
0.94%
4/426
|
1.6%
7/429
|
|
General disorders
Pyrexia
|
2.1%
9/426
|
2.3%
10/429
|
|
General disorders
Rigors
|
5.2%
22/426
|
3.3%
14/429
|
|
Infections and infestations
Fungal Infection
|
1.2%
5/426
|
0.47%
2/429
|
|
Infections and infestations
Osteomyelitis
|
1.2%
5/426
|
0.93%
4/429
|
|
Infections and infestations
Pneumonia
|
1.2%
5/426
|
0.23%
1/429
|
|
Infections and infestations
Urinary Tract Infection
|
1.4%
6/426
|
0.93%
4/429
|
|
Infections and infestations
Vaginal candidiasis
|
1.2%
5/426
|
0.00%
0/429
|
|
Infections and infestations
Vaginal mycosis
|
1.2%
5/426
|
1.4%
6/429
|
|
Metabolism and nutrition disorders
Anorexia
|
2.3%
10/426
|
2.3%
10/429
|
|
Metabolism and nutrition disorders
Decreased appetite
|
3.1%
13/426
|
4.0%
17/429
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
2.6%
11/426
|
1.9%
8/429
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.23%
1/426
|
1.6%
7/429
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.23%
1/426
|
1.4%
6/429
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
2.8%
12/426
|
1.9%
8/429
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
3.3%
14/426
|
1.9%
8/429
|
|
Musculoskeletal and connective tissue disorders
Muscle Cramp
|
1.2%
5/426
|
1.4%
6/429
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
1.9%
8/426
|
1.6%
7/429
|
|
Nervous system disorders
Dizziness
|
6.3%
27/426
|
8.2%
35/429
|
|
Nervous system disorders
Dysgeusia
|
36.6%
156/426
|
7.2%
31/429
|
|
Nervous system disorders
Headache
|
19.2%
82/426
|
16.1%
69/429
|
|
Nervous system disorders
Hypoaesthesia
|
0.70%
3/426
|
1.2%
5/429
|
|
Nervous system disorders
Paresthesia
|
0.70%
3/426
|
1.2%
5/429
|
|
Psychiatric disorders
Agitation
|
0.94%
4/426
|
1.4%
6/429
|
|
Psychiatric disorders
Anxiety
|
4.2%
18/426
|
3.3%
14/429
|
|
Psychiatric disorders
Confusional State
|
1.6%
7/426
|
0.93%
4/429
|
|
Psychiatric disorders
Insomnia
|
16.7%
71/426
|
12.4%
53/429
|
|
Psychiatric disorders
Restlessness
|
0.94%
4/426
|
1.4%
6/429
|
|
Renal and urinary disorders
Dysuria
|
1.6%
7/426
|
1.2%
5/429
|
|
Renal and urinary disorders
Haematuria
|
1.4%
6/426
|
0.00%
0/429
|
|
Renal and urinary disorders
Renal Insufficiency
|
1.2%
5/426
|
0.23%
1/429
|
|
Renal and urinary disorders
Urinary Incontinence
|
1.4%
6/426
|
0.70%
3/429
|
|
Renal and urinary disorders
Urinary Abnormality
|
16.2%
69/426
|
1.9%
8/429
|
|
Reproductive system and breast disorders
Genital Pruritis Female
|
1.9%
8/426
|
1.4%
6/429
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.8%
12/426
|
3.0%
13/429
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
2.3%
10/426
|
1.6%
7/429
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal Pain
|
3.5%
15/426
|
3.0%
13/429
|
|
Respiratory, thoracic and mediastinal disorders
Productive Cough
|
0.23%
1/426
|
1.2%
5/429
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
1.4%
6/426
|
2.6%
11/429
|
|
Skin and subcutaneous tissue disorders
Erythema
|
1.4%
6/426
|
3.0%
13/429
|
|
Skin and subcutaneous tissue disorders
Exanthem
|
1.6%
7/426
|
0.93%
4/429
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
2.3%
10/426
|
2.1%
9/429
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
5.9%
25/426
|
13.5%
58/429
|
|
Skin and subcutaneous tissue disorders
Pruritis generalized
|
4.5%
19/426
|
9.3%
40/429
|
|
Skin and subcutaneous tissue disorders
Rash
|
4.0%
17/426
|
5.4%
23/429
|
|
Skin and subcutaneous tissue disorders
Rash generalized
|
0.23%
1/426
|
2.1%
9/429
|
|
Vascular disorders
Hot Flush
|
0.47%
2/426
|
1.6%
7/429
|
|
Vascular disorders
Hypertension
|
1.4%
6/426
|
1.6%
7/429
|
|
Vascular disorders
Hypotension
|
2.8%
12/426
|
1.6%
7/429
|
Additional Information
Steven Barriere, Pharm.D., Vice President, Clinical and Medical Affairs
Theravance, Inc.
Phone: 650-808-6132
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60